SANTA BARBARA, Calif., Dec. 05, 2016 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ:SIEN), a medical aesthetics company, today announced that it has received U.S. Food and Drug Administration (FDA) pre-market supplement approval (PMA) for four new breast implant styles in both shaped and round as well as additional profile and sizing options for nine existing implant offerings.
Jeffrey M. Nugent, Chairman and Chief Executive Officer of Sientra, said, “This FDA approval of our previously filed PMA supplement to expand our product offering, marks another step forward in building a broader and more differentiated product portfolio. This approval greatly increases our ability to meet both physician and patient needs. Included in this PMA Supplement are larger implant sizes, which will help us further penetrate the $235 million U.S. breast reconstruction market in combination with our recently announced acquisition of the Specialty Surgical Products, Inc.’s breast tissue expander portfolio. We look forward to bringing these new offerings to our customers.”
Mr. Nugent continued, “Separately, we remain on track to reestablishing a high-quality uninterrupted manufacturing supply, in collaboration with our partner Vesta. We continue to expect to submit our FDA pre-market approval supplement for the implants manufactured at this new facility by the end of the first quarter 2017 and expect to deliver newly manufactured product to the market by the end of the fourth quarter of 2017.”
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.
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 a long-term manufacturing solution, including the ability and timing to submit a PMA supplement for the Vesta manufacturing facility and to qualify a manufacturing facility for the manufacture of product for the Company’s customers. Such statements are subject to risks and uncertainties, including the dependence on positive reaction from plastic surgeons and their patients and risks associated with contracting with Vesta or any third-party manufacturer and supplier, including 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 integration of recently acquired product lines will not achieve the anticipated benefits. 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 forward-looking statements. Estimates and other 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 estimate or forward-looking statement.
Investor Contacts: Patrick F. Williams Sientra, Chief Financial Officer (619) 675-1047 firstname.lastname@example.org Nick Laudico / Brian Johnston The Ruth Group (646) 536-7030 / (646) 536-7028 IR@Sientra.com