FDA gives green light to SynGen for cord blood-processing products

Buoyed by another round of multimillion-dollar financing, Sacramento-based startup SynGen Inc. has cleared a significant federal hurdle to get its cord blood-processing products on the market.

The midtown Sacramento medical device startup, which develops stem cell harvesting systems, announced Monday that it has received U.S. Food and Drug Administration clearance to market three related products to process cord blood.

All three are related to the company's SynGenX-1000 system, which harvests stem and progenitor cells from units of collected umbilical cord blood.

The company says harvested cells can be used for treatment of numerous medical conditions, including leukemia, lymphoma and more than 70 genetic diseases.

"We thank the FDA for guiding us through the clearance process. SynGen is dedicated to developing products that consistently exceed our customers' expectations," said Philip Coelho, company president and CEO.

Last year, SynGen received $5 million from San Francisco venture capital firm Bay City Capital LLC to further develop what Coelho has called the next generation in stem cell harvesting systems.

SynGen recently received additional financing of up to $3 million from Bay City.

Established in 1997, Bay City bills itself as a "life sciences venture capital firm investing in opportunities across the various life sciences sectors." It has invested in more than 100 companies.

Noting the new financing, Coelho said "we look forward to providing U.S. cord blood banks with the competitive advantage they will enjoy by using our products."

Coelho said the SynGenX-1000 system improves the recovery of stem and progenitor cells from cord blood units, which should increase the amount of clinical-grade cord blood available for transplants.

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FDA gives green light to SynGen for cord blood-processing products