LivaNova Provides Update on RECOVER Clinical Study Evaluating VNS Therapy for Treatment-Resistant Depression in Unipolar Patients

Rhea-AI Summary

LivaNova announced preliminary results for the unipolar patient cohort in its RECOVER clinical study of VNS Therapy for treatment-resistant depression. The primary endpoint (PE) did not achieve statistical significance due to an unforeseen strong response in the sham group. However, select secondary endpoints showed statistically significant and clinically meaningful benefits, with no safety concerns reported. The company plans to publish detailed data in peer-reviewed journals by Q4 2024. The RECOVER study's bipolar patient cohort continues, and discussions with U.S. Medicare and Medicaid Services for VNS Therapy coverage are ongoing.

Positive

• Statistically significant and clinically meaningful benefits observed in select secondary endpoints.
• No safety concerns identified in the study.
• Plans to publish comprehensive data in peer-reviewed journals by Q4 2024.
• Conducting an in-depth analysis of the data to determine the path forward.

Negative

• Primary endpoint for the unipolar patient cohort did not achieve statistical significance.
• Strong unforeseen response in the sham group affected results.
• No immediate resolution or next steps provided for the unipolar cohort findings.

Insights

Medical Research Analyst

The RECOVER clinical study on VNS Therapy for treatment-resistant depression in unipolar patients revealed mixed outcomes. While the primary endpoint (PE) was not achieved, statistically significant improvements in secondary endpoints were noted, indicating clinically meaningful benefits. The medical community pays close attention to secondary endpoints, especially in studies where the PE is narrowly missed. The lack of safety issues further strengthens the case for VNS Therapy, highlighting its potential as a viable treatment option for patients with limited alternatives.

Unipolar depression is notoriously difficult to treat, especially in individuals resistant to multiple treatments. Despite the unforeseen robust response in the sham group, the data suggests that VNS Therapy could benefit a subset of these patients. This kind of nuanced result often paves the way for more tailored therapeutic approaches in the future. Moreover, the ongoing analysis and anticipated peer-reviewed publications will be critical in shaping both clinical opinions and regulatory perspectives.

For a retail investor, recognizing the importance of secondary endpoints is crucial. These results may not only influence future regulatory decisions but could also impact market perception as the broader dataset becomes publicly available. Investors should stay informed about forthcoming analyses and publications, as these will offer deeper insights into the therapy's efficacy and potential market acceptance.

Market Research Analyst

The mixed results from LivaNova's RECOVER study for VNS Therapy in unipolar depression could have varied implications for investors. The fact that no safety concerns were raised is a positive sign, likely preventing any immediate negative fallout. However, the failure to meet the primary endpoint means that market sentiment may remain cautious until further data is published.

The secondary endpoints showing meaningful benefits do offer a silver lining. These results can be leveraged in marketing strategies to highlight potential efficacy, particularly in a market with few effective treatments for severe, treatment-resistant depression. Such positive secondary outcomes often provide a foundation for additional studies, potentially leading to revised treatment protocols and insurance coverage considerations.

Investors should consider both the short-term impacts, including potential stock volatility due to the mixed results and the long-term opportunities. The ongoing analysis and future peer-reviewed publications may sway market opinion and attract renewed interest from stakeholders. Observing the company's strategic communication and partnerships with regulatory bodies like CMS will also be vital in assessing future prospects.

Primary endpoint did not achieve statistical significance in unipolar patient cohort

Statistically significant and clinically meaningful benefits seen in select secondary endpoints; no safety concerns identified

LONDON--(BUSINESS WIRE)-- LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced the preliminary results for the unipolar patient cohort of the RECOVER clinical study, assessing the use of VNS Therapy™ in treatment-resistant depression. The study did not meet its primary endpoint (PE) for the unipolar cohort; however, statistical significance was achieved in select secondary endpoints.

The PE measured the difference between active and sham VNS Therapy on the rate of Montgomery–Åsberg Depression Rating Scale (MADRS) response for the unipolar patient cohort with a predetermined p-value of p<0.023. Over the course of 12 months, the active treatment arm demonstrated statistically significant and clinically meaningful improvement from the treatment arm’s baseline. Due to a strong response in the sham group, which was unforeseen in the study design, statistical separation between the treatment and sham arms for the PE was not achieved by the end of the study. Despite this, the totality of data supports a meaningful treatment effect for those who received active VNS Therapy particularly given that the RECOVER unipolar patient population has a significant unmet need after having failed numerous other treatment modalities.

“We would like to thank the patients and physicians who participated in RECOVER to date, as well as the U.S. Centers for Medicare and Medicaid Services, who we partnered with to design this study,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “Despite not achieving statistical significance for the primary endpoint for the unipolar cohort in the RECOVER study, the effect of active VNS Therapy was within our expectations and resulted in clinically meaningful benefits in select secondary endpoints. We are conducting an in-depth analysis of the data with key stakeholders and will determine the path forward in the coming weeks."

The Company expects to publish the unipolar cohort data, including details on the PE and secondary endpoints, in peer-reviewed journals in the fourth quarter of 2024. Importantly, no safety issues were reported.

“I am encouraged by the clinically meaningful outcomes for the RECOVER unipolar patient population that is markedly treatment resistant,” said Dr. Charles R. Conway, Director of the Washington University in St. Louis Resistant Mood Disorders Center and Principal Investigator for RECOVER. “As we have previously published, the unipolar patients who entered the RECOVER study were of a greater severity than we had anticipated in the study design and have very few treatment options remaining. We now have a large body of data to evaluate, and I look forward to better understanding it in totality.”

The bipolar patient cohort continues for RECOVER and LivaNova will continue its discussions with the U.S. Centers for Medicare and Medicaid Services (CMS) regarding reconsideration of coverage for VNS Therapy for treatment-resistant depression.

About RECOVER

LivaNova’s VNS Therapy has been approved for the treatment of depression since earning CE Mark in 2001 and 510(k) from the U.S. Food and Drug Administration in 2005. RECOVER – which stands for A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy™ System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression – is a clinical study initiated in September 2019 as part of a Coverage with Evidence Development framework per the U.S. Centers for Medicare and Medicaid (CMS) National Coverage Determination process.

The largest randomized clinical study of its kind, RECOVER is examining up to 1,000 patients ages 18 or older who have unipolar or bipolar depression that is difficult to treat. The double-blind, randomized controlled study is assessing how VNS Therapy can offer patients relief from their depressive symptoms and improve quality of life. It is being carried out at up to 100 leading hospitals and medical centers across the United States. For more information on the RECOVER clinical study, please visit www.RECOVERVNS.com.

About VNS Therapy for Depression

The VNS Therapy™ System, Symmetry™, is FDA approved and indicated in the U.S. for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Commonly reported side effects are hoarseness, shortness of breath, sore throat and coughing. Side effects typically occur during stimulation and are less noticeable over time. Safety information is available here.

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 www.livanova.com.

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 progress relating to the RECOVER study and the VNS Therapy System, Symmetry. 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.

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LivaNova Investor Relations and Media Contacts

+1 281-895-2382

Zachary Glazier

Manager, Investor Relations

InvestorRelations@livanova.com

Deanna Wilke

VP, Corporate Communications

Corporate.Communications@livanova.com

Source: LivaNova PLC

FAQ

What did the RECOVER clinical study evaluate for LIVN?

The RECOVER clinical study evaluated VNS Therapy for treatment-resistant depression in unipolar patients.

Did LivaNova's RECOVER study meet its primary endpoint?

No, the primary endpoint for the unipolar patient cohort did not achieve statistical significance.

Were there any significant findings in LivaNova's RECOVER study?

Yes, there were statistically significant and clinically meaningful benefits in select secondary endpoints.

What were the safety concerns in LivaNova's RECOVER study?

No safety concerns were identified in the RECOVER study.

When will LivaNova publish detailed data from the RECOVER study?

LivaNova plans to publish the detailed data in peer-reviewed journals by Q4 2024.

What is the next step for LivaNova after the RECOVER study results?

LivaNova is conducting an in-depth analysis of the data with key stakeholders to determine the path forward.