Celution System approved in China- Cytori Therapeutics

Cytori Therapeutics has announced that its exclusive licensee, Lorem Vascular, has been granted regulatory clearance for the Cytori Celution System by the State Food and Drug Administration of the People’s Republic of China (CFDA). 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 Cytori Celution System in China, Hong Kong, Malaysia, Singapore, and Australia.

Comment: Lorem Vascular has placed an opening order of 23 Celution Devices and 1,100 Celution Consumable Sets, which is anticipated to be fulfilled throughout 2015. Following this opening order, Lorem Vascular has agreed to purchase annually a minimum of fifty (50) Celution Devices and fifty (50) Celution Consumable Sets for each of the Celution Devices for the next three years from CFDA clearance.

Comment; Cytori has been cutting costs as it progresses the Celution System through Phase II to Phase III trials. Data from the ADVANCE trial was presented at the AHA meeting 2014 showing that small volume fat harvest for Adipose Derived Regenerative Cells (ADRC) preparation and subsequent intracoronary infusion is feasible and can be performed with an acceptable safety profile in patients with acute STEMI under dual antiplatelet therapy. This finding is consistent with that found in the previously reported APOLLO trial.