Establishment Labs Holdings Inc. - ESTA STOCK NEWS

Establishment Labs Holdings (Nasdaq: ESTA) announced a $50 million registered direct offering, comprising 765,696 common shares at $45.71 per share and pre-funded warrants for 328,161 shares at $45.709 per warrant. The company may issue additional shares and warrants if the stock price doesn't exceed $45.71 between January-August 2025. The offering, expected to close around November 12, 2024, will fund general corporate purposes, including sales, marketing, R&D, administrative matters, working capital, and capital expenditures.

Establishment Labs (NASDAQ: ESTA) reported Q3 2024 revenue of $40.2 million, compared to $38.5 million in Q3 2023. The company updated its 2024 revenue guidance to $165-168 million, down from previous $174-184 million. Q3 operating loss improved to $13.1 million from $21.0 million year-ago. The company strengthened its balance sheet with proforma cash of $114.0 million, including a $25.0 million credit facility and $50.0 million from stock sale. FDA approval of Motiva Implants was received on September 26, 2024, with expected U.S. revenue exceeding $35 million in 2025. The company has onboarded over 250 new accounts in the first three weeks of U.S. launch.

Establishment Labs Holdings (NASDAQ: ESTA) presented three-year clinical results for Mia Femtech™ at the 9th World Symposium on Ergonomic Implants in Barcelona. The clinical study, involving 100 subjects enrolled between December 2020 and April 2021, showed remarkable safety outcomes with no reports of major complications including capsular contracture, ruptures, infections, hematoma, or changes in sensation. The study maintained a 93% follow-up compliance rate. The data demonstrates some of the best breast implant results reported at three years, positioning minimally invasive procedures as the future of breast aesthetics.

Establishment Labs Holdings (NASDAQ: ESTA), a global medical technology company focused on women's health and breast aesthetics, will release its Q3 2024 financial results on November 7, 2024, after market close. The company will host a conference call at 4:30 pm ET to discuss the results. The company has delivered nearly four million Motiva® devices across 85+ countries since 2010, and offers solutions including the Motiva Flora® tissue expander and Mia Femtech™. Establishment Labs operates two FDA-compliant manufacturing facilities in Costa Rica.

Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company focused on women's health and wellness in breast aesthetics and reconstruction, has published its 2024 Post Market Surveillance (PMS) Report. The report highlights the company's Motiva Implants, which show device-related complication rates of less than 1% after 14 years in the market.

CEO Juan José Chacón-Quirós noted the strong market demand for Motiva as they begin shipping across the United States. Rosalyn Cole d´Incelli, SVP of Clinical, Medical & U.S. Regulatory Affairs, emphasized the consistent performance of Motiva implants across various sources, including internal registries, warranty claims, international registries, peer-reviewed publications, and a US FDA study.

Establishment Labs has delivered nearly four million Motiva devices to plastic and reconstructive surgeons since 2010, setting a new standard for safety and patient satisfaction in over 85 countries.

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.