Sientra® Provides Update on Manufacturing Solution
Announces Services Agreement with Vesta
Santa Barbara, CA – August 9, 2016 – Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a medical aesthetics company, today provided an update on its progress towards establishing a long-term manufacturing solution for its breast implant products. Sientra has entered into a services agreement with Vesta, a Lubrizol LifeSciences company and a leading medical device contract manufacturer of silicone products and other medical devices.
Under terms of the agreement, Vesta is establishing manufacturing capacity for Sientra and is working with the Company to finalize a long-term supply arrangement for its PMA-approved breast implants. Sientra anticipates that all project milestones will be achieved for the Company to submit a PMA Supplement to the FDA during the first quarter of 2017.
Jeffrey M. Nugent, Chairman and Chief Executive Officer of Sientra, said, “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.”
Mr. Nugent continued, “We are also looking forward to the prospects of working with Lubrizol LifeSciences and Vesta in the future on additional aesthetics technologies and innovations that can help meet unmet needs for our surgeons and their patients.”
“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,” said Deb Langer, Vice President and General Manager Lubrizol LifeSciences. “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.”
Headquartered in Santa Barbara, California, Sientra is a medical aesthetics company committed to making a difference in patients’ lives by enhancing their body image, growing their self-esteem and restoring their confidence. The Company was founded to provide greater choice to board-certified plastic surgeons and patients in need of medical aesthetics products. The Company has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company sells its breast implants and breast tissue expanders exclusively to board-certified and board-admissible plastic surgeons and tailors its customer service offerings to their specific needs. The Company also offers a range of other aesthetic and specialty products including bioCorneum®, the professional choice in scar management.
Headquartered in Franklin, Wisconsin, Vesta Intermediate Funding, Inc. (“Vesta”) is a Lubrizol LifeSciences company. Vesta has more than 40 years of experience serving the medical device industry, exclusively specializing in precision thermoplastic extrusion and comprehensive silicone fabrication. Vesta’s quality, competency and reliability have earned the company business relationships with hundreds of OEMs worldwide. For more information, please visit the company's website at www.vestainc.com or contact Vesta at firstname.lastname@example.org.
Forward- looking statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements include, but are not limited to, statements regarding the Company’s development of and progress towards a long-term manufacturing solution, the ability and timing of Vesta and the Company to complete the development and validation of a manufacturing facility in order for the Company to obtain FDA approval of its PMA Supplement, the Company’s plan to provide an uninterrupted supply of its Breast Products, and the prospects of any future collaboration with Vesta or Lubrizol regarding additional aesthetic technologies. Such statements are subject to risks and uncertainties, including the risks associated with contracting with any third-party manufacturer and supplier, as well as uncertainties that the development and validation of Vesta’s manufacturing facility will be timely completed, that a PMA Supplement or other regulatory requirements will be timely approved by the FDA or other applicable regulatory authorities, and that the Company and Vesta will successfully negotiate and enter into a definitive long-term supply arrangement. Additional factors that could cause actual results to differ materially from those contemplated in this press release can be found in the Risk Factors section of Sientra’s most recently filed Quarterly Report on Form 10-Q and and its Annual Report on Form 10-K for the year ended December 31, 2015 which Sientra filed with the Securities and Exchange Commission on March 10, 2016. All statements other than statements of historical fact are forward-looking statements. The words “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan,” or the negative of those terms, and similar expressions that convey uncertainty of future events or outcomes are intended to identify beliefs, estimates, projections and other forward-looking statements. Forward-looking statements speak only as of the date they were made, and, except to the extent required by law, the Company undertakes no obligation to update or review any forward-looking statement.
The Ruth Group
Nick Laudico / Zack Kubow
(646) 536-7030 / (646) 536-7020