RenovaCare, Inc. Completes Engineering, Research, and Studies Required to File 510(k) Submission to the FDA for its Novel Medical-Grade Liquid Spray Device

NEW YORK & PITTSBURGH–(BUSINESS WIRE)–RenovaCare, Inc., a developer of novel medical grade liquid spray devices and patented CellMist™ and SkinGun™ technologies* for isolating and spraying a patient’s own stem cells onto burns and wounds for rapid self-healing, today announced that the company has successfully completed the engineering, studies, and associated efforts required for submission of its foundational 510(k) filing to the U.S. Food and Drug Administration (FDA). The company’s planned submission will focus on its liquid sprayer technology. The FDA’s clearance of a 510(k) submission allows for the marketing of a medical device in the United States.
A successful 510(k) submission is an important benchmark in medical device development. In addition to enabling marketing of the device, the clearance of a submission helps meet the threshold for undertaking clinical research to support additional indications and uses of the device.
“I’m pleased to report that our research, engineering, and regulatory teams have completed the important studies and work required to lay the groundwork for filing this foundational FDA submission,” said Thomas Bold, President and CEO of RenovaCare, Inc. “This submission marks the first step towards moving our novel medical liquid sprayer towards clinical trial phases for commercial roll-out.”
The RenovaCare spray device is a medical-grade sprayer that uses a liquid-into-air stream injection system to gently create a well-dispersed spray of wound care and/or irrigation fluids.
The RenovaCare liquid sprayer device targets the estimated $45 billion plus wound care market in the U.S. alone.
*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.
In addition to its liquid spray devices for wound irrigation, the company’s pipeline products under development target the body’s largest organ, the skin. The RenovaCare CellMist™ System will use the patented SkinGun™ to spray a liquid suspension of a patient’s stem cells – the CellMist™ Solution – onto 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 U.S. 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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