LivaNova PLC reports developments as a global medical technology company focused on selected neurological and cardiac conditions. Company news commonly covers revenue results and guidance, performance in its Cardiopulmonary and Epilepsy businesses, and updates tied to medical-device commercialization and clinical evidence.
Recurring product themes include VNS Therapy for drug-resistant epilepsy, real-world evidence from the CORE-VNS study, and obstructive sleep apnea technology using proximal hypoglossal nerve stimulation. Updates also include FDA regulatory decisions, including premarket approval for the aura6000 System, investor conference appearances, and business update calls.
LivaNova PLC (Nasdaq: LIVN) has announced that its Chief Executive Officer, Damien McDonald, will participate in a fireside chat at the Barclays Global Healthcare Conference in Miami, Florida. The event is scheduled for 9 a.m. Eastern Time on Thursday, March 16. Interested parties can register for the webcast through www.livanova.com/events, with a replay available on the company's website for 90 days after the presentation. LivaNova is a global medical technology company dedicated to improving patient outcomes with innovative solutions.
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.