Establishment Labs Announces First U.S. Commercial Procedure with Motiva Flora Tissue Expander
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The introduction of the Motiva Flora® SmoothSilk® Tissue Expander represents a significant innovation in the field of breast reconstruction, especially for breast cancer patients. Its patented SmoothSilk® surface technology has been scientifically shown to produce less inflammation and foreign body response, which are critical factors in the success of reconstructive surgeries. The absence of magnets in the device, which makes it MR conditional, addresses a common issue with existing tissue expanders that contain magnets and interfere with MRI diagnostics and radiation therapy. This technological advancement could potentially lead to improved patient outcomes by enhancing the precision of oncology treatments and reducing post-surgical complications.
Establishment Labs Holdings Inc.'s FDA clearance and subsequent first use of the Motiva Flora® in the United States is a strategic milestone for the company, positioning it within the lucrative U.S. breast reconstruction market. As the largest market for breast reconstruction, the U.S. represents a significant commercial opportunity for Establishment Labs. The company's core principle of improving women's health aligns with the growing demand for patient-centered innovations in medical technology. The long-term success of the product will depend on its adoption by surgeons, patient satisfaction and the demonstration of superior outcomes compared to existing alternatives. The market will closely monitor the impact of this product launch on Establishment Labs' financial performance and market share.
From a clinical perspective, the introduction of the Motiva Flora® Tissue Expander is a notable advancement in the field of plastic and reconstructive surgery. The device's MR conditional status and non-magnetic port design offer a new level of compatibility with imaging and radiation therapy, which are integral components of cancer treatment and post-operative care. This could translate into more seamless integration of reconstructive surgery into the overall cancer care pathway, potentially reducing the number of procedures patients need to undergo and improving aesthetic outcomes. The RFID-enabled port also suggests enhanced operability and patient safety, which are paramount in reconstructive procedures.
"This Flora device is a new resource in our toolkit for breast cancer reconstruction,” Dr. Clemens noted. “It introduces features such as being MR conditional and also reduces interference during radiation therapy. It's essential for patients to have access to innovative solutions that may improve their treatment outcomes and facilitate their journey of restoration."
The Flora® Tissue Expander includes several proprietary innovations, including Establishment Labs’ patented SmoothSilk® surface technology and an RFID-enabled, non-magnetic port, labeled as MR Conditional by the FDA. SmoothSilk® has been shown to produce the least amount of inflammation and foreign body response compared to other device surfaces1. By being magnet-free, Flora avoids the interference that magnets cause during MRI and may improve the precision of radiation oncology treatment. All other commercially available breast tissue expanders include magnets.
“We are so pleased to enter
- 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
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
Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in
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Investor/Media Contact:
Raj Denhoy
415-828-1044
rdenhoy@establishmentlabs.com
Source: Establishment Labs Holdings Inc.
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