StimLabs, a regenerative medicine company focused on advancing wound care solutions, has received 510(k) clearance from the US Food and Drug Administration (FDA) for Theracor, the first human umbilical cord-derived medical device available in sheet form.

The clearance represents a key milestone for the wound care segment and further strengthens StimLabs’ position in human tissue-based medical devices. Theracor builds on the earlier FDA clearance of Corplex P, the first umbilical cord-derived wound management device approved in a particulate format, and expands the company’s portfolio to address a broader range of clinical needs.

Theracor is derived from human umbilical cord extracellular matrix (ECM) and is designed to cover and protect wounds while maintaining a moist healing environment. The device is indicated for the same range of applications as Corplex P, including partial- and full-thickness wounds, pressure ulcers, venous and diabetic ulcers, chronic vascular ulcers, tunnelled and undermined wounds, surgical wounds, traumatic injuries such as abrasions and burns, and draining wounds. The sheet format provides clinicians with a continuous application option as an alternative to particulate products.

John Daniel, founder and chief executive officer of StimLabs, said the FDA clearance highlights the company’s ongoing commitment to innovation in regenerative medicine. He noted that the approval of Theracor offers clinicians and patients additional FDA-cleared options for managing acute and chronic wounds using human tissue-based solutions.

With both Corplex P and Theracor now cleared by the FDA, StimLabs is positioned to offer an expanded suite of umbilical cord-derived wound care devices tailored to different clinical preferences and treatment requirements.

Theracor is expected to be available for use in medical settings in the near term.

StimLabs focuses on regenerative medicine solutions for wound care and surgical applications, with an emphasis on addressing unmet clinical needs through scientifically validated, regulatory-approved products.