Welcome to our dedicated page for Establishment Labs Hldgs news (Ticker: ESTA), a resource for investors and traders seeking the latest updates and insights on Establishment Labs Hldgs stock.
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 (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.
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.
FAQ
What is the current stock price of Establishment Labs Hldgs (ESTA)?
What is the market cap of Establishment Labs Hldgs (ESTA)?
What is the primary business of Establishment Labs Holdings Inc?
How does the company ensure the safety and quality of its products?
Who are the main customers of Establishment Labs?
What distinguishes its implants from those of competitors?
How is innovation emphasized within the company?
In which geographic regions does Establishment Labs operate?
