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Bio-Matrix Scientific Enters into Contract With Validation Systems to Finalize FDA cGMP Quality Systems for First Adult Stem Cell Bank Focused on Fat Tissue

Posted on: Monday, 14 May 2007, 09:00 CDT

Bio-Matrix Scientific Group Inc. (OTCBB:BMSN), a biotechnology company focused on stem cell cryogenics and disposable stem cell/tissue transfer instruments, announced today it has entered into a contract with Validation Systems, Inc. to complete and finalize its FDA Good Manufacturing Practices (cGMP) Quality Systems documentation. Once this documentation is finalized and the Company receives clearance from the State of California, stem cell specimens can be cryogenically stored. Bio-Matrix intends to open in the months ahead what it believes to be the first commercial adult stem cell processing and banking facility in the world for harvesting stem cells from adipose or fat tissue, which is a new dimension in stem cell banking.

Validation Systems Inc. (VSI) is a full-service validation contractor and laboratory service provider. VSI has been servicing the pharmaceutical, biotechnology, and medical device industries since 1990. VSI is owned and operated by validation professionals having consulting backgrounds that include large publicly-traded biotechnology companies. VSI will provide Bio-Matrix with validation and technical services for its cGTP (Good Tissue Practices) and cGMP (Good Manufacturing Practices) for the processing and cryo-storage (in liquid nitrogen) of adult stem cells.

"We believe our relationship with VSI represents the last piece in completing our goal of getting the facility open," said Dr. David Koos, Chairman and CEO of Bio-Matrix. "Once VSI and Bio-Matrix finalize the quality systems documentation and we gain the anticipated regulatory approvals, we can then implement our business model -- moving towards revenue."

Dr. Koos explained VSI will handle Bio-Matrix's validation master plan by outlining the tasks required to complete the validation process. VSI will also establish the level of validation for each system/piece of equipment. "To achieve a smooth validation process, the concepts of validation must be incorporated during the design phase. VSI's experience in the biotech, pharmaceutical and medical device industries allows its professionals to provide broad reviews encompassing not only validation concerns, but also long-term control, current technology, cost/benefits, ease of maintenance and ability to meet regulatory requirements," said Dr. Koos.

Bio-Matrix's new 15,000 sq. ft. state-of-the-art facility, which is located in the heart of San Diego's biotechnology corridor, will house the Company's secure Cryogenic Stem Cell Bank, three research laboratories, aseptic cellular/tissue class 10,000/100 processing laboratory, hematology, microbiology and flow cytometry laboratories.

About Bio-Matrix Scientific Group Inc

Bio-Matrix Scientific Group Inc. (www.BMSNonline.com) is a biotech research and development company that commercializes medical devices and monitoring systems for the growing, worldwide stem cell research market.

The Company aligns itself with strategic partners that offer key technologies in biomedical device development, tissue engineering, cell culturing, genome therapy and drug delivery systems to become a leading source for stem cell research technology and innovation. Bio-Matrix intends to soon open a state-of-the-art facility in San Diego to cater to the growing stem cell research segment of the $75 billion biotechnology and medical device industry.

DISCLAIMER: This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

Source: Business Wire

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