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SmartTRAK Life Sciences News and Analysis Blog

3 min read

Meet John Hatchell: SmartTRAK's Director of Sales for the Commercial Team

By Sharon O'Reilly on 7/18/24 9:45 AM

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.

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5 min read

ASPN 2024: SmartTRAK's Interview with Tim Deer, MD

By Anne Staylor on 7/16/24 8:41 PM

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?

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7 min read

What's New in Sports Medicine: SmartTRAK at AOSSM 2024

By Thomas Wallick on 7/10/24 9:45 AM

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

  • 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'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 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

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11 min read

What's New in Interventional Pain Management? News to Know Before ASPN in Miami

By Thomas Wallick on 7/2/24 9:45 AM

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

  •  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 SmartTRAKInceptiv 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

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2 min read

M&A in the Total Joints Market

By Lisa Mahan on 6/25/24 9:45 AM

Companies riding the wave of tuck-in acquisitions.

While the chances are relatively low that the Total Joints Market will see a tsunami-size merger in 2024 that would materially change the market landscape, SmartTRAK expects to see a ripple effect from companies that continue to seek out mergers and acquisition (M&A) deals despite the challenging economic climate. Since the beginning of 2023, deals that had a more subtle effect on the market include those providing expanded international reach or initial entrance into the market. In this downloadable article, SmartTRAK highlights the acquisitions taking place since the beginning of 2023 and outlines the sentiment of some of the major companies towards future M&A. SmartTRAK also looks at what may be coming for the top Total Joints Market players, including Zimmer Biomet, Stryker, J&J/DePuy Synthes and Smith+Nephew, as they continue riding the wave of tuck-in acquisitions ...

Just click the button below to read the complete "M&A in the Total Joints Market" perspective article written by Lisa Mahan, SmartTRAK VP Product Development & IT, Sr. Analyst Total Joints. Read the Article


SmartTRAK is the Medtech industry’s only global Insights-as-a-Service solution for the Orthopedics, Wound Care, Regenerative Medicine and Neuro Therapy markets. SmartTRAK’s propriety methodology turns disparate data from hundreds of sources into powerful insights customers can rely on as the trusted source for strategic decision-making. The SmartTRAK enterprise platform includes rich daily updates, comprehensive market coverage and simple-to-use tools and dashboards for market, product and financial analysis. Customers leveraging the SmartTRAK platform also have direct access to market experts for inquiries and advisory services. If you would like a demo of what SmartTRAK offers and how we can help increase proficiency, improve productivity and reduce costs for your company, just click here.

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3 min read

SAWC Spring 2024: Highlighting the Hot Topic of Skin Substitute Reimbursement

By Jay Merkel on 6/19/24 11:55 AM

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)

Just click the button below to download and read the complete " SAWC Spring 2024: Highlighting the Hot Topic of Skin Substitute Reimbursement " Perspective article by Jay Merkel, SmartTRAK Sr. Analyst.
Read the Article

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4 min read

INS 2024: The Past, Present and Future of Neuromodulation

By Anne Staylor on 6/17/24 12:16 PM

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. 

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3 min read

Orthopedic Enabling Tech Trends at AAOS and Beyond

By Elise Wolf on 6/4/24 9:45 AM

SmartTRAK highlights four key trends to watch in orthopedic enabling tech displayed at the 2024 AAOS and Canaccord Genuity Musculoskeletal Conferences.

Enabling technology was a hot topic of discussion at the 2024 Canaccord Genuity (CG) Musculoskeletal Conference and was a big focus at this year’s American Academy of Orthopaedic Surgeons (AAOS) annual meeting in San Francisco, California.   SmartTRAK  highlights four key trends noted at the meetings and expected through 2024 and beyond in orthopedic enabling tech and reports on key news from 17 companies in this space, ranging from multinational strategics to start-ups.
 

SmartTRAK's four key trends to watch in orthopedic enabling tech, which are discussed in detail in this downloadable Market Outlook article, are: 

    • Continued Growth in Ortho Robotics 
      • Similar to the last several years, robotics continued to be a large focus of orthopedic enabling tech at this year’s meetings, with SmartTRAK projecting ... (read more)
    • Navigation Targeted to ASC
      • Newer navigation technologies are overcoming the hurdles of traditional navigation systems and are making headway into the ASCs with designs targeted specifically to ... (read more)
    • Augmented Reality Gaining Traction
      • Intraoperative augmented reality continued to be an area of interest at the AAOS and Canaccord meetings this year, and SmartTRAK noted an ever-expanding number of ... (read more)
    • Advances in Smart Implants
      • Smart implants will continue to advance in 2024 as companies launch new products and work toward expanded applications. In addition to next-generation knee robotics and partial cementless knees ... (read more).
Click the button below to download and read the complete "Orthopedic Enabling Tech Trends at AAOS and Beyond" Market Outlook article by Elise Wolf, GM & VP, SmartTRAK Orthopedics, Digital & Quality. Read the Article
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3 min read

Medicare Administrative Contractors' (MACs) LCD Changes: Impact on Skin Substitutes/CTPs

By Susan Paquette on 5/29/24 9:45 AM

All seven MACs, in a united front, released proposed changes to the LCDs, which govern Skin Substitute/CTP use for DFUs and VLUs. SmartTRAK lookat the potential impact on the market.

A long-awaited update to Medicare coverage for skin substitutes has arrived. On April 25, 2024, all seven MACs issued the same proposed Local Coverage Determination (LCD) governing the use of skin substitutes/CTPs for the treatment of diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs). For seasoned SmartTRAK subscribers, the decision to release an updated LCD was not a surprise. Several of the MAC directors have openly discussed tackling the LCDs. In 2022, a few of the MACs issued a different proposal, and in August of 2023, three MACs issued a final LCD governing skin substitutes for implementation later in 2023, only to be rescinded days before the effective date. In August 2023,  SmartTRAK published an article, " Impact of Medicare Administrative Contractor LCD Changes on Skin Substitutes/CTP Changes," discussing the potential impact of those earlier attempts.


Since the article was published last year, SmartTRAK has identified explosive market growth in some new care sites and added a new category, Mobile+, for expanded coverage. 

In this downloadable article, SmartTRAK delves into Mobile+, the key provisions in the proposed LCDs, patients affected and the estimated financial impact on the market, including:

  • Key Policy Changes
    • One of the key limitations of these LCDs is the number of product applications. Previous LCDs often had a ... (read more)
  • Impact on Patients
    • With the united front from all the MACs, this LCD will impact all traditional Medicare patients across the US. Patients enrolled in Medicare Advantage plans are also impacted by ... read more)
  • Market Impact
    • By reviewing the LCD coverage changes and mapping them to the various sites of care that have varying payment models, SmartTRAK sees ... (read more)
  • Links to LCDs and Articles from the CMS Announcement
  • List of Covered Products with Companies and Ulcer Sizes
  
Just click the button below to download and read the complete "Medicare Administrative Contractors' (MACs) LCD Changes: Impact on Skin Substitutes/CTPs" Perspective article by Susan Paquette, SmartTRAK VP & General Manager, Wound and Jay Merkel, SmartTRAK Sr. Analyst, Wound.Read the Article
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3 min read

Key Trends in Neurovascular Intervention for 2024

By Shelly Caruso on 5/21/24 9:45 AM

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. Read the Article

Topics: Neurovascular
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