BioStem Forms Subsidiary on Development of Amniotic Tissue-Based Therapies
Published: Aug 10, 2018 By Alex Keown
Shares of Pompano Beach, Fla.-based BioStem Technologies are down more than 6 percent this morning following the company’s announcement it has launched a new life sciences subsidiary, the Amnion Division of BioStem Life Sciences, focused on the development of amniotic tissue-based therapies.
The new division will supply products made from minimally-manipulated amniotic tissue, or amnion based PHSA 361 products. The products use human placental tissue allografts for multiple sectors of healthcare, BioStem said this morning. Products determined to be “361” are not required to be licensed by the U.S. Food and Drug Administration, BioStem said in its statement this morning. These 361 products are regulated under Section 361 of the Public Health Service Act.
The new division will serve as a platform for developing additional amniotic tissue-based products, BioStem said. The product development is expected to generate year-over-year growth and revenue for the company, BioStem added. With the new division, BioStem said it will 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.”
“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,” BioStem Chief Executive Officer Henry (Chip) Van Vurst said in a statement.
BioStem did not announce who was helming its new division, but the company said the established management team is well versed in developing, processing and selling the amniotic tissue products within the United States. Among those are amniotic and chorion products, flowable allografts’ and wound care products, the company said.
The addition of the new division follows some growth the company has shown earlier this year through M&A activity. In February the company announced its intent to acquire Grupo Impulso De Incentivacion Para Nuevas Tecnologías (GIINT), a Mexico based stem cell company focused on innovative regenerative medicine. More recently, BioStem subsidiary Nesvik Pharmaceuticals acquired new drug compounds from CCM Pharma Solutions. Nesvik and CCM will work together to reformulate four drug compounds (BSEM-120, BSEM-125, BSEM-130, and BSEM-135) for potential regulatory approval. At the time of the deal, BioStem did not provide additional information as to what the compounds will target. The company expects to bring the new formulations to the market through the FDA’s 505(b)(2) pathway.