RenovaCare Announces Successful FDA Meeting

RenovaCare, Inc., (RCAR), announced today positive outcomes from its pre-submission meeting with the United States Food and Drug Administration (FDA) 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.

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RenovaCare SkinGun™ Ultra-Gently Sprays Patient's Own Stem Cells to Heal Wounds (Photo: Business Wire)

"The level of engagement exhibited by the FDA team has been very encouraging. With this guidance in-hand, I’m proud to announce that RenovaCare will formally make our submission to the FDA for the SkinGun™ and CellMist™ systems, initially for use in burn victims,” stated Mr. Thomas Bold, President and CEO of RenovaCare, Inc.

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.

*RenovaCare products are currently in development. They are not available for sale in the United States. There is no assurance that the company’s planned or filed submissions to the U.S. Food and Drug Administration, if any, will be accepted or cleared by the FDA.

About RenovaCare:

RenovaCare, Inc. is developing first-of-their-kind autologous (self-donated) stem cell therapies for the regeneration of human organs, and novel medical grade liquid sprayer devices. RenovaCare, Inc. is developing first-of-its-kind autologous (self-donated) stem cell therapies for the regeneration of human organs. Its initial product under development targets the body’s largest organ, the skin. The company’s flagship technology, the CellMist™ System, uses its patented SkinGun™ to spray a liquid suspension of a patient’s stem cells – the CellMist™ Solution – on to wounds. RenovaCare is developing its CellMist™ System as a promising new alternative for patients suffering from burns, chronic and acute wounds, and scars. In the US alone, this $45 billion market is greater than the spending on high-blood pressure management, cholesterol treatments, and back pain therapeutics.

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