FDA Grants 510(k) Clearance to First Umbilical Cord–Derived Sheet Formulation for Wound Care

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Theracor, the first human umbilical cord–derived medical device offered in a sheet formulation, according to an announcement from StimLabs on December 29, 2025.1

“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,” said John Daniel, founder and chief executive officer of StimLabs, in a statement.1

The clearance is an expansion upon the FDA’s prior authorization of Corplex P, the first FDA 510(k) cleared human umbilical cord-derived medical device for wound management provided in a particulate format. Unlike particulate formulations, the sheet format is designed for clinicians who require a continuous wound coverage option with a comparable human tissue-based medical device. The sheet formulation offers an alternative delivery format for these clinicians, according to the statement from StimLabs.1,2

Theracor is derived from human umbilical cord extracellular matrix (ECM) and is intended to cover and protect wounds while maintaining a moist wound environment. The device is indicated for the same wound types as Corplex P, including partial- and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled and undermined wounds, surgical wounds including donor sites, grafts, post-Mohs surgery, and wound dehiscence, trauma wounds, partial-thickness burns, skin tears, and draining wounds.1,2

According to the company, the clearance reflects the continued expansion of FDA-cleared umbilical cord–derived medical devices intended for use in complex wound management settings.1

“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," stated John Daniel. "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."1

References

1. StimLabs. StimLabs® Announces FDA Clearance of TheracorTM: The First Human Umbilical Cord-Derived Medical Device Sheet. Prnewswire.com. Published December 29, 2025. Accessed December 29, 2025. https://www.prnewswire.com/news-releases/stimlabs-announces-fda-clearance-of-theracor-the-first-human-umbilical-cord-derived-medical-device-sheet-302649759.html

2. FDA Clears Groundbreaking Corplex-PTM: The First Human Umbilical Cord-Derived Medical Device Corplex-P. StimLabs. https://stimlabs.com/Corplex-P_Press_Release/

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