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]