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SmartTRAK Life Sciences News and Analysis Blog

Elizabeth Anderson

Senior Analyst, Wound Biologics

Recent Posts

3 min read

Will the New Skin Substitute Reimbursement Policies Create an Access to Care Crisis?

By Elizabeth Anderson on 2/10/26 9:30 AM

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)

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3 min read

Exosomes in Wound Care: The Next Big Thing?

By Elizabeth Anderson on 1/16/26 10:05 AM

SmartTRAK interviews Suneet Varma, CEO of INTENT Biologics, to discuss the company’s novel exosome technology for advanced wound care.

In this interview, the CEO of INTENT Biologics details how Purified Exosome Product (PEP), a high-potency exosome therapy, achieved a remarkable 0% recurrence rate in Phase II wound care trials for diabetic foot ulcers (DFUs). Discover the science behind why this acellular alternative is poised to expand the options for treating DFUs and other chronic wounds.

To learn more about INTENT Biologics, spun out of RION Therapeutics, click on the following video (23: 28 min). A link to download a complete transcript of the interview is also provided below.

Interview Transcript:


SmartTRAK: My name's Elizabeth Anderson. I'm with SmartTRAK, and today I'm speaking with Suneet Varma, who is currently a senior advisor for RION Therapeutics and also CEO of INTENT Biologics. This is a very interesting space that they're in and developing the exosomes, and they are looking into just finishing up a Phase II trial for diabetic foot ulcers. Today, we're going to talk a little bit about exosomes, their role in the marketplace and his thoughts on bringing this product to the market, so welcome.

Suneet Varma:   Thank you so much. So great to be with you, Elizabeth.

Can you tell us a little bit about the genesis of the exosomes, the plasma-derived exosomes, and talk a little bit about the genesis and this coming out of the Mayo Clinic?

SV: Very exciting. More than a decade ago, two physicians from the Mayo Clinic, Dr. Atta Behfar and Dr. Andre Terzic, made a discovery as part of the regenerative medicine center at Mayo that exosomes, not stem cells, are regenerative. In other words, exosomes are the material within our body. They're the messengers between cells and their function is really determined from whence they came.

RION essentially took the mantle forward of, ‘How do I now develop these exosomes into other uses in the healthcare environment?’ RION was formed with that purpose and started to develop exosomes and made further discoveries ...

Want to learn more about INTENT Biologics novel exosome technology for advanced wound care? Click the button below to download and read the complete transcript of our interview with Suneet Varma conducted by  Elizabeth Anderson, SmartTRAK Senior Analyst.Get the Transcript

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2 min read

Insights Involving Real-World Evidence and Wound Care

By Elizabeth Anderson on 6/12/25 10:33 AM

Caroline Fife, MD, CMO of Intellicure and Executive Director of the US Wound Registry, discusses real-world evidence in wound care and other topics in an interview with SmartTRAK. 

Caroline Fife, MD, discusses insights from the Intellicure database about what diabetic foot ulcer (DFU) and venous leg ulcer (VLU) patients look like, the role of real-world evidence in wound care and the challenges in treating wound care patients.

To find out more, including the challenges for manufacturers and the systemic issues in wound care and payment policies, click on the following video to listen to the interview (37:48 min). A link to download the complete transcript of the interview is provided below. Interview topics by timecode are also provided below. 

 

Interview Outline by Timecode: 

00:30 Overlap between diabetic foot ulcers and venous leg ulcers.
08:19 Challenges in wound classification and diagnosis.
14:02 Limitations of randomized controlled trials and the role of real-world evidence.
17:38 Potential for biomarkers and intermediate outcome measures.
21:57 Neglected wound types and nutritional deficiencies.
29:14 Barriers to wound care implementation.
32:50 Opportunities for change in wound care practices.
34:31 Local coverage determinations (LCDs) and manufacturer challenges.
35:16 Systemic issues in wound care and payment policies.

Click the button below to download and read the complete transcript of SmartTRAK's interview with Caroline Fife, MD, CMO of Intellicure, conducted by  Elizabeth Anderson, SmartTRAK Senior Analyst, Wound Biologics.Get the Transcript

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