StimLabs Earns Landmark FDA Clearance for Theracor, the First Umbilical Cord-Derived Wound Care Sheet

ROSWELL, GA – December 29, 2025 – The landscape of advanced wound care has taken a significant step forward today as StimLabs, a Georgia-based leader in regenerative medicine, announced it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Theracor™ medical device. This clearance is a pivotal moment for the industry, as Theracor is the first medical device derived from human umbilical cord to be offered in a sheet form for wound management.

The announcement solidifies StimLabs' position as a key innovator in a field dedicated to healing the most challenging acute and chronic wounds. This achievement follows the company’s previous success with Corplex P®, a particulate version of the same umbilical cord-derived technology, which also secured 510(k) clearance. With Theracor, StimLabs now offers clinicians a more comprehensive toolkit to address a wide spectrum of patient needs.

A New Standard in Regenerative Wound Care

Theracor is a sheet-like device meticulously engineered from the extracellular matrix (ECM) of human umbilical cord tissue. Its primary function is to cover and protect wounds, creating a moist, clean environment conducive to the body's natural healing processes. The maintenance of a moist wound bed is a foundational principle of modern wound care, known to accelerate healing, reduce pain, and minimize scarring.

The range of applications for Theracor is extensive, covering a vast array of complex wounds that pose significant challenges to clinicians. Its indications for use include partial and full-thickness wounds, such as debilitating pressure ulcers, venous ulcers, and diabetic ulcers, which affect millions of patients annually. Furthermore, it is cleared for use on chronic vascular ulcers, tunneled or undermined wounds, and a variety of surgical wounds, including donor sites, post-Mohs surgery sites, and cases of wound dehiscence. Its utility also extends to trauma wounds like abrasions, lacerations, partial-thickness burns, and skin tears.

By providing this technology in a sheet format, StimLabs directly addresses a clinical need for a continuous wound covering. While particulate forms are ideal for filling irregularly shaped or deep wounds, a sheet provides a simple and effective way to cover larger, more uniform wound surfaces, ensuring consistent contact and protection.

Building on a Foundation of Innovation

The clearance of Theracor is not an isolated event but rather the culmination of a deliberate, long-term strategy. It is predicated on the earlier 510(k) clearance of Corplex P, which established the foundational safety and efficacy data for StimLabs' umbilical cord-derived medical devices. This methodical approach demonstrates a deep commitment to not only innovation but also to rigorous regulatory validation.

John Daniel, Founder and Chief Executive Officer of StimLabs, emphasized the company's decade-long dedication to pushing the boundaries of medical technology. "After 10 years, StimLabs continues to focus on innovating technologies and driving advancements that redefine standards and progress in healthcare," he stated. "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."

The introduction of a sheet format alongside the existing particulate option empowers healthcare providers with greater flexibility. This strategic portfolio expansion allows them to select the most appropriate format based on the specific characteristics of a wound and their preferred application technique.

"We are thrilled to announce 510(k) clearance of Theracor," Daniel added. "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. 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."

The Significance of a 510(k) Medical Device Clearance

Achieving 510(k) clearance is a critical differentiator in the crowded field of regenerative medicine. This regulatory pathway requires a company to submit a premarket notification to the FDA, demonstrating that its product is "substantially equivalent" in terms of safety and effectiveness to a legally marketed predicate device. It is a demanding process that involves comprehensive testing and documentation of design, materials, and performance.

For a product derived from human tissue, this level of clearance elevates it beyond the status of many other offerings on the market. It classifies Theracor as a regulated medical device, providing clinicians and healthcare systems with a high degree of confidence in its manufacturing, quality control, and intended use. This stringent oversight ensures consistency from one lot to the next, a crucial factor for patient safety and predictable clinical outcomes. By successfully navigating this path, StimLabs has set a high bar for human tissue-based products, signaling a move towards greater standardization and regulatory certainty in the wound care sector.

Harnessing the Regenerative Potential of Umbilical Tissue

The use of umbilical cord tissue in medicine is based on its unique biological properties. The umbilical cord's extracellular matrix (ECM) is a complex, natural scaffold rich in proteins like collagen, as well as other biomolecules that provide structural support to cells. When processed into a medical device like Theracor and applied to a wound, this ECM can act as a temporary scaffold, providing a framework that supports the patient's own cellular repair mechanisms.

This scaffold helps to organize the healing process, creating an environment where the body’s cells can migrate, proliferate, and begin to rebuild the damaged tissue. As a protective cover, Theracor shields the delicate wound bed from the external environment, reducing the risk of infection and preventing the tissue from drying out. This dual action—providing both a protective barrier and a supportive biological scaffold—is what makes such advanced biologics a promising option for wounds that have failed to heal with conventional treatments.

With Theracor soon to be available for clinical use, StimLabs continues to execute its mission of delivering superior regenerative solutions. This latest FDA clearance is more than a corporate milestone; it represents a new, validated option for clinicians and a new source of hope for patients struggling with the debilitating effects of chronic and acute wounds.