Basking Ridge, NJ, November 22, 2016 – Caladrius Biosciences, Inc. (NASDAQ:CLBS) (“Caladrius” or the “Company”) announced today that PCT, its cell therapy contract development and manufacturing subsidiary, has earned re-accreditation by the Foundation for the Accreditation of Cellular Therapy (“FACT”). This accreditation confirms that PCT operates in compliance with the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration at both its Allendale, New Jersey and Mountain View, California sites.
FACT is an internationally recognized accrediting body for hospitals and medical institutions involved with stem cell transplant, and accreditation indicates that the reviewed institution has met the most rigorous standards in every aspect of hematopoietic stem cell therapy. This covers the entire spectrum of stem cell therapy, from clinical care to donor management, cell collection, processing, storage, transportation, administration, and cell release. FACT-JACIE Standards are defined by leading experts based on the latest knowledge of the field of cellular therapy transplantation.
With its initial accreditation in 2000, PCT was the first cell therapy manufacturing organization to ever receive FACT Accreditation and it has consistently earned re-accreditation upon periodic review in the intervening years.
“We are delighted to maintain our FACT accreditation as it is an independent affirmation of the high standard met by our Quality Systems. While serving as a point of differentiation for PCT from its competitors in cell therapy contract manufacturing services in the U.S., it most importantly acknowledges our focus on producing the highest quality products for the patients who receive them,” said Robert A. Preti, PhD, President of PCT and Senior Vice President, Manufacturing and Technical Operations and Chief Technology Officer of Caladrius. “By achieving FACT re-accreditation, we are informing patients, medical professionals, health insurance companies and the government that we adhere to the most rigorous standards in patient care and laboratory practices.”
About Caladrius Biosciences
Caladrius Biosciences, Inc. is a cell therapy development company with cell therapy products in development based on multiple technology platforms and targeting autoimmune and cardiology indications. The company’s subsidiary, PCT, is a leading development and manufacturing partner exclusively focused on the cell therapy industry and has served over 100 clients since 1999. PCT provides a wide range of innovative services including product and process development, GMP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support. For more information on Caladrius please visit www.caladrius.com and for more information on PCT please visit www.pctcaladrius.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. All statements other than statements of historical fact contained in this press release are forward-looking statements. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Factors that could cause future results to materially differ from the recent results or those projected in forward-looking statements include the “Risk Factors” described in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 15, 2016, and in the Company’s other periodic filings with the SEC. The Company’s further development is highly dependent on, among other things, future medical and research developments and market acceptance, which are outside of its control.