LivaNova (NasdaqGS:LIVN) Q4 2025 Earnings call February 25, 2026 08:00 AM ET Company ParticipantsAhmet Tezel - Chief Innovation OfficerAlex Shvartsburg - CFOAnthony Petrone - Managing Director and Equity ResearchBrianna Gotlin - Vice President of Investor RelationsJohn McAulay - Associate VPVladimir Makatsaria - CEOConference Call ParticipantsAdam Maeder - Managing Director and Senior Research AnalystBrett Fishman - VP and Senior Equity Research AnalystDavid Rescott - Senior Research AnalystMichael Polark - ...

Core Insights - The article highlights the increasing federal focus on deep brain neurostimulation as a promising therapy for conditions such as TBI, PTSD, stroke recovery, and Alzheimer's disease, with Nexalin Technology, Inc. playing a significant role in this emerging field [1][4][10] Legislative Developments - Recent bipartisan Congressional initiatives have expanded federal support for deep brain neurostimulation research, particularly through the U.S. Department of Veterans Affairs (VA) and the National Institutes of Health (NIH) [1][4] - H.R. 7091, introduced on January 15, 2026, aims to expand clinical trials for deep brain neurostimulation and establish a compassionate use pathway within the VA system [7] - The Military Construction, Veterans Affairs, and Related Agencies Appropriations Act, 2026, includes provisions for neuromodulation research focused on stroke recovery among veterans, signed into law by President Trump [7] - The Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act, 2026, expands NIH-supported research using deep brain stimulation for Alzheimer's and Parkinson's diseases, also signed into law by President Trump [7] Company Initiatives - Nexalin Technology's DIFS™ technology is recognized as a sophisticated form of non-invasive deep brain neurostimulation and is currently being evaluated in research with UC San Diego and the San Diego VA veterans' community [2][5] - The company is actively engaged in policy advocacy to support the inclusion of deep brain neurostimulation in federal legislation, which has raised awareness of its therapeutic potential among policymakers [8][9] - Nexalin believes that the expanding federal support for neuromodulation research aligns with its strategic focus on developing non-invasive technologies to address significant unmet medical needs [5][9] Market Opportunity - Conditions such as TBI, PTSD, stroke-related neurological impairment, Alzheimer's disease, and Parkinson's disease represent multi-billion-dollar addressable markets with significant unmet medical needs [10] - As federal research initiatives expand, Nexalin is positioned to advance emerging neurostimulation therapies within the VA system and the broader healthcare infrastructure [10][11]

Core Viewpoint - CVRx, Inc. is set to release its fourth quarter 2025 financial and operating results on February 12, 2026, after market close, followed by a conference call to discuss the results [1]. Company Overview - CVRx, Inc. is a commercial-stage medical device company that specializes in developing, manufacturing, and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases [3]. - The company's flagship product, Barostim™, is the first FDA-approved medical technology that utilizes neuromodulation to alleviate symptoms in heart failure patients [3]. - Barostim is an implantable device that sends electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3]. - The device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as being compliant with EU Medical Device Regulation (MDR) and holding CE Mark for heart failure and resistant hypertension in the European Economic Area [3].

Core Insights - CVRx, Inc. reported preliminary unaudited revenue results for Q4 and full year 2025, indicating growth and strategic progress in the commercialization of its neuromodulation solutions for cardiovascular diseases [1][2][18] Financial Performance - Q4 2025 revenue is expected to be between $15.9 million and $16.1 million, reflecting a growth of approximately 4% to 5% compared to Q4 2024 revenue of $15.3 million [3][8] - Full year 2025 revenue is projected to be between $56.5 million and $56.7 million, representing an increase of approximately 10% to 11% over 2024 revenue of $51.3 million [4][8] - For Q1 2026, the company anticipates total revenue between $13.7 million and $14.7 million [6] Business Outlook - The company expects full year 2026 revenue to be between $63 million and $67 million, indicating growth of 11% to 18% [8] - The transition to Category I CPT codes effective January 1, 2026, is expected to enhance reimbursement dynamics and support commercial efforts [2][8] Operational Highlights - As of December 31, 2025, CVRx had 252 active implanting centers, up from 250 as of September 30, 2025 [4] - The number of sales territories in the U.S. increased to 53, adding three territories during Q4 2025 [4] Debt Facility - On January 9, 2026, the company amended its term loan agreement, increasing the facility by $50 million to a total of $100 million, with an additional $10 million borrowed at closing [11] - The amended loan has an interest rate of 9.40% or prime plus 2.65%, with an extended interest-only period [11] Clinical Development - The FDA approved the BENEFIT-HF trial design in November 2025, which aims to evaluate Barostim's impact on heart failure patients [10] - The trial is set to randomize 2,500 patients across 200 centers in the U.S. and Germany, with expected costs of $20 million to $30 million over five to seven years [10]

Core Insights - BrainsWay's strategic investment in Neurolief has led to the FDA granting Premarket Approval for the Proliv™Rx system, the first at-home neuromodulation device for major depressive disorder (MDD) patients who have not responded to previous antidepressants [1][2][3] Company Overview - BrainsWay is a leader in noninvasive brain stimulation technologies, focusing on advanced treatments for mental health disorders [5] - The company utilizes its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform to provide effective treatments for various mental health conditions, including MDD, obsessive-compulsive disorder, and smoking addiction [5] Neurolief Overview - Neurolief is a pioneering company in neuromodulation, known for developing the first wearable, non-invasive, multi-channel brain neuromodulation system designed for home use [4] - The Proliv™Rx device is indicated for adults with MDD who have not achieved satisfactory improvement from at least one prior antidepressant [4] Regulatory Milestone - The FDA's approval of Proliv™Rx marks a significant advancement in the treatment landscape for refractory MDD, allowing for treatment in both home and clinical settings [2][3] Strategic Positioning - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its addressable market by providing access to patients who may struggle to visit clinics [3]

Core Insights - The FDA has granted Premarket Approval for Neurolief's Proliv™Rx system, making it the first at-home neuromodulation treatment for patients with major depressive disorder (MDD) who have not responded to previous antidepressant medications [1][2] Group 1: FDA Approval and Market Impact - The approval signifies a major regulatory milestone, expanding treatment options for refractory MDD patients beyond traditional in-clinic care [2] - Proliv™Rx is now recognized as an adjunctive treatment for MDD, indicating its potential to improve patient access to care [4] Group 2: Strategic Positioning of BrainsWay - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its total addressable market [3] - The FDA approval validates BrainsWay's investment strategy and reinforces its commitment to data-driven mental health care [3] Group 3: Company Backgrounds - Neurolief is focused on developing innovative therapies for mental health and neurological disorders, with its Proliv™Rx device designed for home use [4] - BrainsWay is a leader in noninvasive neurostimulation treatments, with a proprietary Deep TMS™ platform and multiple FDA-cleared indications for mental health disorders [5]

Core Insights - CVRx, Inc. has transitioned to Category I Current Procedural Terminology (CPT) codes for its Barostim device, effective January 1, 2026, replacing the previous Category III codes, which is expected to enhance adoption, coverage, and reimbursement for the therapy [1][2][3] Company Overview - CVRx, Inc. is a commercial-stage medical device company that specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - The Barostim device is the first FDA-approved medical technology that utilizes neuromodulation to alleviate symptoms in heart failure patients [3] - Barostim functions by delivering electrical pulses to baroreceptors in the carotid artery, aiming to restore balance to the autonomic nervous system and reduce heart failure symptoms [3] Regulatory and Market Impact - The new Category I CPT codes are anticipated to provide more predictable and consistent reimbursement for healthcare professionals and patients using Barostim therapy [3] - The Barostim device has received FDA Breakthrough Device designation and is approved for use in heart failure patients in the U.S., as well as being compliant with EU Medical Device Regulation and holding CE Mark approval for heart failure and resistant hypertension in the European Economic Area [3]

Company Overview - electroCore is a publicly traded neuromodulation company listed on NASDAQ under the symbol ECOR, focusing on non-invasive vagus nerve stimulation devices [3] - The company was founded in 2006 and has developed into a multi-indication business with 7 FDA authorizations for headache treatments [5] Product and Service Channels - The company operates across three main channels: prescription medical devices for headache and migraine, the Truvaga direct-to-consumer wellness brand, and a specialized military and government division featuring the ruggedized TAC-STIM product [4] - The nVNS platform delivers a two-minute therapy session aimed at rebalancing the autonomic nervous system [3] Market and Clientele - electroCore serves major customers including the U.S. Department of Veterans Affairs and the U.K.'s National Health Service, indicating a strong foothold in both governmental and healthcare sectors [5]

Core Insights - BrainsWay Ltd. (BWAY) has expanded insurance coverage for its Deep TMS therapy in adolescent depression, indicating increased payer confidence in non-drug neurostimulation treatments and enhancing reimbursement visibility for younger patients [1][10]. Company Developments - Optum Behavioral Health has expanded its medical policy to include eligible adolescents, significantly increasing the number of covered lives and reinforcing the clinical acceptance of Deep TMS [2][10]. - The expansion of coverage is expected to strengthen BrainsWay by broadening its reimbursable patient base, improving utilization, and enhancing the lifetime value per system [4]. - BWAY's market capitalization stands at $334.8 million, with projected earnings growth of 100% for the current year [5]. Stock Performance - Following the announcement of the coverage expansion, BWAY shares rose by 10.1% at the market close, with a 53.6% increase over the past six months compared to the industry’s 5.5% growth and the S&P 500's 15.1% gain [3]. Industry Context - The global neuromodulation devices market is projected to grow from $5.80 billion in 2024 to $10.39 billion by 2030, with a CAGR of 8.51% from 2025 to 2030, driven by the rising incidence of chronic pain, neurological disorders, and mental health conditions [13]. - The expansion of Deep TMS coverage is particularly significant given the estimated 5 million adolescents aged 15-21 in the U.S. affected by major depression, a demographic with limited effective treatment options [12]. Future Prospects - BrainsWay is advancing its clinical footprint beyond depression with a new multicenter clinical trial for its next-generation Deep TMS 360 system aimed at treating Alcohol Use Disorder (AUD) [14].

Core Insights - CVRx, Inc. is a commercial-stage medical device company focused on innovative neuromodulation solutions for cardiovascular diseases [3] - The management team will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026, at 3:45 p.m. (PT) [1] - Barostim™ is the first FDA-approved medical technology using neuromodulation to alleviate heart failure symptoms [3] Company Overview - CVRx specializes in developing, manufacturing, and commercializing neuromodulation solutions for patients with cardiovascular diseases [3] - Barostim is an implantable device that delivers electrical pulses to baroreceptors in the carotid artery, aimed at restoring balance to the autonomic nervous system [3] - Barostim has received FDA Breakthrough Device designation and is approved for heart failure patients in the U.S., as well as certified under EU Medical Device Regulation [3] Event Information - A live webcast of the J.P. Morgan Healthcare Conference presentation will be available at ir.cvrx.com, with an archived version accessible for a limited time [2]