Latest news with #LivaNovaPLC
Business Wire
3 days ago
- Health
- Business Wire
CORE-VNS Study Further Validates Effectiveness of LivaNova's VNS Therapy on Severe Focal Seizures in Both Children and Adults with Drug-Resistant Epilepsy
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced completion of the CORE-VNS study, evaluating comprehensive outcomes of real-world evidence for more than 800 people with epilepsy treated with VNS Therapy™ worldwide. With the clinical study report (CSR) now complete, the final 36-month data further validate the effectiveness of VNS Therapy for severe focal seizures in both children and adults with drug-resistant epilepsy (DRE) and demonstrate early and lasting outcomes of adjunctive VNS Therapy on severe focal seizures. With the clinical study report now complete, the final 36-month data further validate the effectiveness of VNS Therapy for severe focal seizures in both children and adults with drug-resistant epilepsy and demonstrate early and lasting outcomes. Share 'It is critically important to conduct long-term, real-world studies like CORE-VNS, and it is pleasing to see these clinically meaningful and durable results demonstrating the effectiveness of VNS Therapy for people living with drug-resistant epilepsy,' said Arjune Sen, Professor of Global Epilepsy at The University of Oxford and Consultant Neurologist at Oxford University Hospitals NHS Foundation Trust. Prof. Sen is also coordinating investigator for the CORE-VNS study. The CORE-VNS 36-month data analysis reaffirms the effectiveness of VNS Therapy, in pediatric and adult patients, and expands upon LivaNova's presentation of interim 24-month data evaluating the effectiveness of VNS Therapy in children ages 4 to 18 years old with focal onset seizures at the American Epilepsy Society's annual conference in December 2024. 1 Within the full 36-month analysis, the greatest proportion of patients at all ages reported focal onset seizures with impaired awareness (FIA) to be their most disabling seizure type. CORE-VNS study data demonstrate the impact of VNS Therapy, including: In children 4 to 18 years old, FIA motor seizures, for example, reduced by a median of 87% at 36 months. Including adults, 34% of people with FIA motor seizures reported 100% seizure reduction (freedom from these seizures over the three months prior to their three-year study visit), with an overall median reduction of 80%. In children 4 to 18 years old, focal to bilateral tonic-clonic (FBTC) seizures reduced by a median of 100% at 36 months. Including adults, 49% of people with FBTC seizures reported 100% seizure reduction at the three-year study visit, with an overall median reduction of 95%. The effectiveness of VNS Therapy was noted as early as three months after implantation, followed by further substantial reduction noted in both FIA and FBTC seizures at the 12-, 24-, and 36-month study visits. Unlike many long-term follow-up studies on DRE, CORE-VNS had a high patient-retention rate throughout the three years of follow-up (82%). 'LivaNova is deeply committed to advancing epilepsy research and in every study of VNS Therapy to date, we continue to see that effectiveness can be achieved early and continue to improve month by month and visit by visit. This remained true over the course of three years in CORE-VNS,' said Kathryn Nichol, Ph.D., Vice President Global Medical Affairs, LivaNova. 'Further, CORE-VNS confirms that VNS Therapy is effective for the most severe focal seizures in pediatric and adult patients. Not all seizures are created equal—this is why evaluating severe focal seizures that may have a larger impact on quality of life and outcomes in people with drug-resistant epilepsy is so important.' CORE-VNS is the largest prospective study of VNS Therapy ever conducted worldwide. The full, 36-month CORE-VNS study results will be published later this year. "The strong outcomes from the CORE-VNS study bolster our efforts to narrow the DRE treatment gap, increase access to care, and drive awareness of surgical therapies for this significantly under-addressed patient population,' said Stephanie Bolton, LivaNova President, Global Epilepsy. About CORE-VNS CORE-VNS is a real-world, long-term, open-label study focused on the outcomes of VNS Therapy™ in people diagnosed with drug-resistant epilepsy (DRE). Enrolling more than 800 people from 61 worldwide sites, the study is the most comprehensive assessment of the effectiveness of VNS Therapy to date and provides modern insights into the global use of VNS Therapy in the management and control of seizures. Adverse events in the CORE-VNS study were typical of those reported in the product labeling and experienced following placement of a VNS Therapy device. The most commonly reported (>5%) adverse events overall included respiratory, thoracic, and mediastinal disorders (dysphonia, dyspnea, cough) and general disorders/administration site conditions. See important safety information at About VNS Therapy for Epilepsy VNS Therapy™ is clinically proven safe and effective as an add-on treatment to reduce the frequency of seizures in adults and children as young as 4 years old with drug-resistant epilepsy and partial onset seizures. It is a unique treatment approach developed for people with drug-resistant epilepsy—a condition that affects approximately one in three people with epilepsy. Unlike some other surgical treatment options for people with drug-resistant epilepsy, VNS Therapy implantation involves an outpatient procedure and does not require penetration of the skull. Outside the United States, the VNS Therapy indications for use may vary. For more information, visit References About LivaNova LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit Safe Harbor Statement This news release contains 'forward-looking statements' concerning the Company's goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the CORE registry and VNS Therapy™ for epilepsy. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
Yahoo
15-05-2025
- Business
- Yahoo
LivaNova to Present at the Jefferies Global Healthcare Conference
LONDON, May 15, 2025--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced Vladimir Makatsaria, Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference in New York. The presentation will take place Thurs., June 5, at 3:10 p.m. Eastern Time. The discussion will be available to all interested parties who register to attend the webcast, which is accessible via Listeners should log on approximately 10 minutes in advance to ensure proper setup to receive the webcast. A replay will be available on the LivaNova website within 24 hours after the live presentation for 90 days after the event. About LivaNova LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit Safe Harbor Statement This news release contains "forward-looking statements" concerning the Company's goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding participation in upcoming events. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances. View source version on Contacts LivaNova Investor Relations and Media Contacts+1 281-895-2382Briana Gotlin VP, Investor RelationsInvestorRelations@ Deanna Wilke VP, Corporate
Business Wire
15-05-2025
- Business
- Business Wire
LivaNova to Present at the Jefferies Global Healthcare Conference
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced Vladimir Makatsaria, Chief Executive Officer, will participate in a fireside chat at the Jefferies Global Healthcare Conference in New York. The presentation will take place Thurs., June 5, at 3:10 p.m. Eastern Time. The discussion will be available to all interested parties who register to attend the webcast, which is accessible via Listeners should log on approximately 10 minutes in advance to ensure proper setup to receive the webcast. A replay will be available on the LivaNova website within 24 hours after the live presentation for 90 days after the event. About LivaNova LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit Safe Harbor Statement This news release contains 'forward-looking statements' concerning the Company's goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding participation in upcoming events. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
Business Wire
07-05-2025
- Health
- Business Wire
LivaNova Announces 12-month Data from OSPREY Clinical Study for Moderate to Severe Obstructive Sleep Apnea, Demonstrating Strong Response and Durability of Therapy
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced 12-month, top-line data from its OSPREY randomized controlled trial (RCT), evaluating outcomes with the aura6000™ System for the treatment of moderate to severe obstructive sleep apnea (OSA). At 12 months of therapy, the treatment arm responder rate was 65% with responders defined as those who realized at least a 50% improvement from the baseline apnea-hypopnea index (AHI) and an AHI value below 20. The study features a differentiated neurostimulation modality called proximal hypoglossal nerve stimulation (p-HGNS), which utilizes six electrodes placed on the proximal trunk of the hypoglossal nerve, offering broad access to the muscles controlling the airway and providing customized titration. 'The OSPREY trial demonstrated rapid and sustained improvement for patients who received active proximal hypoglossal nerve stimulation,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. In , the company announced that OSPREY met its primary and secondary endpoints following six months of therapy. Study patients in the treatment arm of OSPREY have since shown continued improvement. When comparing baseline median values to six and 12 months of therapy (assessed at the seven- and 13-month follow-up visits, respectively), OSPREY subjects showed significant reductions in AHI and oxygen desaturation index (ODI) over time: AHI reduced by 68% when the median at baseline of 34.3 is compared to the median of 11.0 at 12 months (versus the median of 11.6 at six months). ODI reduced by 68% when the median at baseline of 34.9 is compared to the median of 11.1 at 12 months (versus the median of 12.8 at six months). Further, after 12 months of treatment, OSPREY subjects in the device stimulation group experienced clinically meaningful improvements in the Epworth Sleepiness Scale (ESS) and the Functional Outcomes of Sleep Questionnaire (FOSQ). ESS and FOSQ as compared to baseline are secondary outcome measures within the study. ESS is a patient questionnaire that assesses how likely the patient is to fall asleep during the day and FOSQ is a patient questionnaire that assesses the effects of fatigue on daily activities. "OSPREY is the first major multi-center randomized, controlled pivotal trial of hypoglossal nerve stimulation. Patients in the device stimulation group experienced a rapid onset of therapy with continued improvement over time,' said Dr. Atul Malhotra, lead investigator for the study, who is also a professor of medicine at University of California San Diego School of Medicine and sleep medicine specialist at UC San Diego Health. 'Responder rates in the treatment group were strong throughout the first year with one in four patients responding on day one, 50% responding by month three, and 65% responding by the 12-month mark. In addition, patient-reported outcomes for daytime sleepiness and functional outcomes of sleep quality demonstrated meaningful improvement over the course of 12 months.' Dr. Malhotra will present the OSPREY six-month results and 12-month top-line data at the American Thoracic Society International Conference on Tuesday, May 20, at 9:51 a.m. PDT in San Francisco. OSPREY baseline values of OSA severity and body mass index (BMI) were representative of the general OSA population. Relative to other large-scale trials of hypoglossal nerve stimulation (HGNS) in support of U.S. Food and Drug Administration (FDA) approval, OSPREY included patients with greater OSA severity and higher BMI. Plus, OSPREY was designed to include patients with complete concentric collapse (CCC). Based on a recently presented predictive algorithm 1, it was determined that the OSPREY study enrolled patients at increased risk of CCC at a ratio aligned with the general OSA population seen in clinical practice. Response rates and AHI reductions at month 12 for patients in OSPREY with predicted risk for CCC were consistent with the results for the full study population, demonstrating the robustness of the therapeutic response 2. 'The OSPREY trial demonstrated rapid and sustained improvement for patients who received active proximal hypoglossal nerve stimulation, including those with severe obstructive sleep apnea, elevated body mass index, and high risk of complete concentric collapse,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. 'The OSPREY 12-month results further validate the potential of this therapy as a treatment alternative for the large and growing OSA population. With the strength of our clinical data, expertise of our neuromodulation team, and strategic growth opportunity ahead, we are eager to bring this innovation to patients.' LivaNova recently completed its premarket approval submission to FDA for the aura6000 System based on meeting OSPREY's primary safety and efficacy endpoints following six months of treatment. LivaNova has also provided FDA with interim 12-month results from the OSPREY study and intends to share the full 12-month dataset with FDA during its review. The aura6000 System is an investigational implantable proximal hypoglossal neurostimulator undergoing clinical evaluation for the treatment of adult patients with moderate to severe OSA. There were no serious adverse device-related or procedure-related events reported during OSPREY. References The PREDICTOR algorithm was presented at the 2024 International Surgical Sleep Society Educational Update in Miami ( The presentation occurred on Friday, Sept. 27, 2024, with the lecture being delivered by Jordan Weiner, MD ( CYB-03127-R1 About OSPREY OSPREY is a prospective, multi-center, randomized controlled open-label trial evaluating the safety and efficacy of the aura6000™ System versus a no stimulation control in subjects with moderate to severe OSA who have failed or are unwilling to use positive airway pressure treatment. CAUTION—the aura6000 System is an investigational device. Limited by Federal (or United States) law to investigational use. About LivaNova LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit Safe Harbor Statement This news release contains 'forward-looking statements' concerning the Company's goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the OSPREY study, the aura6000™ System, and presentations at upcoming conferences. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
Yahoo
27-04-2025
- Business
- Yahoo
Is LivaNova PLC (LIVN) the Best Undervalued UK Stock to Buy Right Now?
We recently published a list of the . In this article, we are going to take a look at where LivaNova PLC (NASDAQ:LIVN) stands against other best undervalued UK stocks to buy right now. The global markets entered 2025 in the hope that the bullish run of the fourth quarter will continue in the first quarter of 2025. However, the uncertainty due to the tariffs led to the reversal of all gains made in the fourth quarter leading to a loss of 4.5%. However, on the positive side, the UK and the European market saw some excellent returns during the first quarter of 2025. Rory McPherson, the Chief Market Strategist of Wren Sterling, noted that the first quarter of 2025 was the best quarterly return quarter for the UK market since 2022. For the European market, it was their best quarterly return in over a year. The performance of the UK and the European markets was based on several factors. Firstly, for Europe, the approval of a 500 billion Euro infrastructure fund and the lifting of restrictions on defense spending in Germany helped take the overall European market higher. This was also backed by the continued stimulus from the Chinese government to help fire up the engines of China and Germany. On the other hand, the UK market mainly benefitted from the better-than-expected corporate earnings, particularly from the banking sector. The UK's banking sector reaped the advantage of its diversification, followed by its cheaper valuations, and increased profitability. As per Wern Sterling's report, the UK banking sector grew its earnings by 30% year-over-year during the first quarter of 2025, which was similar to the growth of the Magnificent Seven in the United States. On top of this, the sector benefited from its extremely cheap valuation as compared to the top US stocks. The report also highlighted that the UK's banking sector is using its excess cash to buy back stocks and increase dividends which makes it even more lucrative for shareholders. On April 24, Andrew Bailey, Bank of England governor, joined CNBC to talk about the impact of tariffs on the UK's economy. He segregates the impact of tariffs into two portions, which are the impact on growth and the impact on inflation. He said that unfortunately, if we talk about the impact on growth, tariffs will have an impact in the longer run due to the closed nature of the global economy. Bailey elaborated that if we reduce the trade and openness of the global economy it directly impacts the growth trajectory of the economy. On top of this, there is the uncertainty effect which has led CEOs and consumers alike to postpone investment decisions. He noted that the UK already has a high saving rate, which shows that the people are simply uncertain about the economic and policy conditions that are restricting them from making investment decisions. In terms of the inflationary impact, Bailey remains confident that the tariffs are not having an inflationary impact. He explains that inflation factors in a lot of other indicators, for instance, if trade with the United States is restricted the economy can redirect its exports to other markets. On the other hand, retaliation from the UK government could also lead to a deflationary impact. To conclude, Bailey is more concerned about the impact of tariffs on growth as compared to inflation. He noted that the UK administration not only needs to address the supply and demand side issues related to growth but also has to tackle the trade issues with effective policies. To curate the list of the 11 best undervalued UK stocks to buy right now, we used the Finviz stock screener, Seeking Alpha, and Yahoo Finance as our sources. Using the screener we aggregated a list of UK stocks that are trading below the Fwd P/E of 15. Next, we cross-checked the Fwd P/E of each stock from Seeking Alpha and earnings growth from Yahoo Finance. Finally, we ranked these stocks in ascending order of the number of hedge funds that hold stakes in them, as of Q4 2024. Please note that the forward P/E data was collected on April 23, 2025. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (). A close-up of a medical device used for therapeutic solutions in a world-class hospital. LivaNova PLC (NASDAQ:LIVN) is an international medical technology company based in the United Kingdom. It specializes in innovative devices for therapies related to cardiac and neurological conditions. The company operates three main segments including Cardiopulmonary, Neuromodulation, and Advanced Circulatory Support. On March 17, Needham analyst Michael Matson maintained a Buy rating on the stock. The analyst commented that the company's financial outlook has improved after the Italian Supreme Court ruled in favor of the company. The court confirmed LivaNova PLC's (NASDAQ:LIVN) liability for SNIA obligations but reduced the expected liability from about $493 million to $363 million. Matson also highlighted LivaNova's strong cash position. The company had $429 million in cash and $295 million in restricted cash at the end of 2024, which gives him confidence in the company's ability to pay back the liability. Moreover, he also noted that the market has already factored in the case therefore the risk has already been priced in the current stock price. In addition to this LivaNova PLC (NASDAQ:LIVN) posted financial growth and clinical progress in its fourth quarter results. The revenue of the company improved 3.8% on a reported basis to reach $321.8 million. On the other hand, the OSPREY clinical study for obstructive sleep apnea met its primary safety and efficacy endpoints. LivaNova PLC (NASDAQ:LIVN) is the best undervalued UK stock to buy right now. Greenlight Capital stated the following regarding LivaNova PLC (NASDAQ:LIVN) in its Q4 2024 investor letter: 'We sold our position in LivaNova PLC (NASDAQ:LIVN) after three and a half years at a -6% IRR. When we bought the shares, we believed that LIVN had three exciting opportunities in its pipeline. None of those materialized and we decided to move on.' Overall, LIVN ranks 1st on our list of best undervalued UK stocks to buy right now. While we acknowledge the potential of LIVN to grow, our conviction lies in the belief that AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than LIVN but that trades at less than 5 times its earnings, check out our report about this . READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey.
