StimLabs has received 510(k) clearance from the US Food and Drug Administration for Theracor, the first human umbilical cord-derived medical device to be offered in sheet form, marking a significant milestone for the wound care sector and expanding the company’s regenerative medicine portfolio.
StimLabs is a regenerative medicine company with a primary focus on wound care and surgical applications. The company maintains a comprehensive product portfolio spanning multiple clinical uses and has developed a substantial intellectual property catalog. StimLabs positions itself as a partner to physicians and patients, with an emphasis on delivering tissue-based solutions designed to improve patient care in areas with significant unmet needs.
The FDA clearance builds on the earlier approval of Corplex P, the first FDA 510(k)-cleared human umbilical cord-derived medical device for wound management available in a particulate format. With Theracor, StimLabs extends its product range to address the needs of a broader patient population and provide clinicians with an additional FDA-cleared option in a continuous sheet format rather than a particulate.
Theracor is a sheet device derived from human umbilical cord extracellular matrix and is intended to cover, protect and help maintain a moist wound environment. It is designed for the same indications as Corplex P, including partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled and undermined wounds, surgical wounds such as donor sites and grafts, post-Mohs surgery, post-laser surgery, podiatric wounds and wound dehiscence, as well as trauma wounds including abrasions, lacerations, partial-thickness burns and skin tears, and draining wounds. The sheet format allows clinicians advanced human tissue-based medical device.
Theracor is expected to be available soon for use in medical settings. The clearance comes as StimLabs marks a decade of work focused on developing technologies aimed at advancing standards in healthcare.
With Corplex P already FDA-cleared and available nationwide, the addition of Theracor completes a broader offering of human umbilical cord-derived devices for wound care, strengthening the company’s position in addressing unmet clinical needs while adhering to regulatory standards.
