American CryoStem Statement on the Receipt of a Warning Letter from FDA
EATONTOWN, NJ / ACCESSWIRE / January 8, 2018 / American CryoStem Corporation (PINK SHEETS: CRYO)) today issued a statement acknowledging that it has received a warning letter issued by the U.S. Food & Drug Administration (FDA) dated January 3, 2018 relating to its adipose derived stem cell product and its production facilities. This action follows the earlier inspections of the Company’s New Jersey facility by the agency between July 17 and July 26, 2017.
CRYO CEO, John Arnone commented, “We take any comments or suggestions by the U.S. FDA very seriously. We have initiated the changes in response to the FDA’s initial observations dated July 26, 2017. With regard to quality and cGMP compliance matters, we stand by our commitment to fully comply with the cGMP quality standards at our facility. We will further respond with an updated comprehensive plan to address FDA’s updated observations contained in the letter received January 3, 2018, within the stipulated time-frame of 15 business days. We will actively engage with the agency to resolve these issues and continue to improve our quality systems and processes, as an organization-wide priority.”
We consider the agency our partners with the goal of ensuring healthcare safety. In alignment with this commitment, we have made it an organization-wide priority initiative to continually optimize quality systems and processes, including completing and submitting an Investigational New Drug (IND) application.
About American CryoStem Corporation:
American CryoStem Corporation (PINK SHEETS: 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, Shenzhen, 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 that supports a growing pipeline of stem cell applications and biologic products. We are leveraging our proprietary platform and a developed product portfolio to create a domestic and global footprint of licensed laboratory affiliates, physician’s 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 works in conjunction with our patented (non-animal) medium lines. The Company’s R&D efforts are focused on discovering, developing and commercializing 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.
Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may,” “will,” “should,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults, currency exchange rates, interest rates, persistency levels and frequency/severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues.
The company assumes no obligation to update any information contained herein.
SOURCE: American CryoStem Corporation