Sunrise, FL – June 19, 2017 – (OTC:USRM) U.S. Stem Cell, Inc., a leader in the regenerative medicine, cellular therapy industry providing physician based stem cell therapies to human and animal patients as well as a developer of novel autologous cell therapies, announces an aggressive plan to expand an additional 12 stem cell treatment centers and clinics in the US. US Stem Cell has been in discussions with the FDA regarding Regenerative Medicine Advanced Therapy (RMAT) Designation for the Myocell product and at this time, the company has decided not to further invest in RMAT Designation and instead invest and focus on our in-clinic therapies for patients.
According to the 21st Century Cures Act, within one year of enactment, the FDA must issue draft guidance clarifying how the FDA will evaluate devices used in the recovery, isolation, or delivery of regenerative advanced therapies. Until this guidance document is published, it is unclear how this regulation will affect the MyoCell program. Until then, U.S. Stem Cell will focus on opening new clinics around the country to better serve patients in need. In addition to the original Sunrise clinic (that has successfully treated hundreds of patients and generated over $2m in revenues in the past 12 months alone), recent clinic openings include Miami and Palm Beach, Florida. Upcoming openings include Dallas, Texas (thanks in part to the early adoption of patient rights by the State of Texas), Chicago, Atlanta and Denver—as well as other clinics in the northeast and the west coast.
To be clear, U.S. Stem Cell will focus on our revenue generating programs that are treating patients NOW–which have successfully helped over 7000 patients thus far. Our company was founded in 1999 and has completed more clinical treatments (for both humans and animals) than any other regenerative medicine company in the world. In addition to our efforts at US Stem Cell Training and VetBiologics, our focus will be expanding and opening additional clinics throughout the U.S. to offer these cutting edge technologies to more patients.
About U.S. Stem Cell, Inc.
US Stem Cell, Inc. (formerly Bioheart, Inc.) is an emerging enterprise in the regenerative medicine / cellular therapy industry. We are focused on the discovery, development and commercialization of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. We believe that regenerative medicine / cellular therapeutics will play a large role in positively changing the natural history of diseases ultimately, we contend, lessening patient burdens as well as reducing the associated economic impact disease imposes upon modern society.
Our business, which includes three operating divisions (US Stem Cell Training, Vetbiologics and US Stem Cell Clinic) includes the development of proprietary cell therapy products as well as revenue generating physician and patient based regenerative medicine / cell therapy training services, cell collection and cell storage services, the sale of cell collection and treatment kits for humans and animals, and the operation of a cell therapy clinic. Management maintains that revenues and their associated cash in-flows generated from our businesses will, over time, provide funds to support our clinical development activities as they do today for our general business operations. We believe the combination of our own therapeutics pipeline combined with our revenue generating capabilities provides the Company with a unique opportunity for growth and a pathway to profitability.
Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as “may”, “will”, “to”, “plan”, “expect”, “believe”, “anticipate”, “intend”, “could”, “would”, “estimate”, or “continue”, or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled “Risk Factors” in its Annual Report on Form 10-K for the year ended December 31, 2016, and its Quarterly Reports on Form 10-Q.