NEW YORK & PITTSBURGH--(BUSINESS WIRE)--RenovaCare, Inc., (OTCQB:RCAR), a developer of novel medical grade liquid spray devices and patented CellMist™ and SkinGun™ technologies*, today announced favorable outcomes from laboratory studies conducted by Berlin-Brandenburg Center for Regenerative Therapies (BCRT), a translational research center at Charité – Universitätsmedizin Berlin, one of the world’s largest university hospitals.
“Our goal is to work towards the use of our CellMist™ and SkinGun™ technologies to quickly isolate a patient’s own stem cells and gently spray them onto burns and wounds for rapid self-healing,” said Thomas Bold, President and CEO of RenovaCare, Inc. “Today’s study results provide pre-clinical support for our methodology for first isolating keratinocytes from skin samples, and subsequently achieving even and gentle spray application without harming these powerful yet delicate cells.”
Charité scientists presented their findings from in vitro studies at the EPUAP Focus Meeting 2016 in Berlin, Germany. Data demonstrated that human skin stem cells sprayed with the company’s patented SkinGun™ device maintained 97.3% viability. Cell viability is essential to regenerating skin for burns, wounds, and cosmetic applications. Cell growth was comparable to pipetting, the industry’s widely accepted ‘gold-standard’ for the deposition of cells.
“The results show that the described method consistently allows isolating keratinocytes with characteristics suitable for therapeutic applications. This indicates that use of the SkinGun™ for spray application of keratinocytes may allow for even distribution of cells with no impairment of cell viability or cell growth when evaluated in vitro, in contrast to those evaluations with conventionally seeded cells,” concluded study authors, Dr. Christa Johnen, Nadja Strahl, and Dr. Katrin Zeilinger.
Among specific aims of the study, was evaluation of several factors important to the regeneration of human skin, including cell yield, viability, metabolic activity, and cell growth. Positive results were reported from experiments related to each of these investigations.
After spraying skin stem cells using the RenovaCare SkinGun™, investigators recorded favorable metabolic activity from measurements of glucose consumption and lactate release. Cell morphology was evaluated by microscopic observation, and cell integrity was determined by LDH release.
The study was funded by RenovaCare, Inc. Tissue samples for skin cell isolation were obtained from surgical treatments with approval of the Charité ethical committee.
*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 http://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.
