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.

For additional information, please call Drew Danielson at: 888-398-0202
or visit: http://renovacareinc.com

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No statement herein should be considered an offer or a solicitation of
an offer for the purchase or sale of any securities. This release
contains forward-looking statements that are based upon current
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viable products on the basis of its technologies. In addition, other
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