RedDress Launches ActiGraft PRO with G-Code Reimbursement Status for the US Wound Care Market

Tel Aviv, Israel and Jacksonville, FL -- July 18, 2023 -- RedDress, a personalized and autologous wound care solution created from patients own whole blood, today announced that its ActiGraft PRO product is now commercially available throughout the US and is eligible for reimbursement nationally from Medicare and Medicare Advantage via NCD 270.3 and G-0465 & G-0460 codes. ActiGraft PRO is the most advanced whole-blood wound care solution on the market, offering a quick procedure time while eliminating the need for a centrifuge or a needle for blood transfer. Reimbursement for the procedure through Medicare and Medicare Advantage is $1726 per application for up to 20 applications in hospital outpatient facilities and wound care centers.

Between fifteen to twenty-five percent (15-25%) of the US diabetic population gets diabetic ulcers annually, which translates to 1.5 million diabetic wounds per year. With over 34 million Americans with diabetes, annual costs reach $327 billion and of that, over $100 billion is spent annually treating diabetic foot ulcers (DFU’s). Per patient, diabetic foot ulcers cost around $58,000 per year and if amputation is required - every four minutes, there’s a limb lost to diabetes - each amputation procedure costs as much as $100,000. With ActiGraft PRO, RedDress is significantly lowering the cost of treatment and impacting outcomes in patients where amputation is recommended, and with a 72% wound closure rate in just 12 weeks - compared to 22% using the standard of care - is substantially lowering the time of treatment and financial strain on patients and national insurance programs.

To obtain reimbursement eligibility, RedDress worked with the Centers for Medicare Services to amend the code of the National Coverage Determination (NCD) for Blood-Derived Products for Chronic Non-Healing Wounds in order to include ActiGraft PRO’s procedure. The NCD 270.3 now affirms that ActiGraft PRO is recognized as a blood derived product for chronic, non-healing wounds which utilizes whole blood and includes both: (1) platelet derived growth factors (PDGF) and (2) the gel contains whole blood cells including white cells, red cells, plasma, platelets, fibrin, stems and fibrocyte precursors. The gel is used by physicians in clinical settings in treating chronic, non-healing wounds. The main differences to the code, which describes the procedures reflecting the coverage, are that RedDress uses patients whole blood with no need for a centrifuge and only requires mixing with its proprietary coagulation agent, unlike platelet-rich plasma (PRP) which requires a centrifuge and is more time consuming and costly.

“Launching ActiGraft PRO, our most advanced wound care product, along with Medicare reimbursement status for patients across the US, is a significant milestone for us as a company and for the national wound care market as a whole”, said Alon Kushnir, CEO and co-founder of RedDress. “Our whole blood approach to solving the problem of non-healing wounds is proven to be one of the most effective solutions on the market and will significantly lower the time and cost of treatment for patients, providers and insurance companies. We are excited to be on the front lines of advancing new and innovative treatment for chronic wounds and to explore the treatment of other chronic conditions as we move forward.”

The ActiGraft PRO system is an autologous, point-of-care wound management solution created from patient's whole blood. Once applied, the blood clot serves as a protective covering and optimizes the body's own healing potential. ActiGraft PRO is designed to jump-start wound healing and to meet the needs of today’s high-volume practices and centers, offering practitioners a premium wound healing solution that delivers a quick, easy, and clean procedure. Applied directly to the wound surface, the ActiGraft PRO blood clot is created at the patient's bedside in under five minutes by mixing fresh whole blood with our proprietary coagulation powder. ActiGraft PRO contains whole blood cells including white cells, red cells, plasma, platelets, and fibrin, in the optimal concentration required in the wound healing process. Once applied, ActiGraft PRO reignites the healing cascade, serving as a protective covering that supports wound healing processes which occur naturally in the body.

While reimbursement for ActiGraft PRO currently applies only to diabetic patients with lower extremity, non-pressure injury chronic wounds, ActiGraft PRO can be used for a wide variety of chronic wounds including but not limited to: Diabetic and Neuropathic Ulcers, Venous Ulcers, Traumatic Wounds, Post-Surgical Wounds, Skin Tears and Surgical Wounds.

Since RedDress received FDA clearance and a CE Mark in 2020, ActiGraft has helped over 6,000 patients across the spectrum of healthcare facilities in the United States and 30 other countries.

Disclaimer: The information provided shall not be constructed as a statement, promise, or guarantee that reimbursement will be received. Reimbursement requirements are subject to change at any time. Check with your local payer regularly.

About RedDress

RedDress is the leading provider of personalized and autologous wound management solutions created from patients own blood. The company’s suite of ActiGraft products are transforming wound care, treating a wide variety of chronic wounds including diabetic and neuropathic ulcers, venous ulcers, pressure injuries, traumatic wounds, post-surgical wounds, skin tears, surgical wounds and more. ActiGraft wound care systems are available in 30 countries across five continents including Brazil, Canada, Hong Kong, India, Mexico, Turkey, United Arab Emirates, South Africa, Ireland, Italy, and more. RedDress is a privately held, Israel-based company with a U.S. subsidiary, RedDress Inc., located in Jacksonville, Florida. Founded in 2009 with the goal of developing more effective, natural, and economically viable treatments for chronic wounds, RedDress is dedicated to using its whole-blood technology to find solutions to other human ailments. For more information, please visit www.reddressmedical.com

Source: RedDress