U.S. Stem Cell Confirms Date for Appeals Court Oral Arguments
SUNRISE, FL / ACCESSWIRE / September 30, 2020 / U.S. Stem Cell, Inc. (OTC PINK: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 guidance," 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.
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 and represent our management's beliefs and assumptions only a of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements, even if new information becomes available in the future. The Company's business and the risks and uncertainties of the business are described in its filings with the Securities and Exchange Commission which can be found at sec.gov.
U.S. Stem Cell, Inc.
1560 Sawgrass Corporate Parkway, 4th FL
Sunrise, FL 33323
SOURCE: U.S. Stem Cell, Inc.
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