Peer-Reviewed Publication Validates RenovaCare Approach to Rapidly-Processing Stem Cells for Burns and Wounds

NEW YORK & PITTSBURGH--()--RenovaCare, Inc., (OTCQB:RCAR), has announced that its approach to isolating a patient’s own stem cells for subsequent spray onto burns and wounds has been validated by researchers in ‘Differentiation’, a leading peer-reviewed scientific publication. According to their findings, the methodology, which has been adopted by RenovaCare, successfully isolates those specific cell populations with the greatest regenerative capacity to support the growth of fully-functioning skin.

“It’s very exciting to have this scientific validation that our approach is ideal for rapid and natural skin regeneration”

Today’s announcement follows recent highlights from an independent analysis of treatment results on a variety of wide-area and severe burn injuries published in Burns, the peer-reviewed Journal of the International Society for Burn Injuries. The treatment method, adopted by RenovaCare, involved isolating and spraying the patient’s own skin stem cells on the burn wounds, and it is the technology underlying the company’s patented CellMist™ and SkinGun™.

(Click here to see before-after photos of severe second-degree burn patients who received skin stem cell spray grafting treatment; Journal Burns.)

RenovaCare harvests a patient’s stem cells from a small area of skin, as little as one-inch square. These cells are placed in a water-based suspension and delicately sprayed onto the wound using the RenovaCare SkinGun™, where the cells begin growing new skin.

As in the case of state trooper Matt Uram, one of dozens of burn victims treated with autologous skin stem cell spray, patients are able to leave the hospital within only a few days rather than the many weeks required by alternative treatments such as in-vitro cultured epithelial grafts.

In contrast to the speed and effectiveness of the RenovaCare procedure -- taking as little as 90-minutes -- in-vitro cultured grafts require harvesting cells from a patient, which are then transported to a specialized external laboratory where they take weeks to form sheets of skin. These fragile sheets must then be sent back to the hospital for surgical stitching onto a patient’s wounds, a process that is complicated, time-consuming and expensive.

“It’s very exciting to have this scientific validation that our approach is ideal for rapid and natural skin regeneration,” explained Mr. Thomas Bold, President and CEO of RenovaCare, Inc. “We’ve always had confidence that our methodology isolates the body’s most regenerative cell population before spray application with our ultra-gentle SkinGun™.”

In the 2015 article published in ‘Differentiation’, researchers identified the advantages of freshly-isolated cells and compared their regenerative properties against the concept of culturing skin cells, used to grow sheets of skin.

Findings demonstrate that, under the tested conditions, freshly-isolated skin cells have far greater regenerative capacity than cells which have been repeatedly cultured. Cultured cells lose specific cell populations which support skin regeneration, necessary to healing.

In the RenovaCare approach, adopted from the study, freshly isolated cells derived from the basal layer grow both in size and number and include rapid-cycling cells responsible for quick healing. The high presence of these cells assures entirely natural regeneration of the skin without the use of external chemical support, growth factors, and drugs -- important advantages highlighted by RenovaCare.

According to authors of the ‘Differentiation’ publication, the approach of applying freshly isolated stem cells to the wound is, “A concept that is thought to preserve the proliferative and regenerative capabilities of basal layer derived cells for the patient's wound healing in a more physiological way than applying the cells to the same wound only after several weeks of in vitro culture.”

The paper further concludes that by directly applying these freshly-isolated cells onto the wound, the patient’s own body can provide the nutrients and vascular support needed in order to promote skin regeneration.

The article titled, “In vitro keratinocyte expansion for cell transplantation therapy is associated with differentiation and loss of basal layer derived progenitor population,” by: Roger Esteban-Vives, Matthew T. Young, Patrick Over, Eva Schmeltzer, Alain Corcos, Jenny Ziembicki, and Jörg Gerlach, was published in June 2015 by Elsevier in Differentiation. (doi: 10.1016/j.diff.2015.05.002.)

Copies of the article are available to credentialed journalists upon request; please contact Elsevier’s Newsroom at newsroom@elsevier.com or +31 20 485 2492.

Study authors, Dr. Roger Esteban-Vives and Dr. Jörg Gerlach currently have a financial interest in the SkinGun™ spray-grafting technology through payments from RenovaCare, Inc. Dr. Esteban-Vives, currently Director of Cell Sciences at RenovaCare, Inc., was a postdoctoral fellow at the University of Pittsburgh when this work was conducted and did not have such financial interest at that time.

*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 Burns

Burns aims to foster the exchange of information among all engaged in preventing and treating the effects of burns. The journal focuses on clinical, scientific, and social aspects of these injuries and covers the prevention of the injury, the epidemiology of such injuries, and all aspects of treatment including development of new techniques and technologies and verification of existing ones. Regular features include clinical and scientific papers, state of the art reviews, and descriptions of burn-care in practice.

About RenovaCare, Inc.

RenovaCare, Inc. is developing first-of-its-kind autologous (self-donated) stem cell therapies for the regeneration of human organs. Its initial product under development targets the body’s largest organ, the skin. The company’s flagship technology, the CellMist™ System, uses its 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 US 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.

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