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Designed to transform the art and science of fat transfer, Viality addresses significant unmet market need
IRVINE Calif., Dec. 5, 2022 /PRNewswire/ -- Sientra, Inc., a medical aesthetics company focused on enhancing lives by advancing the art of plastic surgery launched the Viality lipoaspirate wash system at the Beauty Through Science meeting in NYC this past Saturday. This product will be commercially available in the United States beginning in Q1 of 2023.
Fat transfer, a procedure used to relocate fat from one area of the body to another where volume is desired, has increased in popularity in recent years and is used in both breast reconstruction and augmentation procedures, as well as across other body areas such as the buttocks, hands and face. Despite fat transfer's growing popularity, physician satisfaction with the currently available fat transfer systems on the market is low1. Developed by researchers at Harvard and Massachusetts General Hospital, the Viality system solves this market need. Viality is the only fat transfer system with AuraClens™, a proprietary cleansing mechanism (lipoaspirate wash) to better retain viable fat leading to more predictable results. In addition, the design enables gentle fat mixing to protect viable fat cells from damage and a super absorbent foam layer that removes unwanted fluids and maximizes the concentration of fat. The device also has the capability of processing from 50 to more than 1000cc in a single run.
"As the first-of-its-kind technology, Viality will escalate the standards for fat transfer across the industry," said board-certified Plastic Surgeon Dr. Brad Calobrace, who is a principal investigator for the ongoing Viality clinical study. "Viality has brought innovation and intention together in the operating room. The use of this system has revealed a new, extraordinary approach to fat transfer, providing better predictability and results for my patients."
Studies have shown that Viality produced an average of 94% cell viability and 89% average fat concentration with low processing time and increased volume for reinjection2. In addition, the AuraClens concentrating wash was shown in a 20-patient study to improve fat retention by more than 31% compared to saline rinse3.
"At Sientra 'good' has never been enough and we are thrilled to be able to offer plastic surgeons, and their patients, this new innovation that will elevate the standards of plastic surgery and the entire fat transfer category." said Ron Menezes, President and CEO of Sientra. "We believe that the launch of Viality will significantly increase Sientra's addressable TAM and add meaningful top-line revenue growth in 2023 as we initially target the breast reconstruction and augmentation market while looking to expand into other body areas."
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™ lipoaspirate wash system, and BIOCORNEUM®, the #1 performing, preferred and recommended scar gel of plastic surgeons(*).
* Data on file
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.
References:
1. Sientra Fat Grafting Study April 2022
2. An Y, Panayi AC, Mi B, Fu S, Orgill DP. Comparative Analysis of Two Automated Fat-processing Systems. Plast Reconstr Surg Glob Open. 2020;8(1):e2587. Published 2020 Jan 17. doi:10.1097/GOX.0000000000002587
3. Data on file. In-vivo comparison of gluteal augmentation, P188 vs saline wash. P188 cohort achieved average retention of 71% of volume at 1 year vs 40% for saline wash.
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 anticipated launch of Viality in Q1 2023, the increase of Sientra's TAM, the addition of top line revenue growth due to Viality launch, and the expansion of Viality into body areas outside of the breat. Such statements are subject to risks and uncertainties, including the timing of the launch of the Viality system, the positive reaction from plastic surgeons and their patients to the Viality system, the Company's ability to successfully convert accounts to purchase the Viality system, and the Company's ability to execute on its commercial, sales and marketing 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.
Sientra Contact:
Investor Relations
Aman Patel
aman.patel@westwicke.com
Media
EvolveMKD
sientra@evolvemkd.com
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SOURCE Sientra