Cytori announced it has received approval for its Cellution Cell Therapy System consumable bundle in Japan as a Class III medical device.
The Cellution Cell Therapy System is a medical device designed to automate processing of adipose tissue to obtain regenerative cells suitable for treating thermal and radioactive burn wounds.
The company also said it successfully outsourced an important assembly portion of the production process for the Celution Cell Therapy consumables to Viant Medical. The first consumable lots following the new process were shipped to consumers in November, Cytori said.
Why It's Important
The Class III designation, an indicator of the highest level of safety and efficacy for medical devices in Japan, vests Cytori with the ability to expand its commercial efforts in the country, providing a clear framework for future expanded regulatory claims and reimbursement under the November 2014 PMD Act.
"This approval coupled with the outsourced production allows Cytori to meet forecasted product demand, particularly in Japan, and better prepares us for the data read out in our Japan ADRESU pivotal trial next year," Cytori President and CEO Marc Hedrick said in a statement.
Cytori expects double-digit growth in utilization in Japan for 2018, especially as the device was earlier sold mostly for aesthetic and orthopedic indications under a Class I designation.
The company said it expects one-year data readout from the 45 patients treated in Japan under the ADRESU trial in the first half of 2019.
The ADRESU trial is evaluating Cytori's ECCI-50 cellular therapeutic, comprising the regenerative cells and adipose cells, for treating stress urinary incontinence arising out of complications from prostate intervention in men.
Cytori shares were trading up 0.36 percent at $10.31 at the time of publication Monday.
The Week Ahead In Biotech: ASH Presentations Pick Up Pace, PDUFA Dates, Clinical Trials And IPOs
Attention Biotech Investors: Mark Your Calendar For These December PDUFA Dates
See more from Benzinga
© 2018 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.