GeniPhys lands FDA clearance for wound care product
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The U.S. Food and Drug Administration has awarded 510(k) clearance to Indianapolis-based biotech company GeniPhys for its flagship collagen product used for soft tissue restoration, the company announced this week.
The Collymer Self-Assembling Scaffold is designed to restore tissue without causing the inflammation that can occur with traditional implantable materials.
GeniPhys said in a news release that the clearance paves the way for commercial launch for the product.
“It’s deeply rewarding to see this technology move closer to clinical use, where it has the potential to address critical unmet needs for millions of patients,” founder and Chief Technology Officer Sherry Harbin said in the release. “Our collagen polymer platform was developed to overcome limitations associated with conventional implantable materials, and its ability to adapt to complex wound geometries marks a meaningful advancement for both patients and clinicians.”
Collymer SAS was created to manage various types of wounds, including partial- and full-thickness wounds, skin ulcers, surgical wounds, and trauma wounds.
Harbin, who is also a professor of biomedical engineering and courtesy professor of basic medical sciences at Purdue University, led the development of the Collymer platform. GeniPhys is licensing the technology through the Purdue Innovates Office of Technology Commercialization.
GeniPhys completed a $6 million Series A round of funding in March 2023. The following month, the company said it would hire more than 40 people at its Indianapolis headquarters.
The company is currently raising capital to support commercialization of the Collymer SAS platform, including in-house and contract manufacturing. Last October, GeniPhys received a $500,000 National Science Foundation grant to fuel commercialization efforts.
An estimated timeline for a future product launch was not given.
Earlier this year, GeniPhys won the inaugural BioCrossroads Life Sciences Innovation Team of the Year award at the TechPoint Mira Awards.