Financial Data and Key Metrics Changes - Revenue for Q2 2025 was $564,000, down from $901,000 in the same period last year, with a six-month revenue of $1,300,000 compared to $1,600,000 in the prior year [9] - Gross profit was $245,000 or 43% of revenue in Q2 2025, compared to $470,000 or 52% of revenue in the prior year quarter, with a six-month gross profit of $568,000 or 44% of revenue compared to $940,000 or 58% in the previous year's period [10] - Operating expenses totaled $3,100,000 in Q2 2025, down from $4,300,000 in the prior year period, reflecting a 29% reduction driven by lower expenses across various departments [11] - Net loss for Q2 was $2,800,000 or $0.36 per share, compared to a net loss of $3,800,000 or $8.16 per share in 2024, with a six-month net loss of $6,400,000 compared to $7,400,000 in the same year-ago period [12] Business Line Data and Key Metrics Changes - The Catamaran platform is advancing with real-world adoption in complex spine procedures, supported by FDA clearance for uses in thoracolumbar fixation [4] - The Catamaran SE, a second-generation low-profile implant, is on track for full commercial launch in the coming weeks, with positive feedback from alpha reviews [4] - The company is preparing for initial alpha surgeries using the newly developed Symmetry Plus system, expected to begin in Q4 2025 [5] Market Data and Key Metrics Changes - The strategic acquisition of SciVantage enhances the company's commercial organization and market access, providing new pathways through hospital approval processes and distribution networks [3] - The acquisition is expected to increase active case volume and revenue-generating technologies, contributing to the company's growth trajectory [2] Company Strategy and Development Direction - The company is focused on delivering solutions that promote true biologic fusion and structural stability for patients with sacropelvic disorders, with a commitment to driving value for patients, physicians, and shareholders [14] - The integration of SciVantage is expected to create a more diversified product offering, allowing the company to address various clinical needs in the sacropelvic region [20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in recovering from the recent decline in revenue, anticipating a quick rebound as the integration with SciVantage progresses [28] - The company is optimistic about the upcoming launches of Catamaran SE and Symmetry Plus, which are expected to drive top-line growth [12][44] Other Important Information - The company ended the quarter with $7,800,000 in cash and no debt, providing flexibility to execute its strategic roadmap [12] - The company hosted 16 physician workshops in Q2 to support long-term adoption strategies and accelerate the learning curve for new users [7] Q&A Session Summary Question: How does the acquisition help achieve scale? - Management confirmed that the acquisition provides a pathway to scale and enhances access to hospital systems and contract groups, allowing for a more diversified product offering [17][20] Question: What is the timeline for filing audited financials for the acquisition? - The company indicated a 75-day post-close period to file the audited financials for SciVantage, expected by mid-October [24][27] Question: How should investors view Catamaran revenues in Q3 and Q4? - Management suggested that Q2 was disrupted by the acquisition process but expects a quick recovery in Catamaran revenues moving forward [28][30] Question: What is the reimbursement landscape for the new products? - The new products will participate in existing CPT codes for SI procedures, similar to the Catamaran system, with a focus on supporting technologies with data [40][41] Question: What is the expected impact of the Symmetry Plus launch? - The Symmetry Plus launch is anticipated to begin with alpha surgeries in October, with a full-scale launch expected early next year [44]

Financial Data and Key Metrics Changes - Total GAAP costs and expenses increased by $8.5 million to $20.3 million compared to $11.7 million in the prior year period [20] - GAAP net loss in 2025 was $19.2 million compared to $11.4 million in the prior year period [21] - Cash and cash equivalents totaled $106.3 million as of June 30, 2025, compared to $26.2 million as of June 30, 2024 [21] Business Line Data and Key Metrics Changes - The NSPFA Percutaneous Electrode System is FDA cleared for the ablation of soft tissue, with over 140 patients treated in the pilot program to date [9][12] - Surgeons are transitioning procedures to ambulatory surgery centers (ASC) or operating rooms (OR) for better patient and surgeon experience [10] - The company expects to generate initial revenue from the percutaneous electrode in the second half of the year [23] Market Data and Key Metrics Changes - The market potential for the NSPFA device in benign thyroid disease is significant, with hundreds of thousands of patients in the US alone [7] - The prevalence of thyroid nodules is estimated to be 50% or greater in the population, increasing with age [28] - Approximately 250,000 patients are diagnosed with thyroid issues annually, with 150,000 undergoing thyroidectomy [32] Company Strategy and Development Direction - The company is focused on advancing its NSPFA technology and expanding its market presence through pilot programs and clinical studies [5][19] - A strategic partnership in the electrophysiology space is being pursued to enhance market opportunities [19][39] - The company aims to demonstrate that NSPFA may be a better treatment than surgery for many patients suffering from benign thyroid disease [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical value proposition of NSPFA technology and its potential to transform treatment options [16] - The company anticipates increased cash usage as it invests in commercial infrastructure and clinical studies [22] - Management highlighted the importance of generating high-quality clinical data to support technology adoption and regulatory filings [17] Other Important Information - The company is engaged in a multicenter prospective clinical study to generate additional clinical data for the NSPFA technology [11] - The FDA awarded Breakthrough Device Designation for the Cardiac Surgical Clamp Ablation Device, which is under review for IDE submission [13][14] Q&A Session Summary Question: Can you share some patient baseline characteristics driving the pull through for NSPFA? - Management noted that symptomatic patients with benign nodules often seek therapy due to discomfort and the risks associated with thyroidectomy [28][30] Question: Is the expectation still for a single-arm study for catheter ablation? - Management confirmed it would be a single-arm study for electrophysiology [35] Question: Is Pulse collaborating with a market leader in cardiac ablation? - Management affirmed ongoing partnership discussions with a market leader in cardiac ablation [38][39] Question: How does the ASC opportunity position the NSPFA platform? - Management highlighted that the NSPFA system is well-suited for ASCs due to rapid procedure times and low neuromuscular stimulation [44][46] Question: Will the data collected overseas play into the PMA application for the clamp? - Management confirmed that human data collected will be included in IDE submissions, which is beneficial for FDA approval [53][55]

Core Viewpoint - NeurAxis, Inc. (NRXS) has demonstrated significant revenue growth in Q1 2025, with a notable stock performance compared to the S&P 500, despite reporting a net loss that widened year over year [1][3]. Revenue and Earnings Performance - In Q1 2025, NeurAxis reported revenues of $0.9 million, a 38.5% increase from $0.6 million in the same quarter of the previous year [2]. - Unit sales increased by 46% year over year, driven by higher patient volumes with full insurance reimbursement and financial assistance [2]. Profitability Metrics - The company reported a net loss of $2.3 million, compared to a $2.1 million loss in Q1 2024, resulting in a per-share loss of $0.33 versus $0.32 a year ago [3]. - Gross margin decreased to 84.4% from 88.4% due to a higher proportion of discounted sales and increased manufacturing and shipping costs [3]. Operating Expenses - Operating expenses rose by 26.9% to $3.1 million in Q1 2025 from $2.4 million in the same quarter last year [4]. - Excluding a one-time legal settlement, operating expenses remained relatively flat, indicating effective cost controls [4]. Cash Position and Financial Health - As of March 31, 2025, NeurAxis had cash and cash equivalents of $2 million, down from $3.7 million as of December 31, 2024, with no long-term debt reported [5]. - Net cash used in operations for Q1 2025 was $1.6 million, compared to $1.3 million a year ago [5]. Management Insights - CEO Brian Carrico noted that Q1 2025 marked the third consecutive quarter of robust revenue growth, attributing this to improved billing practices and expanding insurance coverage [6]. - CFO Tim Henrichs indicated that while operating expenses may rise in the short term due to sales and marketing efforts, they are expected to decrease as a percentage of sales [7]. Market Dynamics - Revenue growth was supported by the adoption of NeurAxis' proprietary technology, but pricing pressure from financial assistance patients constrained gross margin expansion [8]. - A one-time legal settlement of $750,000 impacted operating and net losses, but without this charge, net loss would have improved by 22% year over year [9]. Future Outlook - Management is optimistic about revenue acceleration in upcoming quarters, driven by the publication of academic guidelines and the implementation of a permanent CPT code for IB-Stim [11]. - FDA clearance is pending for expanding IB-Stim's indication, which could double the addressable market [12]. Regulatory Developments - NeurAxis achieved regulatory milestones, including a broadened FDA label for IB-Stim and 510(k) clearance for its rectal expulsion device [13]. - The company settled a legacy lawsuit for $750,000, payable over 12 months starting January 2026 [14].

Core Insights - SINTX Technologies is undergoing a disciplined transformation to focus on high-growth medical applications of silicon nitride, aiming for sustainable value creation [2][3] Operational Progress - The company is transitioning from a diversified industrial-ceramics business to a pure-play medical device innovator, targeting large clinical needs in infection resistance and tissue healing [3] - Recent initiatives include improved financial positioning, operational streamlining, and strengthened governance with a reconstituted Board of Directors [4][5][6] Financial Position - As of March 31, 2025, SINTX reported $6.5 million in cash, nearly doubling from $3.6 million at year-end 2024 [8] - The company reduced operating cash burn from $2.7 million in Q1 2024 to $1.3 million in Q1 2025 due to cost optimization efforts [8] - A recent $5 million private placement in February 2025 supports strategic initiatives, with potential to raise an additional $5 million from warrant exercises [8] Strategic Focus Areas - SINTX is strategically aligned around orthopedic implants, spinal fusion devices, dental products, and medical textiles, including wound care and surgical masks [7] - The company is actively developing new R&D programs targeting implantable and antipathogenic products, with ongoing partnerships and licensing discussions with leading medical OEMs [8]