Healthcare Industry News:  blood collection 

Devices FDA

 News Release - January 10, 2007

GenesisBPS Announces the North American Distribution and FDA 510K Clearance of the SEPAX Cell Separation System for Cord Blood Processing

HACKENSACK, N.J., Jan. 10 (HSMN NewsFeed) -- GenesisBPS (www.genesisbps.com) has announced that the SEPAX Cell Separation System, developed and manufactured by Biosafe SA (www.biosafe.ch) has received 510(k) marketing clearance from the U.S. Food and Drug Administration's Center for Biologics Evaluation & Research (CBER) for use as a cord blood-processing device.

Cord blood is increasingly used as a source of adult stem cells to treat blood disorders such as leukemia, but also contains somatic cells that have potential in the emerging field of regenerative medicine. Collected immediately after birth, cord blood is sent to public and private banking facilities where it is processed and cryogenically stored until needed. The SEPAX system allows fast, automated, reproducible processing of cord blood in a closed, sterile environment.

Introduced with CE Mark in 2001, the SEPAX System has rapidly gained acceptance within the international cord blood community and is used by a majority of NETCORD members, an association of the largest public cord blood banks in the world. The SEPAX technology is a versatile platform that is able to process various cellular products and is also routinely used in non-US markets for the processing of bone marrow and peripheral blood stem cells.

Claude Fell, President and CEO of Biosafe, said, "The SEPAX System, built around a unique proprietary separation technology, is the only fully-automated system available in the growing market of adult stem cell processing. The FDA 510(k) clearance to market this device in the US is a significant milestone in establishing Biosafe as a global leader in the field of automated cell processing. Biosafe is pleased to be able to offer a safe and reliable processing system at a time when major efforts are being made to increase cord blood inventory in the US. We are pleased to have GenesisBPS as our distribution and marketing partner for North America. Their experience and current product line are a complementary fit for the SEPAX technology."

Jerrold Grossman, PhD, President and CEO of GenesisBPS said, "We are pleased to be able to offer the SEPAX technology to US and Canadian cord blood processing organizations. Our current portfolio of blood banking and laboratory devices, along with the addition of the SEPAX, allows us to provide turnkey equipment solutions to both established and start-up cell processing organizations. The SEPAX is complimented by our Sterile Tube Welder, Tube Sealers and other supplies and will allow the busy and growing cord blood collection and processing agencies a single, reliable resource for their processing needs. GenesisBPS is pleased and honored to have been selected as the exclusive N. American distributor for the SEPAX from Biosafe, the world leader in automated cord blood processing."

About GenesisBPS

GENESISBPS (Hackensack, NJ) is a privately held company involved in the marketing, sales, distribution and specification developing of specialty blood collection and Blood Processing equipment and supplies. GenesisBPS offers a comprehensive product portfolio which encompasses a wide range of items designed to meet the unique and demanding requirements of blood collection and processing organizations. GENESISBPS offers stem cell processing organizations turnkey laboratory equipment solutions build around the SEPAX Cell Separation System. Contact GenesisBPS at www.GenesisBPS.com or 201-708- 1400 or 866-71-BLOOD (25663) to learn more about its product portfolio.

About Biosafe SA

Biosafe, based in the Lake Geneva region of Switzerland, is a privately held company engaged in the design, manufacture and worldwide marketing of automated cell processing systems. These systems address important medical markets such as stem cell banking, stem cell transplantation and regenerative medicine. To learn more about Biosafe and its products please visit www.biosafe.ch or call +41 22 365 2727 (CET).


Source: GenesisBPS

Issuer of this News Release is solely responsible for its content.
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