StimLabs Unveils Theracor: A New Era for Wound Healing Technology

ROSWELL, GA – December 29, 2025 – Regenerative medicine firm StimLabs has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Theracor, a groundbreaking medical device for advanced wound care. The clearance marks a significant milestone, establishing Theracor as the first human umbilical cord-derived medical device to be offered in a continuous sheet format. This innovation promises to expand treatment options for millions suffering from complex and chronic wounds.

The announcement positions StimLabs, a privately held company founded in 2015, at the forefront of the rapidly evolving advanced wound care sector. Theracor is designed to cover and protect wounds, providing a moist environment conducive to healing. It complements the company's existing particulate device, Corplex P, by offering clinicians a new, versatile tool for managing a wide array of challenging wound conditions.

A Scientific Leap in Regenerative Healing

Theracor is derived from the human umbilical cord's extracellular matrix (ECM), a complex scaffold rich in biological components essential for tissue repair. The ECM contains a unique combination of proteins, growth factors, and other molecules that signal the body's cells to proliferate, migrate, and form new blood vessels, all of which are critical processes in the healing cascade. Clinical research has increasingly validated the use of umbilical cord-derived materials for treating persistent wounds that fail to respond to conventional therapies.

Until now, such products from StimLabs were available in a particulate format, Corplex P, which is ideal for packing and filling deep or irregularly shaped wound cavities. The introduction of Theracor in a sheet format directly addresses a different clinical need. The continuous sheet provides a versatile covering for larger, more uniform wound surfaces, offering a protective barrier while delivering the regenerative properties of the umbilical cord ECM. This dual-format approach allows clinicians to tailor their treatment strategy to the specific geometry and needs of each wound.

Studies on similar dehydrated human umbilical cord (dHUC) products have demonstrated their potential to treat both acute and chronic wounds. Research into decellularized umbilical cord scaffolds has shown they can promote epithelialization and the maturation of new tissue. While direct comparative studies between sheet and particulate forms are emerging, the fundamental benefit lies in the application. The sheet format provides a continuous, stable covering that is easy to apply and can remain in place, offering sustained contact with the wound bed.

Reshaping a Competitive Market

The FDA clearance for Theracor is not just a clinical advancement; it's a strategic move in the highly competitive global advanced wound care market. Valued at over $16 billion in 2025, this market is projected to grow significantly, driven by an aging global population and the rising prevalence of chronic diseases like diabetes and obesity, which are major contributors to non-healing wounds. The burden is immense, with chronic wounds affecting more than 40 million people worldwide and posing a significant challenge to healthcare systems.

StimLabs is carving out a leadership position in this crowded field, which includes established giants like Smith & Nephew, 3M, and Mölnlycke Health Care. The company's success is built on a foundation of navigating the complex regulatory pathways for human birth tissue-based products. The prior 510(k) clearance for Corplex P (under the same clearance number K231325) was a landmark achievement, setting a precedent for bringing such products to the wound management market. The subsequent clearance for Theracor reinforces the company's regulatory expertise and innovative edge.

By diversifying its portfolio with both particulate and sheet formats, StimLabs can now address a wider spectrum of clinical scenarios. This product line expansion strengthens its competitive posture, allowing it to capture a larger share of the market by offering a more comprehensive solution set. The company's focus on a robust intellectual property catalog further solidifies its unique position, creating a defensible niche in the high-growth regenerative medicine sector.

Offering New Hope and Versatility for Patients

For clinicians on the front lines and the patients they treat, Theracor represents a tangible advancement in care. The device is indicated for an extensive range of wound types, from acute trauma wounds like burns and lacerations to chronic, hard-to-heal ulcers, including diabetic ulcers, venous ulcers, and pressure ulcers. It is also cleared for use on complex surgical wounds, such as post-Mohs surgery sites and dehisced incisions.

The availability of a sheet-form option provides newfound flexibility. A physician treating a large, shallow venous ulcer on a patient's leg, for example, can now use the Theracor sheet to provide continuous coverage. In contrast, a deep, tunneled wound might be better suited for the Corplex P particulate. This ability to choose the optimal format empowers healthcare providers to deliver more personalized and effective care, potentially leading to faster healing times and improved patient outcomes.

This versatility is crucial, as current therapeutic alternatives often fall short in addressing the multifaceted challenges of chronic wounds, such as persistent inflammation and poor oxygenation. By providing a biologically active and structurally supportive scaffold, Theracor aims to overcome these hurdles and restart the healing process in wounds that have been stalled for months or even years.

Paving the Way for Access and Reimbursement

Innovation is only impactful if it is accessible. StimLabs appears to be acutely aware of this, actively working to navigate the intricate landscape of medical reimbursement. The FDA's 510(k) clearance is a critical first step, as it officially classifies Theracor as a medical device, paving the way for coverage discussions with Medicare and private insurance payers. This regulatory pathway distinguishes it from certain other birth tissue products in fields like orthopedics, which have faced reimbursement challenges after being classified by the FDA as unapproved drugs.

For advanced wound care products, coverage is typically determined by medical necessity, guided by policies from the Centers for Medicare & Medicaid Services (CMS) and specific Local Coverage Determinations (LCDs). StimLabs' investment in a dedicated field reimbursement team and support tools indicates a proactive strategy to help healthcare facilities and clinicians secure coverage for their products.

By clearing these regulatory and financial hurdles, StimLabs is working to ensure that Theracor can be integrated into standard clinical practice. This focus on accessibility is vital for translating a scientific breakthrough into a widely available treatment that can make a meaningful difference in the quality of life for patients struggling with the debilitating effects of chronic wounds.