Sientra, Inc. announced that the Food and Drug Administration (FDA) has granted a 510(k) clearance for the Company’s novel Portfinder™ technology.
IRVINE, Calif., May 17, 2023 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a medical aesthetics company focused on enhancing lives by advancing the art of plastic surgery, announced that the Food and Drug Administration (FDA) has granted a 510(k) clearance for the Company’s novel Portfinder™ technology. Portfinder™ is an electronic handheld device that allows for the subcutaneous location of ports in Sientra’s Dermaspan® and AlloX2® Pro tissue expanders. This new technology replaces the traditional dangle magnet mechanism and provides a more accurate port location with improved useability for clinicians.
“Portfinder™’s state-of-the-art proprietary technology improves the user experience during tissue expander filling sessions, allowing for more precision and confidence in the port location. The Portfinder™’s unique interactive screen guides the user towards the center of the ports and allows for precise identification and marking of both fill and drain ports in Dermaspan® and AlloX2® Pro expanders, making it a very versatile device”, said Dr. Denise Dajles, Sientra’s Chief Technical Officer.
“The FDA’s clearance of Portfinder™ marks another first for Sientra and reflects our ongoing commitment to innovation and improvement of the patient experience in reconstruction cases,” said Ron Menezes, President and CEO of Sientra. “We look forward to commercializing this product and putting it in the hands of the most skilled plastic surgeons, our customers.”
About Sientra
Headquartered in Irvine, California, Sientra is a medical aesthetics company exclusively focused on plastic surgery. The Company mission is to offer proprietary innovations and unparalleled partnerships that radically advance how plastic surgeons think, work and care for their patients. Sientra has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company’s product portfolio includes its Sientra round and shaped breast implants, the first fifth-generation breast implants approved by the FDA for sale in the United States, its ground-breaking AlloX2® breast tissue expander with patented dual-port and integral drain technology, the Viality™ with AuraClens™ enhanced viability fat transfer system, the SimpliDerm® Human Acellular Dermal Matrix, and BIOCORNEUM® the #1 performing, preferred and recommended scar gel of plastic surgeons (*).
Sientra uses its investor relations website to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Sientra is routinely posted and is accessible on the Company’s investor relations website at www.sientra.com.
(*) Data on file
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 are made only as of the date of this release. The words ‘‘believe,’’ ‘‘may,’’ ‘‘might,’’ ‘‘could,’’ ‘‘will,’’ ‘‘aim,’’ ‘‘estimate,’’ ‘‘continue, ‘‘anticipate,’’ ‘‘intend,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘position,” 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. Forward-looking statements may include information concerning the Company’s possible or assumed future results of operations, including descriptions of the Company’s revenues, profitability, outlook, and overall business strategy, the Company’s ability and timing to successfully integrate the Portfinder™ product into its existing operations, the reception of plastic surgeons to the Company’s products, and the Company’s ability to capture additional market share and customer accounts in the plastic surgery market. Such statements are subject to risks and uncertainties, including the positive reaction from plastic surgeons and their patients to the Company’s products, the ability to meet consumer demand, including any potential supply issues resulting from the COVID-19 pandemic or the war in Ukraine, the growth of the plastic surgery market and breast procedures, and the ability of the Company to execute on its commercial, marketing, research and development and regulatory plans. 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 public filings with the Securities and Exchange Commission. 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,’’ ‘‘position,” 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. You are cautioned not to place undue reliance on these forward-looking statements, and such 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. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in the Company’s business.
Investor Relations Contact
Aman R. Patel, CFA
aman.patel@westwicke.com
