Interview Transcript

This is Kris Flinn with SmartTRAK.Today, I am joined by Giuseppe Tronci, lead academic founder and chief scientific officer, and Chris Stephenson, non-executive director from HYFACOL Limited.

HYFACOL is a UK-based spin-out from the University of Leeds. The company has developed HyFaCol, a collagen manufacturing platform that improves the production and quality of medical-grade collagen. A key initial focus is on chronic wound care, with the US skin substitute market worth almost $12 billion in 2025 and currently undergoing a reset following new reimbursement rules. In this interview, we'll discuss the development of the HyFaCol platform, how it's been used on patients, and look at what the future may hold.

Giuseppe and Chris, thank you for joining me today. Can we please start by telling me about HYFACOL as a company and the journey that you've been on?

Giuseppe Tronci: Thank you, Kris. So HYFACOL is a University of Leeds spin-out company that is basically developing a collagen manufacturing technology for skin substitute applications. It builds on more than 10 years of academic research into collagen. And through this phase of development, we have substantially de-risked technology, secured patents in the US and Europe, and also, and most importantly, shown that the products that we are developing enable full closure in animals, and more recently, at least 88% wound closure in pressure ulcers and diabetic foot ulcers in humans. So before going into the commercial phase and the next phase of development, let me perhaps describe a bit more what we have been doing in terms of technology development.

As you know, collagen plays a key role in wound healingin vivo. But when collagen is extracted ... 

Click the button below to download and read the full transcript of SmartTRAK Wound GM Kris Flinn’s interview with HYFACOL's Giuseppe Tronci and Chris Stephenson discussing the company’s patented collagen manufacturing platform, HyFaCol, the path to FDA approval and the outcomes of a recent clinical study.

SmartTRAK interviews two leaders from the Alliance of Wound Care Stakeholders to discuss its aim to be the unified voice for the wound care community, ensuring quality care for all patients with chronic wounds.

• Bacteria are becoming resistant to silver, making it less effective.
• Several existing antimicrobial technologies may induce cytotoxic effects.
• Silver dressings are commoditized, and the market is hungry for novel and innovative alternatives.
• Stricter medical rules (antimicrobial stewardship) now require clinicians to be more careful about how they use germ-killing treatments, as there has been a widespread habit of using these dressings on wounds that do not actually need them.

In the complete downloadable article, SmartTRAK highlights in detail four companies to watch in 2026 with advanced dressings that offer new approaches to attacking bioburden and infection while limiting antimicrobial resistance. They are:

• Convatec: Seeing Great Potential with ConvaNiox 
   Convatecis the global leader in the antimicrobial dressings market with its Aquacel Ag range. It is evident that they are convinced that ConvaNiox will be their next big brand in wound care ... (read more)

•  Polaroid Therapeutics
   Polaroid Therapeutics (PTx) is a Swiss-based biotech start-up developing innovative products and solutions using its proprietary novel antimicrobial technology  ... (read more)

SmartTRAK reviews how the changes to skin substitute reimbursement reforms may impact each site of service and what it means for patients, providers and manufacturers.

 In response to the meteoric rise in spending, the Centers for Medicare and Medicaid Services (CMS) enacted payment reforms, establishing a standardized reimbursement rate of ~$127/sq cm for skin substitutes across physician offices, mobile and hospital outpatient departments (HOPD). SmartTRAK believes that these reimbursement reforms could trigger an access-to-care crisis for some patients in the wound care sector. This could result in care being shifted to the high-cost, inpatient operating room (OR) for the most critical patients or lead to an increased number of amputations. The system may realize short-term savings on grafts, but the systemic result could be a spike in the total cost of care for some patients and, for others, no advanced care at all.

Since 2021, the US Advanced Wound Care Market has undergone a transformation defined by a "site-of-service" migration away from the hospital outpatient department (HOPD). As CMS implemented restrictive bundled-payment models in HOPDs in 2014 that capped reimbursement in “high” and “low” buckets, care began to shift toward... (read more)

• The Physician Office (PFS) - In the physician office (PO), the $127/sq cm rate could result in a "reverse triage" effect, where minor or complex wounds become ...(read more)

Throughout 2025, SmartTRAK empowered MedTech professionals to Be The Expert by providing timely, data-driven insights across key markets. From orthopedics and wound care to regenerative medicine and neurotherapy, our analysts delivered meaningful real-time analysis you could act on. Scroll down to see a dozen of SmartTRAK’s most impactful blog posts of 2025.

These blog posts are just a glimpse of the data we cover every day. Want to see the real-time analytics and deep-dive reports behind these headlines? Schedule a demo today to see how SmartTRAK can help you master your market in 2026.

1. The Future of “Skin Substitutes” - What’s the Alternative?
   SmartTRAK reviews possible alternatives to LCDs and CMS’ proposed payment model for Cellular, Acellular, and Matrix-like Products (CAMPs) commonly referred to by the Center for Medicare & Medicaid Services (CMS) as “skin substitutes” and the potential impact on the market.
   
   
2. Terumo Neuro: Aiming for #1 in Neurovascular 
   Carsten Schroeder, president and CEO of Terumo Neuro, discusses the company’s plans to capture share and become the market leader in neurovascular.
   
   
3. What's Next in Orthopedic Trauma? 
   SmartTRAK reviews the evolving trauma startup landscape in 2025, spotlighting five innovators, followed by a comparative chart mapping 19 emerging companies.
   
   
4. Impact of Final Physician Fee Schedule on US Skin Substitutes in 2026
   Wound GM Kris Flinn and Senior Analysts Elizabeth Anderson and Jay Merkel discuss the impact of the final physician fee schedule on US Skin Substitutes in 2026.
   
   
   
   

SmartTRAK spoke with the Westbrook Weaver, CEO of Tempo Therapeutics, to discuss the company’s new technology, how it works and the results of the clinical work they’ve completed so far.

In the wound care space, there has always been an unmet need for a product that can provide volumetric wound filling in addition to simply closing the wound. Tempo Therapeutics is looking to utilize microporous annealed particle technology, or MAP, to address this need. In an interview with SmartTRAK, Westbrook Weaver, PhD, President and CEO of Tempo Therapeutics introduces their technology for creating a three-dimensional scaffold.

To learn more about Tempo Therapeutics, click on the following video (16:41 min). A link to download a complete transcript of the interview is also provided below.

Interview Transcript:
 

It is with both gratitude and admiration that we announce the retirement of Susan Paquette, our former VP/GM of SmartTRAK Wound Care, after nearly 15 years of dedicated service to SmartTRAK. 

Since joining the company, Susan has been instrumental in building SmartTRAK Wound Care into the industry’s most trusted source of real-time market intelligence. Under her leadership, the Wound Care business has grown from a promising vision into a powerhouse platform providing comprehensive data, news, and analysis on a range of Advanced Wound Care markets. Today, SmartTRAK Wound Care delivers deep coverage across nine distinct areas with broad global reach, relied upon daily by the world’s top wound and orthopedic companies.