FDA OKs Opus breast implant line from Sientra

The FDA this week granted a pre-market approval supplement to Sientra (NSDQ:SIEN) for its Opus line of silicone breast implants.

The implants are made in Wisconsin by Lubrizol LifeSciences subsidiary Vesta, which inked a contract manufacturing deal with Sientra back in August 2016.

Sales of Sientra’s silicone breast implants ground to a halt in the autumn of 2015, when Brazilian authorities suspended production at Silimed, its supplier there, and the U.K.’s Medicines & Healthcare Products Regulatory Agency halted sales. The products were back on the market in the U.S. by March 2016, after Santa Barbara, Calif.-based Sientra tapped a new CEO, Jeffrey Nugent, to oversee the recovery process.

“This FDA approval allows us to commercialize our Opus-branded breast implants with an improved manufacturing process and represents a critical milestone for Sientra. The approval culminates over two years of successful collaboration between the Sientra and Vesta teams. We now once again have access to a supply of implants to support our plan to regain and grow share in the U.S. breast implant market for both augmentation and reconstruction. Our decision to manufacture finished goods product prior to approval has positively positioned us to begin meeting customer demand immediately. We will continue our precision-controlled selling strategy through the first half of 2018 as the new Vesta facility scales its manufacturing to full supply capabilities, which we anticipate will occur during the second half of this year,” Nugent said today in prepared remarks.

“With today’s FDA approval, we have closed the final chapter of our transition and positioned the company with a diversified portfolio of differentiated products to capitalize on significant market opportunities for each of our two core businesses. Overall, we are now poised to continue executing an integrated commercial aesthetics strategy. In the immediate term, we will be leveraging the American Society for Aesthetic Plastic Surgery annual meetings held later this month to showcase each of our brands. Looking further ahead, we expect 2018 to be another pivotal year in which we deliver meaningful incremental value to our customers, patients, and shareholders,” Nugent said.

The approval also triggered access to another $10 million in credit from MidCap Financial Services and Silicon Valley Bank, Sientra said.

SIEN shares are up 19.2% to $12.28 since the April 18 Opus announcement.

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