1. MDXG signed an exclusive US distribution agreement for RegenKit®-Wound Gel. 2. RegenKit® enhances MDXG's Advanced Wound Care portfolio with innovative solutions. 3. The product is FDA-approved and covered by Medicare for certain chronic wounds. 4. MDXG is positioned strongly with CDC clarity on LCD implementation starting January 2026.
FAQ
Why Bullish?
The exclusive distribution agreement and new product offering are likely to boost MDXG's sales and market share, similar to past successful product launches that positively impacted share prices.
How important is it?
The addition of RegenKit® directly affects MDXG’s product line and market competitiveness, indicating high relevance.
Why Long Term?
The new product expands MDXG's portfolio, suggesting sustained growth potential, similar to historical expansions that have driven long-term investor confidence.
MIMEDX Secures Exclusive U.S. Distribution Agreement for RegenKit®-Wound Gel
Marianna, GA – December 22, 2025 – MiMedx Group, Inc. (Nasdaq: MDXG) announced today an exclusive agreement with Regen Lab USA LLC to distribute the innovative RegenKit®-Wound Gel in the United States, expanding its Advanced Wound Care portfolio.
Details of the Agreement
The RegenKit®-Wound Gel is an autologous solution composed of platelet-rich plasma (PRP) and autologous thrombin serum (ATS). This wound gel effectively removes iron-laden red blood cells while concentrating essential growth factors, functional platelets, plasma proteins, and cellular nutrients within a natural fibrin scaffold. The autologous gel has been reinforced by multiple studies demonstrating its effectiveness in treating chronic wounds.
Approved by the FDA in 2022 and covered nationally by CMS under HCPCS code G0465, the RegenKit®-Wound Gel addresses diabetic chronic wounds, providing a critical therapeutic option in the market.
Strategic Impact on MIMEDX’s Portfolio
Kim Moller, Chief Commercial Officer of MIMEDX, stated, “With the addition of RegenKit, we are continuing to broaden our portfolio in Wound Care to offer patients and healthcare professionals an extensive assortment of proven solutions.” Moller highlighted the importance of incorporating an autologous option, anticipating it will complement MIMEDX’s expanding suite of wound care products significantly.
This agreement also aligns with recent updates regarding the Local Coverage Determination (LCD), which will be implemented on January 1, 2026, positioning MIMEDX in a robust competitive stance as the company approaches the new year.
About Regen Lab USA LLC
Regen Lab USA LLC, headquartered in Jersey City, New Jersey, specializes in autologous regenerative medicine. Founded in 2003 by Antoine Turzi, the company is recognized for designing and manufacturing high-quality medical devices that facilitate cell therapies and the preparation of autologous PRP from patients’ blood for bedside procedures.
About MIMEDX
As a pioneer in the healing sector, MIMEDX focuses on assisting healthcare professionals in managing chronic and difficult-to-heal wounds. With a robust portfolio targeting wound care, burn, and surgical sectors, MIMEDX aims to be the leading global provider of healing solutions through relentless innovation, dedicated to restoring quality of life for patients.
For more information on MIMEDX and its products, please visit www.mimedx.com.