SCOTTSDALE, Ariz., Aug. 14, 2019 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com) today announced the issuance of a new patent (U.S. Patent Number 10,376,658) allowing the Company’s novel medical device to now spray all varieties of tissues and cells, thus opening the door for its potential application in the regeneration of tissues and organs, beyond skin.
A video of the ultra-gentle RenovaCare SkinGun™ sprayer can be seen here.
“Just as we’ve used needles to inject drugs and vaccines in the 20th century, the syringe of tomorrow could be our patented SkinGun™, spraying a gentle healing mist of self-donated stem cells to regenerate human organs and tissue,” stated Dr. Ben Walthall, former Johnson & Johnson R&D Worldwide Director of Surgical Wound Care and Tissue Regeneration, and recently appointed RenovaCare Advisory Board member.
Today’s important patent award, which is a continuation of U.S. Patent 9,505,000, accelerates RenovaCare’s commitment to develop new products and expand its proprietary cell spray technology platform for medical conditions beyond burns and beyond skin, which itself is the largest organ in the human body.
“There have been important breakthroughs in stem cell regenerative technologies for organs and tissues, such as the heart, liver, kidney, bone and others,” stated Dr. Esteban-Vives, RenovaCare Vice President, Research and Product Development.
“Today’s patent opens the door for our novel SkinGun™ to gently spray the vast array of these highly potent, regenerative cells, just as we have done with skin stem cells for burns and wounds.
“While we remain focused on advancing our core skin spray stem cell therapy through the FDA regulatory pathway, I am also thrilled about the possibilities our new patent affords us.”
Following a November 2018 equity financing of $15.5 million by Kalen Capital Corporation, wholly owned by Mr. Harmel S. Rayat, the Company’s Chairman, RenovaCare has:
- allocated greater resources in its pursuit of human clinical trials of the SkinGun™ and CellMist™ System for the treatment of burns;
- increased its new product development budget and accelerated investigation of the Company’s cell spray technologies for reconstructive surgery and cosmetic applications, and
- expanded its scientific, clinical and regulatory team.
Spraying Skin Stem Cells onto Burns and Wounds
To date, 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, such as in-vitro cultured epithelial grafts that require a specialized and expensive external laboratory.
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 weeks of hospitalization. Clinical outcomes of early experimental treatments have been peer-reviewed and published in several medical journals, including Burns and Annals of Plastic Surgery.
Patients who undergo skin grafting, today’s default treatment of care, can remain hospitalized for weeks and even months, often enduring painful and costly surgeries and prolonged physical therapy. Some of these patients may also suffer from the psychological effects of disfigurement caused by permanent scarring and cope with the use of pain medications and protracted joint mobility issues.
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.
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.
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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.