Establishment Labs Announces FDA Clearance of Motiva Flora SmoothSilk Tissue Expander

Rhea-AI Summary

Establishment Labs receives FDA clearance for Motiva Flora® SmoothSilk® Tissue Expander

Positive

• The U.S. FDA has granted 510(k) clearance for Establishment Labs' Motiva Flora® SmoothSilk® Tissue Expander, a magnet-free and MR Conditional device for breast reconstruction. The tissue expander offers proprietary innovations, including SmoothSilk® surface technology that reduces inflammation and foreign body response. Flora has shown higher aesthetic and comfort scores, as well as reduced pain and sensitivity compared to other expanders. Surgeons reported higher satisfaction with Flora's expansion and footprint. Flora did not affect the image quality of breast MRI and showed better dosimetric results for heart and lungs in radiotherapy planning. The technology allows patients to undergo MRI safely and women working in the MRI environment to work around the system during tissue expansion.

Negative

• None.

Flora is the only magnet-free and MR Conditional tissue expander cleared for the U.S. market.

NEW YORK--(BUSINESS WIRE)-- Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Motiva Flora^® SmoothSilk^® Tissue Expander.

The Flora^® SmoothSilk^® Tissue Expander offers several proprietary innovations, including Establishment Labs’ patented SmoothSilk^® surface technology. SmoothSilk^® has been shown to produce the least amount of inflammation and foreign body response compared to other implant surfaces.¹ Flora also includes an RFID-enabled, non-magnetic port, labeled as MR Conditional by the FDA. By being magnet-free, Flora avoids the interference that magnets can cause during MRI and may improve the precision of radiation oncology treatment. All other commercially available breast tissue expanders include magnets.

“This is an incredibly important day in the history of Establishment Labs, as the first of our implantable technologies has been approved by the FDA,” said Juan José Chacón-Quirós, Founder and Chief Executive Officer of Establishment Labs. “Our SmoothSilk^® surface will now be available to women in the United States, and this technology is transformative for our industry and patient outcomes. Tissue expanders have seen little innovation for more than a generation, and, in partnership with breast cancer centers, Establishment Labs is creating a new standard of care in breast reconstruction.”

The Motiva Flora Tissue Expander has been available in Europe and other global markets since 2021 and has been studied in several independent scientific publications. Among the notable findings:

• In a blinded head-to-head study where patients were randomized to receive Flora in one breast and a U.S. commercially available tissue expander in the other, patients reported significantly higher aesthetic and comfort scores, as well as less breast pain, discomfort, and nipple sensitivity with Flora. Surgeons reported higher satisfaction with lower pole expansion as well as with the footprint created by Flora. The capsule tissue around the Flora expander was thinner and the peri-prosthetic fluid was significantly lower than with the comparative device.²
• In the first in-human multi-center study of patients undergoing 3-Tesla MRI, Flora did not affect the image quality of the most important part of the breast MRI protocol and there were no MRI-related complications or MRI-related damage to the expander port.³
• In a radiotherapy planning study comparing the dosimetric effect of traditional metallic ports to the RFID port in Flora, Flora showed better dosimetric results to the heart and lungs vs traditional metallic ports, potentially reducing side effects to these organs. The RFID port materials also reduced artifacts on CT imaging compared to the metals used in conventional expanders.⁴

“The technology used by the Flora SmoothSilk^® Tissue Expander that enabled it to be labeled MR Conditional will have a critical impact on patients during their breast reconstruction journey, permitting them to undergo MRI, the most important diagnostic imaging modality,” said Dr. Frank G. Shellock, Director of MRI Safety and Professor of Radiology and Medicine at the University of Southern California. “Furthermore, women working in the MRI environment now have a safe option that will allow them to work in and around an MRI system during their breast tissue expansion process.”

“At our breast center in Madrid, we help thousands of women each year, from annual screenings to treatment of breast cancer and breast reconstruction,” said Dr Antonio Tejerina, Plastic and Reconstructive Surgeon at the Madrid Breast Center in Spain. “After using this tissue expander in more than 180 cases over the past two years, I can confidently state that Motiva Flora is a new standard of care and the best tool to achieve an aesthetic breast reconstruction. Including and informing women about the most advanced possibilities in their treatment is the first step in helping them own their recovery.”

1. Doloff, J.C., Veiseh, O., de Mezerville, R. et al. The surface topography of silicone breast implants mediates the foreign body response in mice, rabbits and humans. Nat Biomed Eng 5, 1115–1130 (2021). https://doi.org/10.1038/s41551-021-00739-4
2. Schoberleitner I, Augustin A, Egle D, Brunner C, Amort B, Zelger B, Brunner A, Wolfram D. Is it all about surface topography? An intraindividual clinical outcome analysis of two different implant surfaces in breast reconstruction. J. Clin. Med. 2023, 12, 1315. doi: 10.3390/jcm12041315
3. Schiaffino S, Cozzi A, Pompei B, et al. MRI-Conditional Breast Tissue Expander: First In-Human Multi-Case Assessment of MRI-Related Complications and Image Quality. J. Clin. Med. 2023, 12, 4410. https://doi.org/10.3390/jcm12134410
4. Hwang NH, Kim M, Lee NK, Lee S, Hwang J. Dosimetric effect of injection ports in tissue expanders on post-mastectomy volumetric modulated arc therapy (VMAT) planning for left-sided breast cancer. Applied Sciences. 2022, 12 (13), 6461. doi:10.3390/app12136461

About Establishment Labs

Establishment Labs Holdings Inc. is a global medical technology company dedicated to improving women’s health and wellness through the power of science, engineering, and technology. The Company offers a portfolio of Femtech solutions for breast health, breast aesthetics and breast reconstruction. The over three million Motiva® devices Establishment Labs has delivered to plastic and reconstructive surgeons since 2010 have created a new standard for safety and patient satisfaction in the over 85 countries in which they are available. The Motiva Flora® tissue expander is used to improve outcomes in breast reconstruction following breast cancer and it is the only regulatory-approved expander in the world with an integrated port using radio-frequency technology that is MR conditional. Mia Femtech™, Establishment Lab’s unique minimally invasive experience for breast harmony, is the Company’s most recent breakthrough innovation. These solutions are supported by over 200 patent applications in 25 separate patent families worldwide and over 50 scientific studies and publications in peer reviewed journals. Establishment Labs manufactures at two facilities in Costa Rica compliant with all applicable regulatory standards under ISO13485:2016 and FDA 21 CFR 820 under the MDSAP program. In 2018, the Company received an investigational device exemption (IDE) from the FDA for Motiva Implants® and began a clinical trial to support regulatory approval in the United States. Please visit our website for additional information at www.establishmentlabs.com.

Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States. The Company’s implants are undergoing PMA clinical investigation pursuant to U.S. FDA regulations for investigational medical devices.

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,” “intends to,” “would,” “will,” “may” or other similar expressions in this press release. Any statements that refer to projections of our future financial or operating performance, anticipated trends in our business, our goals, strategies, focus and plans, including related product development and commercialization and regulatory approvals, 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 and the timing of events may differ from our expectations, and those differences may be material. Factors, among others, that could cause actual results and events to differ materially from those described in any forward-looking statements include risks and uncertainties relating to: our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product offerings; the rate of adoption of our products by healthcare providers or other customers; the success of our marketing initiatives; the safe and effective use of our products; our ability to protect our intellectual property; our future expansion plans and capital allocation; our ability to expand upon and/or secure sources of credit or capital; our ability to develop and maintain relationships with qualified suppliers to avoid a significant interruption in our supply chains; our ability to attract and retain key personnel; our ability to scale our operations to meet market demands; the effect on our business of existing and new regulatory requirements; and other economic and competitive factors. These and other factors that could cause or contribute to actual results differing materially from our expectations include, among others, those risks and uncertainties discussed in the company’s annual report on Form 10-K filed on March 1, 2023 and in the company's quarterly report on Form 10-Q filed on August 9, 2023, which risks and uncertainties may be updated in the future in 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20231016421597/en/

Investor/Media Contact:

Raj Denhoy

415-828-1044

rdenhoy@establishmentlabs.com

Source: Establishment Labs Holdings Inc.

FAQ

What is the FDA clearance for?

The FDA has granted 510(k) clearance for Establishment Labs' Motiva Flora® SmoothSilk® Tissue Expander.

What are the proprietary innovations of the tissue expander?

The tissue expander offers proprietary innovations, including SmoothSilk® surface technology that reduces inflammation and foreign body response.

What are the advantages of Flora compared to other expanders?

Flora has shown higher aesthetic and comfort scores, as well as reduced pain and sensitivity compared to other expanders.

What were the findings in the studies?

Surgeons reported higher satisfaction with Flora's expansion and footprint. Flora did not affect the image quality of breast MRI and showed better dosimetric results for heart and lungs in radiotherapy planning.

What does MR Conditional mean?

MR Conditional means that the device can be safely used in the MRI environment without causing interference.

Can patients undergo MRI with Flora?

Yes, Flora's technology allows patients to undergo MRI safely.

Can women working in the MRI environment use Flora?

Yes, women working in the MRI environment can safely work around the system during tissue expansion with Flora.