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.
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 an uninterrupted supply of our breast implant products. We believe our arrangement with Vesta will provide us a best-in-class supply chain that we can scale moving forward to support our long-term growth objectives,” Nugent said in prepared remarks.
Nugent said Sientra is also exploring other cosmetic devices with Lubrizol LifeSciences and Vesta.
“Lubrizol LifeSciences/Vesta is excited about furthering its commitment to deliver the highest quality medical components and products with an innovative strategic partner like Sientra,” added Lubrizol vice president & general manager Deb Langer. “Our experience in the implantable cosmetic market and our know-how of silicone component manufacturing positions us well to best support Sientra’s continued success.”
SIEN shares, which plunged as low as $2.78 apiece in the wake of the Silimed debacle, were up 4.1% to $7.40 apiece today in pre-market training.