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SmartTRAK Life Sciences News and Analysis Blog

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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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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2 min read

Vaporox Company Spotlight

By Susan Paquette on 5/2/24 6:33 PM

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. Read the Article

Topics: Wound Care
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3 min read

Polaroid Therapeutics: Start-Up Spotlight

By Kris Flinn on 4/12/24 10:42 AM

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.

Download the Transcript

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 ...

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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

Desert Foot 2023: Caring for Patients with DFUs

By Susan Paquette on 3/12/24 9:30 AM

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)

  • 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.
      Read the Article
Topics: Wound Care
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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

Advanced Wound Dressings: 2024 Market Outlook

By Lennart Stadler on 2/20/24 9:30 AM

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. Read the Article

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3 min read

HMP Global’s Wound Care Learning Network Partners with SmartTRAK to Provide Wound Care Market Intelligence, Analysis

By SmartTRAK on 2/15/24 1:44 PM

Rich ongoing data updates and comprehensive expert analyses will deliver evolving market trends and conditions for wound care professionals.

MALVERN Pa., (February 15, 2024) — HMP Global’s Wound Care Learning Network (WCLN) today announced a partnership with SmartTRAK, a comprehensive life sciences market intelligence solution providing real-time market data and analysis along with expert insight on evolving trends and conditions of interest for wound care professionals.

Topics: Wound Care
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2 min read

Wound Debridement 2024 Outlook

By Kris Flinn on 2/12/24 12:08 AM

With the eyes of the wound care world focused on the markets for Skin Substitutes and Antimicrobials, SmartTRAK discusses how 2024 could be a disruptive year for Debridement.

SmartTRAK forecasts that the WW Debridement Market will grow at a 5-year CAGR of +4.9% to 2027E, at which point it will be valued at over half a billion dollars. In this article, Kris Flinn, SmartTRAK's Sr. Analyst, Wound, does a deep dive into what's ahead for the debridement market, including the indexed growth for Advanced Wound Care (AWC) and Debridement for each of the three SmartTRAK geographical regions: US, Europe (EU) and the Rest of World (ROW).

Among the topics covered in detail in this market outlook article, which can be downloaded here, are:

  • Chemical Debridement Growing Pains
    Chemical Debridement is the smallest of the Debridement segments The WW 5-year CAGR of +69.1% promises a brighter future, with usage growing across all geographic regions, including ...
  • New Enzymatic Debridement Technologies Continue to Build Evidence
    MediWound presented Phase IIB clinical trial results for bromelain-based EscharEx at the SAWC Spring meeting in May 2023. The 120-patient venous leg ulcer, multicenter, randomized control trial compared EscharEx with a placebo gel vehicle and a non-surgical standard of care (SoC). Results showed...
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