EATONTOWN, NJ / ACCESSWIRE / May 18, 2017 / American CryoStem Corporation (OTC PINK: CRYO) a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular technologies for the Regenerative and Personalized Medicine industries, today announced the engagement of Target Health Inc. (Target), New York, NY, to assist the Company with the filing of a Drug Master File (DMF) to support its ongoing efforts for regulatory approval of its processing methods, material(s) and ATCELL and ACSelerate medium product for regenerative and cellular therapies.
Target Health Inc, is a full service CRO and Clinical Trials Software company with staff dedicated to all aspects of Regulatory Affairs, Strategic Planning, Clinical Research, Biostatistics, Data Management, Medical Writing and Internet-Based Paperless Clinical Trials.
Target will assist CRYO with the review and assessment of data accumulated by CRYO under IRB studies over the past several years. In addition to development and filing of one or more Drug Master Files, Target will also assist CRYO in seeking 510K registration of its recent internationally released ACSelerateMAX cell culture medium and an evaluation of CRYO's other mediums for potential FDA registration. ACSelerateMax is CRYO's flagship XENO free cell culture medium designed to produce greater cell numbers and lower cell passage which the Company believes makes it more suitable for use in delivering large cell cultures, at low passages and low population doublings, in line with the current needs of clinical researchers.
"With the excellent work of our scientific and laboratory development team, we are now in a position to pursue the next phase of our global strategy to provide fully functional and regulatory approved products and services for the cellular regenerative market," stated Anthony Dudzinski, COO of American CryoStem. "Upon completion of the filings and 510K registration of our CELLECT, ATGRAFT, ATCELL and ACSelerate Mediums, we can address the unmet need for an end to end, one stop solution for clinicians to quickly organize and complete clinical trials focused on the use of adult stem cells to treat patients suffering from injury, and disease."
American Cryostem has previously announced a manufacturing and global distribution deal with PeproTech, Inc. of Rocky Hill, NJ, for its ACSelerateMax cell culture medium which provides CRYO with the ability to internationally distribute its innovative new products.
About American CryoStem Corporation
American CryoStem Corporation (OTC PINK: CRYO); was founded in 2008, and has evolved to become a biotechnology pioneer, standardizing adipose tissue derived technologies (Adult Stem Cells) for the fields of Regenerative and Personalized Medicine. The Company operates a state-of-art, FDA-registered, clinical laboratory in New Jersey and licensed laboratories in Hong Kong, China and Tokyo, Japan, operating on our proprietary platform, dedicated to the collection, processing, bio-banking, culturing and differentiation of adipose tissue (fat) and adipose derived stem cells (ADSCs) for current or future use in regenerative medicine. CRYO maintains a strategic portfolio of intellectual property (IP) that surrounds our proprietary technology which supports a growing pipeline of stem cell applications and biologic products. CRYO is leveraging its proprietary FDA compliant platform and a developed product portfolio to create a domestic and global footprint of licensed laboratory affiliates, physicians networks and research organizations who purchase tissue collection, processing and storage consumables from our Company. Our laboratory stem cell bank/line products are characterized adult human Mesenchymal Stem Cell (MSC's) derived from adipose tissue that work in conjunction with our 13 patented (non-animal) medium lines. The Company's R&D efforts are focused on university and private collaborations to discover, develop and commercialize ADSC therapies by utilizing our standardized collection-processing-storage methodology and laboratory products combined with synergistic technologies to create jointly developed regenerative medicine applications and intellectual property.
For more information please visit: www.americancryostem.com
SOURCE: American CryoStem Corporation