Sientra inks contract manufacturing deal with Lubrizol ’ s Vesta

Sientra (NSDQ:SIEN) said today that it inked a contract manufacturing deal for its breast implants with Lubrizol LifeSciences subsidiary Vesta. Santa Barbara, Calif.-based Sientra was off the market for 4 months after Brazilian regulators shut down production last year at its sole supplier. The company, which was back on the market March 1, was stymied after Brazilian regulator Anvisa last October suspended production at Silimed, Sientra’s supplier, and the U.K.’s Medicines & Healthcare Products Regulatory Agency halted sales. SIEN share prices hit a 52-week low on the news, but clawed back some of their value in January after new CEO Jeffrey Nugent said independent testing found the implants to be safe. Today the company said it’s finalizing a long-term supply arrangement with Vesta, a medical device contract manufacturer that specializes in products made with silicone. Sientra said it expects to be able to file a pre-market approval supplement with the FDA during the 1st quarter of 2017. “Our relationship with Vesta is an important component of our comprehensive manufacturing plan. Vesta is an established manufacturer with proven capabilities in producing implantable silicone medical devices and components with a strong reputation for quality and safety. We have already made significant progress with Vesta and we are confident that this ongoing relationship will enable us to uphold our promise to board-certified plastic surgeons to maintain...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Contract Manufacturing Cosmetic/Aesthetic Lubrizol LifeSciences Sientra Vesta Source Type: news