RenovaCare Clinical Trial to Start at U.S. Burn Centers
RenovaCare (RCAR) has announced the initiation of its CELLMIST-1 clinical trial at four U.S. burn centers following FDA's Investigational Device Exemption (IDE) approval. This trial aims to evaluate the safety and feasibility of its electronic SkinGun™ and CellMist™ System for treating deep second-degree burn wounds. Enrollment begins this week at MedStar Washington Hospital Center and will expand to other centers shortly. This marks a significant milestone in RenovaCare's path towards Premarket Approval (PMA) for its novel autologous skin stem cell therapy.
- FDA IDE approval received, enabling clinical trials.
- Initiation of CELLMIST-1 trial at four burn centers.
- Milestone in clinical program towards Premarket Approval.
- None.
ROSELAND, N.J., June 07, 2021 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), today announced that it is initiating a clinical trial at four burn centers in the United States. This follows the Company’s recent Investigational Device Exemption (IDE) approval by the U.S. Food and Drug Administration (FDA).
The clinical trial, designated CELLMIST-1, utilizes our electronic SkinGun™ spray device and CellMist™ System to render the skin and stem cells uniquely from both the epidermal and dermal layers of the patient’s own skin tissue and then topically spray these cells onto burn wounds to facilitate wound healing. This clinical study will evaluate the safety and feasibility of the Company’s autologous skin stem cell therapy for the treatment of deep second-degree, partial-thickness burn wounds in adults.
“The CELLMIST-1 clinical study marks a milestone in the Company’s clinical program – the first controlled clinical study and the first step on the Premarket Approval (PMA) regulatory pathway towards U.S. marketing,” stated Dr. Robin Robinson, RenovaCare’s Chief Scientific Officer.
The CELLMIST-1 clinical study is slated to start enrollment this week at the Burn Center of MedStar Washington Hospital Center (Washington D.C.). In coming weeks, clinical study sites at UMC Burn Center at University Medical Center New Orleans (New Orleans, LA), University of Florida Health Shands Burn Center (Gainesville, FL), and the Regional Burn Center, Tampa General Hospital, University of South Florida Medical Center (Tampa, FL) will open for enrollment.
Details of the CELLMIST-1 clinical study with the RenovaCare electronic SkinGun™ spray device and CellMist™ System can be found at www.clinicaltrials.gov.
About RenovaCare
RenovaCare, Inc. is developing new-generation autologous (self-donated) cell therapies for the regeneration of human 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 tissue abnormalities when applied topically as a gentle mist of cells using the patented RenovaCare SkinGun™. The Company’s SkinGun™ is used to spray a liquid suspension of a patient’s stem cells – the CellMist™ Suspension – onto wounds.
Development and commercialization of next-generation biomedical technologies and devices for addressing unmet medical needs is taking place at the RenovaCare Research and Development Innovation Center, located at StemCell Systems GmbH in Berlin, Germany. StemCell Systems is a biomedical engineering and prototyping company. 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 currently 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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FAQ
What is the CELLMIST-1 clinical trial for RenovaCare (RCAR)?
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