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. 

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.  

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.

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.

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.