NeurAxis Earnings Call Transcripts
Fiscal Year 2026
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The company reported record Q1 revenue and strong gross margins, driven by expanded insurance coverage and a new Category 1 CPT code. Commercial efforts are focused on pediatric and VA markets, with new hires and resumed commercialization of the RED device supporting growth.
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Q1 2026 revenue grew 80% year-over-year to $1.6 million, with gross margin expanding to 86.4% and cash burn declining. Commercial focus is on deepening adoption in covered pediatric markets and expanding VA presence, while payer coverage and execution remain key growth drivers.
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Significant milestones include a new Category I CPT code, expanded insurance coverage, and strong clinical data supporting a non-drug device for pediatric and adult GI disorders. Financials show solid margins and a clear path to profitability, with a focus on scaling coverage and revenue.
Fiscal Year 2025
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Q4 2025 saw double-digit revenue growth and major milestones, including expanded payer coverage and a new CPT code. Gross margins remained strong despite product mix shifts, and liquidity improved with new capital raised. Execution focus and expanding policy coverage are expected to drive further growth.
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Q3 2025 saw 22% revenue growth and the fifth straight quarter of double-digit gains, driven by IB-STIM adoption and FDA label expansion. The new Category 1 CPT code effective in 2026 is expected to accelerate adoption and improve margins, with cash runway into H2 2026.
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IB-Stim is the first FDA-cleared treatment for pediatric functional abdominal pain and dyspepsia, addressing a major unmet need. With new NASPGHAN guideline support, a Category I CPT code effective January 2026, and expanding insurance coverage, significant market penetration and revenue growth are expected.
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Q2 2025 saw 46% revenue growth, major milestones including FDA indication expansion, and assignment of a favorable Category I CPT code. Gross margin declined due to discounting, but profitability and cash flow breakeven remain on track as insurance coverage expands and new policies take effect.
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A neuromodulation company is expanding its pediatric GI therapy indications, supported by strong clinical data, a new Category 1 CPT code effective in 2026, and growing insurance coverage. Recent capital raises ensure over a year of runway as the company prepares for major growth catalysts.
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Double-digit revenue growth continued in Q1 2025, driven by IB-Stim and RED, with expanding insurance coverage and a new Category I CPT code set to accelerate future growth. Gross margin remains strong, and cash flow break-even is targeted as key academic guidelines and policy coverage are expected soon.
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Achieved a key regulatory milestone with a category one CPT code effective 2026 and expanded insurance coverage to 51 million lives. Strong clinical data and a growing pipeline support significant market opportunity, with profitability in sight and new product launches underway.
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A med tech firm with two FDA indications and a flagship pediatric device is rapidly expanding insurance coverage and achieved a category one CPT code effective January 2026. Q3 and Q4 2024 saw revenue growth of 40% and 50%, with further growth expected as insurance and reimbursement milestones are met.
Fiscal Year 2024
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Q4 2024 saw 43% revenue growth and expanded insurance coverage to 51 million lives. Category I CPT code and FDA label expansion position the company for accelerated growth, with breakeven targeted at $10–$12 million in annual revenue.
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Q3 2024 saw 40% revenue growth and a 50% increase in unit sales, driven by expanded insurance coverage and key regulatory milestones. The company expects accelerated growth and profitability in 2025, supported by the upcoming RED launch and further insurance adoption.
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A pediatric med tech firm is commercializing a non-drug device for GI disorders, supported by strong clinical data and growing insurance coverage. With a robust pipeline, FDA submissions, and a focus on profitability by early 2025, significant revenue growth is anticipated.
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Insurance coverage for IB-Stim expanded significantly, driving optimism for revenue acceleration in late 2024 and profitability in Q1 2025. Q2 revenue declined 5% year-over-year, but unit sales rose 16%. RED device commercialization is expected late 2024.