RENOVACARE INC - RCAR STOCK NEWS

RenovaCare, Inc. (RCAR) announced significant management changes, including the resignation of Dr. Kaiyo Nedd as Interim President and Mr. Justin Frere as CFO, effective March 24, 2022. The resignations were amicable, with both individuals agreeing to support the company in a limited capacity following their departure. Chairman Harmel S. Rayat will serve as interim CEO and CFO. The changes are part of broader cost-cutting efforts due to low patient enrollment in clinical trials and ongoing legal battles, which continue to strain the company's financial health.

RenovaCare (RCAR) announced actions to streamline its operations, driven by low patient enrollment in its CELLMIST 1 clinical trial and ongoing legal costs from SEC litigation. The company has suspended patient enrollment, focusing on reducing administrative overhead while maintaining care for previously enrolled patients. RenovaCare is also reviewing its patent portfolio to cut filing costs and enhance collaboration opportunities. Despite these challenges, the company intends to continue its R&D efforts, including developing an automated cell isolation device in Berlin.

RenovaCare, Inc. (RCAR) announced the granting of a new patent for its SkinGun™ technology by the U.S. Patent and Trademark Office (US Patent No. 11,135,380). This patent underscores the company’s dedication to expanding its proprietary cell therapy technologies for skin and tissue regeneration. The patent portfolio is now enhanced with eight families of patents across multiple countries, ensuring a robust intellectual property strategy to protect and commercialize innovative medical solutions. The ongoing CELLMIST 1 clinical trial aims to evaluate the safety and feasibility of the SkinGun™ in treating burn wounds.

RenovaCare has made progress on its CELLMIST 1 clinical trial, focusing on the safety and feasibility of the SkinGun™ and CellMist™ System for treating burn wounds. The trial is currently screening patients at its first burn center, with plans to expand to four centers in the U.S. The study aims to enroll 14 subjects aged 18-65 with partial-thickness burn wounds. Each subject will receive treatment within seven days of injury, followed by seven follow-up visits over 12 months to evaluate safety and recovery.

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.

RenovaCare (RCAR) intends to vigorously defend itself against allegations by the SEC regarding events from over three years ago. The company disagrees with the SEC's statements and highlights its compliance during the investigation. RenovaCare faces claims of violating antifraud provisions and reporting obligations. In positive news, the company received FDA approval for a clinical trial of its SkinGun™ and CellMist™ System for burn wound treatment. This trial will begin at four U.S. burn centers.

RenovaCare announced the FDA's full approval of its Investigational Device Exemption (IDE) application for the SkinGun™ and CellMist™ System, allowing a clinical trial to assess the safety and efficacy of this innovative treatment for burn wounds. This pivotal regulatory approval marks a significant milestone for the company, ensuring the potential use of patient-derived skin cells in treating severe burns. The trial will enroll 14 participants across four U.S. burn centers over one year, showcasing RenovaCare's commitment to advancing regenerative medicine.

RenovaCare (RCAR) announced the retirement of Chairman and CEO Alan Rubino, effective March 25, 2021. Dr. Kaiyo Nedd has been appointed Interim President and CEO, while Harmel S. Rayat becomes Chairman. Dr. Nedd brings over 20 years of medical experience and leadership in chronic pain management and clinical trials, enhancing company expertise. Rayat has significantly invested in RenovaCare, contributing to advancing its patented technologies, including the SkinGun and CellMist System. The transition aims for continuity in leadership as the company prepares for initial clinical studies.

RenovaCare, a clinical-stage developer, announced its participation in the 2021 H.C. Wainwright Global Life Sciences Conference on March 9-10. The company will showcase its patented technologies, CellMist™ and SkinGun™, aimed at regenerating skin and other tissues using self-donated stem cells. An on-demand webcast will be available for registered attendees, including institutional investors and industry executives. RenovaCare focuses on innovative stem cell therapies for skin regeneration, with R&D centered in Berlin, Germany.