Rancho Cordova-based medical equipment firm ThermoGenesis Corp. said today that China's State Food and Drug Administration has approved registration of the company's BioArchive system.
ThermoGenesis said the action clears the way for direct commercial sales of the product in China.
The BioArchive system was developed to freeze and store stem cells harvested from umbilical cords and placentas retrieved in delivery rooms after childbirth.
"This is an essential step in our strategy to be the first-mover in China for automated processing and storage solutions to address what we expect will be a high growth cord blood market," said Matthew Plavan, CEO of ThermoGenesis.
Plavan said the company now looks forward to "facilitating regulatory approval for our AXP AutoXpress, which is currently in final technical review by the SFDA."
The AXP is an automated device used for processing stem cells from umbilical cord blood.
ThermoGenesis already has an established presence in China with three stem cell banks as customers.
Source: The Sacramento Bee