RenovaCare Responds to SEC Complaint
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.
- FDA granted Investigational Device Exemption for SkinGun™ and CellMist™ System.
- Clinical trial for burn treatment to start soon at four U.S. burn centers.
- SEC alleges violations of antifraud provisions and reporting obligations.
- Potential for permanent injunctions and civil penalties against the company.
ROSELAND, N.J., June 01, 2021 (GLOBE NEWSWIRE) -- RenovaCare, Inc. (Symbol: RCAR; www.renovacareinc.com) today announced that it intends to vigorously defend itself and its stockholders against allegations made by the U.S. Securities and Exchange Commission (“SEC”) in a civil complaint filed on May 28, 2021 regarding legacy events (the “Complaint”) from over 3 years ago.
The Company strongly disagrees with statements in the Complaint and is disappointed with the action taken by the agency. RenovaCare looks forward to presenting tangible evidence in support of its position in a fair, balanced and unbiased judicial forum. The Company’s management remains focused on advancing its technologies, continuing to build the fundamentals of the Company’s business, and enhancing and sustaining stockholder value.
RenovaCare has cooperated fully and complied with all requests made by the SEC over the past three-plus years and delivered complete documentation relating to its technology, intellectual property, medical journals, interactions with the U.S. Food and Drug Administration (FDA) and other business matters. The Company believes that the SEC findings and allegations do not relate to these substantive areas.
The Company takes issue with the Complaint, which generally alleges that the Company and Mr. Harmel S. Rayat, RenovaCare Chairman, violated the antifraud provisions of Section 10(b) of the Securities Exchange Act of 1934 and Rule 10b-5 thereunder, and also alleges that Mr. Rayat aided and abetted the Company's violation of those provisions. The Complaint also charges RenovaCare with violating the reporting provisions of Exchange Act Section 15(d) and Rules 15d-11 and 12b-20 thereunder. The SEC seeks permanent injunctions and civil penalties against both defendants, and officer-and-director and penny stock bars against Mr. Rayat. The Complaint may be accessed on the SEC’s website at https://www.sec.gov/litigation/litreleases.htm.
Recently, RenovaCare was granted full Investigational Device Exemption by the FDA, enabling 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 patient. The Company intends to initiate the clinical trial soon at four U.S. burn centers. Further details can be found at www.clinicaltrials.gov.
The Company’s SkinGun™ and CellMist™ System has been 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. In late 2019, RenovaCare was issued a patent allowing the Company’s novel SkinGun™ 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.
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.
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.com.
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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.
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