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Sientra Receives Regulatory Approval To Market OPUS Breast Implants In Japan

SANTA BARBARA, Calif., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ:SIEN) ("Sientra" or the "Company"), a diversified global medical aesthetics company, announced today that it has received

Benzinga · 08/25/2020 12:05

SANTA BARBARA, Calif., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ:SIEN) ("Sientra" or the "Company"), a diversified global medical aesthetics company, announced today that it has received approval from Japan's Pharmaceutical and Medical Device Agency ("PDMA") to market the Company's entire OPUS line of breast implants in Japan.
 

Sientra will market the complete portfolio of OPUS breast implants in Japan through its local partner Medical U&A, Inc. ("Medical U&A"), a leading provider of surgical and medical devices in the fields of plastic and reconstructive surgery. Medical U&A will sell Sientra's implants through a dedicated sales force to over 2,000 hospitals and clinics across Japan.

Jeff Nugent, Chairman and Chief Executive Officer of Sientra, said, "The approval of our OPUS line of implants in Japan represents a major milestone for Sientra, representing our first approval for our breast products outside of the U.S. With this approval, Sientra's implants will be one of only two breast implants approved by the PDMA, which reinforces our clinically proven safety profile."

Jeff continued, "In an era when safety and trust are paramount, Sientra upholds the highest standards for both patients and providers. With our latest generation of clinically supported and FDA approved implants sold only to highly qualified surgeons in the U.S. and now Japan, we believe Sientra consistently provides patients with safe and beautiful outcomes."

Shojiro Matsuda, Chief Executive Officer of Medical U&A, said "Many patients in Japan have long-awaited Sientra's breast implants. In response to the demands of patients and healthcare professionals, and with the full cooperation of Sientra, we submitted the regulatory application and obtained approval in only six months. We are very pleased to be able to distribute these highly differentiated Sientra products that contribute to the quality of life of Japanese patients."