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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) presented 5-year follow-up data from the Motiva US IDE Study at The Aesthetic MEET 2025. The study, focusing on 451 primary augmentation patients, demonstrated high patient compliance at 88.5% after four years.
Dr. Caroline Glicksman, the Study's Medical Director, highlighted the consistently low complication rates, with no increase in capsular contracture or suspected/confirmed rupture cases since the two-year mark. The company received FDA approval for Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants for primary and revision breast augmentation on September 26, 2024.
Interim CEO Peter Caldini reported strong U.S. market momentum with over 800 accounts and more than 550 placing orders, representing a 20% increase from their previous update three weeks ago.
Establishment Labs (NASDAQ: ESTA) has announced a partnership with GRAMMY Award-winner Meghan Trainor, who recently underwent breast augmentation using Motiva Implants®. This partnership follows the US FDA approval of Motiva Implants® in October 2024.
The implants feature the patented SmoothSilk® surface technology, showing a low 0.5% capsular contracture rate and less than 1% device-related complications. Clinical studies report over 97% patient and surgeon satisfaction rates. The technology includes unique features like shape adaptation and enhanced biocompatibility.
Since 2010, over four million Motiva® devices have been delivered in more than 90 countries globally. The company's technologies are supported by over 200 patent applications and more than 100 clinical and scientific studies.
Establishment Labs (NASDAQ: ESTA) reported Q4 2024 financial results with revenue of $44.5 million, up from $31.6 million in Q4 2023. The company achieved a significant milestone with Motiva Implants' U.S. approval and launch, generating $3.3 million in U.S. revenue for Q4.
Q4 highlights include a reduced net loss of $18.7 million (15% improvement YoY) and adjusted EBITDA loss of $13.1 million (25% reduction YoY). The company maintains a strong cash position of $90.3 million, with access to an additional $25 million credit facility.
Management reaffirmed 2025 revenue guidance of $205-210 million, representing 23-26% growth over 2024, with expected U.S. sales of $35 million. The company projects Q1 2025 U.S. revenue of approximately $5.5 million and targets its first positive EBITDA quarter in 2025.
Establishment Labs Holdings (NASDAQ: ESTA), a global medical technology company focused on women's health in breast aesthetics and reconstruction, has announced its participation in TD Cowen's 45th Annual Health Care Conference. Founder and CEO Juan José Chacón-Quirós and CFO Raj Denhoy will present in a fireside chat on March 4, 2025 at 2:30 p.m. ET.
The presentation will be available via live webcast on the company's investor relations website, with archived versions accessible afterward. Establishment Labs offers solutions for breast health, aesthetics, and reconstruction in over 90 countries, having delivered more than four million Motiva devices since 2010.
The company's portfolio includes minimally invasive platforms such as Mia Femtech, Preservé, GEM (currently in pivotal study), Motiva Flora tissue expander, and Zensor RFID technology with the Zenº biosensor. These innovations are supported by over 200 patent applications and 100+ scientific studies, with manufacturing conducted at two FDA-compliant 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 announced its participation in Citi's 2025 Unplugged Medtech and Life Sciences Access Day. The company's leadership team, including CEO Juan José Chacón-Quirós, President Peter Caldini, and CFO Raj Denhoy, will present on February 27, 2025, at 8:00 a.m. ET.
The company has delivered over four million Motiva® devices to surgeons since 2010 and operates in more than 90 countries. Their product portfolio includes innovative solutions such as Mia Femtech®, Preservé™, GEM®, Motiva Flora® tissue expander, and Zensor™ RFID technology platform. These solutions are backed by over 200 patent applications and more than 100 scientific studies. Manufacturing takes place at two Costa Rica facilities compliant with ISO13485:2024 and FDA standards.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) has launched Preservé™ in Brazil, marking the first country in its global rollout. Preservé is the company's second minimally invasive platform product, following Mia Femtech®. The technology is designed to preserve breast tissue during aesthetic breast surgery, maintaining structural anatomy and function for more natural outcomes compared to traditional augmentation.
Preservé combines proprietary minimally invasive surgical tools with Ergonomix2 implants featuring patented SmoothSilk® surface. It is intended for primary augmentations up to four cups, hybrid augmentations, and mastopexy augmentations. The launch took place at the Brazilian Breast Meeting in Rio de Janeiro with over 300 surgeons attending, featuring live surgery and academic sessions. Additional global launches are planned throughout the year, though the medical devices are not yet approved for commercial distribution in the United States.
Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company focused on women's health and breast aesthetics, will release its Q4 2024 financial results after market close on February 26, 2025. The company will host a conference call at 4:30 pm ET to discuss the results.
The company has delivered over four million Motiva® devices to surgeons since 2010 across 90+ countries. Their product portfolio includes Mia Femtech®, Preservé™ for breast augmentation, GEM® for gluteal modeling, Motiva Flora® tissue expander, and Zensor™ RFID technology platform. The company operates two FDA-compliant manufacturing facilities in Costa Rica and holds over 200 patent applications across 20 families, supported by 100+ scientific studies.
Establishment Labs Holdings (NASDAQ: ESTA) announced that CEO Juan José Chacón-Quirós will retire effective March 1, 2025, after 20 years of leadership. Peter Caldini, current President, will become Interim CEO. Chacón-Quirós will remain as a board member and advisor, focusing on expanding breast aesthetics markets and technology development.
The company also released preliminary unaudited results for fiscal year 2024, with expected revenue between $166.0-166.5 million. Fourth quarter revenue is anticipated to be $44.5-45.0 million, including approximately $3.2 million from Motiva sales in the United States.
Peter Caldini brings extensive experience from previous roles at Acreage Holdings, Pfizer Consumer Healthcare, and Bayer Consumer Healthcare. The company continues to focus on innovation, U.S. market leadership, and establishing minimally invasive breast aesthetics as an industry standard.
Establishment Labs Holdings (NASDAQ: ESTA), a global medical technology company focused on women's health and wellness, particularly in breast aesthetics and reconstruction, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Juan José Chacón-Quirós, Founder and CEO, and Raj Denhoy, CFO, will deliver a presentation on Wednesday, January 15, 2025, at 3:45 p.m. Pacific Time.
The presentation will be accessible via live webcast on the company's investor relations website at investors.establishmentlabs.com. An archived version will also be made available after the event.
Establishment Labs Holdings (NASDAQ: ESTA), a medical technology company focused on women's health and breast aesthetics, announced its participation in three upcoming investment conferences in November 2024. CEO Juan José Chacón-Quirós and CFO Raj Denhoy will attend the UBS Global Healthcare Conference, while Chacón-Quirós will present at the Jefferies London Healthcare Conference, and Denhoy at the Stephens Annual Investment Conference. Live webcasts of all presentations will be available on the company's investor relations website.
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