Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $27.4 million, representing a 30% year-over-year growth compared to $21.1 million in Q3 2024 [4] - RNS revenue was $22.6 million, reflecting a 31% year-over-year growth [4] - Gross margin for Q3 2025 was 77.4%, up from 73.2% in the prior year quarter [18] - Adjusted EBITDA was positive $0.1 million, a significant improvement from negative $1.6 million in Q3 2024 [26] Business Line Data and Key Metrics Changes - RNS System sales drove revenue growth, totaling $22.6 million, with increased procedural volumes and utilization across existing centers [15] - Dixie sales grew 8% to approximately $4 million, but the focus is shifting away from Dixie products as the distribution agreement winds down [16] - Research service revenue was approximately $770,000, tied to ongoing data collaborations [15] Market Data and Key Metrics Changes - All sales regions exceeded planned sales for the quarter, with prescribers, accounts, and utilization reaching all-time highs [5] - Growth was broad-based across geographies, customers, and programs, particularly from Level 4 centers [5] Company Strategy and Development Direction - The company aims for a long-term growth trajectory of at least 20% in its core RNS business [5] - Focus on expanding indications, including pediatric populations and idiopathic generalized epilepsy (IGE) [9][10] - The company is committed to leveraging AI and data analytics to enhance clinical outcomes and support drug development partnerships [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the long-term growth potential, citing strong execution and positive market trends [31] - The company is raising its full-year revenue guidance to a range of $97 million to $98 million, reflecting continued strength in RNS sales [7] - Management highlighted the importance of the RNS system in the evolving landscape of epilepsy care, emphasizing its unique capabilities [11][27] Other Important Information - The company generated positive adjusted EBITDA for the first time in its history, indicating progress towards sustainable profitability [6] - The PMA supplement for the Nautilus study is on track for submission before year-end 2025 [8] Q&A Session Summary Question: Outlook for 2026 and RNS growth - Management indicated confidence in maintaining a growth rate of over 20% for the RNS business, despite the wind-down of Dixie revenues [30][32] Question: Feedback on partnerships and data utilization - Management noted that partnerships are leveraging the unique capabilities of the RNS system to support drug development and personalized medicine [36] Question: Implied growth for Q4 and Dixie impact - Management explained that the expected decline in Dixie sales is the primary reason for the lower implied growth in Q4, but RNS sales are off to a solid start [40][42] Question: PMA submission timeline for Nautilus - The PMA supplement for Nautilus is expected to be submitted before year-end 2025, with a potential approval timeline around mid-2026 [43] Question: Industry awareness and off-label use - Management clarified that there was no significant impact from off-label use related to Nautilus data in the current quarter [51] Question: Growth from market expansion vs. market share - Management believes growth is a combination of both market expansion and increased utilization of RNS technology [52]

Financial Data and Key Metrics Changes - The company reported total revenue of $22,500,000 for Q1 2025, a 24% increase from $18,100,000 in Q1 2024, driven by strong growth in the RNS business [7][15] - Gross margin improved to 77% in Q1 2025 from 73.6% in Q1 2024, primarily due to increased manufacturing efficiency [16] - Net loss decreased to $6,600,000 in Q1 2025 from $8,900,000 in Q1 2024, indicating improved operational performance [18] Business Line Data and Key Metrics Changes - RNS sales increased by 26% year-over-year, and by 29% when excluding Nautilus study implants from Q1 2024 [8][15] - Sales of Dixie Medical SEEG products also contributed to revenue growth during the quarter [15] Market Data and Key Metrics Changes - The company expects a compound annual growth rate (CAGR) of over 20% through 2027, driven by RNS opportunities [14] - The company anticipates minimal revenue impact from the termination of SEEG product distribution in 2025, as remaining inventory will be sold during the transition [13] Company Strategy and Development Direction - The company is focusing on expanding access to RNS therapy, with key initiatives including Project CARE and a refocused product portfolio [8][12] - The company aims to establish the RNS system as the standard of care for drug-resistant epilepsy patients [12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, citing strong adoption of RNS therapy and ongoing clinical development initiatives [9][14] - The company plans to achieve cash flow breakeven by the end of 2027, supported by a strengthened balance sheet following a recent equity raise [18][19] Other Important Information - The company completed a $75,000,000 follow-on equity financing, enhancing its shareholder base [8] - The company is working on expanding indications for pediatric focal epilepsy and has had discussions with the FDA regarding data from the Pediatric Epilepsy Research Consortium [11] Q&A Session Summary Question: Inquiry about gross margin performance - Management confirmed that the strong gross margin of 77% was primarily driven by the RNS business and increased production volumes [24][25][26] Question: Impact of Project CARE on referral volumes - Management noted that Project CARE has positively impacted referral volumes and implants, with increasing referrals from level three and community centers [33][35] Question: Hiring cadence throughout the year - Management indicated consistent investment in the commercial organization to support growth opportunities in core centers and new geographies [36][39] Question: Challenges in training doctors in community settings - Management stated that while support is required for new centers, the organization is experienced in training and supporting new prescribers [44][46] Question: Feedback from physicians on post-approval study data - Management reported positive feedback from physicians regarding the compelling data presented, which is expected to drive engagement and sales [57][60] Question: Exit from Dixie Medical and its implications - Management acknowledged the loss of visibility in the diagnostic process but emphasized the importance of leveraging existing relationships to maintain patient care quality [78][82]

Financial Data and Key Metrics Changes - Total revenue for the first quarter of 2025 was $22,500,000, representing a 24% increase compared to $18,100,000 in the prior year period [5][12] - RNS sales increased by 26%, or 29% when excluding the impact of Nautilus study implants in Q1 2024 [6][12] - Gross margin for the first quarter of 2025 was 77%, up from 73.6% in the same period of 2024 [13] - Net loss for the first quarter of 2025 was $6,600,000, compared to $8,900,000 in the first quarter of 2024 [15] Business Line Data and Key Metrics Changes - RNS system sales were the primary driver of revenue growth, with a 26% increase year-over-year [12][13] - Sales of Dixie Medical SEEG products also contributed to growth, although specific figures were not detailed [12] Market Data and Key Metrics Changes - The company expects a 20% plus compound annual growth rate (CAGR) through 2027, indicating strong market potential for RNS therapy [11] - The company anticipates minimal revenue impact from the termination of SEEG product distribution in 2025, as remaining inventory will be sold during the transition period [11] Company Strategy and Development Direction - The company is focusing on expanding access to RNS therapy, with a record number of prescribers and ongoing momentum from Project CARE [6][10] - Strategic initiatives include a focus on clinical, product, and market development, with plans to establish the RNS system as the standard of care for drug-resistant epilepsy [6][10] - The company is transitioning away from SEEG products to concentrate on higher-margin RNS business opportunities [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the growth trajectory, citing strong execution and strategic initiatives that are expected to drive future performance [12][18] - The company is on track to achieve cash flow breakeven by the end of 2027, supported by a strengthened balance sheet following a recent equity raise [15][11] Other Important Information - The company completed a $75,000,000 follow-on equity financing, enhancing its shareholder base [6][12] - The gross margin for RNS products was particularly strong due to improved manufacturing efficiency [13] Q&A Session Summary Question: Inquiry about gross margin and Dixie revenue - Management confirmed that the strong gross margin was primarily driven by the RNS business, with negligible Dixie revenue impacting the overall margin [20][21] Question: Impact of Project CARE on referral volumes - Management noted increasing referral volumes into level four centers, contributing to growth, and emphasized the importance of Project CARE in expanding access to RNS therapy [28][30] Question: Hiring cadence and personnel investments - Management indicated a consistent approach to hiring, focusing on building the commercial organization to capitalize on growth opportunities [32][34] Question: Difficulty in training doctors for RNS procedures - Management stated that while support is required for new centers, the organization is experienced in training and supporting clinicians [39][41] Question: Feedback from physicians on post-approval study data - Management reported positive feedback from physicians regarding the compelling data presented, which is expected to enhance engagement and sales efforts [51][56] Question: Exit from Dixie and maintaining visibility - Management acknowledged the loss of some visibility but emphasized leveraging existing relationships and knowledge gained from the Dixie partnership [72][75]

Financial Data and Key Metrics Changes - Total revenue for 2024 increased by 22% to $79.9 million compared to $65.4 million in 2023, with record quarterly revenue reported in Q4 [10][31] - Q4 2024 revenue was $21.5 million, representing a growth of 19% compared to $18 million in Q4 2023 [30] - Gross margins for Q4 2024 were 75.4%, slightly up from 75.2% in Q4 2023 [31] - Net loss for Q4 2024 was $5.3 million, an improvement from $6.2 million in Q4 2023 [34] Business Line Data and Key Metrics Changes - Revenue from sales of the RNS system grew by 27% in Q4 2024, excluding contributions from Nautilus study cases [30] - Revenue from Dixie Medical products accounted for approximately 17% of total revenue in 2024, up from 15% in 2023 [31] Market Data and Key Metrics Changes - The core market opportunity within level four comprehensive epilepsy centers is estimated at approximately $2 billion annually [12] - The Project CARE initiative showed positive early trends with increased implants and referrals contributing to revenue growth in the second half of 2024 [13] Company Strategy and Development Direction - The company’s growth strategy focuses on expanding adoption within level four comprehensive epilepsy centers, expanding service delivery through Project CARE, and expanding indications for the RNS system [11] - The company is advancing several key development programs, including studies for idiopathic generalized epilepsy and pediatric focal epilepsy [15][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving a revenue growth rate of over 20% annually and reaching cash flow breakeven in the next three years [41] - The company anticipates total revenue for 2025 to be in the range of $92 million to $96 million, representing a growth of approximately 15% to 20% over 2024 [37] Other Important Information - The company completed a public offering with net proceeds of approximately $69.8 million, which included a repurchase of shares from an early investor [35][26] - The company plans to release its first AI-enabled software with an AI-powered seizure classifier to enhance treatment efficiency [23] Q&A Session Summary Question: Guidance for 2025 - Management discussed factors influencing revenue guidance, including execution of the three-part strategy and expansion of Project CARE [44][45] Question: Impact of Project CARE - Management noted meaningful impacts from Project CARE, with increased referrals and implants observed in Q4 [48] Question: Capital Prioritization - Management emphasized investment in expanding adoption within level four centers and direct-to-consumer efforts as key priorities for 2025 [53][54] Question: Gross Margin Trends - Management highlighted ongoing volume increases and pricing opportunities as primary drivers for gross margin improvement [58][61] Question: Indication Expansion and Reimbursement - Management confirmed established reimbursement for current indications and plans to work with payers to expand coverage for new indications [66] Question: Revenue Cadence for 2025 - Management expects a steady progression of growth, similar to previous years, with potential acceleration in the second half of the year [70] Question: Project Care and Multiple Implants - Management confirmed seeing multiple implants from new accounts and noted viable economics for RNS outside level four centers [75][76] Question: Pediatric Indication and Service Dynamics - Management explained that pediatric treatment dynamics would be similar to adult patients, focusing on the type of epilepsy rather than age [96] Question: Manufacturing Capacity - Management stated that the company is well-prepared from a manufacturing capacity perspective [99] Question: Nautilus Study Data Presentation - Management indicated plans for a high-profile publication and presentation of Nautilus study data in the second half of 2025 [106][108]