Cytori Therapeutics has obtained approval from the Health Sciences Authority (HSA) in Singapore for the Celution system, designed for autologous re-implantation or re-infusion of a patient’s own adipose-derived regenerative cells (ADRCs).
The Celution system produces a patient's own ADRCs at the point-of-care which may then be used for a range of injuries or conditions.
Cytori Therapeutics president of Asia-Pacific Seijiro Shirahama said Celution System approval and claims in Singapore complements company's existing Asia-Pacific approvals by strengthening market access in the region and reinforcing our global regulatory strategy.
"We will continue to pursue new regulatory approvals in large markets and strategic countries in Asia as well as continue to expand existing claims for the Celution System in the more than 40 countries where we already have approval."
The company anticipates seeing a relevant impact on sales in 2014 as a result of the approval in Singapore, combined with recent approvals and registrations in Australia, New Zealand and in Japan.
