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.