Establishment Labs Hldgs Inc - ESTA STOCK NEWS

Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced the first successful breast augmentations in the United States using Motiva® Implants, following recent FDA approval. The company reports high demand from surgeons and patients, with over 400 plastic surgeons engaged post-announcement. Establishment Labs has doubled its U.S. sales team to 25 representatives.

Motiva Implants feature the SmoothSilk® surface, designed for enhanced biocompatibility and low inflammation. Two styles are offered: Motiva® SmoothSilk® Ergonomix®, which adapts its shape based on body position, and Motiva® SmoothSilk® Round implants for increased upper breast fullness. Surgeons performing the first procedures noted the implants' potential to enhance aesthetic outcomes and reduce complication rates.

Establishment Labs Holdings Inc. (NASDAQ: ESTA) has received U.S. FDA approval for Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants for primary and revision breast augmentation. These implants feature the patented SmoothSilk® surface, designed for enhanced biocompatibility and low inflammation. The Ergonomix® device adapts to body position, maintaining a round shape when lying down and a teardrop shape when standing up.

The Motiva U.S. IDE Study, conducted at 35 centers, showed exceptional results with less than one percent rates of capsular contracture and rupture in the primary augmentation cohort. At three years post-implantation, the Kaplan-Meier risk rates for primary augmentation patients (N=451) were: Capsular Contracture: 0.5%; Rupture: 0.6%; Breast Pain: 0.7%; Infection: 0.9%. Any reoperation was reported at 6.1% and any complication at 8.4%.

Establishment Labs Holdings Inc. (NASDAQ: ESTA) reported Q2 2024 financial results. Worldwide revenue was $44.1 million, with 2024 revenue guidance maintained at $174-184 million. Gross profit was $28.9 million (65.6% of revenue). The company reported a loss from operations of $9.3 million and an Adjusted EBITDA loss of $4.3 million. Cash balance stood at $54.6 million.

Key highlights include:

• FDA PMA preapproval inspection completed
• FDA approval of Motiva Implants expected soon
• 18.7% sequential revenue growth
• Improved adjusted EBITDA loss compared to previous year

The company anticipates strong growth with the upcoming U.S. launch of Motiva Implants.

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company focused on women's health and wellness in breast aesthetics and reconstruction, will announce its Q2 2024 financial results on August 6, 2024, after market close. The company will host a conference call at 4:30 pm ET to discuss the results. Investors can dial (800) 715-9871 (U.S. and Canada) or (646) 307-1963 (International) using conference ID 7160745 to participate.

Establishment Labs has delivered over 3 million Motiva® devices to surgeons since 2010, setting new standards for safety and patient satisfaction in over 85 countries. The company's portfolio includes the Motiva Flora® tissue expander and Mia Femtech™ for minimally invasive breast harmony. With 200+ patent applications and 50+ scientific studies, Establishment Labs manufactures in Costa Rica under strict regulatory standards.

Establishment Labs (NASDAQ: ESTA), a leader in medical technology focused on women's health, announced its participation in two key investment conferences. CEO Juan José Chacón-Quirós and CFO Raj Denhoy will present at the Jefferies Global Healthcare Conference on June 5, 2024, and the Goldman Sachs 45th Annual Global Healthcare Conference on June 10, 2024. Live webcasts of their presentations will be accessible via the company's investor relations website. Establishment Labs is renowned for its Femtech solutions, including the Motiva® breast implants and Motiva Flora® tissue expanders, with a presence in over 85 countries. The company's innovations are backed by extensive patent applications and scientific research, and its manufacturing facilities in Costa Rica comply with stringent regulatory standards.

Establishment Labs Holdings Inc. (NASDAQ: ESTA) reported first quarter 2024 financial results, with worldwide revenue of $37.2 million. The 2024 revenue guidance is $174 million to $184 million, reflecting a 5% to 11% increase over 2023. Gross profit was $24.4 million, with a loss from operations of $8.8 million. Adjusted EBITDA loss improved to $3.7 million. The company's cash balance was $73.0 million as of March 31, 2024. Establishment Labs presented 4-year results from Motiva® U.S. IDE study showing positive outcomes, aiming for FDA approval of Motiva Implants in 2024.

Establishment Labs Holdings Inc. noted the presentation of 4-year results from the Motiva US IDE Study at The Aesthetic Meeting 2024. Dr. Caroline Glicksman presented data for 451 primary augmentation patients, showing low complication rates and high patient follow-up, with Motiva implants potentially becoming a new standard in breast aesthetics.

Establishment Labs Holdings Inc. (NASDAQ: ESTA) announces the appointment of Jeff Ehrhardt as the General Manager of North America. Mr. Ehrhardt brings over 25 years of experience from Allergan Aesthetics, with the responsibility of launching Motiva implants in the U.S. to set new standards in breast aesthetics and reconstruction. The move signifies a significant step for Establishment Labs in expanding its global presence and enhancing women's health and wellness.