StimLabs has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for Theracor, the first human umbilical cord-derived medical device to be offered in sheet form.

The clearance marks a significant milestone for the wound care industry, according to StimLabs. Predicated on the clearance of Corplex P—the first FDA 510(k) cleared human umbilical cord-derived medical device for wound management provided in a particulate format—Theracor expands StimLabs’ offerings to meet the needs of a diverse patient population.

“After 10 years, StimLabs continues to focus on innovating technologies and driving advancements that redefine standards and progress in healthcare,” StimLabs Founder/CEO John Daniel said. “Receiving 510(k) clearance for Theracor underscores our leadership and offers greater options to clinicians and patients who benefit from human tissue-based solutions for the management of acute and chronic wounds.”

Theracor is a sheet device derived from human umbilical cord extracellular matrix (ECM) intended to cover, protect, and provide a moist wound environment. Theracor 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/undermined wounds, surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, partial-thickness burns, and skin tears) and draining wounds. By offering a sheet version, StimLabs can provide clinicians who require a continuous format (rather than a particulate) with a fully FDA 510(k) cleared, comparable human tissue-based medical device.

“We are thrilled to announce 510(k) clearance of Theracor. By expanding our product portfolio, we empower clinicians with choice and strengthen our commitment to innovating around unmet clinical needs while meeting the highest standards,” Daniel stated. “With Corplex P already FDA cleared and available nationwide, Theracor rounds out our offering, arming wound care providers with an expanded suite of human umbilical-cord derived devices.”

Theracor will be available soon for use in medical settings.

StimLabs is striving to advance regenerative medicine, focusing on wound care and surgical applications. Comprised of industry leaders, StimLabs has a product portfolio addressing various clinical applications and has established a strong intellectual property catalog. The firm is based in Roswell, Ga.