Pompano Beach, FL, Aug. 09, 2018 (GLOBE NEWSWIRE) -- BioStem Technologies, Inc. (OTC PINK: BSEM) (“BioStem” or the “Company”), BioStem Technologies, Inc. is a global life sciences corporation, providing innovative technologies with a concentration in Pharmaceuticals and Regenerative Medicine that exponentially improve, extend, and transform the quality of life for patients, has launched a new subsidiary under its Life Sciences division, which will engage in the business of supplying Amnion based PHSA 361 products.
“... 361 products that meet all the criteria outlined in 21 CFR 1271.10(a) are regulated as HCT/Ps and are not required to be licensed or approved by the FDA. These products are called “361 products,” because they are regulated under Section 361 of the Public Health Service (PHS) Act.” [1]
BioStem Technologies, Inc. has launched its Amnion Division, BioStem Life Sciences, to develop and market regenerative and therapeutic biologics utilizing human placental tissue allografts for multiple sectors of healthcare. The established management team has an extensive background of successfully developing, processing, and selling minimally-manipulated Amniotic Tissue products within the U.S., including the likes of amniotic and chorion products, flowable allografts’, and wound care products. This divisional launch will serve as a platform for developing additional amniotic tissue-based products, accelerating year-over-year growth and revenue for the Company. The Company will also be leveraging its assets within the pharmaceutical manufacturing industry to ensure all products will be processed to the American Association of Tissue Banks’ (AATB) standards and that the facility will be operated under GTP and Manufacturing guidelines.
Henry (Chip) Van Vurst said; “We are very excited about the launch of this new division and the revenue possibilities it represents to BioStem Technologies. We are entirely committed to creating and manufacturing Amniotic products using pharmaceutical manufacturing standards which we feel will set us apart from the rest of the industry in quality, safety and efficacy.”
About BioStem Life Sciences, Inc - Amnion Division: A biopharmaceutical company focused on the development of the highest quality placental-based amniotic tissue products for the ophthalmology, orthopedic and wound care markets. an emphasis on advancing ethical, pharmaceutical grade regenerative medical treatments that benefit our society. The Company’s mission is to create a new paradigm of healthcare, using breakthrough therapies that treat patients who otherwise are without effective treatment options.
About BioStem Technologies, Inc. (OTC PINK: BSEM): BioStem Technologies, Inc. is a global life sciences corporation, providing innovative technologies with a concentration in Pharmaceuticals and Regenerative Medicine. The Company’s mission is to discover, develop and produce the most effective Pharmaceutical and Regenerative Medicine products in the world. 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.
[1] Hildreth, Cade. “How Does the U.S. FDA Regulate Cell Therapies? (351 vs 361 Products).” BioInformant, 25 Feb. 2018, bioinformant.com/351-vs-361-products/.