お知らせ • Nov 15
RenovaCare, Inc. announced delayed 10-Q filing On 11/14/2022, RenovaCare, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. お知らせ • Aug 12
Pomerantz LLP Announces A Class Action Lawsuit Has Been Filed Against RenovaCare, Inc Pomerantz LLP announces that a class action lawsuit has been filed against RenovaCare, Inc. and certain of its officers. The class action, filed in the United States District Court for the District of New Jersey, and docketed under 21-cv-13930, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired RenovaCare securities between August 14, 2017 and May 28, 2021, inclusive (the "Class Period"). Plaintiff pursues claims against the Defendants under the Securities Exchange Act of 1934 (the "Exchange Act"). お知らせ • Jul 23
RenovaCare, Inc Provides Update on Clinical Trial for the SkinGun™ and CellMist™ System for Wound Healing RenovaCare, Inc. provided an update on its clinical trial evaluating the safety and feasibility of the SkinGun™ and CellMist™ System to facilitate wound healing using skin cells obtained directly from the burn patient. Currently, CELLMIST 1, the clinical trial is activated and screening patients at its first burn center. The Company plans to expand its clinical trial to up to four centers in the United States. One site is currently under active negotiation; another candidate site has voluntarily withdrawn from consideration; a fourth clinical site has decided to defer continued negotiations to a later date. The CELLMIST 1 clinical study plans to enroll 14 human subjects between 18 and 65 years old that have partial-thickness, second-degree thermal burn wounds encompassing < 30% total body surface area. Each enrolled subject will be treated within seven days of the burn incident with their own skin cells isolated by the manual CellMist™ System and applied topically onto the burn wound(s) with the Electronic SkinGun™ spray device. Seven follow-up visits over 12 months will evaluate the safety and recovery of each subject. お知らせ • Jun 08
RenovaCare, Inc. Clinical Trial to Start At U.S. Burn Centers RenovaCare, Inc. 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 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 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. お知らせ • May 07
FDA Grants RenovaCare, Inc. Full Investigational Device Exemption Approval for Safety and Feasibility Clinical Trial RenovaCare, Inc. 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 the company 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. 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. 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 the company 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, the company 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. お知らせ • Oct 06
Renovacare, Inc. Announces Board Changes RenovaCare, Inc. announced that Alan L. Rubino, Chief Executive Officer and President, has been elected to the additional role of Chairman of the Board of RenovaCare effective October 1, 2020. Mr. Rubino replaces Harmel S. Rayat as Chairman of the Board, who resigned from the Board and as Chairman on the same date. Mr. Rubino was named President and CEO, and a member of the company’s Board of Directors, in November 2019 to build a highly experienced leadership team with a proven track record to focus the company on its planned transition from a pre-clinical stage to a development/commercial stage entity.