Cytori Announces Japan Class III Medical Device Approval for Cell Therapy Product
CYTORI THERAPEUTICS (CYTX)
Last cytori therapeutics earnings: 11/14 04:15 pm
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US:NASDAQ Investor Relations:
ir.cytori.com/investor-relations/default.aspx
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Source: GlobeNewswire
SAN DIEGO and TOKYO, Dec. 03, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics (NASDAQ: CYTX) (“Cytori” or the “Company”) today announced that the Company has received approval for the Celution Cell Therapy System consumable bundle in Japan as a Class III medical device. The Class III designation will allow Cytori to expand its current commercial efforts in Japan and provides a clear framework for future expanded regulatory claims and reimbursement under the November 2014 PMD Act. Furthermore, Cytori announced today that the Company has successfully outsourced an important assembly portion of the production process for its Celution Cell Therapy consumables from San Diego, CA to Viant Medical in San Antonio, Texas. The first consumable lots following this new process were shipped to customers in November 2018. “Obtaining Class III designation follows many months of constructive interaction with the Japanese Ministry of Health, Labour and Welfare following the approval of the 2014 PMD A
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