Sientra Receives FDA Approval of PMA Supplement

Sientra (NASDAQ:SIEN) a medical aesthetics company, today announced U.S. Food and Drug Administration (FDA) approval of the Company’s PMA supplement allowing commercialization of its OPUS-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta’s Wisconsin-based manufacturing facility.

As quoted in the press release:

Jeffrey M. Nugent, Chairman and Chief Executive Officer of Sientra, commented, “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.”

Mr. Nugent added, “As Sientra continues to expand into categories beyond breast surgery, we decided to rebrand our breast products with a name that symbolizes what they represent.  We chose the name Sientra OPUS, the only brand of silicone gel breast implants and tissue expanders marketed exclusively to board–certified plastic surgeons.  OPUS signifies an artist’s best body of work and for our brand, the name evokes excellence, quality, performance and artistry.  We believe our OPUS products provide the true artists with the best tools available to achieve optimal results.”

Click here to read the full press release.