SUNRISE, FL / ACCESSWIRE / September 1, 2022 / U.S. Stem Cell, Inc. (OTC:USRM), a leader in the development of proprietary, physician-based stem cell therapies and novel regenerative medicine solutions, is pleased to announce the long-awaited favorable ruling of the contemporaneous stem cell case against Cell Surgical Network, a stem cell company involved in a similar stem procedure as U.S. Stem Cell Inc. California federal judge, Jesus Bernal, has ruled in favor of Defendants California Stem Cell Treatment Center, Inc., Elliot B. Lander, M.D., Mark Berman, M.D., and Cell Surgical Network Corporation, in the United States v. California Stem Cell Treatment Centers case.
In the August 30th, 2022 judgment, Judge Bernal ruled that the Defendants' Stromal Vascular Fraction (SVF) Surgical Procedure nor its Expanded Mesenchymal Stem Cells (MSC) Procedure are "drugs" within the meaning of the Federal Food, Drug, and Cosmetic Act (FDCA). The SVF Procedure and Expanded MSC Procedure are not subject to the FDCA's adulteration and misbranding provisions. Additionally, the Defendants' SVF Procedure-but not the Expanded MSC Procedure-also qualifies for the Same Surgical Procedure Exception.
U.S. Stem Cell is gratified that judge Bernal of California ordered the case to proceed to trial and took the time to carefully review both the law and science. This is a major victory for the field of regenerative medicine and advocates of alternative stem cell-based treatments.
Since May 9th, 2018, U.S. Stem Cell, 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 alleged, among other matters, that the defendants manufactured SVF products from patient adipose (fat) tissue without first obtaining what the government alleged were necessary FDA approvals for a new drug. The Company has always maintained that stem cell treatments are medical procedures regulated by the respective State medical boards-and a patient's own stem cells are not drugs to be regulated by the federal government.
This new decision in the California case reinforces US Stem Cell Inc's position and is contrary to the ruling made on June 25th, 2019, where Florida-based (and now retired) federal court judge Ursula Ungaro ruled in favor of the government on summary judgment (and without giving the Company their day in court by holding a trial) and ruled that U.S. Stem Cell must stop most product sales, processes, and procedures. Judge Jesus Bernal instead allowed the complex matter to proceed to trial where Cell Surgical Network prevailed.
"Judge Bernal's ruling is a huge step forward in the field of regenerative medicine" states Mike Tomas, President & CEO. Adding "This ruling demonstrates our position that a patient's own stem cells are not a drug and provides us grounds to continue fighting to overturn U.S. Stem Cell's ruling."
Taking advantage of the different technologies housed within U.S. Stem Cell, the Company will take steps to rebrand and restructure to focus on the animal health division, including pet care regenerative medicine, geriatric care, and wellness through the subsidiary VetBiologics.
U.S. Stem Cell, Inc. is an emerging leader in the regenerative medicine / cellular therapy industry specializing in physician training, certification and stem cell products, as well as veterinary stem cell training and creation and management of stem cell clinics. 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.
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.
SOURCE: U.S. Stem Cell, Inc.
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