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Overview
Establishment Labs Holdings Inc (ESTA) is a distinguished global medical technology company that designs, develops, manufactures, and markets innovative silicone-filled implants for breast aesthetics and reconstructive surgery. With a rich heritage spanning decades in the medical device industry, the company is renowned for its commitment to advanced engineering, rigorous safety protocols, and clinical research. Its technology-driven product portfolio is tailored to meet the evolving needs of both plastic surgeons and patients.
Core Business Areas
The company specializes in:
- Product Innovation: Utilizing cutting-edge research and patented technology to develop silicone implants that offer superior biocompatibility and a natural look and feel.
- Safety and Quality: Integrating advanced design features such as proprietary surface technologies to promote low inflammation and reduce complication rates.
- Global Distribution: Delivering its products through direct sales channels to medical distributors, hospitals, clinics, and plastic surgery practices across Europe, Latin America, Asia-Pacific/Middle Eastern regions, and beyond.
Technological Excellence
At the heart of its operations is a commitment to technological excellence and safety. The company employs state-of-the-art manufacturing practices compliant with rigorous regulatory standards. Emphasis on design innovation, such as adaptive implant shapes that complement the natural dynamics of the human body, is evident in its portfolio. These advancements underscore the company’s focus on combining aesthetic outcomes with patient safety.
Industry Position and Significance
Establishment Labs stands as an authority in the specialized market of medical devices and aesthetics. Its long-standing experience in implant manufacturing, coupled with innovative product development, positions the company as a pivotal contributor within the medical aesthetics and reconstructive surgery sectors. The strategic focus on quality, clinical evidence, and regulatory compliance has solidified its reputation with healthcare professionals globally.
Commitment to Research and Clinical Excellence
Dedicated to advancing the field, the company supports a robust framework of clinical studies and scientific research, underpinning its product innovations with peer-reviewed evidence. This commitment reinforces its market presence and serves as a cornerstone for its sustained trustworthiness in healthcare technology.
Customer and Distribution Focus
By aligning its product development with the practical and aesthetic requirements of both surgeons and patients, the company builds strong relationships within the healthcare community. Its direct sales model and global distribution strategy ensure that high-quality products are accessible to a wide range of medical professionals, further enhancing its industry impact.
Conclusion
In summary, Establishment Labs Holdings Inc embodies a blend of pioneering technology and extensive industry experience. Its comprehensive approach to product innovation, quality assurance, and global distribution makes it a vital entity in the realm of medical devices and aesthetic surgery. Investors and industry observers can appreciate the company for its in-depth commitment to safety, its integration of technology and clinical data, and its clear operational focus on enhancing patient outcomes.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) has initiated a public offering of its common shares, with a possible additional 15% for underwriters. The offering's proceeds will fund general corporate needs, including sales, marketing, research, and working capital. Market conditions will dictate the offering's completion and terms. Jefferies, J.P. Morgan, Citigroup, and TD Cowen are the joint book-running managers, while BTIG acts as co-manager. The offering materials are detailed in a prospectus supplement filed under the company's existing shelf registration.
This action reflects Establishment Labs' commitment to advancing women’s health through its innovative Femtech solutions, including the Motiva® devices. These devices have redefined safety and satisfaction standards in 85 countries.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced preliminary unaudited financial results for Q1 2023, reporting revenue of approximately
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.
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