SmartTRAK reports from the recent Wounds UK conference and discovers optimistic resilience in the face of challenging conditions.

SmartTRAK forecasts a challenging future for the UK Advanced Dressings Market. The UK has accessible outpatient reimbursement for dressings, has minimal higher-priced technologies such as Skin Substitutes and is the home market for two of the biggest global dressing companies. So why does this market show such low growth potential?

At the recent Wounds UK 2024 event, in an uncharacteristically sunny Harrogate, UK, SmartTRAK explored what is driving these variances and found a market in a period of change, as companies address commercial challenges with optimistic resilience, focusing on the following key topics:

• Pricing and Contracts
  • The fall had seen large tenders completed for The NHS Supply Chain and NHS Wales. These offered the first opportunity for significant price reviews for dressings in the hospital channel since COVID-19. Most companies that SmartTRAK spoke to anticipate prices to ... (read more)
• Wound Clinics
  • Private wound clinics continue to grow in the UK. The National Health Service (NHS) has been under significant pressure since COVID-19, and members of the public are increasingly open to ... (read more)
• Lack of Product Innovation
  • There was a noticeable lack of new innovative products at the conference, with leading companies primarily focusing on ... (read more)

Click the button below to download and read the complete "UK Market Growth Undermined by Advanced Dressings Challenges" perspective article by Kris Flinn, SmartTRAK Senior Analyst - Wound.

SmartTRAK looks at the market’s response to the recently finalized LCDs and the potential impact on the US Market for Skin Substitutes.

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)
    
• 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)

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.

 

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.

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.

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.