Sacramento startup gets FDA approval to sell stem cell therapy products

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

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

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."

The Sacramento company also said it has received certification to market products in Europe. SynGen's focus is the development and commercialization of medical systems that harvest stem and progenitor cells from umbilical cord blood, bone marrow, peripheral blood and other tissues.

Coelho is the founder and former CEO of Rancho Cordova-based ThermoGenesis Corp., leaving that company's board of directors in 2008. He co-founded SynGen in 2007.

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Sacramento startup gets FDA approval to sell stem cell therapy products

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