SUNRISE, FL – June. 8th, 2021 – U.S. Stem Cell, Inc. (OTC: USRM), a corporation that has
historically focused on the regenerative medicine / cellular therapy industry specializing in physician
training and certification and stem cell products in both human and veterinary stem cell processes , has
received the results of the Appeal from the United States 11th District Court for the Southern District of
Since May 9th, 2018, U.S. Stem Cell, as one of the parties named on a legal action by the FDA, 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 alleged, among other matters, that the defendants manufactured
“stromal vascular fraction” (SVF) products from patient adipose (fat) tissue without first obtaining what
the government alleged are necessary FDA approvals for a new drug. The Company had always
maintained that stem cell treatments are medical procedures regulated by the respective State medical
boards—and a patients’ own stem cells are not drugs to be regulated by the federal government.
- On June 25th, 2019, Florida-based federal court judge Ursula Ungaro ruled in favor of the
government on summary judgement (a ruling without providing the Company with a trial) and
ruled that U.S. Stem Cell and the other defendants must stop most product sales, processes and
- On August 23rd, 2019, the Company filed an appelate brief challenging Judge Ungaro’s decision
and respectfully requesting the Company’s due process rights of a trial.
- On January 27th, 2020, on a similar case, California-based federal court judge Jesus Bernal
ruled against the government on summary judgement and ordered the case to proceed to trial.
- On January 13th, 2021, the 11th District Court of Appeals heard the Company’s oral arguments.
- On June 1st, Judge Ungaro retired from the bench after 29 years of distinguished service and
joined the board of directors of another clinical stage biotechnology company developing cellular
therapies for chronic, aging-related and life-threatening conditions.
- On June 2nd, 2021, the Eleventh Circuit Court ruled to affirm Judge Ungaro’s judgement on the
basis, generally, that neither the same day surgical procedure exception nor the 361 HCT/Ps
exception applies to the Company’s and the other defendants’ surgical practices.
“The ongoing case has been a long, expensive and arduous fight and although the results of the appeal are
disappointing, the Company will, of course, continue to abide by the court’s decision” states Mike Tomas,
President & CEO. Adding “Nonetheless, we will both examine future legal options on this court case
while looking forward to exploring other avenues of growth for the Company.”
The company will continue to monitor the ongoing trial in California, 5:18-cv-01005 where a federal
judge ruled that a stem cell company involved in a similar stem cell procedure was entitled to a trial and
has yet to rule on whether the stem cell procedures may be regulated by the FDA as a ‘drug.’
As a result of this court case result and taking advantage of the different capabilities housed within U.S.
Stem Cell, the Company will take steps to rebrand, restructure, and relaunch the Company to refocus on
its other divisions.
U.S. Stem Cell, Inc. is a corporation that has historically focused on the regenerative medicine / cellular
therapy industry specializing in physician training and certification and stem cell products in both human
and veterinary stem cell processes. To management’s knowledge, USRM has completed more clinical
treatments than any other stem cell company in the world in the past 20 years, and has certified more than
700 physicians and veterinarians in autologous stem cell therapy worldwide. The company will refocus
on its animal health division while it evaluates its future opportunities for its human division and
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 historical 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.