NEW YORK, PITTSBURGH & BERLIN--(BUSINESS WIRE)--RenovaCare, Inc., (OTCQB: RCAR), today highlighted an analysis of treatment results from 44 patients treated for severe second-degree wide-area burn injuries, as published in Burns, the peer-reviewed Journal of the International Society for Burn Injuries. The treatment method, which involved isolating and spraying the patient’s own skin stem cells on to burn wounds, is the technology underlying the RenovaCare patented SkinGun™* and CellMist™ System*.
The results, published in the November 2017 issue of Burns, report the retrospective analysis of outcomes in 44 severe second-degree burn patients who received skin stem cell spray grafting treatment under an innovative practice approach.
According to the Burns article, spraying deep partial-thickness burn wounds with a patient’s own skin stem cells “...can achieve rapid wound re-epithelialization, particularly in large wounds.” Re-epithelialization marks the final stage of successful healing and is an essential component of wound closure. At this stage, skin function is restored and the risk of infection is eliminated.
“Treated patients presented with a variety of burn wound etiologies and a wide range of TBSA (Total Burn Surface Area). Overall clinical results were very satisfying,” stated the authors.
Regardless of the severity or size of the wound, the average days of healing and discharge remained low. “The mean days to [hospital] discharge was 6.28 +/- 4.1 with a median of six days,” according to the study.
“This data is especially compelling because patients were successfully treated for a broad spectrum of burn injuries and vast burn surface areas. Importantly, patients had very short hospital stays, which, we believe could deliver a better healing experience for patients and lower costs for hospitals and insurance providers,” stated Mr. Thomas Bold, President and CEO of RenovaCare, Inc.
“The clinical outcomes and minimal hospital stays for severe burn patients published in this article supports our conviction to bring our SkinGun™ technology to market as quickly as possible,” continued Mr. Bold. “Presently, we’re finalizing the requisite documentation for filing with the FDA to demonstrate the safety of our approach for treating wounds using a patient’s own skin cells.”
The retrospective analysis covered 44 patients treated for deep partial-thickness burns, including gas and chemical explosions, and electrical, gasoline, hot water and tar scalding burns. Patients were treated for burns as large as 7.53 square feet (7,000 cm2). The majority of burns were between 1.2 to 3.2 square feet (1,000 - 3,000 cm2).
The Burns article titled, “Cell-spray auto-grafting technology for deep partial thickness burns: Problems and solutions during clinical implementation,” by: Roger Esteban-Vives, Alain Corcos, Myung S. Choi, Matthew T. Young, Patrick Over, Jenny Ziembicki, Jörg C. Gerlach, was published by Elsevier in the November 2017 issue of Burns 2017 Nov 25. pii: S0305-4179(17)30558-2. doi: http://dx.doi.org/10.1016/j.burns.2017.10.008. Epub 2017 Nov 25).
A previously published Burns article titled, “Second-degree burns with six etiologies treated with autologous noncultured cell-spray grafting”, by: Roger Esteban-Vives, Myung S. Choi, Matthew T. Young, Patrick Over, Jenny Ziembicki, Alain Corcos, and Jörg Gerlach, was published by Elsevier in the November 2016 issue of Burns (Nov;42(7):e99-e106. doi: 10.1016/j.burns.2016.02.020. Epub 2016 Aug 25).
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, who 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 and 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.
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.
RenovaCare, Inc. is developing first-of-their-kind autologous (self-donated) stem cell therapies for the regeneration of human organs, and novel medical grade liquid sprayer devices. 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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