RenovaCare announces outcome of pre-submission FDA meeting
RenovaCare announced positive outcomes from its pre-submission meeting with the United States Food and Drug Administration regarding the RenovaCare SkinGun and CellMist System for isolating and spraying a patient's own stem cells onto burns and wounds for rapid self-healing. During the meeting, the FDA provided recommendations that are consistent with the device-specific testing RenovaCare has successfully undertaken and already completed. This testing is valuable to the current study design as well as the follow-on premarketing process. Importantly, the company and the FDA reached alignment on clinical risk mitigation measures, including protocol-specified guidelines and additional investigator and patient education regarding cell harvesting, processing, spraying, and patient follow-up. RenovaCare received targeted feedback from the FDA regarding the proposed US regulatory pathway, clinical study protocols, planned non-clinical evaluations and data requirements. The company confirms that it will perform feasibility clinical studies designed in accordance with feedback and guidance from the pre-submission meeting with the FDA.