On January 13, 2025, NeurAxis, Inc. CEO Brian Carrico issued a letter to shareholders, summarizing the company's significant achievements in 2024 and outlining its vision for 2025. The letter emphasized the company's focus on driving growth for IB-Stim and advancing the commercialization of the Rectal Expulsion Device (RED).
In 2024, IB-Stim was prescribed for approximately 1,000 IBS patients, and insurance coverage for the PENFS technology expanded significantly to approximately 51 million lives, a substantial increase from 4 million a year prior. Key milestones included FDA 510(k) clearance in November for an expanded IB-Stim indication (ages 8-21, four-week treatment) and the American Medical Association's approval of a new CPT Category I code for PENFS procedures, effective January 1, 2026.
The letter also highlighted the December 2024 FDA 510(k) clearance for the RED device, which benefits from an existing Category I CPT code and positive policy coverage by Medicare and most commercial insurers, with initial revenues expected in the first quarter of 2025. NeurAxis aims to achieve cash flow breakeven in 2026, supported by robust sales growth and recent investments from life science-focused funds.
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