Establishment Labs Holdings Inc. - ESTA STOCK NEWS

Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced preliminary unaudited financial results for Q1 2023, reporting revenue of approximately $46.5 million, a significant increase from $38.5 million in Q1 2022. The company's cash balance is projected at $42.8 million, while total debt, including principal and interest, is expected to be around $184.0 million. These preliminary results are subject to change pending audits. Establishment Labs focuses on women’s health and offers innovative solutions in breast aesthetics and reconstruction, with a strong portfolio including the Motiva® devices.

Establishment Labs Holdings Inc. (NASDAQ: ESTA) presented a three-year follow-up report from the Motiva US IDE Study at The Aesthetic Meeting 2023 in Miami, Florida. The study involved 451 primary augmentation patients with a compliance rate of 92.4%. Key findings showed low complication rates: capsular contracture at 0.5%, rupture at 0.6%, and infection at 0.9%. The overall complication rate was reported at 8.4%. Dr. Caroline Glicksman, the study's Medical Director, noted the consistent clinical outcomes, highlighting the performance of Motiva implants and signaling hope for eventual FDA approval. The Motiva device remains under investigation and is not FDA-approved for commercial sale in the United States.

Establishment Labs Holdings Inc. (NASDAQ: ESTA) has launched its innovative Mia Femtech™ in Japan, aimed at enhancing breast aesthetics and addressing the specific needs of women in the region. This launch follows a decade of recognizing unmet demands in traditional breast augmentation. Mia Femtech offers a minimally invasive solution, requiring only 15 minutes and no general anesthesia, with minimal downtime. The procedure is offered at prestigious clinics in Tokyo and Osaka, marking significant growth potential as it creates a new category in breast aesthetics globally. Establishment Labs has delivered over three million Motiva® devices since 2010, establishing high safety and satisfaction standards in breast health.

Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced its participation in The Aesthetic Meeting 2023, occurring from April 19-23 in Miami, Florida. Dr. Caroline Glicksman will present an update on the Motiva US IDE Study during the event on April 20 at 3 PM ET. The Motiva Implants, currently not FDA-approved for commercial use in the U.S., are under clinical investigation. Establishment Labs focuses on women's health and wellness through advanced medical technology, providing breast aesthetics and reconstruction solutions. Motiva devices have set safety standards in over 85 countries since 2010.

Establishment Labs Holdings Inc. (NASDAQ: ESTA) has achieved a significant milestone by surpassing three million Motiva® devices sold globally, with less than 1% device-related complications reported over 12 years. This reflects the company's commitment to advancing women's health and wellness in breast aesthetics and reconstruction. CEO Juan José Chacón-Quirós highlighted their innovation-driven approach, while Dr. Heather Brennan emphasized the upcoming Sulàyöm Campus that will more than double manufacturing capacity. The company continues to prioritize safety and clinical performance, supported by extensive research and patent filings.

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.