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Sientra Receives Regulatory Approval to Market Breast Implants in Saudi Arabia

Sientra Receives Regulatory Approval to Market Breast Implants in Saudi Arabia

By Sientra, Inc.
Published - Sep 20, 2022, 08:07 AM ET
Last Updated - Jun 24, 2023, 08:54 AM EDT

SANTA BARBARA, Calif., Sept. 20, 2022 (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 today that it has received approval from the Saudi Food & Drug Authority to market the Company’s line of smooth surface, High-Strength Cohesive (HSC and HSC+) silicone gel breast implants in the Kingdom of Saudi Arabia.

Ron Menezes, President and Chief Executive Officer of Sientra, said, “The swift SFDA approval of Sientra implants for the KSA market represents another stamp of approval from the global community which is actively seeking Sientra’s products to address the needs existing manufacturers fail to meet, and is a testament to the quality Sientra brings in safety, innovation and execution. As the largest country in the Middle East and GCC, and a growing aesthetics hub for the region, we see the Kingdom of Saudi Arabia as the tremendous launchpad for our international expansion efforts into the Middle East region.”

Sientra will market its breast implants in the GCC through its local partner Rose Aljazera, an established leading distributor of medical aesthetics solutions for the Middle East region for over two decades.

“Rose Aljazera is committed to providing the most innovative solutions and services to the medical aesthetics and plastic surgery community,” said Khalid AbuGhali, CEO of Rose Aljazera. “Surgeons in the GCC region have sought out Rose Aljazera to bring Sientra into the Middle East because of the brands’ clinical data and unrivalled safety profile. We are extremely excited to be the partner of choice both by our surgeons and by Sientra.”

This is the second new expansion market for the company in 2022, reaching a new milestone in global reach to provide even more patients with both choice and safety. Sientra continues growing at an accelerated pace both in the United States and internationally, through its successful programs and broad portfolio of products with technologically differentiated characteristics, supported by strong clinical outcomes.

About Sientra

Headquartered in Santa Barbara, California, Sientra is a medical aesthetics company exclusively focused on plastic surgery. The Company’s 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 AuraGen fat grafting system, 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.

For Canadian plastic surgeons and consumers seeking further information about Sientra silicone gel breast implants, including important safety information concerning breast implants, please visit www.sientra.ca.

(*)  Dataon 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 expansion into international markets, the Company’s prospects and opportunities in GCC and the Middle East for its breast implants, the adoption of the Company’s products in GCC and the Middle East by plastic surgeons and consumers, and Sientra’s continued growth in the United States and internationally. Such statements are subject to risks and uncertainties, including the positive reaction from plastic surgeons and their patients the Company’s products in the United States and internationally (including GCC and the Middle East), the Company’s ability to successfully leverage its commercial team and brand to generate significant breast implants sales in GCC and the Middle East, the Company’s ability to execute on its commercial, clinical and research and development plans for international expansion. 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

Media Contact
EvolveMKD
Sientra@EvolveMKD.com


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