CAMPs 2025 meeting highlights the use of CAMPs in all sites of care.

SmartTRAK reports the latest news and trends in cellular, acellular and matrix-like products (CAMPs) from the CAMPs 2025 Wound Care Summit held February 28 to March 2 in Fort Lauderdale, Florida. Hosted by the Journal of Wound Care (JWC), CAMPs 2025 showcased new clinical research, consensus guidelines and presentations supporting the use of CAMPs amid uncertainties in reimbursement for these products in the US Market for Skin Substitutes.

The subjects discussed in this downloadable SmartTRAK Perspective article include:

• The Broad Use of CAMPs
  • Sessions at CAMPs 2025 supported the broad use of CAMPs, including applications for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) as well as those for limb salvage, acute care, tunneling wounds, Mohs surgery, trauma, burns and pressure ulcers (PrUs). SmartTRAK expects the use of CAMPs to ... (read more)
• LCD Discussions Taking Center Stage
  • With the implementation of the MAC LCDs delayed until April 13^th, a prevailing question among attendees at the conference was whether the LCDs would actually be implemented or further delayed. SmartTRAK spoke with clinicians and industry representatives to obtain their views on the LCDs and ... (read more)
• Market Disruption – 2025 Earnings Projections
  • For public companies providing skin substitutes to the market, uncertainty was a major theme in their 2025 guidance SmartTRAK  summarizes comments from companies that mentioned the LCD in their 2025 revenue projections ... (read more)

Although a significant amount of discussion with clinicians and industry focused on revising the reimbursement methodology for skin substitutes, companies are still moving forward with clinical studies. SmartTRAK is currently tracking 26 clinical trials for DFUs and VLUs, as mentioned earlier and ...

To find out more about news and trends from CAMPs 2025, just click the button below to download the complete market perspective article "LCD Uncertainty Bringing Disruption to CAMPs" by Susan Paquette, VP & General Manager, Wound.

---

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 has to offer and see how we can help increase proficiency, improve productivity and reduce costs for your company, just click here.

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

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.

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.
    

SmartTRAK highlights the latest news from SAWC Spring 2023 for the ever-changing, continually growing skin substitute/CTP segment.

The skin substitute/CTP segment has seen double-digit growth year after year. Although the category has been known as the skin substitute or CTP (cellular and/or tissue-based products) market and has been dominated in recent years with amniotic tissue and xenograft products, it has recently grown to include non-biologic or synthetic-based products such as those based on polyurethane, polylactic acid, and bioabsorbable glass. The Journal of Wound Care recently published an international consensus document on “best practice for wound repair and regeneration,” with the clinical panel concluding CTPs weren’t the best terminology for the category. The panel suggested a more accurate name is “cellular, acellular and matrix‑like products (CAMPs),” expanding the definition to include "A broad category of biomaterials, synthetic materials or biosynthetic matrices that support repair or regeneration of injured tissues through various mechanisms of action."