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; announced today that it has engaged Biologics Consulting, a full-service regulatory and product development consulting firm for biologics, pharmaceuticals and medical devices, to help facilitate progression of investigational new drug (IND) candidates through the regulatory pipeline.
In the nearly three decades since its founding, Biologics Consulting has built an unprecedented record of achievement, assisting clients all over the globe to address nonclinical, clinical, product development, and regulatory compliance challenges. Biologics Consulting has served more than 3,500 companies in 53 countries, and in the past four years, it has contributed to more than 50 original INDs, 75 BLAs/NDAs (full and supported), 80 510Ks, and 42 IDEs.
Biologics Consulting will help BioStem navigate through the FDA’s Biologics License Application (BLA) process. Biologics Consulting will provide education and support, best practices, and assist with the necessary communications with the relevant regulatory agency groups.
Jason Matuszewski, CEO of BioStem Technologies, states, "We are excited to announce our engagement of Biologics Consulting. Based on their extensive experience in Medical Device and BLA regulatory navigation, they are a perfect strategic partner to help navigate our Local Microenvironment Activation based product candidates through the FDA filing and approval processes."
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™, 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.
BioStem Technologies, Inc.
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