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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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 expectations or beliefs, as well as a number of assumptions about future events. Although RenovaCare, Inc. (the “Company”) believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: the timing and success of clinical and preclinical studies of product candidates, the potential timing and success of the Company’s product programs through their individual product development and regulatory approval processes, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs, termination of contracts or agreements, obsolescence of the Company’s technologies, technical problems with the Company’s research, price increases for supplies and components, litigation and administrative proceedings involving the Company, the possible acquisition of new businesses or technologies that result in operating losses or that do not perform as anticipated, unanticipated losses, the possible fluctuation and volatility of the Company’s operating results, financial condition and stock price, losses incurred in litigating and settling cases, dilution in the Company’s ownership of its business, adverse publicity and news coverage, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists, and other risks. There can be no assurance that further research and development will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that the Company will be able to develop commercially viable products on the basis of its technologies. In addition, other factors that could cause actual results to differ materially are discussed in the Company’s most recent Form 10-Q and Form 10-K filings with the Securities and Exchange Commission. These reports and filings may be inspected and copied at the Public Reference Room maintained by the U.S. Securities & Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information about operation of the Public Reference Room by calling the U.S. Securities & Exchange Commission at 1-800-SEC-0330. The U.S. Securities & Exchange Commission also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the U.S. Securities & Exchange Commission at https://www.sec.gov. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.