SmartTRAK highlights three neurointerventional trends to watch in 2026.

SmartTRAK highlights recent news, research and trends in the market for neurointerventional devices and what’s impacting the US Market for Mechanical Thrombectomy, which is projected to reach a 5-year CAGR of +8.0% according to SmartTRAK. In this comprehensive, downloadable article, three neurointerventional trends to watch in 2026 are discussed in detail. They are:

1. Shift to Precision Thrombectomy - In 2026, SmartTRAK anticipates slower growth to continue in the treatment of patients with distal and medium vessel occlusions (DMVO) following the publication of several randomized controlled trials in 2025 (DISTAL, ESCAPE-MeVO, DISCOUNT) that found ... (read more)

2. Greater Focus on Expanded Indications - Companies competing in the market for neurointervention have been working closely with physicians, conducting research and leveraging neurovascular devices for use in adjacent markets and other indications, including ... (read more) 

3. Momentum Builds in the Intrasaccular Flow Disruptor Segment - In 2025, Terumo marked the 15-year anniversary of its WEB Aneurysm Embolization System, maintaining its single-player US market dominance in the intrasaccular flow disruptor market. That same year, the neurovascular space saw a surge of clinical activity in the segment, with multiple devices entering or advancing through clinical trials, showcasing ... (read more) 

Click the button below to download the complete "Neurovascular Intervention: Trends to Watch in 2026" Market Outlook article by Anne Staylor, SmartTRAK Executive Editor, VP & GM of Neuro Therapies and Tracy Martellotta, Senior Analyst.

SmartTRAK interviews two leaders from the Alliance of Wound Care Stakeholders to discuss its aim to be the unified voice for the wound care community, ensuring quality care for all patients with chronic wounds.

SmartTRAK discusses the ambulatory surgery center (ASC) migration – a multi-billion-dollar redistribution of capital, the mandatory Ambulatory Services Model (ASM) and the companies best positioned to benefit in 2026 and beyond. 

The US Spine Market is navigating a structural shift in the site of service, a regulatory-driven financial squeeze and the arrival of the mandatory Ambulatory Service Model (ASM) in spine care. This value-based model holds specialists financially accountable for the "total cost of care" for Medicare patients with low back pain (LBP). Shifting hospital-based procedures to the ambulatory surgery center (ASC) is one of the most significant opportunities for healthcare savings, and it is especially important in 2026 for procedures such as lumbar fusion and total disc replacements (TDRs). 

This downloadable article highlights the key catalysts SmartTRAK expects to shape the US Spine landscape in 2026 and beyond, including:

•  Landmark Changes in CMS Reimbursement Accelerating Lumbar Procedures to the ASC - The Centers for Medicare and Medicaid Services (CMS) finalized the removal of 285 musculoskeletal codes from the Inpatient-Only (IPO) list as part of a three-year phase-out ending in 2028, intended to ... (read more)

• Companies Innovating To Capture ASC Share -  Pure-play spine companies, like ATEC Spine (ATEC), and incumbents are tailoring ASC solutions—offering simplified, modular instrument sets and flexible financing for ... (read more)

SmartTRAK Launches New Software and Service Solutions, Creating a Unified "Smart" Insights Platform for Faster, Smarter Decisions

As the orthopedic industry prepares for the 2026 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS), SmartTRAK today announced a major expansion of its "Smart" portfolio of orthopedic market intelligence and advisory solutions. These enhancements are designed to help MedTech leaders move beyond fragmented data and make faster, more confident strategic decisions.

As orthopedic markets grow increasingly complex, success requires more than information. It demands expert interpretation, integrated intelligence and decisive strategy. SmartTRAK continues to combine proprietary data, advanced analytics and deep analyst expertise to power confident growth across MedTech.

• Bacteria are becoming resistant to silver, making it less effective.
• Several existing antimicrobial technologies may induce cytotoxic effects.
• Silver dressings are commoditized, and the market is hungry for novel and innovative alternatives.
• Stricter medical rules (antimicrobial stewardship) now require clinicians to be more careful about how they use germ-killing treatments, as there has been a widespread habit of using these dressings on wounds that do not actually need them.

In the complete downloadable article, SmartTRAK highlights in detail four companies to watch in 2026 with advanced dressings that offer new approaches to attacking bioburden and infection while limiting antimicrobial resistance. They are:

• Convatec: Seeing Great Potential with ConvaNiox 
   Convatecis the global leader in the antimicrobial dressings market with its Aquacel Ag range. It is evident that they are convinced that ConvaNiox will be their next big brand in wound care ... (read more)

•  Polaroid Therapeutics
   Polaroid Therapeutics (PTx) is a Swiss-based biotech start-up developing innovative products and solutions using its proprietary novel antimicrobial technology  ... (read more)

The American College of Foot & Ankle Surgeons (ACFAS) is once again bringing together the leading clinicians, researchers and manufacturers to the Venetian Resort in Las Vegas for the ACFAS 2026 Annual Meeting, to be held February 23-27.

SmartTRAK will be represented at ACFAS 2026 by Natasha Weeks, SmartTRAK GM & Senior Analyst, Trauma & Extremities, Dave Shepherd, GM & Senior Analyst Orthobio & Regen Med and Thom Clark, Sr Director, Enterprise Strategy & Solutions. If you would like to meet with us, please reach out to natasha.weeks@smarttrak.com, david.shepherd@smarttrak.com, or just click the link below.

To get you up to speed before the meeting, SmartTRAK has put together highlights of recent foot & ankle news. The following is just a small sampling of recent foot & ankle-related news and updates from around the world compiled, reviewed and posted in real-time every day by the expert analysts at SmartTRAK.

Market

• SmartTRAK estimates full-year US Foot & Ankle revenues for 2025 will grow in the high single-digit range YoY, in line with SmartTRAK’s US Foot & Ankle Market Overview projection of +8.8% YoY growth. SmartTRAK Financial Dashboard.
• Based on Foot & Ankle Fixation revenue YTD 2025, the US Foot & Ankle Fixation segment is driving growth in the overall US Foot & Ankle Market, growing +9.1%, in line w/ SmartTRAK’s original Foot & Ankle Fixation Market projection of +8.8% YoY growth. SmartTRAK Financial Dashboard
• The Total Ankle Replacement Market is also propelling the US Foot & Ankle Market, up +8.8% YTD in line w/ SmartTRAK’s original Total Ankle Replacement Market projection of +9.0 YoY growth. SmartTRAK Financial Dashboard

We are pleased to announce that Kent Pendleton has joined the SmartTRAK team as Senior Director of Spine, Neuro and Osteobiologic Solutions. Kent joins us after successful positions in Medtech, Life Science and SaaS Managed Services with an emphasis on Data Analytics.

Kent started his career in med device selling blood chemistry analyzers for Becton Dickinson and Dade-Behring before being hired by Synthes USA (now DePuy-Synthes), where he spent the next 20 years supporting trauma and joint replacement systems in the operating room. Following a desire to learn how Software - and Insights-as-a-Service can fuel the success of a business, Kent moved to ADP, a company with a data set so large that the US government relies on it for the national jobs report. Kent and his family reside in the northwest suburbs of Chicago.

Meet Kent Pendleton:

What is your role with SmartTRAK? As Senior Director of Spine, Neuro and Osteobiologic Solutions, my role is to guide clients to better understand and anticipate their markets, with a high degree of specificity, in order to sharpen their commercial strategy and gain a competitive advantage.

What do you like about SmartTRAK? SmartTRAK is a lean team of tenured industry experts with the firepower to make our clients better at what they do. That might sound broad and even bold, but when I consider how many areas across the breadth of a business that we can empower – from R&D to legal, clinical & regulatory, marketing & sales, finance, even equity investors – it’s clear we can bring a significant impact.

What is something special or unique that you bring to SmartTRAK subscribers? My career has required me to bring value in the OR and in the boardroom, which are two very different skill sets.

Consultative selling in orthopedics taught me that the right device in a well-trained surgeon’s hands can make a major difference in a patient’s outcome. There is tremendous specificity and nuance in that equation, and it fueled my passion for this unique industry.

More recently my focus has been

SmartTRAK reviews how the changes to skin substitute reimbursement reforms may impact each site of service and what it means for patients, providers and manufacturers.

 In response to the meteoric rise in spending, the Centers for Medicare and Medicaid Services (CMS) enacted payment reforms, establishing a standardized reimbursement rate of ~$127/sq cm for skin substitutes across physician offices, mobile and hospital outpatient departments (HOPD). SmartTRAK believes that these reimbursement reforms could trigger an access-to-care crisis for some patients in the wound care sector. This could result in care being shifted to the high-cost, inpatient operating room (OR) for the most critical patients or lead to an increased number of amputations. The system may realize short-term savings on grafts, but the systemic result could be a spike in the total cost of care for some patients and, for others, no advanced care at all.

Since 2021, the US Advanced Wound Care Market has undergone a transformation defined by a "site-of-service" migration away from the hospital outpatient department (HOPD). As CMS implemented restrictive bundled-payment models in HOPDs in 2014 that capped reimbursement in “high” and “low” buckets, care began to shift toward... (read more)

• The Physician Office (PFS) - In the physician office (PO), the $127/sq cm rate could result in a "reverse triage" effect, where minor or complex wounds become ...(read more)

Throughout 2025, SmartTRAK empowered MedTech professionals to Be The Expert by providing timely, data-driven insights across key markets. From orthopedics and wound care to regenerative medicine and neurotherapy, our analysts delivered meaningful real-time analysis you could act on. Scroll down to see a dozen of SmartTRAK’s most impactful blog posts of 2025.

These blog posts are just a glimpse of the data we cover every day. Want to see the real-time analytics and deep-dive reports behind these headlines? Schedule a demo today to see how SmartTRAK can help you master your market in 2026.

1. The Future of “Skin Substitutes” - What’s the Alternative?
   SmartTRAK reviews possible alternatives to LCDs and CMS’ proposed payment model for Cellular, Acellular, and Matrix-like Products (CAMPs) commonly referred to by the Center for Medicare & Medicaid Services (CMS) as “skin substitutes” and the potential impact on the market.
   
   
2. Terumo Neuro: Aiming for #1 in Neurovascular 
   Carsten Schroeder, president and CEO of Terumo Neuro, discusses the company’s plans to capture share and become the market leader in neurovascular.
   
   
3. What's Next in Orthopedic Trauma? 
   SmartTRAK reviews the evolving trauma startup landscape in 2025, spotlighting five innovators, followed by a comparative chart mapping 19 emerging companies.
   
   
4. Impact of Final Physician Fee Schedule on US Skin Substitutes in 2026
   Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the impact of the final physician fee schedule on US Skin Substitutes in 2026.
   
   
   
   

Theradaptive’s Chief Scientific Officer Frank Vizesi provides an overview of the company’s unique protein and how it hopes to disrupt the bone replacement market in an interview with SmartTRAK at the 2025 NASS Biologic Interventions Meeting.

Frank Vizesi, chief scientific officer of Theradaptive, discusses how the company is focused on creating a new recombinant BMP-2 to solve existing problems within the Bone Replacement Market in an interview with SmartTRAK on May 9, 2025, at the 2025 North American Spine Society (NASS) Biologics Interventions meeting in Chicago, Illinois. The company is developing a new version of recombinant BMP-2 called AMP-2, an adhesive variant of BMP-2 that retains the whole protein structure of BMP-2 and all its potency to bind to implant surfaces tightly.

Click on the following video (10:47 min) to learn more. A link to download a complete transcript of the interview is also provided below.

SmartTRAK: Hi, this is Erin Dorgan, senior analyst here at SmartTRAK. I'm here today with Frank Vizesi, chief scientific officer at Theradaptive. Thank you so much. I appreciate your time. Do you mind sharing a little more about your background and role at Theradaptive?

Frank Vizesi: Sure. Thanks for having me today. So my background, originally PhD, biomedical engineer from Sydney, Australia. Was very lucky to do my studies with the great professor, Bill Walsh, a good friend, and we still talk almost daily at this point.

My background now, I've been in the spine industry based out of San Diego, California for almost 20 years. Started off with NuVasive in the biologics R&D team there. I then left to join a spin out called SeaSpine. Ultimately I was the chief scientific officer of SeaSpine. Then we were acquired and merged with Orthofix and I became the chief scientific officer of the combined company then.

About a year ago, just a little over a year ago, I left to join a new startup called Theradaptive, the company who I've been tracking for probably about five or six years. Being in the biologic space I'm always interested to find out where the next most advanced bone graft is going to come from. I've been tracking quite a few different companies and I just sort of fell in love with the technology of Theradaptive, it's very advanced, and the team there. And decided that the best way to help bring your really advanced bone biologic product to market that can really help patients and solve problems would be to come and join the company.

It was the first time for me to join a startup, my previous background all being in publicly traded companies, but I've been having a blast.

Can you share a little bit more about the technology at Theradaptive and what they're doing?

FV: Yeah, sure. So let me start first with maybe the opportunity or the problem. So right now in the biologic space, surgeons really have a choice between ...

Want to learn more about Theradaptive and how it hopes to disrupt the bone replacement market? Click the button below to download and read the complete transcript of our exclusive interview with Frank Vizesi, CSO of Theradaptive, conducted by Erin Dorgan, SmartTRAK Sr Analyst, Spine & Bone Replacement.

SmartTRAK spoke with the Westbrook Weaver, CEO of Tempo Therapeutics, to discuss the company’s new technology, how it works and the results of the clinical work they’ve completed so far.

In the wound care space, there has always been an unmet need for a product that can provide volumetric wound filling in addition to simply closing the wound. Tempo Therapeutics is looking to utilize microporous annealed particle technology, or MAP, to address this need. In an interview with SmartTRAK, Westbrook Weaver, PhD, President and CEO of Tempo Therapeutics introduces their technology for creating a three-dimensional scaffold.

To learn more about Tempo Therapeutics, click on the following video (16:41 min). A link to download a complete transcript of the interview is also provided below.

Interview Transcript:
 

The North American Neuromodulation Society (NANS) is once again bringing together the leading clinicians, researchers and manufacturers to Caesar’s Palace in Las Vegas for the NANS 2026 Annual Meeting, to be held January 22-25.

SmartTRAK will be represented at NANS 2026 by Anne Staylor, SmartTRAK’s Executive Editor and VP & GM, Neuro Therapies, and Thom Clark, Sr Director, Enterprise Strategy & Solutions. If you would like to meet with us, please reach out to anne.staylor@smarttrak.com, or just click the button below.

To get you up to speed before the meeting, SmartTRAK has put together highlights of recent neuromodulation news. The following is just a small sampling of recent neuromodulation-related news and updates from around the world compiled, reviewed and posted in real-time every day by the expert analysts at SmartTRAK.

Market

• SmartTRAK estimates full-year US DBS Market revenues for 2025 will be up approximately +11% YoY, which is in line w/ SmartTRAK’s US DBS Market Overview projection of +10.8% YoY growth. SmartTRAK Financial Dashboard
• Based on SCS revenue YTD 2025, the US SCS Market is growing +2.9% YoY, which is in line w/ SmartTRAK’s original SCS Market Overview projection of +3.0% YoY growth. SmartTRAK Financial Dashboard
• Payer scrutiny and preauths will continue to place downward pressure on SCS, particularly because of CMS’ WISeR model set to launch 1/1/26. WISeR is piloting the preauth of SCS perm implants (NCD 160.7) for standard Medicare pts in 6 states. SmartTRAK Q325 Neuromodulation Recap
• GMED sees an opportunity to grow the NVRO business through surgeon conversion and competitive rep recruitment and views SCS as a continuum of spine care rather than as a standalone therapy. SmartTRAK Q325 Neuromodulation Market Recap
• A large unmet need exists in epilepsy, as one-third of patients (36%) do not benefit from drugs. This results in a global DRE prevalence of approximately 10MM people, w/ 1MM in the US, 2MM in Europe and 7MM in the ROW. LIVN 2025 Investor Day Presentation 
• Bioventus believes the acquisition of Nalu by BSX validates the potential of the PNS mkt. In the US, the PNS mkt is ~$200MM and is estimated to grow above 20% annually, exceeding $500MM by 2029. Bioventus Q325 Earnings Presentation  

Clinical/Regulatory/New Products

• NPCE announced it filed a FDA PMA-S application to expand the RNS System’s labeled indication to include pts w/ medication-resistant idiopathic generalized epilepsy w/ generalized tonic-clonic seizures. The PMA-S was supported by preliminary results of the NAUTILUS trial.
• The FDA approved BSX’ PMA supplement for the WaveWriter SCS MRI Safety Guidelines to add the MDT Specify SureScan MRI Leads to the list of compatible w/ the BSX M8 Adaptor and to label WaveWriter Alpha SCS Mixed System using MDT’s Specify SureScan leads as MRI scan eligible.

Chance Leonard and R. Sean Churchill, MD, MBA, of Genesis Innovation Group and Capitan Orthopedics, discuss their SupraSpacer implant for treatment of massive irreparable rotator cuff tears in an interview with SmartTRAK. 

In an interview with SmartTRAK, Chance Leonard and R. Sean Churchill, MD, MBA, of Genesis Innovation Group and Capitan Orthopedics, discuss the innovative SupraSpacer implant for the treatment of massive irreparable rotator cuff tears and how it can provide a minimally invasive procedure that delivers stable, pain-free range of motion and helps preserve future surgical options.

To find out more about Capitan Orthopedics and the SupraSpacer implant, click on the following video (37:07 min). A link to download a complete transcript of the interview is provided below. 

Interview Transcript:

Hey everybody. It's Andy Knapik here from SmartTRAK. I am senior analyst for soft tissue fixation and arthroscopic technologies. And today I'm really excited to be joined by a couple of gentlemen who are designing what I think is a pretty unique and very much needed product right now in the rotator cuff space. So I'm joined by Chance Leonard, who's the CEO of Genesis Innovation Group. And then Doctor Sean Churchill, who is a board member of the Genesis Innovation Group. Gentlemen, thanks for joining me today. It's nice to meet you.

Chance Leonard: Very nice to meet you as well.

Dr. Sean Churchill: Thanks for taking the time with us today.

So let's just start with an introduction. So maybe, Chance, start and talk to us about what is Genesis Innovation and your background a little bit so people get to know you a little.

CL: You bet. Well, thank you, Andy, for the opportunity to connect. My name is Chance Leonard, and as you mentioned, I currently serve as Chief Executive Officer of Genesis Innovation Group. We are a medical device development company, solely focused on med tech and in orthopedics, particularly. And we basically provide ...

Click the button below to download and read the complete transcript of our interview with Chance Leonard and R. Sean Churchill, MD, as they discuss the innovative SupraSpacer implant for the treatment of massive irreparable rotator cuff tears, conducted by Andy Knapik, SmartTRAK Sr. Analyst, Soft Tissue & Arthroscopic Technologies.

The Musculoskeletal New Ventures Conference meeting offers a glimpse into emerging and promising technologies that are shaping the US Spinal Hardware Market.

The Musculoskeletal New Ventures Conference (MNVC) took place on November 4-5, 2025, in Memphis, TN. This annual conference highlights new and emerging technologies focused on the orthopedics space, and this year alone had over 45 companies present. In this article, SmartTRAK highlights four spine-focused companies with novel technologies that will impact the broader US Spinal Hardware Market, which is projected to grow at a 5-year CAGR of +4.0% by 2029E, according to SmartTRAK estimates.  

The companies covered in this article are:

• ZygoFix
  Since its presentation at MNVC last year, ZygoFix has begun surgeries in the US and currently has five surgeons incorporating the zLock into their practices. The company plans to expand access in ... (read more)
  
  
• Nanohive
  Nanohive is focused on providing patient-specific interbody implants built on its proprietary soft titanium lattice platform, which has a lower modulus of elasticity than other titanium metals and is closer to ... (read more)
• Lenoss Medical
  Lenoss Medical offers a novel biological allograft implant, Osteopearl, for the VCF market, which eliminates the need for ... (read more)
  
  
• Synergy Spine Solutions
  Synergy Spine Solutions is currently participating in FDA clinical trials to bring its Synergy disc to the US market. This unique disc preserves motion and actively corrects alignment in the cervical spine due to ... (read more)

According to SmartTRAK Product Explorer, there are over 219 companies and approximately 1,150 products competing for market share in the US Spinal Hardware Market today. The MNVC meeting provided a glimpse into new and promising technologies for the US Spinal Hardware Market.

To learn more about MNVC 2025 and the companies presenting, click the button below to download the complete article by Erin Dorgan, SmartTRAK Sr Analyst, Spine & Bone Replacement.

This SmartTRAK interview features a panel of experts discussing the clinical shift in hip preservation toward pre-sutured, "off-the-shelf" allograft solutions.

In this interview, SmartTRAK hosts a distinguished panel featuring Andrew Jimenez, MD (Yale School of Medicine), Winston Gwathmey, MD (University of Virginia), and Kevin Whitten (chief commercial officer, AlloSource) to discuss the clinical realities of modern hip preservation. The conversation highlights the shift from time-consuming autograft preparations to innovative "off-the-shelf" allograft solutions. Specifically, the panel explores the operational and clinical advantages of AceConnex, a pre-prepared fascia lata allograft designed to reduce intra-op time and standardize outcomes in labral reconstruction procedures. Click on the following video to learn more (17:44 min). A link to download a complete transcript of the interview is also provided below.

SmartTRAK: Hi, this is David Shepard with SmartTRAK. It's my pleasure to be joined by Dr. Andrew Jimenez, the assistant professor of orthopedics and rehabilitation at Yale School of Medicine, and Dr. Winston Gwathmey, professor of orthopedic surgery at UVA. We're also joined by Kevin Whitten, chief commercial officer at AlloSource, and tonight we're going to be talking about AceConnex.

Thank you very much for joining us, gentlemen. And feel free to jump in at any time, so whoever wants to start with these questions, and again, feel free to interject and jump in. But the first thing I wanted to do is try to get a sense of exactly what type of clinical procedure we're doing here, or what's the issue that occurs with these patients, where AceConnex comes in and is an excellent solution for these patients.

Dr. Winston Gwathmey: I can get started. Hip arthroscopy is a procedure that addresses injuries of the hip that are soft tissue injuries, labral injuries, femoroacetabular impingement. And we've seen a proliferation of this procedure in the past 20 years or so. And with that, we're learning a lot more and more about how the hip functions. And what we're seeing in 2025 is that sometimes the labrum, the soft tissue gasket ring that fits around the hip joint, is not in a situation that can be repaired or salvaged. And so luckily, we've learned a procedure called a labral reconstruction in which we replace part or all of the labrum with the cadaver graft. And what that does is it provides a lot of labral functions and anatomy in a situation where the labrum is deficient or not repairable.

Dr. Andrew Jimenez: And just to piggyback off that, there's been a real evolution in terms of labral treatment and management. Early days of hip arthroscopy, starting off with just labral debridement and labral excision. As our techniques and our implants became better, we moved onto doing labral repair. And what we invariably came up with was ...

Want to learn more about the shift from time-consuming autograft preparations to innovative "off-the-shelf" allograft solutions? Click the button below to download and read the complete transcript of our roundtable discussion, conducted by David Shepard, SmartTRAK GM/Sr Analyst, Orthobio & Regen.

The high costs and complexity involved in manual manufacturing hinder the commercial viability of regenerative cell therapies. Octane Biotherapeutics seeks to remove these barriers by integrating its automated "Cocoon" production system with the well-established Novocart 3D and Novocart Inject platforms. SmartTRAK interviews Dr. Robert Spiro, CEO of Octane Biotherapeutics, to explore the company's strategic acquisition of assets from Aesculap Biologics and TETEC AG, and their plan to make a significant entry into the US Cartilage Repair Market. 

Click on the following video to learn more (09:37 min). A link to download a complete transcript of the interview is also provided below.

SmartTRAK: Hi, this is David Shepard with SmartTRAK, and I'm here with Dr. Robert Spiro, the CEO of Octane Biotherapeutics. Thank you for taking the time, really appreciate it.

Robert Spiro: Good to see you, Dave. Thank you.

Yes, good to see you as well. Tell me a little bit about Octane and the acquisition of Novocart 3D and Novocart Inject by Octane.

RS: Sure. It's a journey. It really started about 2010, '11, when I first started with Aesculap Biologics in this space. And having been in the cartilage regenerative space through several companies, really knowing that the scale-up of any type of manual culture, cell culture system was a big challenge from a commercial standpoint. We have always been looking for ways to automate this process. We started some on our own, but I encountered this technology with Octane, which was back in 2011—started that collaboration to transfer our manual autologous chondrocyte culture process to an automated system. They had already really started on this Cocoon technology, but we started to marry it to the Novocart program that long ago.

The relationship was there, all along, with the divestiture away from B. Braun Aesculap as they restructured all of their portfolio. It was really a natural progression for Octane to step in and acquire the company, not only Aesculap Biologics, but our sister company in Germany, TETEC AG, that developed the same technology. Octane Biotherapeutics is fully global, both German as well as US. And so, the Cocoon technology is an important step for us to commercialize both Novocart 3D and Novocart Inject for a number of reasons, and anyone in the cell culture space understands that scale up, scale out of those kind of manual process is expensive. It's one of the things that drives the cost of these products so high. So, it's been a great collaboration, and the fact that they stepped in through the acquisition just made a lot of sense for everybody.

RS: The hallmark of this is why it's really ideal for autologous cells. It's this ...

Want to learn more about how integrating the automated "Cocoon" cell production system with Novocart 3D and Novocart Inject platforms will disrupt the complexity and costs of the US Cartilage Repair Market? Click the button below to download and read the complete transcript of our interview with Dr. Robert Spiro, CEO of Octane Biotherapeutics, conducted by David Shepard, SmartTRAK GM/Sr Analyst, Orthobio & Regen.

Dr. Silverman discusses key takeaways from the AOFAS meeting, along with insights into his practice's shift to ASC settings and the major hurdles of fair reimbursement and staff recruitment.

Lance Silverman, MD, an orthopedic surgeon and foot and ankle specialist at Resurgens Orthopaedics in Roswell, GA, discusses trends and technologies in the Foot & Ankle Market in an interview with SmartTRAK.

Dr. Silverman discusses key takeaways from the recent American Orthopedic Foot & Ankle Society (AOFAS) Annual Meeting 2025, including the critical focus on avoiding revisions in total ankle replacements. He also addresses the role of technology, such as artificial intelligence (AI) surgical planning tools and the instrumentation and jigs used in foot and ankle procedures. Dr. Silverman provides insights into the current landscape of his practice, including his most common procedures, his shift to ambulatory surgery center (ASC) settings, and the benefits and biggest challenges he faces—such as securing fair reimbursement and the struggle to recruit and retain talented team members amid rising living costs and salary expectations.

To listen to the interview, click on the following video (17:46 min). A link to download a complete transcript of the interview is also provided below.

Interview

SmartTRAK: Hi, this is Natasha Weeks General Manager of Trauma and Extremities for SmartTRAK, and I'm here with Dr. Lance Silverman. We're going to take a deep dive into the foot and ankle segment. Dr. Silverman, thanks for being here and talking with me. And it was great to meet you at AOFAS in Savannah last month.

Dr. Lance Silverman: Nice to meet you there too, Natasha. It's a pleasure reconnecting.

Great. So reflecting on AOFAS and the meeting, for you, what was the most impactful message, whether that was clinical discussions you had, any specific posters or symposium talks or even products that you saw displayed? What did you believe coming off of that conference would really be most influential in the surgical management of foot and ankle?

LS: Well, there were a lot of conversations that people had both in lectures and outside of lectures on total ankle replacement. And total ankle replacement has been a growing increasingly performed procedure. And we have now started to see...

Want to learn more about the trends and technologies in the Foot & Ankle Market? Click the button below to download and read the complete transcript of our interview with Lance Silverman, MD, conducted by Natasha Weeks, Managing Editor/Sr. Analyst Trauma & Extremities.

Conmed’s Lisa Donnelly, VP of Marketing for US Orthopedics, and Jeff Ott, Director of R&D, discuss their BioBrace technology in an interview with SmartTRAK at OSET 2025 in Las Vegas. 

Conmed’s Lisa Donnelly, VP of Marketing for US Orthopedics, and Jeff Ott, Director of R&D, sat down with SmartTRAK at the Orthopaedic Summit (OSET) 2025 Annual Meeting in Las Vegas (September 18–25, 2025) to discuss BioBrace and how its bioinductive technology sets it apart from the competition.

To find out more about Conmed and BioBrace, click on the following video (16:30 min). A link to download a complete transcript of the interview is also provided below. 

Hey everybody, it's Andy Knapik with SmartTRAK, here at Ortho Summit in Las Vegas, and I'm happy to be here at the ConMed booth, and joined by a good friend of mine, Lisa Donnelly, who's VP of Marketing for US Ortho for ConMed, and then also Jeff Ott, who is a director of R&D. Why don't you just start by talking to us about how you started with the company? I'm just going to let you go with the intro part.

Jeff Ott: Yes, happy to do that. I joined a small company called Biorez about six or seven years ago as a small startup. We were focused on trying to find ways to help with tendon and ligament healing, and we developed a product called the BioBrace, which now is a part of ConMed.

So, when was that acquired? That was about a year…

Lisa Donnelly: August of 2022.

Okay. So a few years now. Wow. It's flown.

JO: Yes, time has flown by. So the BioBrace, which we developed, we designed a product that is a bioinductive scaffold with strength. What we did is we created a product that can both reinforce a tendon or ligament repair, and it also can ...

Want to learn more about the BioBrace technology? Click the button below to download and read the complete transcript of our exclusive interview with Conmed’s Lisa Donnelly, VP of Marketing for US Orthopedics, and Jeff Ott, Director of R&D, conducted by  Andy Knapik, SmartTRAK Sr. Analyst, Soft Tissue & Arthroscopic Technologies.

Stephania Bell, a licensed physical therapist, ESPN senior writer, and renowned sports injury analyst, brings together her clinical expertise and media experience, exploring how sports injuries in professional athletes intersect with those seen in the general population.

In a recent interview with SmartTRAK, Stephania Bell, a licensed physical therapist, ESPN senior writer and renowned sports injury analyst, brings together her clinical expertise and media experience, exploring how sports injuries in professional athletes intersect with those seen in the general population.

Click on the following video to watch the interview (43:14 min). For more details, interview topics by timecode and a link to download a complete transcript of the interview are provided below.

Interview Topics By Timecode:

02:00 Stephania’s background.

11:15 Work with Arthrex on the education side.

18:50 Where do med device companies fit in with prevention?

21:51 Patient insistance on being treated like the pros.

29:24 Public perception of sports injuries.

The connection between sports injuries in professionals and those in the broader population offers valuable insight into treatment and recovery trends. Click the button below to download and read the complete transcript of our interview with Stephania Bell, ESPN senior writer and renowned sports injury analyst, conducted by  Andy Knapik, SmartTRAK Sr. Analyst, Soft Tissue & Arthroscopic Technologies.

Incoming ICRS President Dr. Christian Lattermann discusses the future of cartilage repair in an interview with SmartTRAK at the 2025 ICRS Global Congress in Boston. 

In this interview, SmartTRAK speaks with Christian Lattermann, MD, the incoming president of the International Cartilage Regeneration and Joint Preservation Society (ICRS), about the future of joint repair. He shares insights on emerging technologies, highlighting advances in mechanical correction, AI and biologics. Dr. Lattermann explains how AI helps clinicians understand causes of degeneration that were previously overlooked. He emphasizes the excitement surrounding orthobiologics, especially extracellular vesicles, as a novel approach to guiding biological responses. 

To find out more, click on the following video (22:22 min). Interview topics, organized by timecode, and a link to download a complete transcript of the interview are provided below.

Interview Outline by Timecode:

00:22 The three pillars of revolution: AI, biology, and mechanics.

06:36 Orthobiologics and extracellular vesicles: From "voodoo" to validated science.

10:25 Rethinking inflammation: fixing the "leak."

13:53 The collaborative alliance: industry, clinicians and researchers. 

16:46: Finding the niche: comparing the roles of MACI, Agili-C, and other technologies.

21:29: Conclusion: the future of individualized patient care.

Curious about the future of cartilage repair? Click the button below to download and read the complete transcript of our interview with the incoming ICRS president, Dr. Christian Lattermann, conducted by  Andy Knapik, SmartTRAK Sr. Analyst, Soft Tissue & Arthroscopic Technologies.

Raul Nogueira, MD, discusses the latest research and innovation in super-bore catheters for the treatment of AIS and the preliminary results from the MARRS pivotal trial in an interview with SmartTRAK.

In an interview with SmartTRAK, Raul Nogueira, MD, interventional and stroke neurologist at the University of Pittsburgh and chief of cerebrovascular medicine at the UPMC Stroke Institute, discusses the latest research and innovation in super-bore catheters for the treatment of acute ischemic stroke (AIS), including preliminary results from the MARRS pivotal trial that he recently presented at the Society of NeuroInterventional Surgery (SNIS) 2025 Annual Meeting in Nashville, TN.

Dr. Nogueira highlights key results from the MARRS pivotal trial, which is evaluating Perfuze Medical’s Millipede super-bore 088 catheter, how the results compare to other super-bore pivotal trials and what factors contributed to MARRS’ high first-pass effect rate. 

Listen to the interview below (43:20 min) to learn more, including how Millipede performed in different parts of the brain and the status of research and innovation that is helping to drive growth in the US Market for Mechanical Thrombectomy. A link to download a full transcript of the interview is also provided below.

Interview by Timecode

00:06 Introduction, background about stroke thrombectomy and the evolution of technology and research in mechanical thrombectomy devices.

10:27 Discussion about the MARRS pivotal trial vs other trials and what contributed to the the high, first-pass effect rate.

18:44 Different studies use different definitions of first-pass effect and good reperfusion. Where does the MARRS study definition fit and compare to how other studies define good reperfusion?

21:47 Discussion about safety data for super-bore catheters vs the Millipede catheter, device designs and comparison to other types of thrombectomy devices.

•  CURVAFIX
  Curvafix is redefining pelvic fracture fixation with a novel intramedullary (IM) implant system designed specifically for curved bone anatomy. The company’s flagship device, the CurvaFix IM Implant, is the first and only FDA-cleared implant that ... (read more)
  
  

• Endeavor Orthopedics
  Endeavor Orthopaedics is a trauma-focused medical device company pioneering implant systems for complex avulsion fractures. Its flagship product, the Summit Patella Plating System, addresses a critical need in the treatment of ... (read more)

• Meduloc
  Meduloc is an early-stage orthopedic startup advancing intramedullary fixation solutions for small, long-bone fractures. The company’s proprietary system combines ... (read more)

• OrthoXel
  OrthoXel is an orthopedic trauma company developing advanced intramedullary nailing systems designed to optimize healing biomechanics and surgical workflow. Based in Cork, Ireland, the company has commercialized two flagship platforms ... (read more)

• Reselute Medical
  Reselute Medical is a pre-commercial orthopedic startup developing a novel class of intramedullary implants capable of localized antibiotic delivery for the treatment of severe traumatic long bone fractures. The company’s lead product is ... (read more)

Curious about what's next in Orthopedic trauma and the companies that are rethinking the fundamentals of fracture care? Click the button to get the full article by Nick Fitzpatrick, SmartTRAK Associate Market Analyst – Orthopedics.

TOBI President Michael Khadavi, MD, shares his thoughts on the institute's future, key insights from this year’s conference, and exciting new techniques and technologies in the orthobiologics field.  

Dr. Michael Khadavi, a triple-boarded physician in physical medicine and rehab (PM&R), sports medicine, and ultrasound, and the current president of the Orthobiologic Institute (TOBI), discusses the organization's future plans, including expanding its educational programs, research initiatives and strengthening partnerships with industry in an interview with SmartTRAK. Dr. Khadavi also reviews the use of musculoskeletal ultrasound in orthobiologics and highlights the promising results of intraosseous subchondral injections for joint treatments, citing encouraging data from recent studies. Click on the following video (08:22 min) to learn more. A link to download a complete transcript of the interview is also provided below.

SmartTRAK: Hi, this is David Shepard with SmartTRAK. It's my pleasure to be joined by the president of TOBI. This is Dr. Michael Khadavi, triple-boarded physician in PM&R, sports and ultrasound. Thank you very much for joining us.

Michael Khadavi, MD: It is an honor.

Thanks a bunch. So, we're just wrapping up with TOBI, fantastic presentations throughout the week. It's been really, really great. What's your take-home message to all the people that couldn't make it? What are the things that you learned from these last two days? What's the summary of what you learned here?

MK: This was a strong conference, if I've ever been to a good conference. My biggest take-homes are ...

Click the button below to download the full transcript of our exclusive interview with TOBI President Michael Khadavi, MD, conducted by David Shepard, SmartTRAK GM/Sr Analyst, Orthobio & Regen.

It is with both gratitude and admiration that we announce the retirement of Susan Paquette, our former VP/GM of SmartTRAK Wound Care, after nearly 15 years of dedicated service to SmartTRAK. 

Since joining the company, Susan has been instrumental in building SmartTRAK Wound Care into the industry’s most trusted source of real-time market intelligence. Under her leadership, the Wound Care business has grown from a promising vision into a powerhouse platform providing comprehensive data, news, and analysis on a range of Advanced Wound Care markets. Today, SmartTRAK Wound Care delivers deep coverage across nine distinct areas with broad global reach, relied upon daily by the world’s top wound and orthopedic companies.

Dr. Steve Sampson, founder of The Orthopedic Institute (TOBI) and the Orthohealing Center, discusses the evolution of orthobiologics, highlighting the integration of machine-based therapies like shockwave and a focus on patient safety, with patients traveling overseas for untested biologic treatments. 

In this interview with SmartTRAK, TOBI founder Steve Sampson, DO, discusses the development of orthobiologics, highlighting a key inflection point where technologies like shockwave and light therapy are used to boost the body's natural healing process. Dr. Sampson also mentions patients traveling abroad for treatments. He warns about the lack of regulatory oversight, potential complications and offers solutions through the Orthohealing Alliance.

Click on the following video (11:10 min) to learn more. A link to download a complete transcript of the interview is provided below.

SmartTRAK: My name is David Shepard. I'm with SmartTRAK, and I'm here at the 16th annual TOBI meeting. and it's my pleasure to be joined by Dr. Steve Sampson. Thanks so much for taking the time. I really appreciate it.

Steve Sampson, DO: Thanks for having me. Looking forward to chatting.

Absolutely. So, the agenda of this year's conference is... It's got a wide range of topics. What do you think is reflected in this year's agenda that really typifies the technologies that are happening out there in the field today?

SS: It's probably the most exciting time in my 20-year career that I feel like we're at this inflection point with new technologies, including machine-based therapies. So, the concept is the human body is remarkable, and we're made of 37 trillion cells, and we have our own drug store, our own ability to self-repair. Our role as physicians is to try to facilitate that. So, machine-based treatments are a big point of this conference where there's a session on shockwave therapy, photo-biomodulation light therapy, hyperbaric oxygen. They're all different machine-based treatments that are trying to boost our body's healing capacity. Then I also have a new session of mesenchymal stem cells or MSCs overseas.

SS: A lot of times, in clinic, we find patients are going to Mexico, Panama, Thailand, and some of them have unlimited resources, but they may not be getting the best level of care and bigger isn't always better.

Right.

SS: So, understanding what are some of the regulatory challenges here in the United States, why are patients going overseas ,,,

Click the button to get the full transcript of our exclusive interview with TOBI founder Steve Sampson, DO, conducted by David Shepard, SmartTRAK GM/Sr Analyst, Orthobio & Regen.

Are you passionate about healthcare and market research? SmartTRAK is looking for talented, self-motivated individuals to join our team. We're currently seeking a Junior Analyst for our Wound Market team and a part-time Compression Market Analyst. These are fantastic opportunities for skilled professionals to contribute to a leading provider of market data and business intelligence in the MedTech industry.

Junior Analyst, Wound Market 

The ideal candidate for this full-time remote role has strong analytical and writing skills and a keen interest in the wound care sector. As a Junior Analyst, you will be a key part of the Wound Market team, helping to track and analyze the latest developments in wound care.

Your responsibilities will include:

• Collecting and analyzing market data, clinical trial information, and regulatory filings.
• Drafting market updates, news briefs and insights for our subscribers.
• Assisting senior analysts with research and strategic reports.
• Maintaining SmartTRAK's content and databases for the wound market.

Compression Market Analyst 

We are also looking for a dedicated professional to fill a part-time remote position as a Compression Market Analyst. This role is perfect for someone with strong knowledge of the global Compression Therapy space, including bandaging, hosiery, and Lymphedema pumps. You will be responsible for providing expert insights and analysis on this dynamic market.

Your responsibilities will include:

• Maintaining and updating the Compression module, including market models and company profiles.
• Writing concise articles and market updates for subscribers.
• Supporting our sales and marketing teams with your expertise.
• Attending industry conferences to report on new trends and topics.

Why Join the SmartTRAK team?

At SmartTRAK, we value a strong work ethic and a collaborative spirit. If you're a self-starter with a passion for MedTech, we encourage you to apply. Don't miss out on these opportunities to grow your career with a leading name in the industry.

• Work remotely with flexible hours.
• Gain visibility in the MedTech community through published insights and event coverage.
• Join a collaborative team of analysts, marketers and data experts. 

To learn more and apply, visit the original job postings:

• Junior Analyst, Wound Market
• Compression Market Analyst

In an interview with SmartTRAK, TendoNova's National Sales Director, Ben Browne, discusses the TendoNova device, a minimally invasive percutaneous tool for treating refractory tendinopathy.

In this SmartTRAK interview, National Director of Sales Ben Browne shares his insights on the TendoNova device, a minimally invasive tool for treating refractory tendinopathy through soft tissue fragmentation and debridement that can also be combined with orthobiologics like platelet-rich plasma (PRP). Click on the following video to learn more (08:37 min). A link to download a transcript of the complete interview is also provided below.

SmartTRAK reports from Boston, where discussions about the future of wound care were distracted by significant changes to reimbursement.

We are pleased to announce that Thom Clark has joined the SmartTRAK team as Senior Director, Enterprise Strategy + Solutions. Thom Clark joins us after successful positions in Medtech, Life Science and SaaS enterprise strategy, marketing and customer success.

Thom started his career in the diabetes care industry before being hired by Synthes USA. After a successful stint as both a trauma consultant, then regional manager, Thom moved into solutions and services (consulting) first within the Depuy-Synthes Advantage franchise, then Solutions Innovation,  and finally with JNJ's umbrella Medtech Strategic Customer Group (SCG). Working with the Top 150 health systems, Thom and his team of Directors delivered a broad suite of solutions including operative efficiency, clinical pathway improvement, clinician wellbeing, supply chain management, and patient navigation. After leaving JNJ in 2020, Thom moved to running US Orthopedic Marketing + Solutions at Pacira, then as chief strategy and customer officer for Elation, a human performance and coaching SaaS startup based in Wyoming. Thom and his family reside in the greater Philadelphia area.

Meet Thom Clark:

What is your role with SmartTRAK? As Senior Director, Enterprise Strategy + Solutions, my role as I initially see it is to help both product and commercial strategy in the core ortho solutions portfolio while contributing to SmartTRAK’s overall go-to-market success. As I become more familiar with the people, culture and solutions, I plan to be a catalyst working cross-functionally to help different teams across the organization, including marketing, messaging, contracting, content, research, and consulting – having some experience in each of these functions. Ultimately, it's all about our customers.

What do you like about SmartTRAK? I would have to say the amazing People and the concept of Insights-as-a-Service vs the normal SaaS offering. During the interview process, all my questions were focused on people, culture, innovation, and marketplace. I am also super stoked to begin working with many of my former colleagues in Medtech and Life Science.

What is something special or unique that you bring to SmartTRAK subscribers? I have a unique history, having moved from sales and sales management to health system consulting in the orthopedic market, focused on TJA and Trauma. Starting with clinical pathway improvement and moving to operational efficiency, supply chain improvement, clinician wellbeing and burnout, patient navigation, and digital surgery, our team under the umbrella of JNJ’s Strategic Customer Group had the privilege of working with the top 100 health systems across the US and even OUS. I also worked in Life Sciences at Pacira and then a human and team performance and coaching SaaS startup business called Elation. I believe I bring a very different view on how unique and powerful data and insights can be leveraged for success. It's also fun to understand both industries from a data and insights perspective.

How/why did you get into the life sciences industry? After college, I was blessed to get into the diabetes market and then hired by Synthes as a trauma rep, then regional manager, health system consulting director, and finally running a national consulting team. I learned very early in my career at Synthes the huge impact you can make on patient outcomes and health system efficiency. I was hooked! I have always been fascinated by how things work and being in orthopedics was a dream come true! Now I get to see the entire industry through a different lens.

What are your favorite online websites or resources that you check every day? Well, I know I need to say SmartTRAK first! As I move back into MedTech and Life Science, my focus will be on connecting (and reconnecting) with my network to conduct research on all the market and product channels we now cover. So many blogs, posts, websites, interviews and industry publications fill my day it would be impossible to list them all. 
 
How do you stay current on what’s going on in the industry? There is absolutely nothing that compares to talking to real humans working on real products, marketing plans, and strategy across the industry. As stated, I am really excited to begin my outreach to “interview” as many people as I can virtually or at shows as part of my enterprise role. Combining this with the amazing amount of experience across our team of analysts at SmartTRAK should be more than adequate.

If you could have one superpower, what would it be? I try to live in “reality” as much as possible, so this one is difficult. I would say the ability to sustain a positive and optimistic mindset, regardless of what life throws at me. I know people who possess this trait and am in awe of their ability to weather hardships and remain cheerful and supportive with a growth mindset.

What was the last show you binge-watched? Wow, probably The Office with my 20 year old during his summer break from the University of Scranton (of all places!).

What is your life like outside of SmartTRAK? Married for 25 years to my best friend, supporter, and confidant. We have two boys, Ben (22) and Harrison (20) and two crazy labradoodles, Bentley and Scarlett, who pretty much run the household. I am a human performance nerd who focuses a lot of time on movement, nutrition, healthspan, and ways to optimize physical and mental well-being. I also love to fly-fish, cycle, and work in the yard.  I am a certified financial and retirement coach and in the process of obtaining personal training and nutritional coach certifications to help others reach their goals and redefine what the term "wealthy" means.

What are you most excited about for your upcoming year at SmartTRAK? The ability to get back to my roots in MedTech and Life Science while quickly learning our product and process to make a noticeable impact on our client's market success in the shortest time possible. Always up for a challenge!

If you'd like to learn more about SmartTRAK and how it can increase proficiency, improve productivity and reduce costs for your company, or if you would like to meet with Thom, just click the button below.

SmartTRAK reviews possible alternatives to LCDs and CMS’ proposed payment model for Cellular, Acellular, and Matrix-like Products (CAMPs) commonly referred to by Center for Medicare & Medicaid Services (CMS) as “skin substitutes” and the potential impact on the market.

SmartTRAK attended the Wound Care Influencers Resolution Consultation (WCIRC) Meeting held August 1st , 2025 in Washington, DC, where clinical stakeholders, manufacturers, reimbursement experts, legal counsel and distributors discussed possible alternatives to local coverage determinations (LCDs) and the recently released payment models for the Physician Fee Schedule and Outpatient Prospective Payment System (OPPS).  In this article we will look at the potential market impact of some of the alternatives proposed at WCIRC.

Download the full articlefor an in-depth look at WCIRC’s proposed alternatives, their market impact, and other related topics, such as:

• A Summit Overview
  • Kerser Med Comms and the Serena Group brought together 49 thought leaders from clinical practice and industry to attend WCIRC, a one-day summit on evidence and reimbursement ... (read more)
• The Alternative Payment Rates for Skin Substitutes
  • CMS’ recently proposed rule sets the payment rate for skin substitutes for both the non-facility (i.e. office, home) and the hospital outpatient (HOPD) settings ... (read more)
• Future Rate Setting
  • One provision of Senator Cassidy’s bill on skin substitutes is to tag the reimbursed price of skin substitutes to the increase in the consumer price index (CPI) for all urban consumers instead of being based on the actual ASPs ... (read more)
• NCD vs LCD
  • During the summit, another discussion focused on whether or not to push for an NCD vs the future effective LCDs ... (read more)
• Our Conclusions
  • SmartTRAK believes that Medicare spending in this category has become untenable for CMS, making change inevitable ... (read more)

Click the button below to download and learn about possible alternatives to LCDs and CMS’ proposed payment model in the complete "The Future of Skin Substitutes - What’s the Alternative?" article by Jay Merkel, SmartTRAK Sr Analyst, Wound.

Patient demand, enabling technologies and the ASC shift create a perfect storm for the direct anterior approach (DAA).

The adoption of the direct anterior approach (DAA) for total hip arthroplasty (THA) has accelerated dramatically in the US, cementing its position as a leading technique. Data from the American Association of Hip and Knee Surgeons (AAHKS) reveals a surge in utilization among its members, from 40% in 2018 to 56% in 2022. Based on the trajectory of this growth, SmartTRAK estimates that by 2030, 77% of US orthopedic surgeons will be using the DAA technique for appropriate primary THAs. Pinpointing the number of hip replacements performed using the direct anterior approach is difficult, as no procedure codes specify the technique. However, based on surgeon utilization rates, considering not all patients are candidates for this technique, SmartTRAK estimates that 30% of all hip replacements are currently performed via DAA. This rapid market shift is more than a clinical preference; it reflects a convergence of powerful market forces, including intense patient demand for faster recovery, the economic imperatives of outpatient surgery and a burgeoning ecosystem of enabling technologies designed to shorten the procedure's formidable learning curve.

The topics covered in the complete downloadable article are:

• What’s Driving the Shift?
  • The DAA's growth trajectory is uniquely fueled by forces outside of traditional clinical evidence channels. A primary driver is ... (read more)
• Is the Clinical Evidence Settled? 
  
  • The clinical debate over DAA is maturing, moving from simple claims of superiority to a more nuanced understanding of its risk-benefit profile. The evidence to date clearly shows ... (read more)
• How is Technology Fueling the Growth?
  • The expansion of DAA is now inextricably linked to enabling technologies designed to improve reproducibility and mitigate its challenges. The competitive landscape has shifted, with companies focusing on ...(read more)
• Strategic Implications and Future Outlook
  • Despite its rapid and widespread adoption, key questions remain, particularly regarding ... (read more)

Curious about the reasons behind this rapid market shift to the direct anterior approach (DAA) for total hip arthroplasty?  Click below to read the comprehensive market outlook article "DAA's Ascent: Reshaping the US Hip Market" by Lisa Mahan, SmartTRAK's VP of Product Development & IT, Sr. Analyst Total Joints.

Cerapedics’ CEO Valeska Schroeder discusses the company’s newly PMA-approved PearlMatrix P-15 Peptide Enhanced Bone Graft and its unique advantages over existing bone graft options in an interview with SmartTRAK.

Valeska Schroeder, CEO of Cerapedics, discusses the launch of PearlMatrix, a next-generation bone growth accelerator approved for transforminal lateral interbody fusion (TLIF) procedures, and how its strong clinical data, especially its speed to fusion in high-risk patients, sets it apart in a crowded bone graft market. Click on the following video (16:18 min) to learn more. A link to download a complete transcript of the interview is also provided below.

SmartTRAK: This is Erin Dorgan, senior analyst at SmartTRAK. I'm here today with Valeska Schroeder, CEO of Cerapedics. Valeska, thanks for joining me today.

Valeska Schroeder: Hi. Thanks so much for having me today. I'm excited to be here and to be able to talk more about Cerapedics.

Awesome. Before we kind of get started, can you share a little bit about your background and how you came into your current role today as CEO and chairman of the board?

VS: Sure, I'd be happy to. I started my career as an engineer, so my background is in material science and I have been in the medtech industry for most of my career, starting out more on the R&D side. I was part of a venture group for the six years prior to joining Cerapedics, and that's where I first got to know Cerapedics; that group, KCK, invested in Cerapedics back in 2018. And I joined the board at that point and got more involved with the company in 2021 and joined as CEO in 2022. So I've been super excited about the Cerapedics story for many years and happy to be CEO and be able to share more about the company today.

Thank you. Speaking of that, can you share a little bit more about Cerapedics? Currently, our subscribers come from spine-focused companies, orthopedic companies, so some may not know the name Cerapedics as well as I do, someone who's intimately involved in the bone replacement market. Can you share a little bit more about the history of Cerapedics?

VS: Yes, I'd be happy to. So Cerapedics is a global commercial-stage orthopedic company, and we have drug-device products that are focused on improving bone repair. We're headquartered in Colorado and have been a company for over a decade at this point. Drug device products take a fair amount of time to get onto the market in the US, and our products are used in spinal fusion procedures in the US and broader indications for bone repair in other geographies.

We have a first product, i-FACTOR, that has been available commercially for many years, and that has been used in over 200,000 patients since launch. And in the US, it's indicated for cervical spinal fusion. And just this last month we launched PearlMatrix, which is a bone growth accelerator that is indicated for  ...

 Curious about PearlMatrix, the next-generation bone growth accelerator recently launched in the US? To learn more, click the button below to download the complete transcript of our interview with Cerapedics CEO Valeska Schroeder, conducted by Erin Dorgan, SmartTRAK Sr Analyst, Spine & Bone Replacement.

James Voos, MD, chair of the Department of Orthopedics and Sports Medicine at University Hospitals Cleveland Medical Center, Cleveland Browns team physician, and president of the NFL Physicians Society (NFLPS), shares his goals for the society and offers insight into how he is using biotechnology to monitor recovery, prevent further injuries, and safely return athletes to competition.

James Voos, MD, president of the NFL Physicians Society (NFLPS), discusses the society's efforts to standardize care for NFL players across the league in an interview with SmartTRAK at the American Orthopaedic Society for Sports Medicine (AOSSM) 2025 Annual Meeting recently held in Nashville, TN.

Dr. Voos also shares an update on ongoing clinical research for osteoarthritis treatment with stem cells. To listen to the interview, please click on the following video (4:18 minutes). A link to download a complete transcript of the interview is alsoprovided below. 

SmartTRAK: Hi, this is Dave Shepard. I'm here at the AOSSM 2025. Keep watching for my interview with Dr. James Voos, who is the team physician for the Cleveland Browns, and also the president of the NFL Physicians’ Society. Dr. Voos, thanks for joining us.

James Voos, MD: Thank you very much for the invitation. I appreciate it.

Excellent. Tell me a little bit about the NFL PS and a little bit about what you're doing, what your initiatives are, what your goals are.

JV: As president of the NFL Physician Society, we represent all of the physicians that provide care for our professional athletes in football. That's not only our orthopedic surgeons, but our medical physicians and all of our associated consultants. So we help to provide standards for how to practice across the league, and that way we assure that every athlete and every team has ...

Interested in how biotechnology can be used to monitor recovery, prevent further injuries and safely return athletes to competition? Click
the button below to download the full transcript of SmartTRAK GM/Sr Analyst David Shepard's interview of James Voos, MD, president of the NFL Physicians Society (NFLPS) from AOSSM 2025.

Stewart Strong, Q’Apel Medical’s recently appointed CEO, discusses the company, his priorities and plans for growth in an interview with SmartTRAK at SNIS 2025 in Nashville, TN.

Stewart Strong, Q’Apel Medical’s recently appointed CEO, discusses the company, his priorities and plans for growth in an interview with SmartTRAK at the Society of Neurointerventional Surgery (SNIS) Annual Meeting held in Nashville, TN July 14-18, 2025. 

Strong says with recent challenges behind them, it’s the perfect time for him to join Q’Apel Medical. Given Q’Apel’s leadership position in balloon guide catheters, the full market launch of Zebra and the company’s pipeline leveraging its innovative laser-cut technology, he sees significant opportunity in the years ahead. To find out more, listen to the following video (21:12 min). A transcript of the interview is also provided below. 

SmartTRAK: Hi, everyone. Anne Staylor here with SmartTRAK. Today, I'm at the Society of Neurointerventional Surgery meeting in Nashville, and I have the pleasure of talking with Stewart Strong, the new president and CEO of Q'Apel Medical. Stewart, thanks for talking with me today.

Stewart Strong: Thanks, Anne. Great to be here.

So you are really new to the company. They just announced July 1st that you were in this new role. So I think a lot of people, myself included, want to hear a little bit about you. So do you want to start by just talking about yourself?

SS: Sure. And you're right, four weeks into the role, but I've been really excited about not only the opportunity here at Q'Apel, but also with the space that we're in and the growth of the neurovascular space. So to give you a little bit of background on me, I've been in the medical device industry for over 25 years. I've spent time in spaces like interventional cardiology, electrophysiology, and have really focused on areas where we can drive growth. That's one of the things I really enjoy is joining a company where we can drive exponential above-market growth and continue to add value to customers and to stakeholders through that growth.

I knew you're really experienced from what I had heard. So as you enter this new company, what are your priorities?

SS: I think what I saw in doing my own due diligence on Q'Apel is a company that has terrific innovation. When you think about innovation, you think about quality, you think about Q'Apel, and that's been validated here. I have had a chance to speak with a number of physicians that use our products. Everybody really looks at us as ...

Curious about where Q’Apel Medical is headed next? We sat down with CEO Stewart Strong for an exclusive interview conducted by Anne Staylor, SmartTRAK’s Executive Editor and VP & GM of Neuro Therapies. Click below to download the full transcript and get an inside look at Q’Apel’s future plans, innovations and strategic goals.

In this comprehensive article, SmartTRAK provides an overview of the WISeR Model and its potential market impact on skin substitutes.

Click the button below to download and read the complete article "Skin Substitutes Get WISeR – Will it Impact the Market?" by Jay Merkel, SmartTRAK Sr Analyst, Wound.

SmartTRAK is excited to attend the Society of Neurointerventional Surgery’s (SNIS) 22nd Annual Meeting & Fellows Course in Nashville, Tennessee, from July 14-18, 2025. Anne Staylor, VP/GM of Neuro Therapies, will cover the latest news at the conference and provide updates on key studies, trends, and technologies affecting the market for ischemic and hemorrhagic stroke devices. 

Meanwhile, click the image below to watch Anne’s video update on the US Market for Mechanical Thrombectomy in 2025.

Spinal Simplicity’s Chief Strategy Officer Neil P. Dougherty shares how the company is advancing minimally invasive solutions to enhance patient outcomes.

Neil P. Dougherty, chief strategy officer of Spinal Simplicity, discusses the company’s position in the interventional spine and pain market, what the company looks forward to in the future and how it serves patients treated by spine surgeons and interventional pain management physicians.

Click on the following video (17:18 min) to learn more. A link to download a complete transcript of the interview is also provided below.

SmartTRAK: Hi, this is Erin Dorgan with SmartTRAK. I'm here today with Neil Dougherty, chief strategy officer with Spinal Simplicity. Thanks for joining me today, Neil.

Neil P Dougherty: Glad to be here. Thanks, Erin.

You're welcome. Can you share a little bit more about what you do at Spinal Simplicity? I know, based upon your background, you've been in the interventional space for a while. How did you end up here at Spinal Simplicity?

NPD: Well, in a startup you wear a lot of hats. So I came to Spinal Simplicity first as a vice president of sales and then moved over to focus on just business development and more of an offensive role for our expansion. And as the company grew, an opportunity for promotion was there to get to my now title, chief strategy officer.

I have been in the interventional pain space for a long time. Gosh, it's about 15 years now. Started with Medtronic, doing spinal cord stimulators and intrathecal pumps--just over five years there. Then went over to Vertiflex in that startup campaign bought by Boston Scientific and only a year of integration there after that purchase.

And then how could you forget? When the whole world basically shut down during COVID, I was kind of losing my mind a little bit. I had a couple phone calls from some doctors and also Todd Moseley, the CEO of Spinal Simplicity, and founder. And I started learning more about Spinal Simplicity. I saw their main product, Minuteman. I was like, ‘This is where I need to be.’

Okay. So speaking of Minuteman, and obviously with your background, Boston Scientific recently discontinued Vertiflex Superion. Do you think that is an opportunity for Spinal Simplicity and Minuteman to explore those customers? Or how would you describe that?

NPD: I think so. I'd like to describe it as just an acceleration to where most of those customers were probably going to graduate anyway. Superion was a great idea. I mean, it wasn't even a Vertiflex idea. This is, indirect decompression has been a great studied spine idea for a long time and it certainly wasn't the first ISP out there, but the aim is ...

Click the button below to download and read the complete transcript of SmartTRAK's interview with Neil P. Dougherty, CSO of Spinal Simplicity conducted by Erin Dorgan, SmartTRAK Sr Analyst, Spine & Bone Replacement.

SmartTRAK provides insights into the latest trends, research and consensus opinions in surgical Orthobiologic treatments and non-operative regenerative medicine from this year’s BA Summit and AANA meetings.

Nearly half a billion in US dollars has been invested in Advanced Wound Care over the last 18 months. Learn where the money is going.

Over the past three years the global Advanced Wound Care Market has almost doubled, an exciting market for investment according to SmartTRAK estimates. The biggest deal in Advanced Wound Care (AWC) has been Coloplast's acquisition of Kerecis in 2023. Kerecis, a startup in the US Skin Substitute Market, demonstrated strong growth and the potential to have a global presence, justifying the high price. Startups have been a key component of the market, with new technologies and products over the years, and have been advancing their portfolios through IPOs, strategic partnerships, and investments. 

This downloadable article reviews the recent top deals and investment trends in AWC, including:

• Recent Global Wound Care Investments
  • Top Deals and Investments Jan 2024 through June 2025
• Market Trends
  • Although the US Skin Substitute/ CAMPs Market has seen exponential growth in the last few years, that isn't where global investment is occurring.
• Investment by Geography
  • US and Canada Wound Care Investments
  • UK, Europe, and Rest of World (ROW)
• Early-Stage Investments
  • Non-Dilutive Funding Sources
  • Strategic and Insurance Provider Investments

Want to know which deals are shaping the future of wound care? Click below to download the full article, “Deals in Advanced Wound Care,” co-authored by Dr. Mitchell C. Sanders, CEO, ProDevLabs and Susan Paquette, SmartTRAK Senior Advisor, Wound, to get a firsthand look at the key investment trends driving this dynamic market.

SmartTRAK, the leading provider of actionable market intelligence for orthopedic companies, and Foot Innovate, the premier platform for Foot & Ankle (F&A) surgeon education and clinical insights, are excited to announce a strategic co-marketing partnership. This collaboration brings together two industry leaders to launch a cutting-edge F&A market research solution that fuses robust analytics with real-world surgeon experience.

The joint offering blends SmartTRAK’s trusted data expertise with Foot Innovate’s deep network of engaged surgeons to deliver a

Dr Cheryl Blanchard, president and CEO of Anika Therapeutics, discusses the company, technology and developments for future growth in an interview with SmartTRAK.

In a recent interview with SmartTRAK, Dr. Cheryl Blanchard, president and CEO of Anika Therapeutics, discussed the company’s strategic direction, proprietary technology and advancements in its next-generation osteoarthritis (OA) pain management and regenerative solutions.

To find out more about the company, its differentiated technologies, products and growth strategy, click on the following video (26:40 min).

Interview topics by timecode are provided below, as is a link to download a complete transcript of the interview.

Interview Outline by Timecode:

00:20 Introduction to Anika Therapeutics, president and CEO Dr. Cheryl Blanchard and the company’s strategy.
01:14 The US OA Injectables Market and Anika’s next-generation OA pain solution, Cingal.
02:52 Cingal’s advantages and how it fit in the treatment continuum.
04:56 Cingal’s positioning and clinical trials’ progress.
10:47 Marketing communication, commercial and pricing approach and beyond knee OA.
13:42 Hyalofast, Anika’s next-generation cartilage repair solution.
17:25 Anika’s regenerative platform and the Integrity Implant System.
19:54 Cheryl Blanchard’s take on the next major disruptive force.
22:42 Thoughts around healthcare policy changes, tariffs uncertainty and other macro trends.

Click the button below to download and read the complete transcript of SmartTRAK's interview with Dr. Cheryl Blanchard, president and CEO of Anika Therapeutics, conducted by  Freddy Buntoum, SmartTRAK Senior Analyst, Orthobiologics and Regenerative Medicine.

Nitric Oxide (NO) has numerous benefits for wound healing but has challenges associated with its delivery. Several companies are addressing those challenges and creating an exciting opportunity in wound care.

Nitric oxide (NO) was named “Molecule of the Year” by the journal Science in 1992, and six years later, three US scientists were awarded the Nobel Prize for Physiology and Medicine for their efforts to prove that NO, an endogenous gas and free radical, could have crucial biological effects. One of the well-known medical uses of NO is via nitroglycerin, a precursor to NO, to prevent and treat chest pain (angina). It works by relaxing blood vessels, which decreases the amount of work the heart has to do. NO has been identified for its value in chronic wound healing for many years because of its function in vasodilation, relaxing blood vessels and increasing blood flow, as well as its broad-spectrum antimicrobial and antibiofilm activity.

No products have yet reached the market for chronic wounds; however, SmartTRAK has noted increasing activity related to the benefits of NO for wound healing. In fact, an article was published earlier this year entitled “Emerging Strategies for Nitric Oxide Production and Their Topical Application as Nano Dressings to Promote Diabetic Wound Healing.” The article identified four primary modes in which NO benefits the diabetic wound healing process: providing antimicrobial properties, promoting angiogenesis, regulating inflammation and promoting tissue regeneration and remodeling.

This market outlook article will discuss in detail the following subjects:

Thomas Lash, COO and co-founder of Aatru Medical, talks about the company’s innovative single-use negative pressure device, NP-Sims, a Negative Pressure Surgical Incision Management System.

Thomas Lash, chief operating officer and co-founder of Aatru Medical elaborates on the company’s strategy to mitigate the risk of surgical site infections through NP-SIMS, their single-use negative pressure surgical incision management system. To listen to the interview, please click on the following video (21:21 minutes). A link to download a complete transcript of the interview is provided below. 

SmartTRAK: Hi, this is David Shepard, senior analyst with SmartTRAK. Today it's my pleasure to be joined by Tom Lash, COO and co-founder of Aatru. He's going to talk to us today about a product that he co-invented, called NPSims. Tom, tell us a little about your company and about the product.

Tom Lash: We started the business about eight years ago, a small research and commercialization team with the goal of developing an alternative solution for the single-use, disposable negative pressure wound therapy market.  Kind of a mouthful to say that, but in essence, what we were trying to do is looking at the predicate devices that are on the market, we knew that if we were going to try and have a product that could make an impact on that market segment, it would be necessary for us to find an innovative mode of action to create the negative pressure without the current use of electromechanical pump which powers the leading products that are in use today. They have an electromechanical pump. They're battery-operated. They have software. Those products were primarily devised for the open or chronic wound market, and because of our focus on the surgical incision market, we were able to design something that was different. We believe the current products are probably over-engineered for the surgical incision market. So, our approach was to devise ...

Click the button below to download and read the complete transcript of SmartTRAK's interview with  Aatru Medical's Co-Founder and COO Thomas Lash, conducted by  David Shepard, SmartTRAK Lead Analyst, Orthobio & Regen.

Alyssa Huffman, CEO of Allumin8, discussed the company and its efforts to create a new product category of therapeutic hardware in an interview with SmartTRAK on May 9, 2025, at the 2025 North American Spine Society (NASS) Biologics Interventions meeting in Chicago, Illinois. The company is focused on treating over 200 unique bone disorders and diseases, and its first product is focused on the Spinal Hardware Market.

Click on the following video (8:49 min) to learn more. A link to download a complete transcript of the interview is also provided below.

SmartTRAK: Hi, this is Erin Dorgan, senior analyst here at SmartTRAK. I'm here today with Alyssa Huffman, CEO of ALLUMIN8. Alyssa, thank you for joining me today. Can you share a little bit more about your background and your role at ALLUMIN8?

Alyssa Huffman: Absolutely, Erin. Thanks for being here. I started in the clinic, then worked in the OR, went into sales, distribution. I worked my way into an executive function and then decided I was going to bet on myself. I have 30 years of experience throughout orthopedic spine biologics regenerative therapies.

That's awesome.

AH: And computer navigation.

Well, that's quite extensive. So we're here today at the NASS Biologic Interventions for Spinal Pathologies meeting. Why are you here with ALLUMIN8? What's the purpose for ALLUMIN8 presenting?

AH: Dr. Zorica Buser, she asked me to come and talk to the researchers and physicians about how to design a product that will actually commercialize and can get funded. There's a very different issue that's going on right now where products that only are a little bit, 1% to 3%, better than what's currently available on the market. There's a plethora of those, and so we have ...

Click the button below to download the complete transcript of our interview with Allumin8 CEO Alyssa Huffman, conducted by Erin Dorgan, SmartTRAK Senior Analyst.

SmartTRAK spotlights CytexOrtho, the AAOS 2024 OrthoPitch winner, as it develops its biodegradable implant to address early joint degeneration. 

In this interview with SmartTRAK, CytexOrtho CEO Brad Estes, PhD, discusses the company’s cartilage repair implant, ReNewHip, an engineered bicomponent implant used for cartilage regeneration.

To find out more about CytexOrtho and its technology, click the image below to watch the video (26:37 min). A link to download a transcript of the interview is also provided below.

SmartTRAK: Hi, this is Emily Meng with SmartTrak. Today I'm here with CytexOrtho CEO Brad Estes. Thanks, Brad, for joining me today.

Bradley Estes: Yeah, I'm happy to be here. Thanks for having me.

So, we'll just jump in and start asking you some questions. Let’s start with can you tell me about yourself and your background and how you got started with CytexOrtho.

BE: Yeah, it was kind of a circuitous route to get here. I started my career in the Medtech industry with Sofamor Danek, which was eventually acquired by Medtronic, and kind of did a lot of R&D in the heyday of spine, I like to say it, and was even on the team that did BMP-2. So that was a lot of fun seeing the role of a biologic in orthopedics and what that could really do to change the way patients are treated. And so I spent about eight years in Medtronic and then I left industry, came to academia, did a PhD at Duke and kind of retooled and learned the molecular biology, the stem cell biology, the tissue engineering and just kind of gained a whole new skill set. I got to work with some really great people and that kind of set us off on our journey of where we are today and kind of tie in some product development experience with science and having the right time and the right people and the right funding to push forward with CytexOrtho. And I'm sure I caused more questions in that response than answered, but I'm happy to fill in the gaps, too.

Can you tell us a little bit about CytexOrtho and what you guys are doing, and specifically, I guess, for ReNew Hip, since that's your product that is under development.

BE: So, our goal from the beginning has been to treat that patient that currently has no solutions. I'm talking the patient in their 30s, 40s or 50s that have early-stage hip disease, but they have no solutions right now. Their plight is kind of sad if you think about it. They go see their doctor, they have some hip pain, they're starting to not be able to do the things they want to do. And so, they take some ibuprofen, do some PT, and let's come back and see me in a year and that progresses for about seven or eight years typically. That's what our data tells us. That patient is just living with more chronic pain and increasing disability over that eight years until finally they can't take it anymore and then they replace their hip. And so, our technology is ...

Click the button below to download the complete transcript of our interview with Brad Estes, CEO of CytexOrtho, conducted by  SmartTRAK analyst Emily Meng.

SmartTRAK spotlights SentryX, a clinical-stage biopharmaceutical company developing a non-opioid platform for the treatment of acute pain after surgery,​ in an interview at AAOS 2025 in San Diego. 

SentryX Co-Founder and Chief Medical Officer Jorrit-Jan (JJ) Verlaan, MD, discusses the company’s novel implantable anesthetic for spine surgery applications in an interview with SmartTRAK at the American Academy of Orthopaedic Surgeons (AAOS) 2025 Annual meeting in San Diego. The hydrogel works with all types of small-molecule drugs with a release profile that can be tailored to specific clinical needs and surgical procedures.

To find out more about SentryX and its novel technology, listen to the following video. (13:37 min.) A link to download a transcript of the interview is also provided below.

Hi, I’m Kristine Jacques, a Senior Analyst with SmartTRAK Spine. We are here at the American Academy of Orthopedic Surgeons 2025. I’m sitting down with Dr. JJ Verlaan, a spine surgeon, co-founder, and Chief Medical Officer for SentryX, a Netherlands-based company developing a groundbreaking non-opioid solution for postoperative pain. First of all, Dr. Verlaan, I want to congratulate you on being one of the top four finalists inthe OrthoPitch Event at the Academy this year. It’s quite an honor.

Dr. Jorrit-Jan Verlaan: Thank you very much.

Thank you so much for sitting down with the SmartTRAK team. I’d like to start out with you telling us about your background and how the idea came about for the Hydrogel and starting SentryX.

JJV: Thank you so much. I'm a surgeon from Utrecht in the Netherlands. I've been practicing spine surgery from the moment I got board-certified. Rapidly, during work in my practice, I noticed that patients after spine surgery are all in a lot of pain. The moment that you realize that, and you actually ask the patients how much pain they have, on a scale of 0-10 they sometimes respond with a 12. I had a chat with an anesthesiologist one day in between surgeries. We were discussing what is out there right now to treat pain. The anesthesiologist, she told me, "Well, not much, really. We're still relying on opioids. Maybe we could do something with local anesthetics, but it's not working long enough at this point." That kind of sparked the idea of doing something locally to treat the pain, but differently. Soon after, I hit upon the idea that we're developing right now in the company.

How far along are you in the development?

JJV: We started in 2017, together with my partner Bas Oosterman who is the CEO of the company. First it was just a raw idea. We soon found out that this idea, it had never been done before. That gave us the opportunity to actually file IP on our solution and go for it. At the end of 2017  we officially founded the company. We got our first employees and collaborated with a renowned institute on biofabrication. We developed a new ...

Click the button below to download and read the complete transcript of SmartTRAK's interview with SentryX Co-Founder and CMO Jorrit-Jan (JJ) Verlaan, MD, conducted by Kris Jacques, SmartTRAK Sr Analyst.

Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the impact of delay and how industry players may choose to react.

On April 11, 2025, Centers for Medicare and Medicaid Services announced that the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers Final Local Coverage Determinations (LCDs) effective date will be delayed until January 1, 2026. In this video (16:43 minutes), SmartTRAK Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the impact of delay, and how industry players may choose to react.

The SmartTRAK Wound Team will be in attendance at the upcoming SAWC Spring conference in Grapevine, TX (April 30 to May 4). Please register here to meet the team.

Recently, SmartTRAK's VP of Sales, Joe Mish, sat down with the Alpha Sophia podcast to discuss the impacts of data on the Medtech market. Hosted by Alpha Sophia founder & CEO Paul-Lukas Hoffschmidt, the podcast dives deep into the cutting-edge of MedTech innovations and commercial trends.

In this video, Joe breaks down how SmartTRAK delivers critical market intelligence to MedTech companies, helping them track trends, product performance and market changes. He explores how the Alpha Sophia partnership enhances real-time intelligence, enabling businesses to quickly act on insights, stay ahead of industry shifts, adapt to changing market dynamics and maintain a competitive edge in an evolving market. Click the video below to watch the podcast.

SmartTRAK and Alpha Sophia together offers a data-driven, AI-powered solution for commercial teams in the healthcare sector. Click the button below to watch our webinar titled "Growth in 2025: More Than Targeting" outlining how SmartTRAK and Alpha Sophia can accelerate business opportunities by combining deep market insights with advanced targeting strategies, ultimately enabling sales teams to engage more effectively with the right customers at the right time. 

We are pleased to announce that David Shepard has joined the SmartTRAK team as Senior Analyst, Orthobiologics and Regenerative Medicine. Prior to joining SmartTRAK, for the last 22 years, David has worked for Arthrex as the Senior Director of Orthobiologics and Vet Systems, where he led global business development and product strategy across two diverse portfolios, driving innovation in regenerative medicine and orthobiologics. Before that, he was Director of Donor Services at the University of Florida Tissue Bank, where he oversaw tissue recovery operations and processor distribution for all donors across the UFTB region, confirming compliance, efficiency and optimized recovery rates.

Meet David Shepard:

What is your role with SmartTRAK? I am a senior analyst with the OrthoBio Team.

What do you like about SmartTRAK? I have been using SmartTRAK for years to keep up with the latest developments in the fast-moving Orthobiologics space. This unique environment covers many areas of medical practice, so staying on top of the latest news, emerging tech, research, and IP is critical to the success of any company. Now that I am on the other side, it’s like being a kid in a candy store.

What is something special or unique that you bring to SmartTRAK subscribers? I have worked in various roles in the Orthobiologics space, leading upstream product development from early research to product launch, downstream marketing, sales management, and evaluation of emerging technologies. I have also had the opportunity to work alongside and learn from some of the preeminent thought leaders in the field. This has prepared me to help companies reach their goals using the power of data analytics and experience in this diverse field.

What do you think the biggest promise of medical technology (in your area) is? With incredible materials, instruments, and implants now available to physicians, the one area that remains out of their control is the biology of their patients and how that will impact their final repair and long-term outcome. It is well-accepted that Orthobiologics (Cells, Signals, and Scaffolds) have the best opportunity to improve patient outcomes. While it is hard to pick a single area as the most promising, I would say that cellular and cell secretory factors may hold the most potent potential to direct regenerative repair and even early diagnosis.

What are your favorite online websites or resources that you check every day? For years, I have started my day reviewing the SmartTRAK updates and augmenting these overviews by cruising PubMed to dig into more of the details. Even some of the best research can miss fine details that hold the truth.

How do you keep your medical device research skills sharp? I read, read, read…and I have never been shy about contacting authors to get more details about the research I am reviewing. I enjoy talking to companies about their new technologies and clinicians who are early adopters so I can better understand the problems they are trying to solve and how their technique or product solves those problems. As my father has always told me, surround yourself with people who are better than you, and that is easy to do when working at SmartTRAK.

If you could have one superpower, what would it be? This is a fun question. I would have to say teleportation. I love to travel and hate traffic; this power would resolve that conflict.

What was the last show you binge-watched? Hmmm…tough one. I am more of a binge reader but almost anything in the sci-fi genre will fit the bill regarding series and watching. Separation has been and interesting one. Good characters that you care about are key.

What can we find you doing when you’re not working? You can often find me on the ice. I do my best to stay fit as I remain an avid hockey player, playing 3+ games weekly. All three of my boys also play, so it is a busy house. My wife and I also enjoy hiking in the mountains of NC.

If you'd like to learn more about SmartTRAK and how it can increase proficiency, improve productivity and reduce costs for your company, or if you would like to meet with David, just click the button below.

We are pleased to announce that Elizabeth Anderson has joined the team at SmartTRAK as Senior Analyst, Biologics. Before joining SmartTRAK, Elizabeth got her start at Healthpoint in Texas and has since worked in various roles with several of the top companies in the biological space, including Smith+Nephew and Organogenesis. 

Meet Elizabeth Anderson:

What is your role with SmartTRAK? My role with SmartTRAK will be as a Senior Analyst for the Biologics module.

What do you like about SmartTRAK? I have been using SmartTRAK since the platform started. My favorite feature is the ability to have information relevant to both the commercial and clinical sides of the market in one place. 

What is something special or unique you bring to SmartTRAK subscribers?
The majority of my roles have been responsible for market research and business intelligence. I have extensive experience combining primary and secondary data to get a full picture of the market.

What do you think the biggest promise of medical technology (in your area) is?  In the Biologics space, it isn't easy to choose just one. A lot of research is looking into the ability to impregnate matrices or grafts with growth factors or cell types that a patient may be missing based on their pathophysiology. 

How will it change everything? This would allow clinicians to tailor their tx specifically, giving the patient what is needed to heal. Of course, this hinges on the proper diagnostics, but I think it is where we are headed.

What are your favorite online websites or resources that you check every day? Of course, I stay up to date with SmartTrak and LinkedIn, my go-to sources, but I also monitor the CMS website in this space.

How do you keep your medical device research skills sharp? I keep my skills sharp by attending conferences, reading published clinical studies, and talking to clinicians on the front lines.

What was the last presentation you gave and to who, about what?  My last presentation was a forecast model for a new product launching clinical trials to enter the US market. It was for a US Business Development Director for an OUS manufacturer.

What was the last show you binge-watched? The last show I binge-watched was the limited series American Primeval on Netflix. It is a good story.

What is your life like outside of SmartTRAK? Outside of SmartTRAK, I run a lot, tend to my senior dog, and try to teach myself new baking skills. I have backed off a lot of the long-distance running but still do a few endurance events.

If you'd like to learn more about SmartTRAK and how it can increase proficiency, improve productivity and reduce costs for your company, or if you would like to meet with Elizabeth, just click the button below.

To find out more, watch the following video (4:27 min). A link to a transcript of the interview is also provided below. 

SmartTRAK: Hi, this is Sharon O'Reilly. I'm at the Canaccord Conference before the 2025 AAOS, and I ran into Alessandra Pavesio, who's so excited about her company, Doron Therapeutics.

So, Alessandra, why don't you tell us a little bit about the company and some of the exciting new developments.

Alessandra Pavesio: It's always great to see you, Sharon. I love bumping into you and having some really good news to deliver. First of all, what is Doron Therapeutics? It's a management-led spin-off. We really were passionate about a technology that we've developed with Bioventus, and when Bioventus divested from this program for financial considerations, we were able to negotiate a very favorable deal to actually set up a spin-off company and go raise private capital to invest in the program.

The good news is that, yes, we've set up a company. Yes, we have raised private capital. And so now we are really up and running and getting ready to start a Phase III study.

Big milestone that we've accomplished is that we've been recognized by FDA as an RMAT therapy. RMAT means Regenerative Medicine Advanced Therapy. As such, that means attention from senior officials at FDA that are really partnering with you to get this product to market for the patients that we serve. Super excited.

SmartTRAK: Tell us about the product.

AP: So our lead program is called MOTYS. It's placental-derived injectable therapeutic. It's a biological drug that ...

Click the button below to download and read the complete transcript of SmartTRAK's interview with Doron Therpeutics' CEO Alessandro Pavesio, conducted by Sharon O'Reilly, SmartTRAK Founder and CEO.

SmartTRAK will be attending AAOS 2025 this week. Join us at AAOS to explore our solution and discuss our roadmap for expanding into other orthopedic markets. Learn more about our Brand Tracker here or schedule time to Meet with Us at the show!

• Expanding Reimbursement for Lymphedema Products 
  • One of the biggest growth drivers for compression therapies in 2025 is expanding reimbursement for the treatment of lymphedema. With more than three million lymphedema patients estimated in the US alone, SmartTRAK expects ... (read more)
• Improving Ease of Use for Compression Garments
  • SmartTRAK expects several companies to develop or refine compression garments in the years ahead with a focus on improving ease of use. With the growing number of patients having access to compression garments day and night, it’s become even more important for ... (read more)
• Dynamic Compression Innovations Improving Portability
  
  • In the world of dynamic compression, portability is the name of the game and SmartTRAK expects to see ... (read more)

Want to stay ahead of the curve in the US compression device market for 2025 and beyond? Industry trends, regulatory changes and new reimbursement codes are shaping the future—are you prepared?

Click the button below to download Jay Merkel’s market outlook article, "Feel the Pressure: Compression Trends for 2025." As SmartTRAK’s senior analyst, Wound, Jay provides an informative analysis of the latest market shifts, including new compression codes and major code revisions set to take effect on April 1, 2025.

SmartTRAK’s new global procedure and brand share analytics tools for the hip and knee markets transform MedTech market intelligence with faster, smarter insights

SmartTRAK, the leading MedTech market intelligence platform in Orthopedics, Wound Care, Regenerative Medicine and Neuro Therapies, is revolutionizing strategic decision-making with the launch of new US and global procedure tools, brand share analytic, and price estimation tools. Designed to save time and reduce reliance on costly, complex datasets, these tools deliver unparalleled speed and depth of market insights for MedTech companies.

Empowering the Hip and Knee Markets with SmartTRAK’s Brand Tracker

Now available for the hip and knee markets, SmartTRAK’s Brand Tracker offers a powerful suite of analytics tools, including dynamic charts, growth analyses, and detailed breakdowns of product and company brand share. Updated quarterly, Brand Tracker highlights five years of trends covering product mix, average price, and market share by facility type. Upcoming expansions will include Interventional Spine and other orthopedic markets in the coming year.

Global Reach with OUS Procedure Tracker

For customers operating internationally, SmartTRAK introduces the OUS Procedure Tracker powered by Quomeda, featuring ...

•  Joint Replacement Procedures Continue Migrating to the ASC Setting
  
  • In 2023, SmartTRAK estimated that approximately 10% of all US hip and knee replacement procedures were performed in an ambulatory surgery center (ASC) setting. This trend shows no signs of slowing down. Based on recent procedure trends data, SmartTRAK projects ... (read more)
  • While procedure volumes at ASCs have risen, Medicare reimbursement rates continue to drop. SmartTRAK tracking of Medicare surgeon reimbursement shows ... (read more)
    
• Technology Trends: Streamlining, Personalization, Outcomes
  
  • Technology trends carrying over from 2024 include streamlining, personalization and outcomes. Some of the new products launching in 2025 are ... (read more)
• Potentially Disruptive Orthobiologic Therapies Coming to Market
  
  • New Orthobiologic injection therapies aim to better manage symptoms and modify disease progression in osteoarthritis (OA) patients. SmartTRAK feels this is ... (read more)
• Eight New Therapies on the Horizon That Could Impact Joint Replacement
  • Delaying surgeries by managing symptoms and  ... (read more)
  • Reducing the number of joint replacements performed: Advanced OA injectable therapies that more effectively target pain management could result in ... (read more)

Curious about the latest trends in the joint replacement market for 2025?    Click below to read her comprehensive market outlook article "Joint Replacement Trends to Watch in 2025" by Lisa Mahan, SmartTRAK's VP of Product Development & IT, Sr. Analyst Total Joints.

Carsten Schroeder, president and CEO of Terumo Neuro, discusses the company’s plans to capture share and become the market leader in neurovascular.

Carsten Schroeder, president and CEO of Terumo Neuro, discusses the company’s rebranding, plans for growth and becoming the market leader in neuroendovascular technologies in an interview with SmartTRAK. Listen to the video below to find out more, including how Terumo plans to innovate and take share via new disease states and markets in addition to its core neurovascular markets (ischemic, hemorrhagic and access).

Click on the video below to watch the interview (32:05 min). A link to download the complete transcript of the interview is available here. For more details, interview topics by timecode are provided below.

In 2024, SmartTRAK continued to empower you to Be The Expert in the MedTech industry. As your trusted resource for up-to-date industry insights, we delivered real-time market data, analysis and actionable insights across the orthopedics, wound care, regenerative medicine and neurotherapy markets. Here are SmartTRAK's Top Blog Posts from 2024, offering valuable perspectives from our expert analysts.

1. Skin Substitute Market Rocked by DOJ Investigations
   SmartTRAK believes the billions of dollars of Medicare abuse already uncovered is the tip of the iceberg in services billed to Medicare via the Physician Fee Schedule.
   
   
2. Medtronic: Making Waves At NANS 2024
   Medtronic executives discuss how the company is making waves in interventional pain, minimally invasive spine and deep brain stimulation in an interview with SmartTRAK at NANS 2024.
   
   
3. Spine Market Movers to Watch in 2024
   SmartTRAK highlights companies to watch as they continue their double-digit growth train with multiple catalysts for expansion in 2024.
   
   
   
   

On December 10, 2024, the Medicare Administrative Contractors (MACs) held a town hall session to discuss the Local Coverage Decisions (LCDs), “Skin Substitute Grafts/Cellular and Tissue-Based Products for the Treatment of Diabetic Foot Ulcers and Venous Leg Ulcers,” which were issued on November 14. The proposed LCDs were announced on April 25 of this year, a comment period followed, and then things went black as the MACs contemplated whether any changes should be made to the LCDs. Two key improvements in the final version included an increase in the number of skin substitute applications from four to eight and an increase in care time from 12 to 16 weeks. In this article, SmartTRAK will discuss the ongoing activities since these LCDs were announced, including the requirement for published peer-reviewed clinical evidence, market activities to shore up position and activities to rescind the LCDs. The article will close with SmartTRAK’s forward analysis of the impact of these LCDs on the market should they be implemented as planned.

Q’Apel Medical CEO Jodie Fam discusses the company, strategies for growth and Q’Apel’s approach to innovation in an interview with SmartTRAK at SVIN 2024. 

Q’Apel Medical CEO Jodie Fam discusses the company, its technologies, strategies for growth and Q’Apel’s approach to innovation in an interview with SmartTRAK at the Society of Vascular and Interventional Neurology (SVIN) held November 22-24, 2024 in San Diego, California. 

To find out more, click on the video below to listen to the interview (22:08 min). Click the button below to download a complete transcript of the interview.

In an interview with SmartTRAK, Gennaro Broya de Lucia, president of the National Board of Directors at PMI Sanità, offers a comprehensive summary of the challenges for the medical device market in Italy, which places hundreds of companies at risk in the country.

SmartTRAK’s suite of solutions for procedure and brand share analytics will provide orthopedics, wound care and neuro therapies companies with deeper market intelligence in one comprehensive platform

IRVINE, Calif.   SmartTRAK, the leading Medtech market and business intelligence solution in Orthopedics, Wound Care, Regenerative Medicine and Neuro Therapies, announces partnerships with STATinMED, LLC and Quomeda Ltd for the development of US and global procedure tools. A third partnership with a leading healthcare insights organization will enable SmartTRAK to offer customers a brand share and price estimation tool. These new tools, combined with SmartTRAK’s highly curated content and analyst-driven insights, reduces the need for expensive, complex data sets and increases the speed for strategic decision-making.

In an interview with SmartTRAK, Dr. Willi Schnorpfeil, an expert in reimbursement strategies, offers a comprehensive overview of the regulatory changes for advanced wound care products in Germany, which pose a potential threat to both market stability and patient care.

In an interview with SmartTRAK, Dr. Willi Schnorpfeil, managing partner of Value & Dossier and Reimbursement Specialist, provides insights into the scope, impact and potential future developments of changes in Germany’s reimbursement landscape, specifically concerning the Advanced Wound Dressing Market. Dr. Schnorpfeil highlights the challenges faced by the industry in meeting new evidence requirements and the possible implications for patient outcomes. This conversation sheds light on the complex regulatory environment in Germany and its broader implications for the healthcare sector across Europe.

Click on the video below to listen to SmartTRAK’s interview with Dr. Schnorpfeil (24:18 minutes), which was recorded on August 22. A link to download the complete transcript of the interview is also provided below. 

SmartTRAK is attending the upcoming North American Spine Society (NASS) meeting being held Sept. 25-28 in Chicago, Our team can't wait to see all of our colleagues at the premier meeting for the spine market. To help you get ready for the meeting, in the following video, Elise Wolf, SmartTRAK's VP & GM of Orthopedics and Digital, reviews the latest trends and developments in the Spine Enabling Technologies market.

If you would like to see more of what SmartTRAK has to offer in spine coverage, including some of our recent articles on the trends and developments in the Spine Enabling Technologies market, or if you would like to meet with us at NASS 2024 in Chicago,  just click the button below.

SmartTRAK is attending the upcoming North American Spine Society (NASS) meeting being held Sept. 25-28 in Chicago, and we can't wait to see all of our colleagues at the premier meeting for the spine market. To help you get ready for the meeting, Erin Dorgan, SmartTRAK Senior Analyst, Spine, has recorded this video update with an overview of the bone replacement products and companies to watch at NASS 2024.

If you would like to see more of what SmartTRAK has to offer in spine coverage and the bone replacement market, including some of our recent articles, or meet with us at NASS 2024,  just click the button below.

SmartTRAK is attending the upcoming North American Spine Society (NASS) meeting being held Sept. 25-28 in Chicago, and we can't wait to see all of our colleagues at the premier meeting for the spine market. To help you get ready for the meeting, Erin Dorgan, SmartTRAK Senior Analyst, Spine, has recorded a video update with the trends, key players and innovations to know before the show.

If you would like to see more of what SmartTRAK has to offer in spine market coverage, including some of our recent articles, or meet with us at NASS 2024,  just click the button below.

SmartTRAK takes a look at recent trends impacting the Foot & Ankle market.

As the first half of 2024 closes, SmartTRAK has observed a continued investment in the hallux valgus space. New implants and innovative instrumentation for hallux valgus procedures continue to push this segment to the forefront of the elective foot and ankle fixation space. While hallux valgus is front of mind for fixation, arthroplasty is also making waves as SmartTRAK continues to monitor toe replacement and advancements in ankle replacement.

As companies close out Q2 earnings, SmartTRAKcoverage has indicated slightly mixed results in the Extremities space. In this downloadable article, SmartTRAK examines recent trends impacting the Foot and Ankle market. including what's happening with hallux valgus procedures, which shows no signs of slowing down, and puts a spotlight on arthroplasty in the Foot &  Ankle segment

Click the button below to download and read the complete "Checking the Pulse of the Foot & Ankle Market" article by Natasha Weeks, SmartTRAK Managing Editor/Sr. Analyst Trauma & Extremities.

The 2024 HealtThe 2024 HealthpointCapital Investor Day is taking place on Friday, Sept. 13 in Las Vegas, and SmartTRAK will be there. Elise Wolf, SmartTRAK VP and GM of Orthopedics, has a new video update with everything you need to know before you go.

If you'd like to see more of what SmartTRAK has to offer in orthopedic coverage, including some of our recent articles on extremities, spine, enabling tech and total joints, just click the button below.

SmartTRAK is attending the upcoming American Orthopaedic Foot & Ankle Society Meeting (AOFAS), being held Sept. 11-14  in Vancouver, and we can't wait to see all of our colleagues at the premier meeting for foot and ankle. To help you get ready for the meeting, SmartTRAK's GM of Trauma & Extremities, Natasha Weeks, has recorded a video update with the trends, key players and innovations to know before the show.

If you'd like to meet with Natasha in Vancouver or just read more of SmartTRAK's coverage of the Foot & Ankle market, visit SmartTRAK Foot and Ankle Central.

Amaza Reitmeier, Medtronic’s VP and GM of Brain Modulation, discusses the company’s recent FDA approvals for asleep DBS and expanded MRI labeling, and provides an update on adaptive DBS in an interview with SmartTRAK. 

In an interview with SmartTRAK, Medtronic’s Amaza Reitmeier, vice president and general manager of Brain Modulation, discusses the company’s recent news in deep brain stimulation (DBS), including FDA approval for asleep DBS and MRI expanded labeling that allows patients to undergo additional scan time. She also provides an update on adaptive DBS (aDBS) and the ADAPT-PD trial, which is expected to support the global regulatory submissions to commercialize aDBS in patients with PD.  Medtronic recently filed for US FDA approval of aDBS.

Click on the following video to listen to the interview (14:32 minutes). A link to download a complete transcript of the interview is also provided below.
 

Interview Transcript

SmartTRAK: Hey everybody. Anne Staylor here with SmartTRAK. Today I get to talk to Amaza Reitmeier, the vice president and general manager of Brain Modulation at Medtronic. Hey Amaza, thanks for talking with me.

Amaza Reitmeier: Hi, Anne. Great to see you.

I know that you have some big news around DBS. You guys are advancing pretty quickly. The latest news involves FDA approval for asleep vs awake DBS, MRI expanded labeling, and then maybe you could give me an update on some other aspects of the adaptive DBS. So let's get started.

AR: Fantastic.

What is the significance? Talk a little bit about the FDA approval for asleep vs awake DBS, and why is that important? A lot of people are doing that. Just talk a little bit about the significance of that and what it means for Medtronic.

AR: Thank you, Anne. Well, first and foremost, you know from our prior conversations that we're very focused on the patient and making sure that patients have the best options available to them. While you're right that asleep DBS has been being done for years, it's actually been contraindicated in our labeling. The original labeling for DBS, which was established decades ago, required test stimulation to confirm that the therapy was working. But we also know that ...

Click the button below to download and read the full transcript of the SmartTRAK perspective article "Transforming DBS Therapy - An Interview with Amaza Reitmeier" conducted by Anne Staylor, SmartTRAK's Executive Editor and VP & GM of Neuro Therapies.

SmartTRAK's Anne Staylor, VP & GM Neuro Therapies, will be attending ESMINT 2024

SmartTRAK is excited to attend the ESMINT Congress 2024, which will be held at the Pharo Congress Center in Marseille, France, September 4-6. Anne Staylor, SmartTRAK VP & GM Neuro Therapies, will be there to cover the latest Neurovascular news and developments. In this Market Snapshot video update, Anne provides the latest research and technologies impacting the market for neuro intervention, including trends to look for at the meeting.

If you'd like to meet with Anne at ESMINT, or see more of SmartTRAK's neuro coverage, just click the button below to visit SmartTRAK Neurovascular Central.

Dr Stephen Snyder, MD, a renowned arthroscopic surgeon who now serves as the Medical Director for Pristine Surgical, discusses his experiences in the industry over the past 50 years.

In a recent interview with SmartTRAK, Dr. Stephen Snyder, a renowned arthroscopic surgeon who now serves as the medical director for Pristine Surgical, discussed his experiences in the industry over the past 50 years.

Click on the following video to watch the interview (58:52 min). For more details, interview topics by timecode are provided below. A link to download a complete transcript of the interview is also available below.

Interview Topics By Timecode:

00:50 Dr Snyder’s background.

08:02 The most notable advances that he saw during 40+ years in arthroscopy.

21:36 Some of the first arthroscopic repair procedures.

33:47 Using advanced technologies such as augmented reality.

39:17 The current state of industry meetings.

45:38 His role with Pristine Surgical and the advancing technologies in arthroscopic cameras.

Click the button below to download and read the complete transcript of the "Advances in Arthroscopic Innovation: An Interview with Stephen Snyder, MD" conducted by Andy Knapik, SmartTRAK Senior Analyst, Soft Tissue Fixation and Arthroscopic Enabling Technologies.

Andrew S. Murtha, MD addresses the controversy surrounding kinematic vs mechanical alignment in total knee arthroplasty.

Since the introduction of kinematically aligned knee arthroplasty in the mid-2000s, there has been controversy surrounding kinematic (KA) vs mechanical alignment (MA) in total knee arthroplasty (TKA). Kinematic alignment in total knee arthroplasty (TKA) attempts to restore natural limb alignment, maintaining the natural kinematic axis and ligament balance of the patient's knee. In contrast, the classic method of mechanical alignment aims to create a neutral hip-knee-ankle (HKA) axis. Advocates for KA say the technique intended to mimic a patient’s natural knee alignment will result in a more natural feeling and functioning knee. SmartTRAK had the opportunity to interview Andrew S. Murtha, MD regarding the growing interest in KA, what is driving this interest and what the future holds for KA vs MA with feedback from Benjamin Stronach, MD, associate professor at the University of Arkansas for Medical Sciences. Dr. Murtha is a board-certified orthopedic surgeon who is currently an adult reconstruction fellow at Houston Methodist Hospital. He is also a member of the American Association of Hip and Knee Surgeons’ (AAHKS) committee on Patient and Public Relations.

SmartTRAK: What has been your experience with kinematic alignment in total knee arthroplasty?

Andrews S. Murtha, MD: Kinematic alignment is a technical strategy in total knee arthroplasty that aims to individualize implant position by replacing only the cartilage and bone lost during the arthritis process. In its truest form, it does not place restrictions on the alignment of the components. I do not use an unrestricted kinematic alignment strategy in my practice, but the concept has expanded parameters for what is considered acceptable implant position.

In your estimation, based on your experience, what percentage of surgeons currently use KA vs mechanical alignment?

AM: In my experience, the majority of orthopedic surgeons use an adjusted mechanical alignment strategy. However, there does seem to be greater acceptance for slightly modifying the bone cuts to accommodate the patient’s native anatomy, thus reducing the need for large soft tissue releases to balance the knee. I would estimate that the percentage of surgeons using a truly unrestricted, caliper-based, resurfacing-type kinematic alignment strategy is relatively low.

What trends are you seeing in clinical practice – is KA increasing, decreasing or staying the same? What do you think is driving or limiting adoption?

AM: In general, interest in the kinematic alignment strategy has grown over the past 15 years. This interest seems to be driven by

Ariel Sutton, EVP and GM of Imperative Care’s Stroke business, discusses the Imperative Trial, the company’s Zoom Insert Catheters and more in an interview with SmartTRAK at SNIS 2024. 

Imperative Care’s Ariel Sutton, executive vice president and general manager of the company’s Stroke business, discusses results from the Imperative Trial, what it means for the acute ischemic stroke (AIS) market and the company’s newest innovations in an interview with SmartTRAK at the Society of NeuroInterventional Surgeons (SNIS) 21^st Annual meeting in Colorado Springs, CO held July 22 to 26, 2024.

To find out more, listen to the following video (15:54 minutes). A link to download the complete transcript of the interview is also provided below. 

Interview Transcript (scroll down to download the complete transcript)

SmartTRAK: Anne Staylor here with SmartTRAK. Today I am speaking with Ariel Sutton, EVP and GM of Imperative Care Stroke Business, live from the Society of NeuroInterventional Surgeons annual meeting in Colorado Springs. Ariel, thank you for talking with me today.

Ariel Sutton: Thank you for having me.

Let's start by having you talk about Imperative Care's presence at SNIS. What's important for us to know?

AS: We’re really excited to share the results of the Imperative Trial at SNIS this year. This is a 260-patient prospective trial across 26 centers in the US, evaluating the clinical benefits of the Zoom Stroke Solution, including aspiration with our Zoom 88 catheters. The results from the trial showed high reperfusion rates of 82.2% TICI 2B+, which is similar to previous studies that were submitted to the FDA for 510(k) clearance for reperfusion indication. There are a few metrics that we think are important to highlight from the trial. First is ...  

Click the button below to download and read the full transcript of the interview "SNIS 2024: An Interview with Imperative Care's Ariel Sutton" , conducted by Anne Staylor, SmartTRAK's Executive Editor and VP & GM of Neuro Therapies.

New partnership helps clients find and engage with physicians to accelerate product adoption and complements SmartTRAK’s expert market insights

SmartTRAK, the leading global Medtech business and market software intelligence solution in the Orthopedics, Wound Care, Regenerative Medicine and Neuro Therapy markets, announces a strategic partnership with Alpha Sophia, a leading Medtech commercial intelligence platform, to help clients quickly identify sales opportunities and position for growth in a highly competitive market.

As the trusted source for market intelligence, SmartTRAK now offers Alpha Sophia’s sales targeting capabilities on its real-time SaaS platform, creating a “one stop shop” for customers in need of actionable sales data plus market insights for strategic decision-making. The Alpha Sophia platform is an intuitive tool that enables commercial leaders to easily identify target physicians by region, site of care, specialization, procedure volume, social media presence and more. Comprehensive profiles of practitioners and organizations put unique insights at the fingertips of marketing and sales teams, enabling them to develop personalized engagement approaches.

Customers who access Alpha Sophia’s sales targeting solution through SmartTRAK’s platform will experience all the benefits of a comprehensive market insights solution, including

Arrests were made at the Phoenix Sky Harbor airport in June when two individuals attempting to flee the country were charged by the DOJ for defrauding Medicare over $900.0MM. According to the DOJ case summary, the two individuals “were charged by indictment with various counts of conspiracy, health care fraud, receiving kickbacks, and money laundering in connection with an alleged scheme to fraudulently bill Medicare $900 million for highly expensive amniotic allografts. The defendants targeted elderly Medicare patients, many of whom were terminally ill in hospice care, through their companies—Apex Mobile Medical LLC, Apex Medical LLC, Viking Medical Consultants LLC, and APX Mobile Medical LLC. “

SmartTRAK believes these charges are just the tip of the iceberg in terms of the amount of fraud occurring in the US Market for Skin Substitutes. With a dramatic spike in Medicare claims in 2023, it’s clear widespread Medicare abuse has allowed the US Skin Substitute market to balloon, almost doubling in just one year! The abuse is primarily limited to amniotic tissue products, which held 52.5% of the US market in 2022 and 64.5% of the market in 2023.

In this downloadable article, SmartTRAK discusses in detail the DOJ investigation and its impact on the Skin Substitute market, including:

• SmartTRAK Financial Analysis of the Market
• The Impact on Established Market
• Potential Drivers for Change
• Criteria for Medicare Physician Fee Schedule Focused (MPFS) Players
• What Could Impact the Market
• What the Future Holds

Click the button below to download and read the complete "Skin Substitute Market Rocked by DOJ Investigations" article by Susan Paquette, SmartTRAK VP & General Manager, Wound.  

Artificial Intelligence (AI) is transforming the medical device industry in myriad ways including enhanced diagnostics and imaging tools, more precise and consistent robotics and personalized medicine for improved patient care, and more. Where AI can also make a significant impact is in big data and predictive analytics by reducing staff administration, increasing efficiency and avoiding drowning in volumes of disparate data. But relying on AI alone for data and analytics has its pitfalls, especially when hallucinations occur resulting in flawed results and inaccurate predictions. That’s why having human experts behind the AI is critically important.

In this episode of DeviceTalks AI Podcast, Joe Mish, VP of Sales for SmartTRAK,  summarizes how SmartTRAK leverages AI tools alongside expert analysts to offer device customers one trusted source for market intelligence.  Joe discusses how Medtech customers rely on the unique, combined power of SmartTRAK’s Insights-as-a-Service platform and market and data experts to more quickly make strategic decisions around new product innovations and market expansions. With over a decade's worth of data and collective intelligence in the system, the predictive capabilities of AI and the power of non-hallucinating human insights, SmartTRAK might just be the “holy grail” solution. Just click the video below to listen in to learn more! 

A link to download the complete interview transcript is provided below.

0:00:00 Kayleen Brown: Hi everyone, I’m Kayleen Brown of DeviceTalks. Some exciting news to start. Our first four episodes of AI Meets Life Sci has more than 8500 plays. We’re so grateful that you’re interested in how AI is affecting our industry as much as I am. And as you probably noticed, we took a short break and we did that to speak to our audience in order to better understand how we can evolve that series, we learned two things. One, there’s an appetite for more artificial intelligence focused conversations. And two, we learned that though there’s an appetite for these conversations, there’s a hunger for these conversations to be specific to the medical device industry.

0:00:39 Kayleen Brown: So because of that, we’ve rebranded our series AI Meets Life Sci to DeviceTalks AI. DeviceTalks AI will feature exclusive conversations with the largest medtech OEMs and other industry stakeholders to better understand how they’re using artificial intelligence to reshape the industry. But you can still find us on every major podcast platform. Just search for DeviceTalks and make sure that you’re subscribed to DeviceTalks on YouTube.

0:01:06 Kayleen Brown: Today’s episode is extra special as we premiere under our new name. First, you’ll hear an interview with Joe Mish, vice president of sales at SmartTRAK. Joe reveals how SmartTRAK’s cutting-edge approach to market intelligence combines real-time analysis with the human touch of a world-class team. We will better understand how AI has helped speed up the market analysis process and how these technologies enhance strategic decision-making in market intelligence.

0:01:36 Kayleen Brown: After that is our keynote interview with Dr. Ha Hong, chief artificial intelligence officer at Medtronic Endoscopy. I’ll be joined by my AI Meets Life Sci co-host Brian Buntz, and we’ll discuss how Dr. Hong is integrating AI into Medtronic’s endoscopy unit, the potential impact of AI on healthcare outcomes, the importance of patient-centric AI design, and the promising future of AI in the medical device industry.

0:02:05 Kayleen Brown: As always, I’m so thankful for your continued support and I’m so excited about this new iteration of AI Meets Life Sci. Now, DeviceTalks AI. Again, we’re going to be specifically talking to medtech companies about how they’re integrating artificial intelligence for better health and business outcomes. So, let’s kick off our inaugural episode of DeviceTalks AI with my conversation with Joe Mish, vice president of sales at SmartTRAK.

0:02:36 Kayleen Brown: Joe Mish, vice president of sales for SmartTRAK Business Intelligence welcome to DeviceTalks AI. I’ve been so looking forward to sitting down with you and learning more about how artificial intelligence is integrating into the data world and helping our industry understand how the industry at large can look in the future. So with that, thank you again for joining us. I want to start at a 40,000 foot level, Joe.

0:03:05 Kayleen Brown: So can you tell our audience about SmartTRAK? What do you do and who do you serve?

0:03:11 Joe Mish: Absolutely. So SmartTRAK is a real time software as a service business intelligence platform. We provide rich market-level data, competitive intelligence and strategic insights to the medical device community. Essentially, we partner with medical device companies, OEM manufacturers, even financial service groups like VC and PE groups, as well as consulting organizations that really invest heavily in the medtech sector.

0:03:41 Kayleen Brown: I think your summary was a great high-level summary, but can you walk us through how real-time analysis is being conducted and ...

Click the button below to download the complete transcript of the interview featuring Joe Mish, SmartTRAK Director of Sales.

We are pleased to announce that John Hatchell has joined the team at SmartTRAK as Director of Sales for the Commercial team. John has 13 years of Medical Device sales and leadership experience within Orthopedics, helping to support trauma, joint replacement and robotics for Stryker and Biomet. Most recently, he has been the founder and CEO of TYDEi Health, a provider-focused business intelligence and optimization platform.

ASPN Chairman Tim Deer, MD, discusses the research and innovation at ASPN 2024 and the society’s collaborative approach to improving care for patients with chronic intractable pain in an interview with SmartTRAK.

Timothy R. Deer, MD, chairman of the American Society of Pain and Neuroscience (ASPN), discusses the society's goals, its rapid growth, and how ASPN is collaborating with different stakeholders to improve patient care and offer a wider range of new and innovative treatment options for patients with chronic intractable pain. To find out more, including what’s new in neuromodulation, minimally invasive spine and regenerative medicine, listen to the following video recorded live at the ASPN 2024 Annual Conference held July 11-14, 2024 in Miami Beach, FL. A link to download the complete transcript of the interview is also provided below. 

SmartTRAK: Anne Staylor here with SmartTRAK. I'm at the beautiful Fontainebleau Hotel in balmy Miami Beach, Florida at the American Society of Pain and Neuroscience Annual Conference. Today is the last day of the conference and I have the pleasure of talking with Dr. Tim Deer, the chairman of ASPN. Dr. Deer, thank you for talking with me today.

Dr. Tim Deer: Anne, thank you so much for having me. It's a great pleasure to talk to you and thank you for coming to our meeting.

Yes. Well, as you know, I think three years ago was the last time I was at your meeting, and I've had a colleague cover it who lives on the East Coast since then. Now I'm back covering the meeting and wow, has it grown exponentially since you and Dr. Sayed co-founded this meeting. I think this year, there's been a lot of energy and vibrancy around the content and in the exhibit hall and honestly, there's so much news for me to cover.

But before we get into the meeting, I thought it'd be a good idea to have you start by talking about the meeting itself, how it's grown, what the attendance has been this year, et cetera. And then what have been some of the key goals of society? And what have you and your vice chair, Dr. Sayed, been working toward as a society since you established the meeting?

Meet with SmartTRAK in Denver

The American Orthopedic Society for Sports Medicine (AOSSM) will hold its annual meeting in Denver, CO, from July 10-17, 2024. This meeting will bring together sports medicine physicians, clinicians and industry professionals and feature the latest research, cutting-edge updates and discussion on the future of sports medicine. SmartTRAK will be there.

Andy Knapik, SmartTRAK Senior Analyst, Soft Tissue & Arthroscopic Technologies, will be getting the scoop on what’s new at AOSSM and will be available to meet in person at the meeting. If you or your company have important news you’d like to share, or would like to learn more about SmartTRAK, please reach out to Andy at andy.knapik@smarttrak.com.

SmartTRAK has put together highlights of recent news in sports medicine to catch you up on the “news to know” before going to AOSSM 2024. The following is just a small sampling of recent news and SmartTRAK updates from around the world compiled, reviewed and posted in real-time every day by the expert analysts
at SmartTRAK.

New Products:

• Comparison Techniques For Medium To Massive Posterosuperior Cuff Tears
  

  Researchers look to prove that both transosseous-equivalent suture-bridge and independent double-row techniques provide comparable clinical results and retear rates for medium to massive posterosuperior RC tears. BMC Musculoskelet Disord

• Paragon 28*

  FNA mgmt highlighted five full launches YTD in 2024 in the high growth forefoot, minimally invasive and soft tissue markets including Grappler Knotless Anchor, Bridgeline Adaptive Tape, Mister Tendon Harvester, FJ200 Power Console and Burr System and PRECISION MIS Bunion System.

•  Stryker launches Citrefix Suture Anchor System
  

  Stryker announced the launch of Citrefix, a suture anchor system for foot and ankle procedures. The new system uses Citregen, a bioresorbable material designed to mimic the chemistry and structure of native bone. SmarTRAK reported on the Citrefix 510(k) approval in Feb 2021.

Patents:

•  Tissue Repair Devices and Methods

  US Patent “Tap-in bone anchor with expanding ring” was issued describing devices that can wrap around elongate tissue and are capable of supporting the tissue or keeping two severed ends in close proximity to one another. 12023030

• CONMED*

   CONMED's US Patent Application "MENISCAL TRANSPLANT SYSTEM" was published relating to a meniscal transplant workstation and accompanying tools for preparing a meniscal transplant and tibial surface and mounting the transplant to a tibia. 20240207068

• JNJ/DePuy Synthes*

  JNJ DePuy Synthes was issued US Patent “Methods And Devices For Repairing Meniscal Tissue” describing a suture anchor w/ an expanding ring that provides additional locking force for the device in bone. 12016545

Meet with SmartTRAK in Miami!

The American Society of Pain and Neuroscience (ASPN) will be holding
its 6th Annual Conference in Miami Beach from July 11-14, 2024, which
will feature the latest research, cutting-edge updates and discussion on
topics in pain and neuroscience.

SmartTRAK has put together highlights of recent news in SCS, PNS and
minimally invasive spine to catch you up on the “news to know” before
going to ASPN 2024. The following is just a small sampling of recent
news and SmartTRAK updates from around the world compiled,
reviewed and posted in real-time every day by the expert analysts
at SmartTRAK.

SmartTRAK’s Anne Staylor will be getting the scoop on what’s new at
ASPN, and will be available to meet in person at the meeting. If you or
your company have important news you’d like to share, please reach out
to Anne Staylor, SmartTRAK’s Executive Editor and VP & GM, Neuro
Therapies, at anne.staylor@smarttrak.com,

New Products:

• SPR Therapeutics' SPRINT extensa XT System with Bimodal PNS
  

  BSX was issued a US Patent, “Stimulation Modes To Adapt Customized Stimulation Parameters For Use In A Spinal Cord Stimulation System,” describing a graphical user interface to allow a pt to select a stimulation mode and predict optimal SCS parameters for personalized SCS.12017061

•  SiLO TFX* - Aurora Spine*

   Aurora Spine Corp. announced the successful use of SiLO TFX MIS Sacroiliac Joint Fixation Device in over a dozen patients, providing a minimally invasive surgical option for SI joint pain. Aurora estimates market opportunity > $2.3B/yr in the US and expects full launch by mid-year.

•  Inceptiv SCS: Offering Options in a Closed-Loop Device
  

  David Carr, Medtronic’s (MDT) VP and GM of Pain Interventions, discusses the company’s new Inceptiv SCS, what differentiates it from other SCS devices and what it means for MDT and the SCS market in an interview with SmartTRAK. Inceptiv SCS: Offering Options in a Closed-Loop Device

Patents:

• Nevro*

  NVRO’s US Patent Application, "Selective High-Frequency Spinal Cord Modulation For Inhibiting Pain With Reduced Side Effects, And Associated Systems And Methods," was published from 1.5 KHz to ~50 KHz SCS to treat LBP with reduced side effects.20240181258

• INBRAIN Neuroelectronics

  INBRAIN Neuroelectronics’ US Patent Application “SYSTEM FOR NEUROMODULATION APPLICATIONS” was published describing implantable and non-invasive wearable sensor-driven closed-loop neuromodulation systems that allow patient monitoring for PNS, VNS, DBS and SCS therapy. 20240207618

• SPR Therapeutics

  SPR Therapeutics was granted US Patent “Systems And Methods For Treating Shoulder Pain Related To Subacromial Impingement Syndrome” re one-time, continued or periodic PNS to neurological motor points of the posterior and middle deltoid muscles to mediate shoulder pain. 11944809

The proposed MAC LCDs for Skin Substitutes/CTPs was the hot topic of SAWC and will continue to be until the LCDs are finalized. In this article, SmartTRAK highlights new learnings from discussions at SAWC and the MAC open meetings.

The Symposium on Advanced Wound Care (SAWC) Spring 2024 meeting welcomed clinicians, researchers and industry to Orlando, FL, to learn, earn continuing education credits, share knowledge and network on the latest developments in advanced wound care. As is typical during SAWC, the Alliance of Wound Care Stakeholders also held a meeting of their members. With the Medicare Administrative Contractors (MACs) recently announced proposed changes in the Local Coverage Determination (LCD) governing Skin Substitutes/CTPs (cellular and/or tissue-based products), the Alliance pivoted and invited an expert to speak to the group about how the LCD process works and what laws govern what can be done at the MAC level versus the Center for Medicare & Medicaid Services (CMS) levels. Kudos go out to the team at the Alliance for bringing this meeting together. In addition to the Alliance meeting at SAWC, the MACs held open meetings for these LCDs from May 16 to May 29, and anyone, including manufacturers, could present comments, make a request and provide evidence. SmartTRAK participated in several of these meetings.

In this downloadable article, SmartTRAK gives an overview of LCDs, how they are drafted, the coverage limitations by wound type, issues surrounding evidence for inclusion on the covered list and an implementation timeline. For more information on what the proposed LCDs cover, see also “Medicare Administrative Contractors’ (MACs) LCD Changes: Impact on Skin Substitutes/CTPs.”

The following subjects are covered in detail in this downloadable article:

• The Process for Drafting LCDs
  As background, CMS governs the process for drafting the LCDs in their Medicare Program Integrity Manual (PIM) in Chapter 13, which was most recently updated in 2019 with almost every section re-written. These changes include ... (read more)
  
  
• Coverage Limitations
  The LCD is a literal guide to what is allowed and, conversely, what is automatically denied within the limits written in the LCD. The LCDs for Skin Substitutes/CTPs are for ... (read more)
  
  
• Missing or New Evidence and Reconsiderations
  One area that generated the most questions from manufacturers was how to address coverage decisions if the MAC working groups are missing recently published evidence or have evidence currently in development. The comment submission period was ... (read more)
  
  
• Timeline for LCD Implementation
  During the MAC open meetings, participants had several questions regarding the timeline for LCD implementation, and some requested a delay in implementation. The following timeline applies to all LCDs ... (read more)
  
  

" Perspective article by Jay Merkel, SmartTRAK Sr. Analyst.

INS President Dr. Marc Russo and INS President-Elect Dr. Konstantin Slavin discuss the current “state of the union” in neuromodulation, how the field is evolving and the challenges and opportunities that lie ahead in an interview with SmartTRAK at INS 2024.

At the 16th International Neuromodulation Society World Congress (INS 2024) held in Vancouver, Canada, Dr. Marc Russo, INS president, and Dr. Konstantin Slavin, INS president-elect, discussed the current “state of the union” in neuromodulation, how the field is evolving, where it’s going and trends in research, technology and clinical practice in an interview with SmartTRAK. They also discussed challenges and opportunities in the field, how the INS is addressing recent criticisms about neuromodulation and the promise and potential of neuromodulation across a wide range of clinical applications. 

To find out more, including the promising indications and areas of growth for spinal cord stimulation (SCS) and deep brain stimulation (DBS), click on the following video to listen to the interview recorded live at INS 2024 (51:53 min). Click hereto download a complete transcript of the interview. Topics by timecode are provided below. 

SmartTRAK highlights market and technology trends that will help drive growth in neurovascular interventions in 2024.

The neurovascular intervention market is poised for another exciting year in 2024, with key trends driven by an expanding treatable population and innovative technologies addressing critical gaps in patient care. The percentage of eligible acute ischemic stroke (AIS) patients who receive endovascular therapy (EVT) is projected to increase from ~25% in 2022 to ~40% in 2027E. According to the SmartTRAK US Mechanical Thrombectomy Market Overview, the market will generate a 5-year CAGR of 11.1%. Amidst market growth driven by treatment time window expansions, direct-to-EVT protocols and increasing evidence supporting EVT to treat large core stroke patients, SmartTRAK predicts continued advancements in three key areas: aspiration thrombectomy for ischemic stroke, automated stroke detection software and novel devices for treating intracranial aneurysms.

#1: Innovations to Increase Aspiration Efficiency
Aspiration thrombectomy is a mainstay of stroke treatment. With the increasing adoption of A Direct Aspiration, First Pass Technique (ADAPT), companies are innovating to improve aspiration efficiency, effectiveness, procedure speed, reperfusion and patient functional outcomes. SmartTRAK sees ... (read more)

#2 Accelerating Adoption of Automated Stroke Detection Technologies
Early and accurate stroke diagnosis is critical for timely intervention. Automated stroke detection software is gaining traction, with companies like Brainomix, RapidAI and Viz.ai leading the charge. Studies have shown that ... (read more)

#3 Aneurysm Treatment Beyond Flow Diverters
 While flow-diverting stents (FDS) remain a mainstay in treating intracranial aneurysms, SmartTRAK has witnessed the development of more novel devices catering to a broader range of aneurysm types and sizes since MicroVention introduced the Woven EndoBridge (WEB) device in 2011, the first intrasaccular device developed specifically for the treatment of wide-neck bifurcation aneurysms. This trend towards tailored solutions based on ... (read more)

The neurovascular intervention market is on an exciting trajectory, driven by increasing patient populations, innovative technologies and a focus on improving patient outcomes. 2024 promises to be a year of significant advancements in ... (read more)

Just click the button below to download and read the complete "Key Trends in Neurovascular Intervention for 2024" Market Outlook article by  Shelly Caruso, SmartTRAK Market Analyst/Associate Editor.

ISASS’s Morgan Lorio, MD, president-elect, discusses the obstacles to adopting emerging technologies in spine surgery and the importance of advocating for policy changes to support innovative treatments and improve patient outcomes in an interview with SmartTRAK.

Key topics discussed include ISASS’s successful efforts in addressing coding and reimbursement challenges to ensure access to innovative treatments for patients, the potential impact of artificial intelligence (AI) on reimbursement, the new ICD-10 codes for discogenic pain, regenerative spine treatments, future directions and initiatives for ISASS and fostering collaboration between industry stakeholders and surgeon societies.

Antimicrobial resistance (AMR) was directly responsible for 1.27 million deaths worldwide in 2019, according to the World Health Organization. With AMR now seen as a top global health concern and COVID-19 still in recent memory, the challenge of overcoming infections appropriately and effectively exists in all areas of healthcare and beyond. This includes wound care, with SmartTRAK forecasting that the WW antimicrobial market will exceed $1.00B for the first time in 2024.

One company aiming to tackle the challenge in antimicrobial therapies is Swiss-based Polaroid Therapeutics. The company has developed a proprietary advanced polymer technology that is designed to reduce bio-burden in a variety of settings, including in wound management. SmartTRAK recently caught up with CEO and co-founder Ran Frenkel to discuss the journey that the company has been on. Click on the video below to listen to the interview (15:01 min). A link to download the transcript of the interview is also provided below.

SmartTRAK: This is Kris Flinn with SmartTRAK. Today, I'm joined by Ran Frenkel, CEO and co-founder of Polaroid Therapeutics. Polaroid Therapeutics is a Swiss-based biotech startup focused on the development of innovative antimicrobial technology. The company has developed a proprietary advanced polymer technology that is designed to reduce bio-burden in a variety of settings, including in wound management. Ran, thank you for joining us today. Could you please start by giving me some background on yourself?

Ran Frenkel: Hi, Kris. Thanks. Happy to be here. I'm a pharmacist by training. For the last 25 years, I have been working in the pharmaceutical industry in different kinds of management positions in drug discovery and drug development. For the last 11 years, I was the Chief Development Officer of an oncology company here in the US, where we developed a first-in-class new drug for blood cancers, which was approved in over 50 countries. For the last two years, nearly two years, I joined Polaroid Therapeutics, moving from the oncology space into more of the antibacterials and wound management space.

Fantastic. So, Polaroid is a name that many people will recognize, but could you tell me a little about Polaroid Therapeutics specifically and the journey that the company's been on?

RF: Yeah, and it's a very nice story because everyone is familiar with ...

It is difficult to make it as a small to midsize company in the Global Wound Care Market, which was painfully evident for a few Swedish companies in the fall of 2023. SmartTRAK looks at lessons learned and explains why the future is still bright.

Sweden is traditionally a great place to start a wound care company. Several established global leaders are based there, like Mölnlycke*, Essity* and Arjo*. They fund early-stage companies and act as a source of skilled personnel. Strong universities and leading pharma and medical device companies also contribute to a dynamic market.

In the fall of 2023, not one, not two, but three Swedish companies found themselves in deep trouble. RLS Global filed for bankruptcy, Promore Pharma was liquidated and S2Medical was under reconstruction. In this article, SmartTRAK looks deeper at those companies, what went wrong, and highlights a few startups embarking on the journey. Lessons learned are not limited to the Swedish market but apply everywhere.

The companies covered in detail in this comprehensive Market Perspective article, which can be downloaded in its entiretyhere, are:

• Companies in Trouble
  • RLS Global*
  • Promore Pharma*
  • S2Medical*
• Successful Startups
  • Abigo Medical*  
  • Absorbest*
• Other Startups
  • Amferia
  • Ilya Pharma
  • Colzyx 
  • PressCise
  • ViTri Medical*
  • Odinwell
  • Dermicus
  • Seber Medical

Although the fall of 2023 was challenging for a few companies, the future looks bright for Sweden to maintain its position as a strong generator of ...

* These links can only be accessed by SmartTRAK subscribers. To learn more            about SmartTRAK and how to subscribe, scroll down.

Adam Hattan, VP of marketing for Route 92 Medical, discusses the SUMMIT MAX trial and provides an update on the company and products in an interview with SmartTRAK.

Route 92 Medical (R92) is raising the bar and advancing the treatment of acute ischemic stroke through its 250-patient SUMMIT MAX clinical trial, the first randomized controlled trial to evaluate the safety and effectiveness of “super-bore” 0.088” aspiration catheters. The company recently announced enrollment is complete in SUMMIT MAX, which features the company’s Monopoint Reperfusion System, including the HiPoint 88 and HiPoint 70 Reperfusion Catheters and the Tenzing Catheters. HiPoint is currently approved by the FDA as an access catheter, but the company plans to submit the results of SUMMIT MAX to the FDA to obtain the NRY indication, which would allow physicians to use the device on label as an aspiration catheter.

For an update on R92, its products and what SUMMIT​ MAX means for the company and market, SmartTRAK interviewed Adam Hattan, R92’s vice president of marketing. Click on the video below to listen to the interview, recorded via Google Meet (19:48 min). A link to download the complete transcript of the interview is also provided below.

SmartTRAK experts across orthopedics, sports medicine, spine and enabling technology attended this year’s 2024 Canaccord Genuity Musculoskeletal and American Academy of Orthopedic Surgeons (AAOS) annual conferences. Held from February 12-15 in San Francisco, CA, these gatherings brought together the top minds in the industry. In this post, we share some key insights and updates gleaned from these conferences, offering a glimpse into the latest trends and innovations shaping the future of orthopedic and musculoskeletal care.

• MARKET

Maxx Orthopedics*
SmartTRAK learned at AAOS 2024 that Maxx Medical is going on the offensive to grow its joint replacement business in the US and that the Company plans to launch new hip and knee products in 2024.

Paragon 28*
At AAOS 2024, Paragon 28 noted that its supply chain issues have resolved and does not expect a headwind this year. As a result, Needham believes the company can return to ~20% revenue growth in 2024.

restor3d*
Restor3d reported it currently has 157 active distribution partners calling on ~22,965 orthopedic surgeons and ~18,000 podiatrists. Management noted surgeons will bring difficult cases and from there restor3d can create additional sales opportunities. CG 2024 Musculoskeletal Conference

• REVENUES

BONESUPPORT*
BONESUPPORT highlighted the continued strength of Cerament G in North America with approximate revenues of $17.0MM in Q323 since launching in June 2023. CG 2024 Musculoskeletal Conference

OrthAlign*
At AAOS 2024, SmartTRAK learned that OrthAlign’s 2023 revenue was up +25% to $51MM, led by strong adoption of its Lantern next-generation handheld navigation system and increasing use of the Balance gap balancing feature on Lantern Knee. The company noted +37% growth in the ASC setting.

SmartTRAK takes a look at the trends impacting the Extremities Market in 2024 and beyond.

Among the many topics covered in detail in this market outlook article are:

• CMS Reimbursement Changes Accelerate Shift to Arthroplasty Site-of-Care
  The Centers for Medicare and Medicaid Services’ (CMS) move to reimburse shoulder replacement and ankle replacement in an ambulatory surgery center (ASC) setting will accelerate the move of procedures to ... (read more)
  
  
• An Increase in Pricing Pressure from the Shift to Shoulder ASC Procedures
  The national average CMS facility reimbursement in 2024 for total shoulder arthroplasty in an ASC is approximately $14K, significantly lower than for hospital-based procedures in the range of ... (read more)
  
  
• The Race is on for Shoulder Robotics
  Stryker and Zimmer Biomet appear to be racing to the finish line to be the first to market in the US with a shoulder robotics solution. During Zimmer Biomet’s Q323 earnings call, CEO Ivan Tornos stated they plan to be first on ... (read more)

From OEM manufacturers getting dressings approved in the US to pressure injury prevention focus - SmartTRAK takes a closer look at what to keep an eye on in 2024.

SmartTRAK forecasts the WW Advanced Wound Dressing Market will grow at a 5-year CAGR of +5.2%. The market grew +5.2% in Q323 and +5.6% in the first three quarters of 2023. Advanced Wound Dressings is a market spread relatively evenly across geographies, with Europe currently representing a 44.1% share of the 2023 worldwide (WW) market, the US representing 27.9% and the ROW 28.0%.

Looking ahead, SmartTRAK sees three trends continuing in 2024. They are:

• Growing Use of OEM Manufacturers in the US
  In the US, most dressings require 510(k) clearance by the FDA. A strong trend in recent years is that original equipment manufacturer (OEM) providers have been getting their products approved for sale in the US and then ... (read more)
  
  
• Major Players Investing in Infrastructure
  Another trend of interest is more activity than usual from leading companies investing in infrastructure. SmartTRAK examines recent events and the potential drivers behind those decisions ... (read more)
  
  
• Growth in Dressings for Pressure Injury Prevention
  SmartTRAK expects the use of dressings for pressure injury prevention to be a key growth driver in the Advanced Wound Dressing Market in the coming years. The trend is supported by an increasing body of evidence indicating that ... (read more)
  

SmartTRAK has developed an in-depth analysis of the pressure injury prevention market, including the market size for the US, Europe, and the rest of the world (ROW), five-year forward forecasts, clinical and laboratory evidence, key drivers of market growth, and product technologies and claims. To find out more, please click here.

To download and read the complete "Advanced Wound Dressings: 2024 Market Outlook" by Lennart Stadler, SmartTRAK GM, OUS & Sr. Analyst, Wound and Anikó Szekér, SmartTRAK Sr. Analyst, Wound, just click the button below.

Rich ongoing data updates and comprehensive expert analyses will deliver evolving market trends and conditions for wound care professionals.

MALVERN Pa., (February 15, 2024) — HMP Global’s Wound Care Learning Network (WCLN) today announced a partnership with SmartTRAK, a comprehensive life sciences market intelligence solution providing real-time market data and analysis along with expert insight on evolving trends and conditions of interest for wound care professionals.

With the eyes of the wound care world focused on the markets for Skin Substitutes and Antimicrobials, SmartTRAK discusses how 2024 could be a disruptive year for Debridement.

SmartTRAK forecasts that the WW Debridement Market will grow at a 5-year CAGR of +4.9% to 2027E, at which point it will be valued at over half a billion dollars. In this article, Kris Flinn, SmartTRAK's Sr. Analyst, Wound, does a deep dive into what's ahead for the debridement market, including the indexed growth for Advanced Wound Care (AWC) and Debridement for each of the three SmartTRAK geographical regions: US, Europe (EU) and the Rest of World (ROW).

Among the topics covered in detail in this market outlook article, which can be downloaded here, are:

• Chemical Debridement Growing Pains
  Chemical Debridement is the smallest of the Debridement segments The WW 5-year CAGR of +69.1% promises a brighter future, with usage growing across all geographic regions, including ...
• New Enzymatic Debridement Technologies Continue to Build Evidence
  MediWound presented Phase IIB clinical trial results for bromelain-based EscharEx at the SAWC Spring meeting in May 2023. The 120-patient venous leg ulcer, multicenter, randomized control trial compared EscharEx with a placebo gel vehicle and a non-surgical standard of care (SoC). Results showed...

Medtronic executives discuss how the Company is making waves in interventional pain, minimally invasive spine and deep brain stimulation in an interview with SmartTRAK at NANS 2024.

Medtronic’s David Carr, vice president and general manager of Pain Interventions, and Amaza Reitmeier, vice president and general manager of Brain Modulation, discuss the Company’s latest news, research and innovation in an interview with SmartTRAK at the North American Neuromodulation Society (NANS) 2024 Annual Meeting held January 18-21 in Las Vegas, Nevada.

To find out more, including the Company’s priorities and vision for interventional pain, minimally invasive spine and deep brain stimulation, click on the following video to listen to the interview (32:30 min). Topics by timecode are provided below, and you can click the button to download a transcript of the interview.

Interview Topics by Timecode:

00:27 David Carr introduction and background. Overview of Medtronic’s top news at NANS and the importance of the Company’s broad portfolio of pain intervention solutions, including stimulation, targeted drug delivery and interventional spine. 

04:28 Overview of Medtronic’s presence at NANS regarding clinical and scientific research vs competitors. Highlights of clinical data from Australian ECAPs study to support the introduction of the Inceptiv Spinal Cord Stimulation (SCS) system, what’s next for Inceptiv and how Inceptiv differs from other ECAP-based SCS devices. Discussion of other research and evidence to support expanded indications and health economics. Company strategies for leveraging data to drive adoption, reimbursement and growth in non-surgical refractory back pain and diabetic painful neuropathy (DPN),

Throughout 2023, SmartTRAK led the way in helping you Be The Expert in the MedTech industry. Serving as your trusted resource for the latest industry developments, we provided real-time market data and analysis across the orthopedic, wound care, regenerative medicine and neurotherapy sectors.  Presenting SmartTRAK's Top 12 Blog Posts from 2023, featuring indispensable insights from our expert analysts.

1. Could Reverse Hips Change the Total Hip Game?
   Hip Innovation Technology is betting on its Reverse HRS Hip to change the practice of total hip replacement
   
   
2. Three Ortho Robotics Companies to Watch in 2023
   SmartTRAK identifies three orthopedic robotics companies strategically positioned to shake things up this year in the fast-growing robotic-assisted TJA market.
   
   
3. Saluda Medical: Changing the Game in Spinal Cord Stimulation
   Saluda Medical President and CEO Jim Schuermann discusses the Company, the Evoke System and changing the game in SCS in an interview with SmartTRAK.
   
   
   
   

SmartTRAK talks with Hybrisan CEO Dr. Mortimer to discuss the challenge of biofilms and the Company’s journey to bring its WoundSan technology to market.

The AWC Summit, held biannually, brings together established companies, start-ups, research organizations and various industry stakeholders. SmartTRAK previously covered the US event in July 2023 in Boston, MA, focusing on advancing the commercialization of new technologies in wound care, and was in London, UK to cover the EU Summit. 

A regular feature of the Advanced Wound Care (AWC) Summit is the Innovation Showcase. At the event in London, six companies took turns pitching their technologies, with the delegates voting to award one company as the winner.
Following the vote, the winning organization was announced as Hybrisan. SmartTRAK talked with Hybrisan CEO Dr. Mortimer to discuss its Woundsan technology and the challenge of combating biofilms in wound care. The interview can be viewed below and a transcript can be downloaded by clicking the button:

Future Events

The next AWC Summit will be the US edition and will take place in Boston, MA on the 16^thand 17^thof April, 2024. SmartTRAKwill be in attendance and will be discussing the latest insights within wound care. More information on the event is available  here. The next European event is planned for late 2024, with details to follow.