Core Insights - NeurAxis, Inc. reported strong revenue growth in Q2 2025, with revenues increasing 46% year-over-year to $894 thousand, compared to $612 thousand in Q2 2024 [8][9] - The company achieved significant operational milestones, including FDA clearance for expanded indications and a new CPT code for reimbursement, which are expected to drive future revenue growth [6][7] Financial Highlights - Revenues for Q2 2025 were $894 thousand, a 46% increase from $612 thousand in Q2 2024 [8][9] - Operating expenses decreased by 10% year-over-year to $2.5 million in Q2 2025 from $2.7 million in Q2 2024 [11] - Operating loss improved by 22% to $1.7 million in Q2 2025 from $2.2 million in Q2 2024 [12] - Net loss decreased by 42% to $1.7 million in Q2 2025 from $2.9 million in Q2 2024 [13] - Cash balance as of June 30, 2025, was $6 million, bolstered by a $5 million equity financing round [14] Operational Highlights - The company is approaching a major inflection point with national insurance coverage, as a new CPT code for IB-Stim is set to take effect on January 1, 2026 [6] - NeurAxis secured FDA clearance to expand IB-Stim's indication to include pediatric Functional Dyspepsia, significantly increasing its total addressable market [7] - The company expanded its total covered lives to approximately 53 million [8] Management Commentary - CEO Brian Carrico expressed optimism about the company's trajectory, highlighting strong revenue growth and the focus on expanding insurance coverage and commercializing IB-Stim [4] - The company is confident in achieving breakeven in 2026 based on strong top-line momentum and strategic positioning [9]

Core Insights - NeuroPace announced promising preliminary one-year results from its pivotal NAUTILUS trial, evaluating the RNS System for idiopathic generalized epilepsy (IGE), marking a significant milestone in neuromodulation therapy [1][2] - The trial's strong enrollment and retention rates position NeuroPace to expand its therapeutic reach and enhance its clinical value proposition, supporting potential FDA submission [2][4] Company Performance - Following the announcement, NeuroPace's shares fell by 28.4%, closing at $12.66, although the stock has gained 13.1% year-to-date compared to the industry's 11.2% decline [3] - The company currently has a market capitalization of $579.9 million and expects earnings to improve by 6.5% in 2025 year-over-year [5] NAUTILUS Trial Details - The NAUTILUS trial is a pivotal Phase 3 study assessing the safety and effectiveness of the RNS System in patients aged 12 and older with drug-resistant seizures, with 87 patients enrolled across 23 centers [6][8] - The trial met its primary safety endpoint, reporting a low incidence of serious adverse events, while a subgroup with lower baseline seizure frequency showed significant therapeutic benefits [9][10] Clinical Outcomes - The one-year data from the trial demonstrated consistent clinical improvements, including a robust median seizure reduction and increased responder rates, with improvements continuing into the second year [10]

Core Viewpoint - NeurAxis, Inc. is set to release its financial results for the first quarter of 2025 on May 12, 2025, before market open, followed by a conference call to discuss the results [1]. Financial Results Announcement - The financial results will cover the period ended March 31, 2025 [1]. - A conference call is scheduled for May 12, 2025, at 9:00 a.m. Eastern Time to review the results [1]. Conference Call Details - Interested parties can access the conference call via a live webcast available on the Company's Investor Relations website [2]. - Participants can submit questions through the webcast portal or via email [2]. - Call-in participants must register to receive dial-in information and a unique PIN [3]. Company Overview - NeurAxis, Inc. focuses on neuromodulation therapies for chronic and debilitating conditions in both children and adults [4]. - The company is advancing its proprietary IB-Stim™ therapy, which is FDA cleared for treating functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents aged 8-21 [4]. - Additional clinical trials for PENFS technology are ongoing for various pediatric and adult conditions with significant unmet healthcare needs [4].