Sientra Announces FDA-Clearance of Next Generation AlloX2 Pro™ Tissue Expander
Significant Milestone as the First, and Only, MRI-Compatible Tissue Expander Available on the US Market
Continues Sientra’s Leadership and Innovation in Breast Reconstruction
IRVINE, Calif., June 08, 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 510k-clearance for the Company’s novel, patented1 AlloX2 Pro Tissue Expander. Building upon the proprietary dual port technology of the Company’s ground-breaking AlloX2® tissue expander, the AlloX2 Pro expands this platform by removing 95% of the metal traditionally associated with tissue expander ports. This innovation allows the AlloX2 Pro to be labeled as MRI-conditional, making it the only tissue expander cleared in the United States for exposure to magnetic resonance imaging, an important screening tool for breast reconstruction patients. Other innovative features of the AlloX2 Pro include minimal interference with radiation therapy for post-mastectomy patients,2 faster port filling and drainage, and a softer drain for enhanced patient comfort.
“I am extremely proud to have partnered with Sientra to bring the AlloX2 Pro to market,” commented Dr. Thomas McClellan, a board-certified plastic surgeon in West Virginia and inventor of AlloX2. “Sientra’s commitment to women’s health and technological development in breast reconstruction made them the natural choice to make this important innovation in the treatment of post-mastectomy women a reality.”
“AlloX2 Pro is a remarkable and differentiating advancement in tissue expander technology. The AlloX2 Pro will significantly improve reconstructive approach with both dual ports and MRI-compatibility. These combined features will allow for better and safer treatment options and even allow use expanders in situations where we could not before,” said Dr. Thomas Davenport, a leading board-certified plastic surgeon specializing in reconstruction at Long Island Plastic Surgery. “Reconstructive surgery enhances the lives of our breast cancer patients by restoring their confidence and quality of life. AlloX2 Pro is a game changing innovation which will allow us to deliver the best and safest care to our patients.”
“The FDA clearance of AlloX2 Pro tissue expander represents another significant achievement for Sientra, and is a testament to our unwavering commitment to women’s health, innovation and leadership in reconstruction,” commented Ron Menezes, President and CEO of Sientra. “This is the third new product cleared or approved by the FDA in the past 12 months, setting Sientra apart from the competition and showing that Sientra continues to lead the way offering the most innovative solutions for plastic surgeons and their patients. We are excited to offer this ground-breaking new technology to our customers, and continue our market share gains in reconstruction where we have already reached an all-time high of 23% at the end of Q1.3”
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
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 AlloX2 Pro™ product into its existing operations, the clinical performance of the Company’s products, 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
1 U.S. Patent No. 11,039,898
2 Ramos-Méndez J, Park C, Sharma M., “Dosimetric characterization of single- and dual-port temporary tissue expanders for postmastectomy radiotherapy using Monte Carlo methods,” Front Oncol. 2023 Apr 18;13:1124838. doi: 10.3389/fonc.2023.1124838.
3 IQVIA, SMART-Medical Device Supply Edition, Gel Implants & Breast Expander Purchases.
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