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.
3 min read
Facing the Payback Crisis: Challenges Threatening Italy’s Medical Device Sector
2 min read
Negative Pressure: Still Innovating, Growing and Expanding
SmartTRAK examines the market dynamics, innovations and growth drivers for Negative Pressure Wound Therapy.
Since KCI (now
Solventum) introduced the wound V.A.C. to the market in 1996, traditional Negative Pressure Wound Therapy (tNPWT) has become the standard of care in hospitals for the treatment of hard-to-heal wounds
.
While tNPWT has and will continue to experience low-single-digit revenue growth over the next several years, most of the growth in this space has been in single-use NPWT (sNPWT). According to
SmartTRAK's US External Devices Market Overview, the US Market for sNPWT is forecasted to grow at a 5-year CAGR of roughly +13%
.
In this article, SmartTRAK provides an overview of the market dynamics impacting both the tNPWT and sNPWT segments of the US External Devices Market, including:
- Traditional Negative Pressure
- Solventum and Smith+Nephew (SNN) are two key players in the tNPWT category, with a combined US market share of almost ... (read more)
- Solventum and Smith+Nephew (SNN) are two key players in the tNPWT category, with a combined US market share of almost ... (read more)
- Single-Use Negative Pressure
- Like the tNPWT market, both Solventum and SNN are key players in the sNPWT segment, together owning the vast majority of the market. sNPWT has been attracting a lot of interest from wound care companies, large and small, due to its sustained double-digit growth globally. SmartTRAK identifies and discusses three market strategies that are currently playing out in sNPWT as companies position themselves to capture share in this fast-growing segment. They are:
- Large Dressing Companies Expanding into the sNPWT Adjacency
- Start-Ups Focus on Pump-Free Products.
- Growing the Market Through Expanded Use, Clinical Evidence ... (read more)
- Like the tNPWT market, both Solventum and SNN are key players in the sNPWT segment, together owning the vast majority of the market. sNPWT has been attracting a lot of interest from wound care companies, large and small, due to its sustained double-digit growth globally. SmartTRAK identifies and discusses three market strategies that are currently playing out in sNPWT as companies position themselves to capture share in this fast-growing segment. They are:
Click the button below to access and read the complete "Negative Pressure: Still Innovating, Growing and Expanding" article by Jay Merkel, SmartTRAK Sr Analyst, which highlights key large studies on the use of sNPWT in 2024, breaking them out into the studies that show benefits and the studies with moderate or no benefits. 
Topics:
Wound Care
NPWT
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4 min read
Reimbursement Changes: Wound Dressings Under Threat in Germany
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.
3 min read
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.
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. 
3 min read
SAWC Spring 2024: Highlighting the Hot Topic of Skin Substitute Reimbursement
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)
Topics:
Wound Care
Skin Substitute/CTP
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3 min read
Medicare Administrative Contractors' (MACs) LCD Changes: Impact on Skin Substitutes/CTPs
All seven MACs, in a united front, released proposed changes to the LCDs, which govern Skin Substitute/CTP use for DFUs and VLUs. SmartTRAK looks at 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.
Topics:
Wound Care
Skin Substitute/CTP
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2 min read
Vaporox Company Spotlight
New leadership at Vaporox to launch a second generation of vaporous hyperoxia therapy at SAWC Spring 2024.
With the upcoming launch of its second-generation Vaporous Hyperoxia Therapy (VHT-200), Denver, CO-based Vaporox is well positioned to treat a wide range of chronic, hard-to-heal wounds and expand the company’s presence in the almost five billion dollar US Market for Advanced Wound Care. SmartTRAK spotlights the company, its latest research and VHT, a breakthrough technology designed to accelerate wound healing when combined with standard or advanced wound care.
In this comprehensive SmartTRAK Perspective article, available for download, we delve deep into Vaporox, exploring a variety of detailed topics, including:
- The Overview
Vaporox CEO and President Alan Sage, a successful start-up entrepreneur, brings his decades of experience to the medical device industry to bring VHT-200 to market. The novel technology was developed as a result of work at UCLA Medical Center for children with debilitating bed sores ... - Technology/Key Differentiator
VHT delivers a unique combination of elements that accelerate healing: ultrasonic mist and concentrated oxygen. Vaporox administers these elements in a patented, automated, dual-modality system ... - Market Potential
After starting in the diabetic foot ulcer (DFU) space, the company has quickly expanded into facilities treating all types of wounds, including venous leg ulcers (VLUs), dehisced post-surgical wounds, burns and pressure injuries ... - Business Model/Financing
The Vaporox business model provides the device to the clinician at no cost and charges for the disposable and pay-per-use fees ... - Clinical/Regulatory Status
Vaporox received FDA 510(k) clearance for the second-generation VHT-200 product in the spring of 2023 ... - Reimbursement
VHT is a low-frequency, non-contact, non-thermal ultrasonic mist therapy. It is an FDA-cleared technology that has been clinically validated as a safe and effective adjunctive treatment for healing nine types of skin wounds ... - Goals
The company just hired a new vice president of sales and marketing and is aggressively pursuing high-volume private-practice podiatric surgeons, medical doctors, and nursing facilities ...
To download and read the complete "Vaporox Company Spotlight" perspective article by Susan Paquette, SmartTRAK VP & General Manager, Wound, just click the button below. 
Topics:
Wound Care
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3 min read
Polaroid Therapeutics: Start-Up Spotlight
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 ...
Topics:
Wound Care
Start-up Spotlight
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4 min read
Swedish Wound Care Companies – You Win Some, You Lose Some
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
- Successful Startups
- Other Startups
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.
Topics:
Wound Care
Top Story
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3 min read
Desert Foot 2023: Caring for Patients with DFUs
Established and innovative new biologic products share space at Desert Foot 2023.
The diabetic population in the US continues to rise, with the Centers for Disease Control and Prevention (CDC) estimating that ~11.3% of US adults will be diagnosed with diabetes in 2021, the vast majority having Type II. The number of diabetics is even higher in the Veterans Health Administration (VHA), where one in four (25%) has diabetes, according to recent statistics published in VA News.
According to the Mayo Clinic, Type II diabetes can eventually lead to high blood sugar levels, which can cause disorders of the circulatory, nervous and immune systems. One ailment that often arises with diabetes is the occurrence of a diabetic foot ulcer (DFU) due to poor blood flow and neuropathy that many of these patients experience. The prevalence of a DFU varies with age, ranging from two percent in younger adults to eight percent in adults 65 and older.
In this article, which can be downloaded here, SmartTRAK reports on:
- Skin Substitute Market Leaders at Desert Foot
- Four of the top five US skin substitute/ CTP companies had a strong presence at the meeting. They were ... (read more)
- Four of the top five US skin substitute/ CTP companies had a strong presence at the meeting. They were ... (read more)
- Companies and innovations that caught SmartTRAK’s attention, including:
- MicroVascular Tissues (MVT) - Featured mVASC, an off-the-shelf human tissue allograft consisting of ... (read more)
- Fidia US - Showcased its newly launched Wound Care line of products, including ... (read more)
- Merakris Therapeutics - Provides Dermacyte Amniotic Wound Care Matrix (Dermacyte Matrix) to the market as a skin substitute. However, at Desert Foot, the company discussed its ongoing clinical trial to investigate ... (read more)
- Omeza - Presented its unique Omeza Complete Matrix (OCM) product and started the presentation by stating, “Omeza is not a Collagen Dressing or Product!! OCM is not a Dressing.” The company described OCM as ... (read more)
To download and read the complete "Desert Foot 2024" article by Susan Paquette, SmartTRAK VP & General Manager, Wound, just click the button below.
Topics:
Wound Care
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