Cytori Therapeutics says licensee Lorem gets CFDA nod for Celution System

Nasdaq-listed Cytori Therapeutics ($CYTX) said its exclusive licensee, Lorem Vascular, has been granted regulatory clearance for the Cytori Celution System by the China Food and Drug Administration, triggering a "substantial 2015 product purchase order for Cytori from Lorem Vascular."

Lorem Vascular has worked closely with Cytori during the last year preparing for CFDA clearance and planning for commercial introduction of the Celution family of products in China.

"Today's news marks the first time that Cytori's Celution System has gained any level of access to the mainland Chinese healthcare market," a release said. "Lorem Vascular will begin product launch of Celution in key hospitals in China immediately."

In November 2013, Cytori Therapeutics and Lorem Vascular entered into a 30-year exclusive licensing agreement to commercialize the Cytori Celution System in China, Hong Kong, Malaysia, Singapore and Australia, Cytori said in a press release.

As part of that agreement, Lorem Vascular agreed to pay up to $500 million in fees to Cytori for a 30-year exclusive license for all indications, excluding alopecia, in the licensed territories following specific revenue milestones, as well as royalties of 30% on gross profits from Lorem's operations in China, Malaysia and Hong Kong, Cytori said.

Lorem Vascular is headquartered in Singapore, with offices in Australia, China, Hong Kong and Malaysia, Cytori said. The company's website was under construction.

- here's the release