The Company believes that the information requested by the FDA related to this third and final outstanding submission can be addressed quickly and is working closely with the FDA to resolve these matters in a timely manner.
SANTA BARBARA, Calif., Jan. 30, 2018 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ:SIEN) (“Sientra” or the “Company”), a medical aesthetics company, today provided an update on its pre-market approval (PMA) supplement for a site-change to its U.S. manufacturing facility. Following a successful inspection and resolution of minor 483 observations, the U.S. Food and Drug Administration (FDA) has granted approval of the site-change PMA supplement for its contract manufacturer (Vesta) to manufacture Sientra’s silicone gel breast implants. In support of its move to the Vesta manufacturing facility, the Company also implemented new manufacturing process improvements which, in consultation with the FDA, required three (3) additional PMA supplements. In addition to approving the manufacturing site-change supplement, the FDA has approved two (2) of these three (3) process enhancement supplements, while requesting additional information for the third submission. After discussions with the FDA, the Company believes that the information requested by the FDA related to this third and final outstanding submission can be addressed quickly and is working closely with the FDA to resolve these matters in a timely manner.
Jeffrey M. Nugent, Chairman and Chief Executive Officer of Sientra, commented, “We have maintained our belief that FDA approval to manufacture our best in class breast implants at Vesta’s U.S. facility was a “when” and not an “if” situation. Today, we are very pleased to announce that we have made significant progress with the FDA towards that goal. Notably, the approval of the site-change PMA supplement was a critical step as it approves the Vesta manufacturing site. As we transitioned to the Vesta facility, we decided to implement a few changes to improve select elements of our manufacturing process. We have received FDA approval for two of these improvements and received inquiries from the FDA regarding the third. We are proactively communicating with the FDA and expect to submit our comprehensive response to comments on the final process improvement in the next several days. We remain confident that we can facilitate an efficient resolution to their requests.”
Mr. Nugent concluded, “Though statutorily the FDA has until approximately the middle of the second quarter 2018 to respond to the one outstanding supplement, we believe the questions raised by the FDA should be resolvable before then. We will continue to manage our inventory with a precision controlled approach and our sales team will be actively managing our customers’ needs with respect to implant supply in the near term. Finally, we continue to manufacture finished goods at the Vesta facility, maintaining those products in quarantine, as we prepare a ready supply of our highest demand SKUs for what we consider as inevitable FDA approval of the final outstanding PMA supplement.”
About Sientra
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, and miraDry, the only FDA cleared device to reduce underarm sweat, odor and permanently reduce hair of all colors.
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 ability to address the issues raised by the FDA, the Company’s ability to become a world class, diversified aesthetics organization, and the timing of the re-launch of the Company’s breast implants. 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 any third-party manufacturer and supplier, including uncertainties 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 the Company’s most recently filed Quarterly Report on Form 10-Q and its Annual Report on Form 10-K for the year ended December 31, 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 estimates, projections and other forward-looking statements. Estimates, projections 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, projection or forward-looking statement.
Investor Contacts:
Patrick F. Williams
Sientra, Chief Financial Officer
(619) 675-1047
patrick.williams@sientra.com
Tram Bui / Brian Johnston
The Ruth Group
(646) 536-7035 / (646) 536-7028
IR@sientra.com
