Summary of NeurAxis Conference Call Company Overview - NeurAxis is a growth-stage medtech company focused on pediatric gastrointestinal (GI) conditions, specifically functional abdominal pain and functional dyspepsia in children aged 8 to 21 years [4][9] - The company has two FDA indications: one for functional abdominal pain and another for functional dyspepsia, which includes nausea symptoms [4][9] - The technology used is a percutaneous electrical nerve field stimulator, which operates for four weeks with significant data supporting its efficacy at six and twelve months post-treatment [5][6] Unmet Medical Need - There is a significant unmet need in treating functional abdominal pain and functional dyspepsia, with no FDA-approved treatments available for 30 to 50 years [8][9] - Current treatment options include medications with FDA black box warnings, which are often undesirable for both parents and physicians [8][9] - Approximately 6 million children in the U.S. suffer from functional abdominal pain, with 600,000 being severely affected, missing three or more days of school per week [10][11] Market Opportunity - The total addressable market for NeurAxis is estimated at $5 billion, based on a treatment cost of approximately $5,000 per patient for the 1 million debilitated children [11] - The company has seen organic growth of about 40% per quarter, but penetration remains low at around 0.2% to 1% [30][31] Challenges and Solutions - Major challenges include lack of insurance coverage and reimbursement for the technology, which hampers scaling efforts [13][14] - A Category I CPT code is set to take effect on January 1, 2026, which is expected to streamline billing and improve reimbursement for physicians [17][18] - The proposed RVU for the CPT code is 1.46, which is viewed positively by physicians [17] Insurance Coverage and Guidelines - NeurAxis has made progress with insurance coverage, with approximately 55 million covered lives under various plans, including strong Blue Cross Blue Shield policies [23] - The publication of guidelines by NASPGHAN recommending IB-Stim as a treatment has bolstered the company's position in discussions with payers [25][26] Commercial Strategy - NeurAxis is building a commercial infrastructure to drive utilization, including hiring experienced personnel and leveraging key opinion leaders (KOLs) for outreach [32][33] - The company aims to establish IB-Stim clinic days in children's hospitals to facilitate treatment for multiple patients [35][36] - The focus is on increasing penetration in existing accounts and ensuring that hospitals are prepared for the launch of the CPT code [37][41] Financial Outlook - The company anticipates that the implementation of the Category I CPT code and improved insurance coverage will significantly enhance revenue potential [41][44] - There is cautious optimism regarding the speed of uptake post-launch, with expectations for a substantial increase in patient treatment [44] Conclusion - NeurAxis is positioned for growth with the upcoming CPT code and increasing insurance coverage, aiming to address a critical unmet need in pediatric GI treatment [45]
NeurAxis (NYSEAM:NRXS) 2025 Conference Transcript