RenovaCare, Inc. Receives FDA Conditional IDE Approval of CellMist™ System and SkinGun™ Device, Enabling Clinical Study for Safety and Feasibility
August 11, 2020 at 08:30 am EDT
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RenovaCare, Inc. announced that the US Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to conduct a clinical trial to evaluate the safety and feasibility of autologous stem cells rendered by its CellMist™ System from donor skin and applied topically with the SkinGun™ spray device for treatment of burn wounds. The clinical trial protocol, conditionally approved on August 5, 2020 by the FDA is an open-label single-arm clinical study that will enroll 14 human burn subjects with partial-thickness second- or- third degree thermal burn wounds. The Company expects to conduct the clinical study at multiple U.S. burn centers.
RenovaCare, Inc. is a clinical-stage biotechnology company. The Company is focused on developing autologous (self-donated) stem cell therapies for the regeneration of human organs. The Company through its wholly owned subsidiary, RenovaCare Sciences Corp. is focusing on the research, development and commercialization of autologous (using a patientâs own cells) cellular therapies that can be used for medical and aesthetic applications. The Companyâs CellMist System is a cell isolation procedure that enzymatically renders stem cells from the patientâs own skin or other tissues. The resulting stem cell suspension is administered topically from the Companyâs novel solution sprayer device (the SkinGun) as a cell therapy for wounds including burns to facilitate healing. Its SkinGun spray device is an advanced technology, using a gentle positive-pressure air stream to spray the CellMist Solution onto wounds.
RENOVACARE, INC. 
