When two of the most respected figures in diabetic limb salvage sign on to guide a product’s development, the wound care field tends to take notice. Pittsburgh-based biomaterials company Aethl Bio has announced that Dr. David G. Armstrong and Dr. Charles M. Zelen have joined the company as advisors. Both physicians have dedicated their careers to healing diabetic foot ulcers and preventing amputations, and their reputations in limb salvage research are widely acknowledged.
Their appointments come at a pivotal moment for Aethl Bio, which is preparing its first wound dressing for a planned 510(k) premarket notification with the U.S. Food and Drug Administration. Dr. Armstrong and Dr. Zelen will advise the company on clinical strategy, how the treatment should be applied, research protocols, and the generation of clinical evidence for Nuvoxen, the dressing candidate.
“Wound care has no shortage of products. What it lacks is evidence clinicians and patients can trust. Dr. Armstrong and Dr. Zelen helped build much of the evidence base this field relies on, and their guidance will shape how we build ours,” said Carmelo Montalvo, CEO of Aethl Bio.
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Dr. Armstrong serves as Distinguished Professor of Surgery and Neurological Surgery at the Keck School of Medicine of USC. He has authored more than 790 peer-reviewed papers and is Founding President of the American Limb Preservation Society. Among his many honors, he is the youngest recipient of the American Diabetes Association’s Roger Pecoraro Award and also holds the Karel Bakker Award.
“People living with diabetic foot disease need advances grounded in rigorous science and focused on preserving mobility and independence. As an advisor to Aethl Bio, I’ll help guide clinical strategy and the development of meaningful research protocols, with the goal of giving patients more ulcer-free, hospital-free and activity-rich days,” said Dr. Armstrong.
Dr. Zelen is the founder and president of the Professional Education and Research Institute (PERI) in Roanoke, Virginia, and serves as Podiatry Section Chief in the Department of Orthopedics at HCA LewisGale Medical Center. He holds board certifications in foot surgery, reconstructive rearfoot and ankle surgery from the American Board of Foot and Ankle Surgery, and in podiatric medicine from the American Board of Podiatric Medicine. Dr. Zelen conducted some of the first randomized trials on amniotic membrane grafts in diabetic foot ulcers and has since led or co-authored many of the leading multi-center trials of advanced wound biologics.
“Sound wound care research starts long before the first data point, with the right questions and a rigorous protocol. As an advisor to Aethl Bio, I’ll help make sure its research answers the questions clinicians and patients actually have,” said Dr. Zelen.
Academic and institutional affiliations are listed for identification purposes only and do not imply that any institution endorses, supports, sponsors, or is affiliated with Aethl Bio or its products.
About Aethl Bio, Inc.
Aethl Bio, Inc. is a Pittsburgh-based biomaterials company developing advanced platforms for wound care and wellness applications. Building on its proprietary Hydro-Activated Supersaturation platform, the company is advancing a portfolio of products across skin health, recovery, and wellness. Grounded in scientific rigor, regulatory discipline, and audacious innovation, Aethl Bio is guided by its mission to help people heal deeply and live fully. Learn more at aethl.com.
Aethl Bio’s wound dressing is in development, has not been cleared by the U.S. Food and Drug Administration, and is not available for sale.
Delvina Morrow
Aethl Bio
+1 646-496-3628
delvina.morrow@aethl.com
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Why it matters: For the millions of people living with diabetic foot disease, the gap between product availability and trustworthy evidence has real consequences—often the difference between keeping a limb and losing it. By bringing in researchers who helped define the standard of care, Aethl Bio is signaling that it intends to meet the highest bar for clinical proof, not just regulatory clearance. If Nuvoxen succeeds, it could set a new benchmark for what patients and clinicians should expect from advanced wound dressings.
