Establishment Labs Announces Independent Publication Detailing New Advancements in Hybrid Breast Reconstruction Technique Using Motiva Ergonomix Implants
Establishment Labs Holdings (NASDAQ: ESTA) announced the publication of a study in Plastic and Reconstructive Surgery-Global Open, revealing that hybrid breast reconstruction using Motiva Ergonomix implants enhances outcomes compared to traditional methods. Analyzing 56 reconstructions in 33 patients, the findings highlighted improved control of breast shape and reduced complication risks. CEO Juan José Chacón-Quirós emphasized the commitment to innovative technology for better patient outcomes. It's important to note that these implants are not yet approved for commercial distribution in the U.S.
- Independent study shows Motiva Ergonomix implants improve breast reconstruction outcomes.
- Enhanced control of final breast shape and fewer complications reported.
- Strong patient satisfaction with the clinical results of hybrid reconstruction.
- Motiva Ergonomix implants are currently not approved for commercial distribution in the U.S.
- Future commercialization of the implants remains uncertain, subject to FDA regulations.
SANTA BARBARA, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, announced today that a recently published independent study concluded that the hybrid breast reconstruction approach using Motiva® Ergonomix implants improved outcomes in implant-based breast reconstructions.
Published in Plastic and Reconstructive Surgery-Global Open, this independent study analyzed 56 prepectoral, hybrid breast reconstructions in 33 patients performed between 2014 to 2017. Utilizing the two-step, prepectoral reconstruction approach, the study found that Motiva Ergonomix implants allowed better control of the final breast shape, and complications related to submuscular approaches were avoided. The study further noted that Motiva Ergonomix implants “offer a wide set of advantages related to their surface features that can benefit short- and long-term adverse events related to chronic inflammation and fibrotic reaction.”
“The introduction of ergonomic implants that adapt to the position and motion of the breast is a new advancement in hybrid breast reconstruction surgery that improves patient outcomes over the traditional choice of anatomical and round implants,” said study co-author Filip B. J. L. Stillaert, Assistant Professor of Plastic and Reconstructive Surgery at the Ghent University Hospital in Belgium. “The viscoelastic properties of the Motiva Ergonomix breast implant allow it to adapt better to gravitational force and mimic natural movement. Overall, patients were very satisfied with the clinical outcome and the natural touch of the breast.”
“Based on our success in breast augmentation, Establishment Labs is committed to introducing safe, innovative technologies that fundamentally improve aesthetic outcomes in breast reconstruction, especially for younger women who have suffered from breast cancer,” said chief executive officer Juan José Chacón-Quirós. “We are thrilled to see the aesthetic results of this independent study using our Motiva Ergonomix implants in hybrid breast reconstruction. We believe the use of our Ergonomix implants, alongside our Motiva Flora tissue expander, the only MRI-compatible tissue expander with an integrated valve, will be a tremendous advancement for women undergoing breast reconstruction.”
Motiva Ergonomix® and the Motiva® Flora Tissue Expander are currently not approved for commercial distribution in the United States. Motiva Implants® are undergoing clinical investigation pursuant to U.S. FDA regulations for investigational medical devices. Prof. Stillaert and his co-authors received no compensation or support from Establishment Labs for this study.
About Hybrid Breast Reconstruction
Hybrid breast reconstruction, sometimes referred to as composite breast reconstruction, provides a solution for rebuilding the breast with natural living fat combined with a supplemental breast implant to give added size and projection to the new breast.
About Establishment Labs
Establishment Labs Holdings Inc. (NASDAQ: ESTA) is a global medical technology company focused on women’s health, initially in the breast aesthetics and reconstruction market, by designing, developing, manufacturing and marketing an innovative portfolio of silicone gel-filled breast implants, branded as Motiva Implants®, the centerpiece of the MotivaImagine® platform. Motiva Implants® are produced at our two manufacturing sites that are compliant with ISO13485:2016, FDA 21 CFR 820 under the MDSAP program, and are currently commercially available in more than 80 countries through exclusive distributors or the Company’s direct salesforce. In March 2018, Establishment Labs received approval for an investigational device exemption (IDE) from the FDA and initiated the Motiva Implant® clinical trial in the United States in April 2018. In addition to Motiva Implants®, Establishment Labs’ product and technologies portfolio includes the Divina® 3D Simulation System and other products and services. Please visit our website for additional information at www.establishmentlabs.com.
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 (the “Exchange Act”). You can find many (but not all) of these statements by looking for words such as “approximates,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “would,” “may” or other similar expressions in this press release, and includes statements related our ability to commercialize Motiva Ergonomix implants and the Motiva Flora Tissue Expander for the breast reconstruction market. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results, related to the Company’s performance are forward-looking statements. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995. We caution investors that any forward-looking statements presented in this report, or that we may make orally or in writing from time to time, are expressions of our beliefs and expectations based on currently available information at the time such statements are made. Such statements are based on assumptions, and the actual outcome will be affected by known and unknown risks, trends, uncertainties and factors that are beyond our control. Although we believe that our assumptions are reasonable, we cannot guarantee future performance, and some will inevitably prove to be incorrect. As a result, our actual future results may differ from our expectations, and those differences may be material. Factors that could cause or contribute to these differences include, among others, those risks and uncertainties discussed in the Company’s annual report on Form 10-K filed on March 16, 2020, quarterly reports on Form 10-Q, and other filings made by the Company with the Securities and Exchange Commission. The risks included in those documents are not exhaustive, and additional factors could adversely affect our business and financial performance. We operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for us to predict all such risk factors, nor can we assess the impact of all such risk factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. We are not undertaking any obligation to update any forward-looking statements. Accordingly, investors should use caution in relying on past forward-looking statements, which are based on known results and trends at the time they are made, to anticipate future results or trends.
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