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RenovaCare, Inc. (RCAR)

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3.9000-0.0900 (-2.26%)
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Previous Close3.9900
Open4.0400
Bid0.0000 x 0
Ask0.0000 x 0
Day's Range3.7000 - 4.2850
52 Week Range1.0800 - 4.5000
Volume36,058
Avg. Volume21,398
Market Cap340.674M
Beta (5Y Monthly)2.76
PE Ratio (TTM)N/A
EPS (TTM)-0.0460
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
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  • GlobeNewswire

    RenovaCare Receives FDA Conditional IDE Approval of CellMist™ System and SkinGun™ Device, Enabling Clinical Study for Safety and Feasibility

    ROSELAND, N.J., Aug. 11, 2020 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, today announced that the US Food and Drug Administration (FDA) conditionally approved the Company’s Investigational Device Exemption (IDE) application to conduct a clinical trial to evaluate the safety and feasibility of autologous stem cells rendered by its CellMist™ System from donor skin and applied topically with the SkinGun™ spray device for treatment of burn wounds. "The FDA conditional approval marks a significant milestone for RenovaCare and our technology for spraying an ultra-gentle mist of a patient’s own skin cells for the healing of burns and wounds. We are working to complete the FDA's technical requirements so that we may move forward with the next phase of development," stated Alan L. Rubino, the Company's President and Chief Executive Officer.The clinical trial protocol, conditionally approved on August 5, 2020 by the FDA is an open-label single-arm clinical study that will enroll 14 human burn subjects with partial-thickness second- or- third degree thermal burn wounds. The Company expects to conduct the clinical study at multiple U.S. burn centers."This achievement marks the culmination of our innovative stem cell and spray technologies coupled to applied research and development resulting in a formal clinical evaluation of skin stem cells as a therapeutic to facilitate burn wound healing," stated RenovaCare Chief Scientific Officer, Dr. Robin A. Robinson. "I am proud of our RenovaCare Team and their dedication to our mission and commitment to provide effective and expedited patient healing and look forward to commencing this study as quickly as possible."About RenovaCare RenovaCare, Inc. is developing new generation autologous stem 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.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.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 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.For additional information, please call Amit Singh at: 1-888-398-0202 or visit: https://renovacareinc.comTo receive future press releases via email, please visit: https://renovacareinc.com/investors/register/Follow us on LinkedIn: https://www.linkedin.com/company/renovacare-inc-/Follow us on Twitter: https://twitter.com/RenovaCareIncFollow us on Facebook: https://www.facebook.com/renovacarercarSocial Media Disclaimer Investors and others should note that we announce material financial information to our investors using SEC filings and press releases. We use our website and social media to communicate with our subscribers, shareholders and the public about the company, RenovaCare, Inc. development, and other corporate matters that are in the public domain. At this time, the company will not post information on social media that could be deemed to be material information unless that information was distributed to public distribution channels first.We encourage investors, the media, and others interested in the company to review the information we post on the company’s website and the social media channels listed below: * LinkedIn * Facebook * Twitter* This list may be updated from time to time.Legal Notice Regarding Forward-Looking Statements 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.

  • RenovaCare Appoints Dr. Lydia M. Evans to Its Board of Directors and Increases Board Membership
    GlobeNewswire

    RenovaCare Appoints Dr. Lydia M. Evans to Its Board of Directors and Increases Board Membership

    Dr. Lydia M. Evans, MD Dr. Lydia M. Evans, Director, RenovaCare, Inc.ROSELAND, N.J., Aug. 04, 2020 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com), developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, today announced the appointment of Lydia M. Evans, M.D. to its Board of Directors. A noted dermatologist, oncologist, and doctor of internal medicine, Dr. Evans has held numerous academic, private, and commercial appointments, and brings extensive insights into the science, technology, and market positioning of wound and skin regeneration therapies. “As RenovaCare continues to advance our portfolio of regenerative technologies, strategic leadership from our Board is increasingly critical as we look to regulatory approval and commercialization. Dr. Evans’ knowledge and experience will be a strong addition to our Board at such an important time as the Company continues to pursue bringing first-in-class regenerative therapies to market,” stated Alan L. Rubino, RenovaCare CEO & President."I’m pleased to join the RenovaCare Board of Directors at a time of growing demand for modern therapies that promise natural regeneration for burns, wounds, skin disorders and cosmetic imperfections. The RenovaCare CellMist™ and SkinGun™ represent an impressive therapeutic approach that replaces painful and complex skin grafting procedures with a gentle mist of the patient’s own cells. I look forward to assisting the Company in its development,” concluded Dr. Evans.A Columbia Presbyterian and Memorial Sloan Kettering-educated dermatologist, oncologist and doctor of internal medicine, Dr. Evans specializes in state-of-the-art treatments for aesthetic and medical dermatologic procedures. She is currently an Associate Clinical Attending Physician in the Department of Dermatology at New York Presbyterian Medical Center in New York City, a position which includes significant teaching responsibilities. She is also a Fellow of the American Academy of Dermatology, a Diplomate of the National Board of Medical Examiners, the American Board of Internal Medicine, and the American Board of Dermatology. She is a member of the Leadership Society of the Dermatology Research Foundation and has served as the New York State Chairperson for the Psoriasis Research Foundation. Dr. Evans was Consulting Dermatologist to L’Oréal Paris from 2000 to 2012, spurring new product development in dermatologist-inspired skincare directly to consumers. About RenovaCare 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.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.For additional information, please call Amit Singh at: 888-398-0202 or visit: https://renovacareinc.comTo receive future press releases via email, please visit: https://renovacareinc.com/investors/register/Follow us on LinkedIn: https://www.linkedin.com/company/renovacare-inc-/Follow us on Twitter: https://twitter.com/RenovaCareIncFollow us on Facebook: https://www.facebook.com/renovacarercarSocial Media Disclaimer Investors and others should note that we announce material financial information to our investors using SEC filings and press releases. We use our website and social media to communicate with our subscribers, shareholders and the public about the company, RenovaCare, Inc. development, and other corporate matters that are in the public domain. At this time, the company will not post information on social media that could be deemed to be material information unless that information was distributed to public distribution channels first.We encourage investors, the media, and others interested in the company to review the information we post on the company’s website and the social media channels listed below: * LinkedIn * Facebook * Twitter* This list may be updated from time to time.Legal Notice Regarding Forward-Looking Statements 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.

  • RenovaCare Launches R&D Innovation Center (Berlin) for Organ & Tissue Regeneration
    GlobeNewswire

    RenovaCare Launches R&D Innovation Center (Berlin) for Organ & Tissue Regeneration

    RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com) today announced the official launch of its new RenovaCare R&D Innovation Center in Berlin, Germany, where the Company’s patented technologies for isolating and spraying self-donated stem cells to regenerate tissues and organs have been under development alongside new product initiatives. Important programs at the Center include preclinical support to RenovaCare regulatory submissions for its flagship SkinGun™, which delivers a proprietary gentle CellMist™ spray of a patient’s own skin cells on to burns and wounds. “Our investment in the RenovaCare R&D Innovation Center helps build shareholder value by strengthening our pre-clinical work for regulatory submissions, and positioning us to invent, patent, and clinically translate next-generation biomedical technologies and devices for meeting unmet medical needs, and commercialization,” said Mr. Alan L. Rubino, CEO & President of RenovaCare, Inc.