Core Insights - NeurAxis, Inc. has highlighted its achievements in 2024 and outlined its vision for 2025, focusing on establishing itself as a leader in the gastroenterology space [1][2] Company Achievements - In 2024, NeurAxis achieved significant milestones with its IB-Stim therapy, which is the first FDA-indicated treatment specifically for pediatric IBS, prescribed to approximately 1,000 patients [3][4] - The company successfully expanded insurance coverage for IB-Stim to approximately 51 million lives, up from 4 million the previous year, driven by robust peer-reviewed data [4] - NeurAxis received FDA 510(k) clearance for an expanded indication of IB-Stim, now including patients aged 8 to 21 years, increasing the addressable market by over 75% [6] Future Plans - The company plans to submit to the FDA for expanded indications in 2025, including adult IBS and pediatric functional dyspepsia [2] - NeurAxis aims to sustain exceptional revenue growth, manage costs carefully, and strengthen its balance sheet to deliver value to shareholders [2][12] Regulatory and Market Developments - The American Medical Association approved a new CPT Category I code for PENFS procedures, effective January 1, 2026, which is expected to enhance patient access to IB-Stim [7][8] - A systematic review presented by NASPGHAN indicated that NeurAxis's technology has the highest GRADE certainty for pediatric IBS, which is anticipated to drive medical policy coverage and accelerate insurance adoption [9][10] Product Launches - In December 2024, NeurAxis obtained FDA clearance for its Rectal Expulsion Device (RED) as a screening tool for chronic constipation, with positive policy coverage from Medicare and most commercial insurers [11]
NeurAxis Inc. Issues Letter to Shareholders