Sientra Announces Preliminary Results from Clinical Study and The First Shipment of Viality™ Fat Transfer System

Rhea-AI Summary

Sientra, Inc. (NASDAQ: SIEN) has commenced commercial shipping of its Viality with AuraClens fat transfer system. Preliminary results from an ongoing clinical study indicate over 80% volume retention in patients at both 3 and 6 months post-procedure, marking Viality as the first system to demonstrate such results. The study has enrolled 68 patients, showing minimal volume change (3.59%) between the 3- and 6-month marks. Surgeons report significant demand for Viality, with expectations that the complete study will set a new standard for fat transfer evidence. The full study results will continue to develop.

Positive

• Achieved over 80% volume retention at 3 and 6 months in clinical study.
• Viality is the first fat transfer system to demonstrate such high retention rates.
• Minimal volume change (3.59%) indicates long-term viability of fat transfer.
• Significant demand noted in presales prior to commercial shipping.

Negative

• None.

Data Supports Enhanced Viability of Fat in Breast Augmentation and Reconstruction Using the Viality System

IRVINE, Calif., March 01, 2023 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a medical aesthetics company uniquely focused on plastic surgeons, today announced that it has begun commercial shipping of its Viality™ with AuraClens™ fat transfer system. The Company also announced the release of preliminary results from its on-going, multi-center, long-term volume retention clinical study with Viality. These preliminary results show over 80% volume retention at both the 3- and 6-month timepoints, making Viality the first, and only, system to have clinically demonstrated such high levels of retention.

“The promising results showcased in this preliminary data mirrors what I am seeing clinically with the patients I have treated with Viality to-date,” said board-certified plastic surgeon and clinical study investigator, Dr. Sachin M. Shridharani, MD, FACS. “Fat transfer has been gaining popularity for the past decade, and with Viality, Sientra has not only contributed to an unmet market need though superior fat retention rates, but allows me to offer my patients predictable outcomes, with the natural results they are looking for.”

Based on the preliminary results, with 68 patients* enrolled, the clinical study shows over 80% volume retention at both 3- and 6-months post breast augmentation and reconstruction. In addition, volume changes from 3 to 6 months were on average only 3.59%, indicating the long-term viability of fat transfer when using Viality.

“Sientra is known for elevating industry standards through innovation and unmatched product quality,” said Ron Menezes, President and CEO of Sientra. “This research allows us to best equip surgeons with what they need to generate the best outcomes for their patients. We have experienced a significant demand for the product in presales alone, and look forward to putting Viality in the hands of our plastic surgeon customers as we commence commercial shipping. We anticipate that when the study is completed, the results of this first-of-its-kind study will establish a new standard for evidence in fat transfer.”

The full preliminary results are now available on our website and Sientra will continue to develop the data within the ongoing clinical study.

*Not all patients in the study had reached 3 and 6 month timepoints when preliminary results were released

About Sientra

Headquartered in Irvine, 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 Viality™ with AuraClens™ fat transfer system, and BIOCORNEUM®, the #1 performing, preferred and recommended scar gel of plastic surgeons(*).

(*) 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. All such statements are subject to certain risks and uncertainties, many of which are difficult to predict and generally beyond the control of the Company, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. Forward-looking statements may include information concerning the long-term results of the Company’s clinical study, the anticipated outcomes of the Company’s clinical study, the Company's anticipated sales of Viality, the demand of Sientra’s customers and patients for the Viality system, and the expected results of the Viality system once commercially launched. Such statements are subject to risks and uncertainties, including 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, the long-term clinical results of the Viality system, and the Company's ability to execute on its commercial, sales and marketing plans, as well as other risks and uncertainties described under the “Risk Factors” contained in the Company’s periodic and interim SEC reports, including but not limited to, the preliminary prospectus supplement relating to this offering, its Annual Report on Form 10-K for the fiscal year ended December 31, 2021, its Quarterly Reports on From 10-Q, and its Current Reports on Form 8-K filed from time to time with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof, and the Company does not undertake any obligation to revise and disseminate forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of or non-occurrence of any events.

Sientra Contact:

Investor Relations
Aman Patel
aman.patel@westwicke.com

Media
EvolveMKD
sientra@evolvemkd.com

FAQ

What are the preliminary results of Sientra's Viality fat transfer system clinical study?

The preliminary results show over 80% volume retention at both 3 and 6 months post-procedure, with minimal average volume change of 3.59%.

How many patients are enrolled in the Viality clinical study?

The clinical study currently has 68 patients enrolled.

What is the significance of the Viality system compared to other fat transfer systems?

Viality is the first system to clinically demonstrate over 80% volume retention, addressing an unmet market need in breast augmentation and reconstruction.

When did Sientra commence shipping the Viality system?

Sientra began commercial shipping of the Viality system on March 1, 2023.

What is the anticipated impact of the Viality study's results on the market?

The complete study results are expected to establish a new standard for evidence in fat transfer, enhancing surgical outcomes and potentially increasing demand.