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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.
Allurion Technologies and Compute Health Acquisition Corp (NYSE: CPUH) have entered into a business combination agreement, positioning Allurion to become publicly listed as Allurion Technologies, Inc. This innovative company is focused on obesity treatment, featuring the Allurion Gastric Balloon, a swallowable gastric balloon that allows for procedure-less weight loss. Since its inception, Allurion has treated over 100,000 patients worldwide, achieving an average weight loss of 30 pounds. Revenue has surged from $20 million in 2020 to $64 million in 2022. The transaction includes significant investments from RTW Investments and other notable figures.
Establishment Labs (NASDAQ: ESTA) announced preliminary unaudited revenue results for Q4 and FY 2022, projecting Q4 revenue between
Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced a strategic partnership with Seishin Plastic and Aesthetic Surgery Clinic in Japan, launching Mia Femtech, a minimally invasive breast aesthetics procedure. This collaboration aims to address dissatisfaction among Japanese women regarding breast aesthetic options, potentially expanding the market significantly. The Mia procedure can enhance breast shape by 1 to 2 cup sizes in just 15 minutes, without general anesthesia. While currently not approved for commercial distribution in the U.S., this launch represents the first of many anticipated in 2023.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced that CEO Juan José Chacón-Quirós will present at the 41st Annual J.P. Morgan Healthcare Conference on January 12 at 7:30 a.m. Pacific Time. A live webcast of the presentation will be available on the company's investor relations website, with an archived version accessible post-event. Establishment Labs specializes in women’s health technology, focusing on breast aesthetics and reconstruction, and has delivered over 2.5 million Motiva Implants® globally since 2010.
Establishment Labs Holdings (NASDAQ: ESTA) recently announced the approval of Motiva Implants® and the Motiva Flora® tissue expander for use in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA). These products have also secured reimbursement under the Japanese National Health System for post-mastectomy reconstruction. The first patient was treated successfully in November at Nagoya University Hospital. This launch signifies a commitment to enhancing women's health through innovative products backed by clinical data.
Establishment Labs Holdings Inc. (Nasdaq: ESTA) reported third quarter 2022 sales of $38.2 million, a year-over-year increase of 31.7%. Revenue guidance for 2022 has been narrowed to $158 million to $162 million, reflecting 25% to 28% growth from 2021, with foreign exchange effects expected to reduce revenue by $6.5 million. Gross profit margin improved to 68.1%, while operating expenses rose 27.5% to $36.6 million. The company holds a cash balance of $65.3 million as of September 30, 2022, and plans to commercialize Mia Femtech™ and seek FDA approval for Motiva Implants in early 2023.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) announced participation in the Jefferies London Healthcare Conference and the Stephens Annual Investment Conference, both taking place from November 15-17, 2022. CEO Juan José Chacón-Quirós and CFO Raj Denhoy will present at the Jefferies conference on November 15 at 5:00 PM GMT, while Denhoy will speak at the Stephens conference on November 17 at 11:00 AM CT. Live webcasts and archived versions of the presentations will be available on the company's investor relations website.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) will announce its financial results for Q3 2022 on November 7, 2022, after market close. A conference call will be held at 4:30 pm ET to discuss these results. The company specializes in breast aesthetics and reconstruction, offering advanced silicone gel-filled implants, Motiva Implants®, with over 2 million implants distributed in over 80 countries since 2010. The company aims to continue improving women's health through innovative products.
Holzer & Holzer, LLC is investigating Establishment Labs Holdings Inc. (NASDAQ:ESTA) for potential compliance failures with federal securities laws. Following a report by Hindenburg Research, which alleged undisclosed conflicts of interest in key safety studies of Establishment Labs' breast implants, the company's stock price experienced a decline. The report claims significant pushback was received by a surgeon for publishing higher complication rates than those reported by the company. Shareholders who incurred losses are encouraged to contact Holzer & Holzer for potential legal recourse.
Establishment Labs Holdings Inc. (NASDAQ: ESTA) will host an investor event on October 5, 2022, at 4:30 p.m. ET, to discuss its innovative product, Mia Femtech®. This minimally invasive procedure aims to enhance breast aesthetics, allowing for a breast size increase of 1 to 2 cups in just 15 minutes, without general anesthesia. The company is pursuing regulatory approvals for Mia in Europe and anticipates commercialization in select markets in the first half of 2023.
FAQ
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