FDA Grants RenovaCare Full IDE Approval for Safety and Feasibility Clinical Trial
May 06, 2021 08:30 ET | Source: RenovaCare, Inc. RenovaCare, Inc. Roseland, New Jersey, UNITED STATES
ROSELAND, N.J., May 06, 2021 (GLOBE NEWSWIRE) RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), today announced that its Investigational Device Exemption (IDE) application has been granted full approval by the U.S. Food and Drug Administration (FDA). This approval enables RenovaCare to conduct a clinical trial to evaluate the safety and feasibility of its SkinGun™ and CellMist™ System for the treatment of burn wounds using skin cells obtained directly from the burn patient.
“This marks the first FDA approval of a RenovaCare-sponsored regulatory submission, which is an important inflection point for our company and all our stakeholders,” commented Dr. Robin A. Robinson, RenovaCare Chief Scientific Officer and former director of the