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SmartTRAK Life Sciences News and Analysis Blog

3 min read

Skin Substitute Market Rocked by DOJ Investigations

By Susan Paquette on 8/7/24 10:59 AM

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.

 In June, the Department of Justice (DOJ)   announced  the 2024 National Health Care Fraud Enforcement Action, which resulted in criminal charges against 193 defendants, including 76 doctors, nurse practitioners, and other licensed medical professionals in 32 federal districts across the US, for their alleged participation in various healthcare fraud schemes. Of these, four defendants were charged in a scheme involving amniotic tissue to treat chronic wounds.

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.   Read the Article

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8 min read

Clues Point to Acetabular Reconstruction

By Lisa Mahan on 7/30/24 9:45 AM

Clue s AcetabularRecent patent applications reveal an industry focus on developing acetabular solutions

While enabling technologies in joint replacement continue to be in the spotlight, clues revealed in the shadows of data point to niche focus areas for hip implant advancements. After examining the evidence in US patent applications filed since the beginning of the year, SmartTRAK identified a trend towards acetabular implant solutions. These solutions include implant designs that can address or potentially reduce the risk of acetabular bone loss or instability, often encountered in revision hip arthroplasty.

SmartTRAK’s US Hip Replacement Market Overview points out that revision hip procedure growth remains lower than that for primary hips due to the extended implant survivorship of next-generation implants and materials. However, revision hip procedures are expected to grow with a 5-year CAGR of +3.5% to nearly 110K procedures by the end of 2028. And, according to a paper by Sahil A. Sanghavi, MS, DNB, et al., acetabular bone loss continues to be one of the most challenging issues faced by orthopedic surgeons. (J Am Acad Orthop Surg, May 2024).

At least 15 patent applications published since January 1 are related to acetabular implant solutions. The line-up of patent subjects ranges from trial implants for more accurate cup placement during surgery to custom 3D printed augments with filings from large market players to designing surgeons. In Figure 1 below, SmartTRAK outlines the most recent acetabular implant-related patent applications.

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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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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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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

Spine Market Movers to Watch in 2024

By Kris Jacques on 4/9/24 9:30 AM

SmartTRAK highlights companies to watch as they continue their double-digit growth train with multiple catalysts for expansion in 2024.

Overall, the US Spine Market had a remarkable year in 2023 with the completion of the Globus/NuVasive (GMED) merger creating a new #2 in Spine, displacing the incumbent DePuy Synthes (JNJ). SmartTRAK estimates the US Spine Hardware Market grew ~5.5% in 2023. However, many pure-play spine companies exceeded industry growth with exceptional, double-digit growth rates in 2023, while others approached the $100MM revenue milestone. In this article, SmartTRAK highlights five pure-play spine companies to watch and the catalysts driving their expansion in 2024.
 

Continued Double-Digit Growth in 2024

SmartTRAK  expects three spine companies to see continued double-digit growth in 2024, particularly based on competitive moats developing and the ability to execute in their respective purviews, They are:
  • Alphatec Spine: Expanding Its Competitive Moat in Lateral Procedures
    • Alphatec has grown double digits yearly over the last five years. ATEC is now the #1 pure-play Spine Market leader and #5 in the overall Spine Market. These market share gains can be attributed to ... (read more)
  • SI-Bone: Competition Will Test the SI Fusion Market Leader in 2024
    • SI-Bone has grown double digits over the past three years. SIBN is the market leader in minimally invasive spine (MIS) SI Fusion with over 55% market share in the SI Fusion Market and more than ... (read more)
  • Centinel Spine: Fastest Growing Spine Company in 2023
    • In 2023, Centinel Spine was the fastest-growing spine company in one of the fastest-growing areas in spine, motion preservation. Centinel Spine reported record worldwide total disc replacement (TDR) revenue of nearly ... (read more)

Companies Closing in on $100MM in 2024

Both Spinal Elements and Xtant Medical came close to reaching the $100MM revenue mark in 2023 and SmartTRAK expects both to reach that lofty milestone in 2024. 

  • Spinal Elements: Focus on MIS Innovation, the Aging Spine and ASCs
    • Spinal Elements was just shy of $100MM in revenues in 2023. The company is focused on some of the fastest-growing trends in spine including ... (read more)
  • Xtant Medical:  Integrated Hardware, Biologics and More Acquisitions
    • Xtant Medical (XTNT) is also closing in on the $100MM revenue mark, growing +54.5% over 2022. XTNT had an exciting year of acquisition activity, including ... (read more)

To download the complete "Spine Market Movers to Watch in 2024" article by SmartTRAK's  Kris Jacques, please just click the button below. Read the Article

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4 min read

Swedish Wound Care Companies – You Win Some, You Lose Some

By Lennart Stadler on 4/2/24 9:30 AM

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:

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.

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3 min read

What Impact will GLP-1 Agonists have on Chronic Wounds?

By Kris Flinn on 3/5/24 2:24 PM

With many believing that GLP-1 agonists should be considered a “wonder drug,” SmartTRAK explores what impact their use could have on the market for wound care.

S martTRAK  estimates  that there were 77.7MM chronic wounds worldwide (US, Europe, Japan, Australia, Canada, Brazil, China and India) in 2022, of which 41.4MM were hard-to-heal. Wound numbers are forecast to grow at a five-year CAGR of +0.8%, which is higher than the forecasted population growth of +0.3% but below the growth of those aged over 65 years old.
 
In this article, SmartTRAK provides an overview of GLP-1 agonists, explores the possible impact these drugs will have on the conditions that drive wound prevalence and advises on how the outcomes will influence future estimates.
 
Among the topics covered in this article are:
  • What are GLP-1 Agonists?
    GLP-1 agonists are a class of drugs mimicking the action of a hormone called glucagon-like peptide 1. The drugs stimulate glucose-dependent insulin release from the pancreas. A range of agonists have been developed and launched, with the first product being ... (read more)

  • What is the Future for GLP-1 Agonists?
    Financial indicators suggest that GLP-1 agonists are expected to expand significantly in use around the world. The two companies with drugs licensed for weight loss have seen record share price growth are ... (read more)

  • What Impact Are GLP-1 Agonists Expected to Have on Diabetes and Obesity?
    When GLP-1 agonists were launched in 2005, they required twice daily injections. This was driven by the rapid elimination, or short half-life, of the compounds. With further development, companies have improved usability and weekly injections and ... (read more)
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3 min read

Medtronic: Making Waves At NANS 2024

By Anne Staylor on 2/6/24 9:40 AM

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.

Download the Transcript

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),

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