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Core Viewpoint - NeurAxis, Inc. reported strong financial growth in Q1 2025, with a 39% year-over-year revenue increase, driven by expanding treatment access and positive payer coverage for its neuromodulation therapies [4][7]. Financial Highlights - Revenues for Q1 2025 reached $896 thousand, up from $647 thousand in Q1 2024, marking a 39% increase year-over-year and an 18% increase quarter-over-quarter [7][9]. - Operating loss improved by 9% when excluding a one-time legal settlement, with a reported operating loss of $2.3 million, an increase of 25% compared to $1.8 million in Q1 2024 [12][13]. - Cash balance as of March 31, 2025, was $2.0 million, with no long-term debt [14]. Operational Highlights - The company treated 300 patients in Q1 2025, indicating an annualized treatment rate of 1,200 patients, which is still a small fraction of the 600,000 children in the U.S. suffering from IBS [4][6]. - Positive coverage policies now encompass approximately 51 million lives, a significant increase from 4 million as of December 31, 2023 [5][7]. - NeurAxis received FDA clearance for expanding the IB-Stim label to include patients aged 8-21 and for its rectal expulsion device (RED), which is expected to generate meaningful revenues starting in Q2 2025 [7][8]. Management Commentary - The CEO highlighted that the growth is attributed to physicians becoming more comfortable with billing processes and increased awareness of treatment guidelines [5][6]. - The company anticipates that the upcoming publication of academic society guidelines and the implementation of a Category I CPT code on January 1, 2026, will be critical for expanding insurance coverage and driving national growth [6][9]. Market Position - NeurAxis is focused on expanding its pediatric addressable market and has submitted for FDA clearance to include pediatric Functional Dyspepsia, which could effectively double its market size [8]. - The company is committed to clinical research, with 16 peer-reviewed publications supporting its PENFS technology, enhancing its position for expanding payer coverage [7].

Core Insights - CVRx, Inc. reported financial results for Q1 2025, showing a revenue increase of 15% year-over-year to $12.3 million, driven by growth in the U.S. heart failure market and the addition of new sales representatives [4][11]. Financial Performance - Total revenue for Q1 2025 was $12.3 million, up from $10.8 million in Q1 2024, marking a 15% increase [4][11]. - U.S. revenue was $11.2 million, a 14% increase from $9.8 million in the same quarter last year [5][11]. - Heart failure (HF) revenue in the U.S. reached $11.1 million, up from $9.7 million, with HF revenue units increasing from 319 to 353 [5][11]. - European revenue was $1.1 million, a 23% increase from $0.9 million in Q1 2024, with revenue units rising from 44 to 59 [7][11]. - Gross profit for Q1 2025 was $10.3 million, a 13% increase from $9.2 million in Q1 2024, resulting in a gross margin of 84% [8][11]. Operating Expenses - Research and development (R&D) expenses decreased by 18% to $2.5 million, primarily due to reduced consulting and stock-based compensation expenses [9]. - Selling, general and administrative (SG&A) expenses decreased by 25% to $21.2 million, largely due to a significant reduction in non-cash stock-based compensation [10]. Net Loss and Cash Position - The net loss for Q1 2025 was $13.8 million, or $0.53 per share, compared to a net loss of $22.2 million, or $1.04 per share, in Q1 2024 [14][26]. - As of March 31, 2025, cash and cash equivalents stood at $102.7 million, with net cash used in operating and investing activities amounting to $12.9 million [15]. Business Outlook - For Q2 2025, the company expects total revenue to be between $13.0 million and $14.0 million [17]. - For the full year 2025, total revenue is projected to be between $55.0 million and $58.0 million, with a gross margin between 83% and 84% [20]. Clinical Evidence - Recent clinical data presented at the THT conference indicated that Barostim treatment led to an 85% reduction in heart failure hospital visits, an 84% reduction in cardiovascular hospital visits, and an 86% reduction in all-cause hospital visits [16]. Market Presence - As of March 31, 2025, CVRx had 227 active implanting centers in the U.S., an increase from 223 at the end of 2024, while the number of sales territories decreased to 45 [6].

LivaNova (LIVN) Q1 2025 Earnings Call May 07, 2025 08:00 AM ET Company Participants Briana Gotlin - VP-IRVladimir Makatsaria - CEOAhmet Tezel - Chief Innovation OfficerAlex Shvartsburg - Chief Financial OfficerRick Wise - Managing Director - Medical Technology & SuppliesDavid Roman - Managing DirectorStephanie Bolton - President of Global Epilepsy Conference Call Participants Adam Maeder - Senior Research AnalystMichael Sarcone - AnalystMike Matson - Senior Equity Research AnalystDavid Rescott - Senior Rese ...

Financial Data and Key Metrics Changes - The company achieved $317 million in revenue for Q1 2025, reflecting a 9% increase on a constant currency basis and a 10% increase on an organic basis compared to the prior year [29] - Adjusted operating income rose to $65 million, up from $53 million in Q1 2024, resulting in an adjusted operating income margin of 20% compared to 18% in the prior year [31] - Adjusted diluted earnings per share increased to $0.88 from $0.73 in Q1 2024, driven by operating income growth [32] - Cash balance at March 31 was $738 million, up from $429 million at year-end 2024, primarily due to the reclassification of $295 million of restricted cash [32][33] Business Line Data and Key Metrics Changes - Cardiopulmonary segment revenue was $176 million, a 15% increase year-over-year, with heart-lung machine revenue growing approximately 30% [11] - Epilepsy segment revenue increased by 4%, with U.S. revenue growth at 2% and Europe and rest of world regions combined growth at 13% [14][16] - The company expects cardiopulmonary revenue to grow 9% to 10% for the full year 2025, up from a previous forecast of 7% to 8% [12] Market Data and Key Metrics Changes - The company reported strong demand for oxygenated products, with growth in the high single digits driven by customer demand and pricing [11] - The U.S. epilepsy business faced procedure deferrals due to a voluntary field safety notification, impacting revenue by less than $2 million [15] - The company anticipates low single-digit growth in the U.S. epilepsy market, with Europe and rest of world regions expected to grow in low double digits [16] Company Strategy and Development Direction - The company is focused on expanding its portfolio into areas of high unmet clinical need, particularly in neuromodulation and OSA [52][43] - The company is investing in additional manufacturing capacity to support growth in cardiopulmonary products and anticipates sustaining double-digit growth in heart-lung machines [13][58] - The company is pursuing Medicare coverage for VNS therapy for treatment-resistant depression, which represents a significant growth opportunity [27][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to manage tariff impacts, estimating a negligible effect on adjusted operating income for the year [39][40] - The company believes the Italian Supreme Court's decision regarding the SNEA matter effectively removes a long-standing overhang, allowing for greater capital allocation flexibility [37][43] - Management raised the overall organic growth outlook by 100 basis points to between 7% and 8% for 2025, reflecting strong first-quarter performance [19] Other Important Information - The company recorded a liability of $360 million related to the SNEA litigation, which is expected to impact adjusted diluted earnings per share by approximately $0.20 for the remainder of 2025 [36][37] - The company is implementing a tariff mitigation plan that includes a holistic assessment of its supply chain and potential pricing actions [38][39] Q&A Session Summary Question: Can you help us frame where the OSSPREY data puts you on a market competitive basis? - Management highlighted the strength of the clinical data, noting that the trial enrolled more severe patients and achieved a rapid therapeutic response, with 65% of patients responding at twelve months [47][48] Question: What is the outlook for the HLM business and Essence placement rollout? - Management indicated that Essence represented 40% of all HLM placements in 2024 and is expected to reach 60% in 2025, with strong demand and regulatory approvals in new markets like China [58][59] Question: Can you provide more detail on the U.S. Neuromodulation business and updated guidance? - Management noted improved commercial execution in Europe and rest of the world, with a focus on maximizing VNS therapy access in the underpenetrated drug-resistant epilepsy population [64][66] Question: What is the impact of tariffs on guidance? - Management confirmed that the estimated tariff impact on adjusted operating income is less than $5 million, with mitigation strategies potentially offsetting some costs [70][74] Question: How does the company view its leverage ratio and capital allocation flexibility? - Management stated that the leverage ratio is healthy, allowing for continued investment in core businesses and potential inorganic growth opportunities [88][90]

Core Insights - ReShape Lifesciences is presenting pre-clinical data on its proprietary Diabetes Neuromodulation device at the 12th Annual Minnesota Neuromodulation Symposium, showcasing a novel approach to treating diabetes and hypoglycemia without cardiac side effects [1][4] Group 1: Technology and Mechanism - The Diabetes Neuromodulation technology employs Hypoglycemia Vagus Nerve Stimulation (HVNS) to stimulate the sub-diaphragmatic posterior vagus nerve, effectively increasing blood glucose levels during hypoglycemic episodes [3] - HVNS demonstrated the ability to raise blood glucose levels from a baseline of 45 mg/dL to 58 mg/dL and from 51 mg/dL to 68 mg/dL in a Type 1 diabetic swine model after 30 minutes of stimulation [3] - The technology avoids impacting heart rate, blood pressure, or respiration, addressing limitations of conventional vagal stimulation techniques [3][7] Group 2: Clinical Data and Efficacy - Pre-clinical results showed that HVNS increased glucagon levels from 4.1 pmol/L to 12.3 pmol/L and from 3.5 pmol/L to 7.6 pmol/L, indicating a significant physiological response [3] - The mean heart rate remained stable during stimulation, with vomiting only observed at higher amplitudes, suggesting a clear therapeutic window for effective treatment [3] Group 3: Future Development and Market Potential - The company plans to seek non-dilutive funding and collaborate with leading researchers and corporate partners to advance the commercialization of the Diabetes Neuromodulation device [4] - The ReShape Diabetes Neuromodulation system is positioned as a minimally invasive alternative to traditional diabetes management methods, potentially improving the quality of life for individuals with Type 1 or Type 2 diabetes [5][8]

Core Insights - electroCore, Inc. announced new data at the 2025 International Brain Injury Association World Congress, highlighting the effectiveness of gammaCore® non-invasive vagus nerve stimulation (nVNS) in treating concussive symptoms associated with mild traumatic brain injury (mTBI) [1][3] Study Findings - A study involving 102 patients with mild TBI showed that adjunctive use of gammaCore (nVNS) significantly improved 22 out of 27 measured concussive symptoms, with notable improvements in post-traumatic headache, nausea, dizziness, and depression [3] - The study indicated no significant difference in symptom improvement between patients with recent traumatic brain injuries (three months or less) and those with older injuries (three years or more), suggesting the potential benefits of neuromodulation regardless of the time since injury [3] Expert Commentary - Dr. Michael Ament emphasized the urgent need for nonpharmaceutical treatment options for mild TBI, reinforcing the role of vagus nerve stimulation in alleviating long-term effects [2][4] - Dr. Peter Staats, Chief Medical Officer of electroCore, praised Dr. Ament's research for demonstrating the clinical efficacy of gammaCore in improving concussive symptoms in a large patient cohort [4] Company Overview - electroCore, Inc. is a commercial-stage bioelectronic medicine and wellness company focused on improving health through its nVNS technology platform, aiming to commercialize medical devices for managing and treating specific medical conditions [5]

New patent underscores breadth of application and expansion opportunities for Company's catheter-based technology Continued progress with growing global patent portfolio to over 80 issued patents and 40 pending patent applications THE WOODLANDS, TX, April 16, 2025 (GLOBE NEWSWIRE) -- Autonomix Medical, Inc. (NASDAQ:AMIX) ("Autonomix" or the "Company"), a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated, t ...

Core Viewpoint - NeurAxis, Inc. is set to present at the Planet MicroCap Showcase: VEGAS 2025, highlighting its focus on neuromodulation therapies for chronic conditions in both children and adults [1][2]. Company Overview - NeurAxis, Inc. specializes in medical technology aimed at neuromodulation therapies to treat chronic and debilitating conditions [3]. - The company is advancing its proprietary IB-Stim™ therapy, which utilizes Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, and is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [3]. - Ongoing clinical trials are being conducted for PENFS in various pediatric and adult conditions with significant unmet healthcare needs [3]. Event Details - The presentation will take place on April 23, 2025, at 11:00 AM EST during the Planet MicroCap Showcase: VEGAS 2025 [1][2]. - Investors interested in one-on-one meetings with NeurAxis can register for the event, which will be held at the Paris Hotel & Casino in Las Vegas, NV [2].

Core Viewpoint - CVRx, Inc. anticipates first quarter 2025 revenue of approximately $12.3 million, reflecting a growth of about 15% compared to the same period in 2024, despite falling short of expectations due to seasonal factors and the integration of new sales representatives [1][2][3]. Financial Performance - Expected total revenue for Q1 2025 is approximately $12.3 million, up from $10.8 million in Q1 2024, indicating a 15% increase [3]. - Q1 2024 revenue breakdown includes approximately $11.2 million from the U.S. and $1.1 million from Europe [3]. Sales and Market Strategy - The company is focused on enhancing Barostim adoption through a strengthened sales organization, having recruited new high-quality sales representatives [2]. - The first quarter of 2025 experienced seasonal softness, affecting revenue as patients scheduled procedures around insurance coverage and deductibles [2]. Operational Metrics - As of March 31, 2025, CVRx had 227 active implanting centers in the U.S., an increase from 223 as of December 31, 2024 [4]. - The number of sales territories in the U.S. decreased by 3 to a total of 45 during the first quarter of 2025 [4]. Cash Position - As of March 31, 2025, the company reported cash and cash equivalents of $102.7 million [4]. - During the first quarter, CVRx issued 543,462 shares of common stock for gross proceeds of $9.5 million under its at-the-market offering [4]. Upcoming Events - The company plans to release its full financial and operating results for Q1 2025 after market close on May 8, 2025, followed by a conference call at 4:30 p.m. Eastern Time [5][6].