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RenovaCare FDA IDE Approval
FDA Grants RenovaCare Full IDE Approval for Safety and Feasibility Clinical Trial
ROSELAND, N.J., May 06, 2021 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), today announced that its Investigational Device Exemption (IDE) application has been granted full approval by the U.S. Food and Drug Administration (FDA). This approval enables RenovaCare to conduct a clinical trial to evaluate the safety and feasibility of its SkinGun™ and CellMist™ System for the treatment of burn wounds using skin cells obtained directly from the burn patient.
“This marks the first FDA approval of a RenovaCare-sponsored regulatory submission, which is an important inflection point for our company and all our stakeholders,” commented Dr. Robin A. Robinson, RenovaCare Chief Scientific Officer and former director of the Biomedical Advanced Research and Development Authority (BARDA), which he led for 12 years.
“This approval enables RenovaCare to demonstrate how its CellMist™ System and Electronic SkinGun™ spray device can deliver a regenerative cell therapy to treat burn wounds in a controlled, definitive care setting.”
The clinical trial protocol is an open-label, single-arm clinical study that will enroll 14 adult burn subjects with partial-thickness second degree thermal burn wounds. The Company expects to conduct the clinical study at four U.S. burn centers over twelve months. Details of this clinical study with the RenovaCare CellMist™ System and Electronic SkinGun™ spray device can be found at www.clinicaltrials.gov.
“Acute severe burn wounds are often times debilitating. Severe burns result in symptoms that impact quality of life which commonly persist for years, despite following current standard-of-care medical treatment. Today, the FDA’s approval of our IDE application is a truly momentous occasion for RenovaCare and affirms our mission of delivering breakthrough cell therapy for burn patients around the world," concluded Dr. Kaiyo Nedd, CEO & President of RenovaCare.
Spraying Cells onto Burns and Wounds
To date, over 70 patients with various types of burns have been treated in investigator initiated clinical case studies utilizing the technology underlying the Company’s SkinGun™ and CellMist™ System, which RenovaCare has developed as a potential alternative to skin grafting and other treatment options, such as in vitro cultured skin epithelial cells that require a specialized and expensive external laboratory. Clinical outcomes of these early experimental studies have been peer-reviewed and published in several medical journals, including Burns and Annals of Plastic Surgery.
In late 2019, RenovaCare was issued a patent allowing the Company’s novel SkinGun™ spray device to spray a variety of tissues and cells, thus opening the door for its potential application in the regeneration of other tissues, beyond skin.
RenovaCare, Inc. is developing new-generation autologous (self-donated) cell therapies for the regeneration of human organs and tissues. The Company’s initial product under development targets the body’s largest organ, the skin. The Company’s flagship technology, the CellMist™ System, renders single-cell suspensions of tissue-specific pluripotent cells from donor tissues through sequential protease digestions. The RenovaCare CellMist™ System facilitates rapid healing of wounds or other afflicted tissues when applied topically as a gentle cell mist using the patented RenovaCare SkinGun™. The Company’s SkinGun™ is used to spray a liquid suspension of a patient’s stem cells – the CellMist™ Solution – on to wounds.
Development for next-generation biomedical technologies and devices for addressing unmet medical needs and commercialization is taking place at the RenovaCare R&D Innovation Center, located at StemCell Systems in Berlin, Germany. The Innovation Center houses dedicated RenovaCare cell biology laboratories; additional engineering, fabrication, prototyping and performance testing facilities; and product design studios for medical devices and biomedical products. Experienced contract bioengineers, cell biologists, and support staff work under the direction of a team of MD-PhDs who are experts in regenerative medicine, new product development, and clinical translation.
RenovaCare is developing its CellMist™ System as a promising new alternative for patients suffering from burns, chronic and acute wounds, and scars.
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.
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