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LATEST TEST RESULTS BOLSTER RENOVACARE STRATEGY TO SPRAY STEM CELLS ON WOUNDS AND BURNS FOR RAPID HEALING
RenovaCare, Inc., (OTCQB:RCAR) today announced positive spray test results demonstrating that its novel SkinGun™ technology achieves exceptionally-uniform distribution of fluids with 200 times greater coverage than conventional methods. These outcomes are especially promising to scientists developing patented RenovaCare CellMist™ and SkinGun™ technologies* for spraying fluids containing a patient’s own stem cells onto burns and wounds for rapid scar-free healing.
“These results mark important technical milestones in our pathway to spraying patient wounds with their own stem cells to promote fast and natural skin repair,” said Thomas Bold, President and CEO of RenovaCare, Inc. “Data from ongoing preclinical work supports our long-held conviction that our SkinGun™ technology is superior to standard methods for delivering fluids and stem cells to target sites, achieving excellent coverage while being extremely gentle to the cells.”
Click here to see video of ultra-gentle RenovaCare SkinGun™ sprayer.
In addition to these tests showing high distribution and concentration patterns, the SkinGun™ recently demonstrated the ability to spray powerful yet delicate skin stem cells ultra-gently. Scientists reported impressive 97.3% cell viability after SkinGun™ spraying. Cell viability is essential to regenerating skin for burns, wounds, and cosmetic applications.
Specifically, scientists at one of the world’s largest university hospitals, Berlin-Brandenburg Center for Regenerative Therapies (BCRT), a translational research center at Charité – Universitätsmedizin Berlin, sprayed human skin stem cells using the RenovaCare™ SkinGun™. Among technical 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, and cell growth was comparable to pipetting, the industry’s widely accepted ‘gold-standard’ for the deposition of cells.
In these latest tests, scientists repeatedly sprayed fluids at various airflow rates using the RenovaCare SkinGun™, resulting in 200-times more droplets than conventional ‘syringe deposition’. For example, in an 8cm diameter surface area the SkinGun™ delivered more than 20,000 evenly distributed droplets versus only 91 droplets by conventional needle and syringe methods.
Scientists evaluated droplet size, distribution, and density alongside spray velocity and fluid viscosity in experiments conducted at Stem cell Systems GmbH (Berlin, Germany). Additional testing of the SkinGun™ remains ongoing.
The RenovaCare medical-grade spray device gently sprays a well-dispersed mist of wound care and/or irrigation fluids using a patented liquid-into-air stream system. The device targets the estimated $45 billion plus wound care market in the U.S.
*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.
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.
In addition to the SkinGun™, the company is developing a medical-grade sprayer that uses a liquid-into-air stream system to disperse a gentle spray of wound care and/or irrigation fluids over a wound area.
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Legal Notice Regarding Forward-Looking Statements
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.
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The materials presented have been made available for information purposes only and do not constitute an offer or solicitation to purchase or sell shares of the company’s securities, either generally or in any state or jurisdiction where the offer or sale is prohibited.
None of the information presented herein is intended to form the basis for any investment decision, and no specific recommendations are intended. Accordingly this site does not constitute investment advice or counsel or solicitation for investment in any security. This site does not constitute or form part of, and should not be construed as, any offer for sale or subscription of, or any invitation to offer to buy or subscribe for, any securities, nor should it or any part of it form the basis of, or be relied on in any connection with, any contract or commitment whatsoever. The company expressly disclaims any and all responsibility for any direct or consequential loss or damage of any kind whatsoever arising directly or indirectly from: (i) reliance on any information contained herein, (ii) any error, omission or inaccuracy in any such information or (iii) any action resulting therefrom.
The outcomes described herein are from preclinical studies and single case observations from work conducted under Innovative Practice Approach (IPA) guidelines with Institutional Review Board approval. The IPA work was undertaken by parties other than RenovaCare, Inc. or its affiliates at that time. This treatment was provided with a prototype version of the device, subsequently acquired by RenovaCare, Inc. The company has announced plans to conduct FDA-regulated clinical studies in the future. There is no assurance that such studies will be successfully undertaken, and even if or when initiated, that such studies will be completed or yield clinical outcomes.
