Pompano Beach, Fl. March 25, 2021 BioStem Technologies, Inc. (OTC PINK: BSEM) ("BioStem" or the "Company"), a pre-clinical-stage biotechnology company focused on harnessing elements of perinatal tissue for use in regenerative therapies, today announced that it has received the TRIP (TRG Rapid Inquiry Program) response from the FDA’s Tissue Reference Group (TRG) for the Company’s amniotic membrane allograft, VENDAJE™
The TRIP helps manufacturers of human cells, tissues, and cellular and tissue-based products (HCT/Ps), including stakeholders that market HCT/Ps to physicians or patients, obtain a rapid, preliminary, informal, non-binding assessment from FDA regarding how specific HCT/Ps are regulated.
The TRIP response indicated that VENDAJE™ does meet the criteria in 21 CFR 1271.10(a) for regulation solely under Section 361 of the Public Health Service Act and 21 CFR 1271.
The Company plans to submit the TRIP response to CMS (Centers for Medicare and Medicaid Services) before the end of Q1 2021, in order to complete their submission for a Q code. Once submitted, BioStem anticipates the CMS Q code to be effective by early Q3 2021.
The Q codes are established to identify drugs, biologicals, and medical equipment or services not identified by national HCPCS Level II codes, but for which codes are needed for Medicare claims processing.
About BioStem Technologies, Inc. (OTC PINK: BSEM): BioStem Technologies, Inc. is a pre-clinical-stage biotechnology company focused on harnessing elements of Perinatal Tissue and the body’s innate biology to repair or reverse damage caused by a broad range of degenerative diseases. Our proprietary approach, called Local MicroEnvironment Activation, or LMA, uses combinations of Small Molecules, Cytokines, and Growth Factors to activate the microenvironment within the body to create communication for repair in the tissue. BioStem Technologies offers a comprehensive portfolio of high-quality brands that include RHEO™, OROPRO™, AEON™, VENDAJE™, VENDAJE™ AC, and VENDAJE™ OPTIC. The company is comprised of a diverse group of scientists, physicians, and entrepreneurs who collaborate to create innovative products. These technologies improve the Quality of Life for our patients and, as a result, drive shareholder value.
Forward-Looking Statements: Except for statements of historical fact, the matters discussed in this press release are forward looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. "Forward-looking statements" describe future expectations, plans, results, or strategies and are generally preceded by words such as "future," "plan" or "planned," "expects," believe" or "projected." These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company's control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing, exploiting and protecting proprietary technologies, intense competition and additional risks factors as discussed in reports filed by the company with OTC Markets.