Mastodynia

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 it has received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva ® SmoothSilk ® Ergonomix ® and Motiva ® SmoothSilk ® Round breast implants in primary and revision breast augmentation. “ Today’s approval is transformative for breast aesthetics in the United States. This is a new era, in which women now have a choice of highly differentiated technology that is backed by rigorous scientific and clinical research,” commented Juan José Chacón-Quirós, Founder and Chief Executive Officer. “ Motiva implants have changed the paradigm by proving that women do not have to compromise when it comes to their aesthetic goals. We have never wavered in our commitment to women’s health and our entire organization is ready to bring this passion and technology to the United States.” Motiva ® SmoothSilk ® Round and Ergonomix ® Implants represent state of the art innovation in plastic surgery. These devices feature the patented SmoothSilk ® surface, designed for enhanced biocompatibility and scientifically shown to promote low inflammation. The Motiva ® SmoothSilk Ergonomix ® device is the first breast implant in the world that embodies the science of ergonomics, as it is designed to adapt, react, feel, and move like natural breast tissue. Motiva ® SmoothSilk ® Ergonomix ® implants are unique to the implant market, as their shape can adapt as the body changes position, maintaining a round shape when lying down and a teardrop shape when standing up. The Motiva ® SmoothSilk ® Round implants provide increased upper breast fullness and softness while keeping a round full form regardless of position. “ The Motiva U.S. IDE Study is the most rigorous breast implant clinical trial ever performed under FDA guidelines and it shows that Motiva implants are not only safe and effective but also that women had exceptional results, with less than one percent rates of capsular contracture and rupture in the primary augmentation cohort,” said board-certified plastic surgeon Dr. Caroline A. Glicksman. “ As the Medical Director of the Motiva study and an investigator, I am proud of the quality of the data and the patient follow-up rates of this study. Motiva implants were designed to reduce device related complications, and they will be welcomed by the plastic surgery community and women seeking breast augmentation in the United States.” The Motiva U.S. IDE Study was conducted at 32 centers in the U.S. and three centers in Western Europe. At the study endpoint of three years post-implantation, patient compliance in the primary augmentation cohort of the trial was 92.4%. The three-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort (N=451) were as follows: Capsular Contracture: 0.5%; Rupture, Confirmed or Suspected: 0.6% (MRI Cohort N=176); Breast Pain: 0.7%; Infection: 0.9%. Any reoperation, including an implant size change, was reported at 6.1% and any complication, including reoperations, was reported at 8.4%. “ There has been a real lack of innovation in the U.S. breast implant market for well over a decade,” added board-certified plastic surgeon and study investigator Dr. M. Bradley Calobrace. “ Motiva should transform breast augmentation, both in how we operate and in what we can achieve for our patients. A safer, next generation viscoelastic implant with a uniquely designed low inflammatory surface will undoubtedly improve clinical and aesthetic outcomes. I am pleased to finally be able to offer Motiva implants to my patients in the United States.” Since first becoming commercially available in 2010, nearly four million Motiva ® devices have been delivered to plastic and reconstructive surgeons in over 85 countries. The company’s technologies and products are covered by over 200 patent applications in 20 separate patent families worldwide and are supported by over 100 clinical and scientific studies and peer reviewed publications. The Motiva ® Implant approval announced today is the first new breast implant PMA approved by the U.S. FDA since 2013. “ Motiva is the first and only implant purposefully designed for women and their lifestyles,” said Dr. Kamakshi R. Zeidler, a board-certified plastic surgeon and member of the Establishment Labs Femtech Advisory Board. “ These implants move and feel like natural breast tissue. The rates of complications in the clinical trial were also much lower than we have seen with any other implant in a U.S. PMA study. This is true Femtech. I could not be happier that women in the United States now have access to this revolutionary technology.” 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 nearly four 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 MRI 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 20 separate patent families worldwide and over 100 scientific and clinical 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. 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,” “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 4, 2024 and will be discussed in the company's quarterly report on Form 10-Q filed on August 7, 2024, 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.

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, noted the presentation today of an update on the Motiva US IDE Study. The update will include four-year patient follow-up data for primary augmentation subjects. The Medical Director of the Study, Dr. Caroline Glicksman, who is also an Investigator in the Study, will present the results at The Aesthetic Meeting 2024 in Vancouver, BC Canada. Dr. Glicksman will present data for the 451 primary augmentation patients enrolled in the study through the four-year follow-up visit. Patient compliance in the primary augmentation cohort of the trial at four years was 88.9%. The four-year, by-patient, Kaplan-Meier risk rates of first occurrence of complications for patients (95% confidence interval) in the primary augmentation cohort were as follows: Primary Augmentation 4-year (N=451), 95% CI Capsular contracture (Baker Grade III/IV) 0.5% Rupture, suspected or confirmed; MRI cohort1 0.6% Breast pain 0.9% Infection 0.9% Implant removal, with or without replacement 1.8% Any reoperation2 6.8% Any complication3 9.6% 1. MRI cohort N=176 2. Any surgery on the breast or chest area, device or non-device related, including size change 3. Any device or non-device related event, including reoperation Commenting on the results, Dr. Glicksman said, “The consistency in these clinical results at four years is notable. Since we released the two-year data, we have seen no increase in capsular contracture or in the number of patients with suspected or confirmed rupture, including in the MRI cohort. Relative to historic benchmarks, patient follow-up remains very high and the rates of complication remain very low. The Motiva Implant PMA is under review by the FDA and we look forward to women in the United States having access to this new standard in breast implants very soon.” The Motiva Core pivotal study is an ongoing US clinical trial of an investigational medical device under an FDA-approved Investigational Device Exemption. Establishment Labs' Motiva silicone gel-filled implants are currently not approved for commercial distribution in the United States. This interim report describes preliminary data available to date and does not necessarily reflect final clinical results nor demonstrate the investigational device’s safety and effectiveness for the United States trial. Accordingly, no conclusions should be drawn based on the information presented. 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 MRI 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 . 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 4, 2024, 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.

FDA approves enzalutamide for non-metastatic castration-sensitive prostate cancer with biochemical recurrence On November 16, 2023, the Food and Drug Administration approved enzalutamide (Xtandi, Astellas Pharma US, Inc.) for non-metastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR). The full prescribing information for Xtandi will be posted here. Efficacy was evaluated in EMBARK (NCT02319837), a randomized, controlled clinical trial of 1068 patients with nmCSPC with high-risk BCR. All patients had prior definitive therapy with radical prostatectomy and/or radiotherapy with curative intent, had PSA doubling time ≤ 9 months, and were not candidates for salvage radiotherapy at enrollment. Patients were randomized 1:1:1 to receive blinded enzalutamide 160 mg once daily plus leuprolide, open-label single- agent enzalutamide 160 mg once daily, or blinded placebo once daily plus leuprolide. The major efficacy measure was metastasis-free survival (MFS), assessed by blinded independent central review, for enzalutamide plus leuprolide compared to placebo plus leuprolide. MFS for enzalutamide monotherapy compared to placebo plus leuprolide and overall survival (OS) were additional efficacy outcome measures. A statistically significant improvement in MFS was demonstrated for enzalutamide plus leuprolide compared with placebo plus leuprolide with a median that was not reached for either arm (hazard ratio 0.42; 95% CI: 0.30, 0.61; p-value<0.0001). A statistically significant improvement in MFS was also demonstrated for enzalutamide monotherapy compared to placebo plus leuprolide (hazard ratio 0.63; 95% CI: 0.46, 0.87; p-value = 0.0049). At the time of the MFS analysis, OS data were immature with 12% deaths in the overall population. The most common adverse reactions (≥ 20% incidence) in patients who received enzalutamide plus leuprolide were hot flush, musculoskeletal pain, fatigue, fall, and hemorrhage. The most common adverse reactions in patients who received enzalutamide monotherapy were fatigue, gynecomastia, musculoskeletal pain, breast tenderness, hot flush, and hemorrhage. The recommended enzalutamide dose is 160 mg administered orally once daily with or without food until disease progression or unacceptable toxicity. Enzalutamide may be administered with or without a GnRH analog. Enzalutamide treatment can be suspended if PSA is undetectable (< 0.2 ng/mL) after 36 weeks of therapy. Treatment may be reinitiated when PSA has increased to ≥ 2.0 ng/mL for patients who had prior radical prostatectomy or ≥ 5.0 ng/mL for patients who had prior primary radiation therapy. This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For this review, FDA collaborated with Health Canada, and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies. This review used the Real-Time Oncology Review (RTOR) pilot program, which streamlined data submission prior to the filing of the entire clinical application, and the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 5 weeks ahead of the FDA goal date. This application was granted priority review and Fast Track Designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088. For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. Follow the Oncology Center of Excellence on X (formerly Twitter) Content current as of: 11/17/2023 11/17/2023 Resources for Information | Approved Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description Oncology (Cancer)/Hematologic Malignancies Approval Notifications Ongoing | Cancer Accelerated Approvals Verified Clinical Benefit | Cancer Accelerated Approvals Withdrawn | Cancer Accelerated Approvals Other | Cancer Accelerated Approvals Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description