RenovaCare Strengthens FDA Program with Leading U.S. Regulatory Group and Significant Investment

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.