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LivaNova PLC (symbol: LIVN) is a global leader in medical technology, with nearly five decades of experience and an unwavering mission to enhance patient outcomes around the world. Headquartered in London, UK, LivaNova operates in more than 100 countries and employs approximately 3,000 professionals. The company is publicly traded on the NASDAQ stock exchange.
Specializing in advanced circulatory support, cardiopulmonary solutions, and neuromodulation therapies, LivaNova offers a diverse portfolio of products designed to tackle serious health conditions. Their offerings include surgical heart valves, heart-lung machines, oxygenation equipment, and devices for treating conditions like treatment-resistant epilepsy and depression.
LivaNova was formed through a merger between Cyberonics from the US and Sorin from Italy, combining their strengths to create a powerhouse in medical devices. The company has since streamlined its focus by divesting its cardiac rhythm management and heart valve businesses, allowing it to concentrate on its core strengths.
The company’s commitment to innovation is evident through its continuous development of breakthrough treatments and advanced technologies. By emphasizing both clinical and economic value, LivaNova aims to benefit patients, healthcare professionals, and healthcare systems alike. Approximately half of LivaNova’s revenues are generated from the US, with Europe contributing 21%, and the rest coming from other global markets.
LivaNova’s expertise and global presence make it a significant player in the medical technology sector, dedicated to creating products and therapies that transform lives every day.
LivaNova PLC (Nasdaq: LIVN) reported Q4 2022 revenue of $274.9 million, up 1.8% year-over-year, with adjusted diluted EPS at $0.81. For full-year 2022, revenue was $1.02 billion, down 1.3%, but showed a 2.3% rise when excluding the Heart Valve business divested in 2021. The Cardiopulmonary segment grew 10.5%, driven by increased cardiac surgeries. However, Advanced Circulatory Support revenue fell 29.1% due to fewer ECMO treatments. Looking ahead, LivaNova expects 2023 revenue growth of 3-5% and adjusted diluted EPS between $2.45 and $2.65. The company also ceased its heart failure clinical study due to disappointing data.
LivaNova PLC (Nasdaq: LIVN) has initiated a limited commercial release of the Essenz™ Perfusion System in select European centers, following positive clinical experiences at Catharina Hospital in the Netherlands and San Donato Hospital in Italy. The innovative system integrates a next-generation heart-lung machine and a patient monitor, focusing on providing data-driven, personalized support during cardiopulmonary bypass procedures. Both components have received CE Mark, with further regulatory approvals pending in key regions. The release marks a significant advance in perfusion technology, emphasizing safety and operational flexibility.
LivaNova PLC has launched the SenTiva DUO, an implantable pulse generator designed to provide VNS Therapy for drug-resistant epilepsy. This new device features a dual-pin header, allowing existing patients with dual-pin systems to upgrade without lead revision. It maintains the therapeutic advantages of the original SenTiva, including automatic seizure response and programmable therapy options. The device has received 510(k) clearance from the U.S. FDA and is now available in the U.S. market, aiming to enhance patient care for those requiring advanced epilepsy treatment.
LivaNova PLC (NASDAQ: LIVN) will host a conference call on February 22, 2023, at 1 p.m. London time to discuss its fourth-quarter and full-year 2022 results. The results will be released prior to the call. The audiocast can be accessed via www.livanova.com/events. Participants can join via telephone by calling +1 844 200 6205 (U.S.) or +1 929 526 1599 (international), with access code 041577. A replay will be available for 90 days after the call. LivaNova is a global leader in medical technology, focused on delivering innovative solutions for patients and healthcare systems worldwide.
LivaNova PLC (NASDAQ: LIVN) has received a close-out letter from the FDA regarding the Warning Letter issued on December 29, 2015, related to its Munich facility and 3T Heater-Cooler device. This closure signifies the successful implementation of corrective actions by LivaNova. CEO Damien McDonald expressed gratitude for the FDA's collaboration and the efforts of the LivaNova team during this process. The company emphasized its commitment to quality and safety in its operations.
LivaNova PLC (NASDAQ: LIVN) announced its participation in the American Epilepsy Society 2022 Annual Meeting, taking place from December 2-6 in Nashville, Tennessee. The company will showcase seven scientific posters focused on advancing neuromodulation and improving treatment for drug-resistant epilepsy. Dr. Bryan Olin emphasized the company's commitment to enhancing patients' quality of life. Attendees will have the opportunity to engage with presenters about the research findings.
LivaNova PLC (NASDAQ: LIVN) has received 510(k) clearance from the FDA for its LifeSPARC system, enhancing access to extracorporeal membrane oxygenation (ECMO) for hospitals. This new clearance allows ECMO use beyond six hours for patients in acute respiratory or cardiopulmonary failure, including those affected by COVID-19. LifeSPARC aims to simplify ECMO with a user-friendly design, making it suitable for healthcare facilities of all sizes. The company has a strong track record of 100% customer response to recent updates following a recall.
LivaNova PLC (NASDAQ: LIVN) announces that its CEO, Damien McDonald, will present a business update at three healthcare conferences in New York this month. The conferences include the Stifel Healthcare Conference on November 15, the Wolfe Research Healthcare Conference on November 16, and the Piper Sandler Healthcare Conference on November 29. The Stifel and Piper events will be streamed live, with recordings available afterward, while the Wolfe conference will not be available for streaming. For more details, visit www.livanova.com/events.
LivaNova PLC (Nasdaq: LIVN) reported a third-quarter 2022 revenue of $252.6 million, a 0.2% decline on a reported basis but 5.2% growth on a constant-currency basis compared to the prior year. A U.S. GAAP diluted loss per share reached $2.01, impacted by a non-cash goodwill impairment charge. Neuromodulation revenue increased by 10.4%, while Cardiopulmonary grew by 6.6%. Advanced Circulatory Support faced a significant 43.8% decline. The company maintains its full-year 2022 revenue growth outlook between 4% and 6% on a constant-currency basis.
LivaNova PLC (NASDAQ: LIVN) will hold a conference call on November 2, 2022, at 12 p.m. London time (8 a.m. EDT) to discuss its third-quarter 2022 results, releasing the details prior to the call. Interested participants can access a live audiocast at www.livanova.com/events. Call-in options are also available for both U.S. and international listeners. A replay will be offered for 90 days post-call. LivaNova is headquartered in London, employing approximately 3,000 people globally, focusing on innovative medical technologies for patients.
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