By Erich Kirshner
A wound-care technology developed in a Colorado School of Mines laboratory is now being used to treat patients, marking a major milestone as the Mines faculty-founded startup moves from scientific research into clinical use.
GelSana Therapeutics, founded by Melissa Krebs, associate professor of chemical and biological engineering, has completed U.S. Food and Drug Administration registration for its first commercial product, CleraFlex™, which means the stretchable wound dressing can now be prescribed by physicians to patients.
The company’s initial focus is on hard-to-heal wounds, including diabetic foot ulcers, which represent a particularly significant challenge for patients and health care providers. CleraFlex is also indicated for use on leg ulcers, pressure sores, malignant or fungating wounds, surgical wounds and incisions, and second-degree burns.
For Krebs, the clinical launch of CleraFlex represents a major milestone in a journey that began years ago in her Mines laboratory, where she and her research team developed the polymer technology underlying CleraFlex.
“This is an exciting point in the journey because the technology is no longer just something we are studying in the lab,” said Krebs, CEO of GelSana. “Physicians are using it with patients, and we are now in a position to learn from those clinical experiences and continue building the evidence around the product.”
One physician using CleraFlex is John James, M.D., a Colorado surgeon who is conducting a clinical study examining the product’s use in chronic wounds, including venous ulcers and diabetic foot ulcers.
"Chronic wounds are a huge problem and unfortunately very common -- we see 20-30 patients a day in our wound clinic alone,” James said. “These wounds don’t heal, become infected, and lead to substantial complications. GelSana’s product CleraFlex is unique in that it addresses multiple issues in wound healing all in a single product -- reducing inflammation, preventing infection and speeding healing.”
GelSana is taking a controlled approach to commercialization, Krebs said, with an initial emphasis on wound care clinics and hospital formularies. The company has also established a distribution partnership that will expand access to clinicians in multiple states. Because CleraFlex is intended for use under the direction or supervision of a health care professional, patients cannot purchase the product directly from GelSana. Interested patients in CleraFlex are encouraged to talk to their physicians about CleraFlex, Krebs said.
“We are hearing from patients who want access to the product, and we have to connect with their physicians,” Krebs said. “That is a good problem to have, but it also shows us how important it is to build relationships with clinicians who are treating these wounds every day.”
Read the full story here: https://www.mines.edu/news/all-news/2026/mines-born-gelsana-therapeutics-makes-cleraflex-available-to-health-care-providers.html