SUNRISE, FL – Sep. 30, 2020 – U.S. Stem Cell, Inc. (OTC: USRM), a leader in the development of proprietary, physician-based, and novel regenerative medicine solutions, is pleased to announce that oral arguments for the company’s court case USA v. U.S. Stem Cell Clinic, et al has been set for the docket beginning January 11, 2021.
Since May 9, 2018, U.S. Stem Cell Inc., as one of the parties named, has been challenged by an injunctive action filed by the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration (FDA). The suit alleges that the defendants manufactured “stromal vascular fraction” (SVF) products from patient adipose tissue without first obtaining what the government alleges are necessary FDA approvals for a new drug. The Company has maintained that cellular treatments are surgical procedures regulated by the respective State medical boards—and that a patient’s own tissues are not drugs to be regulated by the federal government. Notwithstanding, on June 25, 2019, a Florida-based federal court judge ruled in favor of the government on summary judgment without holding a trial and ordered that U.S. Stem Cell stop most product sales, processes and procedures. The Company filed an appeal on August 23, 2019.
“We welcome the opportunity to defend our cellular technology as the company transitions to a diversified regenerative medicine platform, complying with both the court rulings and the FDA’s guidances,” stated Mike Tomas, President & CEO. “We are cautiously optimistic that, with the court date for oral arguments being set, the Court is considering whether the summary judgment was entered in error, and whether we were entitled to a trial to present evidence supporting our position.”
U.S. Stem Cell, Inc. is an emerging leader in the regenerative medicine and cellular therapy industry specializing in physician training and certification, as well as veterinary applications, and management of cellular therapy clinics. To management’s knowledge, U.S. Stem Cell has completed more clinical treatments than any other cellular therapy company in the world in the past 20 years, and has certified more than 700 physicians and veterinarians in autologous cell therapies worldwide.
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