NeoStem, Inc. ($NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy industry, and its subsidiary, Progenitor Cell Therapy, LLC ("PCT"), announced today that PCT has been awarded re-accreditation by the Foundation for the Accreditation of Cellular Therapy (FACT). By demonstrating compliance with theFACT-JACIE International Standards for Cellular Therapy Product Collection, Processing and Administration, PCT has earned FACT Accreditation for its Allendale, New Jersey and Mountain View, California sites. PCT's accreditation is effective for three years beginning October 19, 2013.
"We are proud, once again, to obtain accreditation by FACT. We understand that our clients put a great deal of trust in PCT to deliver high quality products and consistent results, and the FACT accreditation is just one of the many ways that we demonstrate that our programs consistently meet or exceed industry standards for the use of cellular products," said Dr. Robert Preti, Chief Scientific Officer of NeoStem and PCT and President of PCT.
FACT is an internationally-recognized accrediting body for hospitals and medical institutions offering stem cell transplant, and indicates the accredited institution has met the most rigorous standards in every aspect of 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.
"FACT accreditation and the certification of other leading regulatory bodies demonstrate that PCT is meeting the highest standards of quality for stem cell therapy," says Dr. Robin Smith, Chairman and CEO of NeoStem. "With more than 15 years of expertise in helping clients achieve their manufacturing and development goals, PCT has set a high bar for the cellular therapy industry."
Progenitor Cell Therapy (PCT), a wholly owned subsidiary of NeoStem, Inc., is a leading contract development and manufacturing organization in the cellular therapy industry. For over 15 years, PCT has provided pre-clinical and clinical cGMP development and manufacturing services to more than 100 clients, advancing regenerative medicine product candidates from the development stage all the way through to human testing. PCT has two cGMP-compliant, state-of-the art facilities in New Jersey and California to serve the cell therapy industry and offers manufacturing of cell therapy-based products, engineering and innovation services, process and product development, cell and tissue processing, collection and storage, regulatory consulting, facility design, validation, and due diligence evaluations. www.pctcelltherapy.com
About NeoStem, Inc.
NeoStem is a leader in the emerging cellular therapy industry, pursuing the preservation and enhancement of human health globally through the development of cell based therapeutics that prevent, treat or cure disease by repairing and replacing damaged or aged tissue, cells and organs and restoring their normal function. The business includes the development of novel proprietary cell therapy products as well as a revenue-generating contract development and manufacturing service business. This combination has created an organization with unique capabilities for cost effective in-house product development and immediate revenue and cash flow generation. www.neostem.com
In December 1994, the International Society for Cellular Therapy (ISCT) and the American Society for Blood and Marrow Transplantation (ASBMT) merged their Standards into a single document covering all aspects of hematopoietic cell therapy (collection, processing, and transplantation). The two societies established FACT in order to develop a voluntary Inspection and Accreditation Program based on the joint Standards. FACT promotes quality medical and laboratory practice of cellular therapy through its peer-developed standards and voluntary inspection and accreditation program.
In 2006, FACT, in collaboration with the Joint Accreditation Committee–ISCT & EBMT (JACIE), developed international standards in the field of cellular therapy. JACIE was founded by the European Group for Blood and Marrow Transplantation (EBMT) and the International Society for Cellular Therapy (ISCT), the two leading scientific organizations involved with cellular transplantation in Europe.
Since 2007, FACT accreditation has been used in determining the U.S. News & World Report rankings of transplant centers for the "America's Best Hospitals" and "America's Best Children's Hospitals" list.
The FACT Inspection and Accreditation Program was developed by Dr. Phyllis Warkentin, Chief Medical Officer of FACT, the FACT Board of Directors, as well as the ISCT and ASBMT Regulatory and Standards Committees. The first edition of the FACT Standards was published in September 1996, and the first inspections began in September of 1997 resulting in the first program being awarded accreditation in 1998.
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. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's ability to develop and grow its business, the successful development of cellular therapies with respect to the Company's research and development and clinical evaluation efforts in connection with the Company's Targeted Immunotherapy Program, CD34 Cell Program and T Regulatory Cell Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry and the performance and planned expansion of the Company's contract development and manufacturing business. 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 13, 2014, the Company's Current Report on Form 8-K filed with the SEC on May 8, 2014 and in the Company's other periodic filings with the SEC. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.