FDA Clears Theracor: A New Era in Wound Healing with Umbilical Cord Tech

ROSWELL, GA – December 29, 2025 – The U.S. Food & Drug Administration (FDA) has granted 510(k) clearance to Theracor, a groundbreaking medical device from StimLabs, marking it as the first human umbilical cord-derived product to be offered in a sheet format for wound management. This regulatory milestone signals a significant advancement in the field of regenerative medicine and expands the therapeutic options available for millions of patients suffering from complex and chronic wounds.

Developed by StimLabs, a company specializing in regenerative technologies, Theracor is designed to cover, protect, and maintain a moist environment for a wide array of wounds. The clearance builds upon the company's previous success with Corplex P, a particulate version of the same umbilical cord-derived technology, solidifying StimLabs' position at the forefront of the advanced wound care industry.

"After 10 years, StimLabs continues to focus on innovating technologies and driving advancements that redefine standards and progress in healthcare," said John Daniel, Founder and Chief Executive Officer of StimLabs, in a company announcement. "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."

A New Tool in the Clinical Arsenal

Theracor enters a market hungry for innovation. Chronic wounds—such as diabetic ulcers, venous ulcers, and pressure ulcers—represent a significant and growing healthcare burden, affecting millions annually and costing billions of dollars to manage. Traditional wound care often focuses on managing symptoms, but advanced biologics like Theracor aim to facilitate the body's own healing processes.

The device is derived from the extracellular matrix (ECM) of the human umbilical cord, a material rich in biological components essential for tissue repair. This includes structural proteins like collagen I and III, as well as hyaluronic acid, a substance known for its ability to retain moisture and support cellular migration. This composition allows Theracor to act as a natural scaffold, providing a structural foundation for new tissue to grow while managing wound exudate and maintaining an optimal healing environment.

The key innovation of Theracor is its sheet format. While its particulate counterpart, Corplex P, is ideal for packing deep or tunneled wounds, the continuous sheet format of Theracor provides a versatile option for covering larger, more uniform wound surfaces. This gives clinicians the flexibility to choose the format best suited for a patient's specific wound topography. According to one wound care specialist not affiliated with the company, having both a particulate and a sheet option from the same biological source allows for a more tailored and comprehensive treatment strategy.

Indications for Theracor are extensive, mirroring those of Corplex P. They include partial and full-thickness wounds, surgical wounds from procedures like Mohs surgery, trauma wounds such as abrasions and partial-thickness burns, and a variety of chronic ulcers. This broad applicability positions the device as a valuable tool across multiple medical specialties, from podiatry to dermatology and general surgery.

Reshaping the Advanced Wound Care Market

StimLabs' strategic introduction of Theracor is poised to make a significant impact on the rapidly expanding advanced wound care market. Valued at over $11 billion in 2024, the global market is projected to grow substantially, with some estimates predicting it could exceed $18 billion by 2034. This growth is fueled by an aging global population, the rising prevalence of diabetes, and an increase in surgical procedures.

Within this landscape, the wound care biologics segment—which includes products derived from human and animal tissues—is a particularly dynamic area. By securing FDA 510(k) clearance, StimLabs has navigated a critical regulatory hurdle that distinguishes Theracor from many other tissue-based products on the market. The 510(k) pathway requires a manufacturer to demonstrate that its new device is "substantially equivalent" in safety and effectiveness to a legally marketed predicate device. In this case, Theracor's clearance was predicated on Corplex P, leveraging the established safety and intended use profile of its predecessor.

This clearance provides a competitive advantage, assuring hospitals and clinicians that the product has met specific FDA regulatory standards. It sets Theracor apart from products regulated solely as human tissues (HCT/Ps), which fall under a different set of criteria. This distinction is crucial for gaining trust and encouraging adoption within a cautious and highly regulated medical community.

By offering a dual-format solution, StimLabs is executing a calculated strategy to capture a larger share of the market. The company can now cater to a wider range of clinical preferences and wound types, effectively creating a comprehensive umbilical cord-based platform for wound management. This move challenges other players in the regenerative medicine space, including those who offer amniotic or other tissue-based allografts, by presenting a fully cleared, versatile, and scientifically advanced alternative.

"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."

New Hope for Patients with Hard-to-Heal Wounds

Beyond market dynamics and regulatory achievements, the introduction of Theracor offers tangible hope for patients. Living with a chronic wound can be a debilitating experience, often involving persistent pain, risk of infection, reduced mobility, and a significant impact on quality of life. For many, the healing process stalls, leading to a frustrating cycle of treatments with limited success.

Regenerative therapies that actively support tissue reconstruction represent a paradigm shift. According to medical experts, the goal of these advanced treatments is not just to close a wound, but to restore normal tissue function and structure, potentially leading to better long-term outcomes and reduced scarring. The biological properties of umbilical cord tissue—its role as a scaffold and its rich composition—are central to this potential.

For clinicians on the front lines, the availability of a new, FDA-cleared tool is a welcome development. The sheet format of Theracor may simplify application on certain wounds, ensuring consistent coverage and contact. This ease of use, combined with its biological activity, could help accelerate healing in wounds that have failed to respond to other advanced therapies. Ultimately, more effective treatments can lead to fewer amputations, reduced hospitalization costs, and a faster return to daily life for patients.

As a privately held company with a decade of focused research and a robust intellectual property portfolio, StimLabs has steadily built its reputation as a leader in the field. The launch of Theracor, which the company says will be available soon, is the latest chapter in its mission to address unmet clinical needs through scientific innovation. Its successful clearance and upcoming market entry will be watched closely by clinicians, competitors, and, most importantly, the patients who stand to benefit most.