INDIANAPOLIS – GeniPhys, a medtech innovator specializing in next-generation regenerative collagen polymeric biomaterials, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its flagship product, Collymer Self-Assembling Scaffold (SAS).

This regulatory milestone paves the way for commercial launch and introduces a novel solution in the wound care market.

“This is a momentous event for GeniPhys and I’m incredibly proud of our team effort in reaching this goal,” said Andy Eibling, president and CEO of GeniPhys. “Achieving this objective supports our current fundraising efforts that will enable commercialization of Collymer SAS.”

Collymer SAS is a two-part, flowable wound management device composed of a highly purified collagen solution and a self-assembly reagent. When combined, the solutions initiate in situ collagen self-assembly, forming a scaffold that supports cellular infiltration and vascularization.

“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,” said Sherry Harbin, founder and chief technology officer of GeniPhys. “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 is indicated for the management of a wide variety of wound types, including partial- and full-thickness wounds, skin ulcers (pressure, venous, diabetic and chronic vascular), tunneled or undermined wounds, surgical wounds (donor sites, grafts, post-Mohs, post-laser, podiatric and wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns and skin tears), and draining wounds. The Collymer platform anchors a growing intellectual property portfolio with nearly 20 issued or pending patents.

Harbin, a professor of biomedical engineering and courtesy professor of basic medical sciences at Purdue University, led the development of the Collymer platform in collaboration with her research team. The technology is exclusively licensed to GeniPhys through the Purdue Innovates Office of Technology Commercialization and is backed by more than a decade of peer-reviewed research that documents the self-assembling behavior and distinctive “regenerative remodeling” of the collagen material in various preclinical models.

GeniPhys is raising capital to support commercialization, including final manufacturing qualification, process validation and scale-up through in-house and contract manufacturing. The company is also pursuing strategic partnerships to accelerate product launch and adoption in the advanced wound care market.