RedDress’ ActiGraft System Receives New FDA Clearance

RedDress, a privately held U.S. and Israel-based wound care company, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its RD2 Ver.02 system. The RD2 Ver.02 System is a continuation of RedDress’ pre-existing RD1 System, marketed as the ActiGraft system.

“The FDA’s approval of the ActiGraft Ver. 02 System allows us to introduce the next generation of the ActiGraft system,” said Robert Mueller, general manager of RedDress. “This launch incorporates feedback from our customers and speaks to our commitment in supporting our health care providers and advancing the treatment of non-healing wounds.”

The ActiGraft Ver.02 System is intended to be used at point-of-care for the safe and rapid preparation of Whole Blood Clot (WBC) from a small sample of a patient’s own peripheral blood. Under the supervision of a healthcare professional, the WBC produced by the ActiGraft Ver.02 System is topically applied to the wound and serves as a protective covering. ActiGraft WBC can be used for the management of exuding cutaneous wounds, such as leg ulcers, pressure injuries, diabetic ulcers, and mechanically or surgically-debrided wounds.

“It is with tremendous gratitude that we announce an additional FDA-clearance for our ActiGraft system. As part of our commitment to solving the challenges associated with chronic, non-healing wounds, we strive to deliver technology that offers the greatest breakthrough potential in the fight against non-healing wounds,” said Alon Kushnir, CEO of RedDress. “The ActiGraft system was launched to clinicians in the second half of 2020, and since then, its presence and use has grown rapidly nationally and internationally. We are looking forward to seeing further adoption of the ActiGraft system and continuing to improve the lives of our patients.”

The ActiGraft system, based on RedDress’ proprietary patented technology, is an FDA-cleared wound care solution that enables health care providers to produce—in real time—an in-vitro blood clot from a patient’s whole blood. Once applied, the blood clot serves as a protective covering and supports wound healing processes that naturally occur in the patient’s body.

ActiGraft WBC is intended for exuding cutaneous wounds. The ActiGraft system includes blood-contacting components that have been sterilized by ethylene oxide, which may cause serious allergic reactions in patients that are sensitized. 

RedDress is a privately held, Israel-based company with a U.S. subsidiary, RedDress Inc., located in Ponte Vedra Beach, Fla. Founded in 2009 with the goal of developing more effective, natural, and economically viable treatments for chronic wounds, RedDress is committed to improving the health and lives of patients around the world with its latest innovation, ActiGraft WBC.