Welcome to our dedicated page for Establishment Labs Hldgs news (Ticker: ESTA), a resource for investors and traders seeking the latest updates and insights on Establishment Labs Hldgs stock.
Establishment Labs Holdings Inc (NASDAQ: ESTA) develops and manufactures Motiva brand breast and body shaping implants, operating at the intersection of medical device technology and aesthetic medicine. News coverage for this company typically centers on regulatory milestones, clinical study results, and strategic developments in the global breast implant market.
Investors and industry observers track Establishment Labs for several distinct news categories. Regulatory submissions and approvals represent high-impact events, particularly regarding FDA interactions for the U.S. market and CE Mark maintenance in Europe. Clinical trial data publications and post-market surveillance reports provide insight into product safety profiles, a critical factor in the medical device industry. Financial reporting covers quarterly and annual results, reflecting performance across geographic segments and product categories.
The company's pursuit of breast reconstruction applications generates news related to medical technology development and healthcare partnerships. Corporate developments including leadership changes, investor communications, and strategic initiatives appear regularly in the news flow. Insider transaction activity, reported through SEC Form 4 filings, provides transparency into executive and director trading patterns.
This news feed aggregates coverage of Establishment Labs from financial news sources, press releases, and regulatory filings. Bookmark this page to follow developments in the medical aesthetics device sector and track material events affecting ESTA stock.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) has announced partnerships with four clinics in Europe and one in Japan for its Mia Femtech™ product. This rollout marks a significant step for the company as it seeks to expand its innovative breast aesthetics offerings. Clinics in Sweden, Switzerland, and Spain are among the new partners, highlighting strong interest in the Mia brand. The CEO expressed optimism about further partnerships and market potential. However, it's important to note that Mia Femtech is not commercially available in the EU or the US at this time.
Establishment Labs Holdings Inc. (NASDAQ: ESTA), a leader in medical technology focusing on women's health, announced that CEO Juan José Chacón-Quirós and CFO Raj Denhoy will present at the Cowen 43rd Annual Health Care Conference on Tuesday, March 7, 2023, at 9:50 am Eastern Time. A live webcast will be accessible through the company's investor relations site, with an archived version available post-event. Established in 2010, the company offers Motiva® silicone gel-filled breast implants, with over 2.5 million units delivered in over 80 countries. Establishment Labs aims to enhance breast health through innovative solutions, including the Motiva Flora® tissue expander and Mia Femtech™.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) submitted the final module for FDA premarket approval of Motiva Implants. The company reported fourth-quarter 2022 sales of $43.8 million, marking a 24.1% year-over-year increase and a new quarterly record. Fourteen million dollars net loss from operations improved from $14.2 million a year ago. For 2023, revenue guidance is set between $200 million and $210 million, reflecting a 24% to 30% growth compared to 2022. Establishment Labs is expanding its Mia Femtech commercialization and expects approval in China in the first half of 2023, enhancing market reach.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) will announce its financial results for the quarter ended December 31, 2022, on February 27, 2023, after market close. A conference call is scheduled for 4:30 PM ET that day to discuss the results. Interested participants can join by dialing (877) 407-8037 for U.S. and Canada or (201) 689-8037 for international callers, using conference ID 13736311. Establishment Labs focuses on women's health, offering innovative breast implants branded as Motiva Implants®, with over 2.5 million units delivered since 2010 across 80 countries.
Allurion Technologies and Compute Health Acquisition Corp (NYSE: CPUH) have entered into a business combination agreement, positioning Allurion to become publicly listed as Allurion Technologies, Inc. This innovative company is focused on obesity treatment, featuring the Allurion Gastric Balloon, a swallowable gastric balloon that allows for procedure-less weight loss. Since its inception, Allurion has treated over 100,000 patients worldwide, achieving an average weight loss of 30 pounds. Revenue has surged from $20 million in 2020 to $64 million in 2022. The transaction includes significant investments from RTW Investments and other notable figures.
Establishment Labs (NASDAQ: ESTA) announced preliminary unaudited revenue results for Q4 and FY 2022, projecting Q4 revenue between
Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced a strategic partnership with Seishin Plastic and Aesthetic Surgery Clinic in Japan, launching Mia Femtech, a minimally invasive breast aesthetics procedure. This collaboration aims to address dissatisfaction among Japanese women regarding breast aesthetic options, potentially expanding the market significantly. The Mia procedure can enhance breast shape by 1 to 2 cup sizes in just 15 minutes, without general anesthesia. While currently not approved for commercial distribution in the U.S., this launch represents the first of many anticipated in 2023.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced that CEO Juan José Chacón-Quirós will present at the 41st Annual J.P. Morgan Healthcare Conference on January 12 at 7:30 a.m. Pacific Time. A live webcast of the presentation will be available on the company's investor relations website, with an archived version accessible post-event. Establishment Labs specializes in women’s health technology, focusing on breast aesthetics and reconstruction, and has delivered over 2.5 million Motiva Implants® globally since 2010.
Establishment Labs Holdings (NASDAQ: ESTA) recently announced the approval of Motiva Implants® and the Motiva Flora® tissue expander for use in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA). These products have also secured reimbursement under the Japanese National Health System for post-mastectomy reconstruction. The first patient was treated successfully in November at Nagoya University Hospital. This launch signifies a commitment to enhancing women's health through innovative products backed by clinical data.
Establishment Labs Holdings Inc. (Nasdaq: ESTA) reported third quarter 2022 sales of $38.2 million, a year-over-year increase of 31.7%. Revenue guidance for 2022 has been narrowed to $158 million to $162 million, reflecting 25% to 28% growth from 2021, with foreign exchange effects expected to reduce revenue by $6.5 million. Gross profit margin improved to 68.1%, while operating expenses rose 27.5% to $36.6 million. The company holds a cash balance of $65.3 million as of September 30, 2022, and plans to commercialize Mia Femtech™ and seek FDA approval for Motiva Implants in early 2023.