New Study Confirms Sientra’s AlloX2’s Unique Value in Managing Seroma and Infection Post Reconstruction Procedures

Rhea-AI Summary

Sientra, Inc. (NASDAQ: SIEN) announced a Stanford University study published in PRS Global Open validating its AlloX2^® dual-port tissue expander for managing seroma and early intervention in prepectoral breast reconstruction. The study involved 49 patients, successfully aspirating up to 95 cm³ of fluid without image guidance. The AlloX2's design reduces reoperation rates and allows for quick infection management, enhancing patient outcomes. Sientra's breast products are seeing growing demand, with a reported 21% increase in the market since 2020.

Positive

• Stanford study confirms AlloX2's effectiveness in seroma management.
• Allows aspiration of fluid without surgery, reducing complications.
• Study results may lower reoperation rates and hospital costs.
• Sientra reports a 21% market growth since 2020 in breast products.

Negative

• None.

SANTA BARBARA, Calif., Aug. 25, 2021 (GLOBE NEWSWIRE) -- Sientra, Inc. (NASDAQ: SIEN) (“Sientra” or the “Company”), a medical aesthetics company uniquely focused on plastic surgery, today announced that a recent independent study out of Stanford University’s School of Medicine, published in PRS Global Open, has confirmed that the Sientra^® AlloX2^® dual port tissue expander enables efficient management of seroma and early targeted intervention in prepectoral breast reconstruction.

Seroma, which is a buildup of fluid under the skin, and infection, are among the most common complications after staged prepectoral implant-based reconstruction. Sientra’s AlloX2 is comprised of a one-of-a-kind dual-port design, which allows for less invasive, non-surgical draining of serous fluids. The AlloX2 is the only tissue expander on the market with an integral drain that provides direct access to the periprosthetic space. The AlloX2 was innovatively designed to mitigate risks associated with breast expansion and ultimately reduce reoperation rates.

In this retrospective study, 49 patients underwent 79 prepectoral staged reconstructions, using the Sientra AlloX2 tissue expander.  Patients successfully had up to 95 cm³ periprosthetic fluid aspirated in clinic through the drain port of the AlloX2, without the need of image-guided intervention. Additionally, aspirated fluid was cultured, which was particularly useful for quick management of infection when encountered.

The authors found the integrated port very useful in efficient management of seroma; they concluded that not only does the AlloX2 permit successful aspiration of periprosthetic fluid, but it also allows aspirated fluid to be sent for culture, thus, providing a lead-time advantage for initiation of targeted antibiotic therapy in cases of postoperative surgical site infection if required. The authors further noted that the ability of the AlloX2 to permit early intervention and fluid aspiration potentially contributed to preventing additional procedures and hospital costs.

“We are proud to see the evidence of positive results coming out of this study. Sientra is leading the way with innovative technologies designed to improve patients’ lives and outcomes,” said Denise Dajles, Vice President of R&D and Regulatory at Sientra.

In addition to a strong portfolio of tissue expanders, Sientra has a robust line of silicone gel implants used in both reconstruction and augmentation procedures. “We are extremely pleased with the outcome of this study and are excited about the continued momentum of our Sientra portfolio,” said Sientra President and CEO Ron Menezes. “AlloX2 continues to pave the way in innovation for our reconstruction business. This is a great compliment to our breast augmentation segment, where we estimate that market growth has surpassed pre-COVID levels, currently up +2% vs 2019 and +21% vs 2020, with additional evidence of heightened demand from board-certified plastic surgeons through the end of the year.”

About Sientra
Headquartered in Santa Barbara, 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, 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 impact of the COVID-19 pandemic on the Company and its operations, 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 to take market share, and the Company’s future growth and overall market growth. Such statements are subject to risks and uncertainties, including the scope and duration of the COVID-19 pandemic, the Company’s ability to recapture delayed procedures resulting from the COVID-19 pandemic, the positive reaction from plastic surgeons and their patients to Sientra’s Breast Products, the ability to meet consumer demand, and the continued demand for plastic surgery procedures and the Company’s products. 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
Leigh Salvo
ir@sientra.com

Media Contact
EvolveMKD
Sientra@EvolveMKD.com 

FAQ

What did the Stanford study reveal about Sientra's AlloX2?

The study confirmed that Sientra's AlloX2 dual-port tissue expander effectively manages seroma and allows for early intervention in prepectoral breast reconstruction.

How many patients were involved in the AlloX2 study?

The study involved 49 patients who underwent 79 prepectoral staged reconstructions using the AlloX2.

What is the significance of the AlloX2's dual-port design?

The dual-port design allows for less invasive fluid drainage, reducing the need for surgical interventions and potentially lowering reoperation rates.

How has the market for Sientra's products changed recently?

Sientra's breast products market has grown by 21% since 2020, surpassing pre-COVID levels.

What are the implications of the study for Sientra's business?

The study's positive results may enhance Sientra's reputation for innovation and improve sales of their AlloX2 product and other breast products.