RenovaCare Strengthens FDA Program with Leading US Regulatory Group and Significant Investment – BioSpace


ROSELAND, N.J., May 28, 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 it has expanded its engagement with MCRA, the leading U.S. regulatory group for medical devices and biologics, with over 600 client engagements, globally, to continue to advance the Company’s FDA program.

MCRA will participate in developing regulatory strategy and play a highly active role as an implementation partner in the execution of tactical priorities under the guidance of RenovaCare CEO and President, Mr. Alan L. Rubino and Chief Scientific Officer, Dr. Robin A. Robinson. Mr. Samuel Pollard, MCRA Associate Director of Regulatory Affairs, will be the project lead in consultation with MCRA Senior VP Mr. Glenn Stiegman, former FDA Branch Chief.  

“Through MCRA, RenovaCare now has access to the full resources and services of a top-tier regulatory firm in its FDA representations and filings to demonstrate the science, safety and therapeutic outcomes of RenovaCare technologies for isolating and spraying a patient’s own cells onto burns and wounds for rapid self-healing,” stated Mr. Alan L. Rubino.

RenovaCare has made it a priority to work on next-generation devices for streamlining point-of-care cell isolation from skin and other tissues. MCRA will assist RenovaCare in the evaluation and optimization of ancillary regulatory pathways for RenovaCare products, including select technologies currently under portfolio development.

“Our scientific and product engineering teams, led by Dr. Robinson, envision our next-generation devices to be useful in a variety of settings, including at a patient’s bedside, in the operating theater, and in outpatient settings like dermatology and plastic surgery clinics. We are focused on being able to offer effective, convenient and low-cost medical devices for spraying a spectrum of cell types to regenerate skin and other tissues, and for the spray of liquid medicines and wound irrigation fluids,” continued Mr. Rubino.

INVESTING IN THE RENOVACARE FDA PROGRAM

Mr. Alan L. Rubino, CEO and President will oversee all regulatory initiatives and the Company’s ongoing relationship with the FDA. In addition, he will continue to direct key investments and implement systems, attract talent, and forge strategic partnerships to enable future clinical trials and build shareholder value.

“Our highest priority this year is to continue advancing the SkinGun™ and CellMist™ System through the FDA regulatory pathway for approvals to conduct clinical trials,” explained Mr. Rubino.

“To do so, we have fortified our regulatory team with the nation’s leading domain experts, and recently made important investments in manufacturing, logistics, and related systems through engagements with Roche, Berkshire Sterile Manufacturing and Pro-Tech Design and Manufacturing.”

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To augment its anticipated clinical programs RenovaCare has directed capital investments which secure a long-term supply of specialized enzymes, the regulated fill-finish and delivery of those enzymes, and validated packaging and delivery of instruments and tools.  Collectively, these components enable the isolation and spray of a patient’s own skin cells using the Company’s SkinGun™ and CellMist™ System.

“So far this year, RenovaCare has built-out a solid regulatory team, made the capital investment needed to bolster our FDA program, and continued expanding our patent portfolio. I’m proud that our organization has continued safely working through the constraints of the COVID-19 health pandemic to accomplish so much,” continued Mr. Rubino.

“In the upcoming weeks and months, I look forward to further deepening our management team with exceptional talent, expanding RenovaCare relationships with key industry partnerships, and shepherding our regulatory program to its next important milestone.”

Today’s news follows the recent appointment of Dr. Robin A. Robinson to his new position as full-time RenovaCare Chief Scientific Officer. Dr. Robinson joins the executive leadership team with substantially expanded research and development responsibilities over his previous part-time consulting position as RenovaCare VP, Scientific Affairs.

Prior to RenovaCare, Dr. Robinson concurrently served as Deputy Assistant Secretary, U.S. Department of Health and Human Services and as the founding Director of the Biomedical Advanced Research and Development Authority (BARDA). Among other initiatives at BARDA,

Dr. Robinson oversaw support for the development of numerous stem cell and other therapies for thermal and radiation burn wounds and acute radiation syndrome illnesses.

Over 70 patients with various types of second-degree burns have been treated on an experimental basis utilizing the technology underlying the Company’s SkinGun™, which RenovaCare has developed as a potential alternative to skin grafting and other treatment options. Sprayed with a gentle mist of their own skin cells, many of these patients left the hospital within days, avoiding generally painful skin graft surgeries and potentially prolonged hospitalization.

About MCRA, LLC

Founded in 2004, MCRA is a leading medical device advisory firm and clinical research organization. MCRA’s value contribution rests within its industry experience at integrating five business value creators—regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance—to provide a dynamic, market-leading effort from concept to commercialization. MCRA’s integrated application of these key value-creating functions provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves more than 600 clients globally.

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.

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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.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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