Spray-On Gene Therapy With RenovaCare SkinGun™ in New Study Underway at King’s College London

Scottsdale, Arizona, UNITED STATES


ROSELAND, N.J., March 30, 2020 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, today announced that the Company’s novel SkinGun™ is now being used to apply regenerative cells in a preclinical study of new gene therapies, underway at King’s College London. Researchers are using the SkinGun™ to ultra-gently spray gene-supplemented cells for accelerated wound healing in Recessive Dystrophic Epidermolysis Bullosa (RDEB), a debilitating skin disease which afflicts young children and leads to premature death.

“We are proud to support this much-needed gene therapy work on RDEB at King’s College London. It’s especially inspiring that this preclinical study marks the first-ever use of our SkinGun™ for a therapeutic application beyond the spray of our own RenovaCare cell therapy for burns and wounds,” stated Mr. Alan L. Rubino, President & CEO of RenovaCare, Inc.

Over 70 patients with various types of second-degree burns have been treated on an experimental basis utilizing the technology underlying the Company’s SkinGun™, which RenovaCare has developed as a potential alternative to skin grafting and other treatment options. Sprayed with a gentle mist of their own skin cells, many of these patients left the hospital within days, avoiding generally painful skin graft surgeries and potentially prolonged hospitalization.

While RenovaCare continues pursuing the regulatory pathway for burns using its own cell isolation, the Company was awarded new patent protections in 2019 expanding the use of its SkinGun™ to spray all varieties of cells and tissues and enabling the gene therapy study announced today.

“Patient-friendly effective therapies for RDEB are desperately needed. Our preclinical investigation of this new gene therapy with the SkinGun™ provides for a non-invasive gentle spray of regenerative cells to the wound site in order to improve the wound site and minimize pain,” explained Co-Principal Investigator, Dr. Su Lwin, Dermatology Registrar and Honorary Clinical Research Fellow at St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust, and King’s College London.

“Our goal from this early work is to realize longer-lasting therapeutic benefits including prevention of scarring, a condition which can severely restrict motion and lead to permanent disfigurement in RDEB such as fusing of the fingers, toes, and mouth, leaving young patients unable to eat and wheelchair-reliant by their teenage years in some cases. Sadly, many do not survive due to skin cancers and other complications,” concluded Dr. Lwin.

“This preclinical study will provide us with essential spray-on gene therapy data required for human applications,” stated Dr Michael Antoniou, Head of the Gene Expression and Therapy Group at the Department of Medical and Molecular Genetics of King’s College London, and Co-Principal Investigator of this study.

“We hope to translate this data into readily-available clinical therapies to benefit a wider population of RDEB sufferers,” stated Professor John McGrath, another Co-PI of this collaboration. Professor McGrath serves as the Mary Dunhill Chair in Cutaneous Medicine at King’s College London and Head of the St John’s Institute of Dermatology, the Guy’s and St Thomas’ NHS Foundation Trust in London. 

The preclinical gene therapy study announced today is the result of a Research Agreement entered into between RenovaCare and King’s College London. King’s College funding for this study is provided by DEBRA UK.

Dr. Su Lwin, Dr Michael Antoniou and Professor John McGrath are Co-Principal Investigators of this spray-on gene therapy study. 

The King’s College team is working directly with Dr. Roger Esteban-Vives, RenovaCare Vice President of Research & Product Development for use of the Company’s SkinGun™.

About RenovaCare
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.

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 will be accepted or cleared by the FDA.

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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.

Dr. Su Lwin, Co-Principal Investigator