SUNRISE, FL – Jan 19, 2021 – 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 in the case United States v. U.S. Stem Cell Clinic, LLC, et al., took place on January 13, 2021, before the federal Eleventh Circuit Court of Appeals. The oral argument was held on the Company’s appeal of a judgment denying it the right to present evidence and testimony in support of its position and practices in a trial. The Company continues to maintain it should be afforded the opportunity to support its position in such a trial.
On May 9, 2018, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration (FDA), filed suit against U.S. Stem Cell, Inc. and others to enjoin defendants from utilizing the SVF Surgical Procedure, in which “stromal vascular fraction” (SVF) cells are removed from a patient’s fat tissue and reimplanted in the patient during the same surgical procedure. The Company has maintained that such cellular therapies are surgical procedures regulated by state law, and that —and that the SVF surgical procedure is excepted from regulation under the federal Food, Drug, and Cosmetic Act (FDCA). On June 25, 2019, the federal court for the Southern District of Florida ruled in favor of the government, enjoining the Company from most product sales, processes and procedures. The Company filed an appeal on August 23, 2019.
During oral argument on January 13, counsel for the Company argued that the SVF Surgical Procedure is not subject to regulation under the FDCA, pursuant to a 2001 FDA regulation that provides an exception for a procedure in which cells are removed from and implanted in the same patient during the “same surgical procedure.” FDA relied upon an interpretation of the “same surgical procedure” exception that precluded its application where the reimplanted cells were derived from fat tissue, arguing that the reimplanted cells were not “in their original form.” The Company’s counsel argued that the FDA’s interpretation, from a 2017 guidance document, should not be given deference, because FDA acknowledged that the 2001 “same surgical procedure” exception was unambiguous. The appellate panel of judges questioned both parties noting the complexity of the subject matter, and also asking about the effect of expert testimony in favor of the Company’s position.
“While the ongoing case has been a long struggle and there can be no assurances for a positive outcome for U.S. Stem Cell Inc, we remain hopeful as we continue to seek a reversal of the June 25th, 2019 ruling,” states Mike Tomas, President and CEO. Tomas further comments, “The regenerative therapies we have pioneered and perfected should be in clinics helping patients, not held hostage by litigation.”
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, the Company 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 as 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.