Neuraxis, Inc. reported a net loss of $7.8 million for the fiscal year ending December 31, 2025, a slight improvement from the $8.2 million loss recorded in the previous year. The company's revenue increased by 32.9% to $3.57 million, up from $2.69 million in 2024, primarily driven by sales of its IB-Stim device and the introduction of the RED device. The gross profit also rose to $3 million, although the gross margin decreased from 86.5% to 84.2%, attributed to higher discounts offered through financial assistance programs for uninsured patients.
In terms of operational developments, Neuraxis has made significant strides in expanding its product offerings and market presence. The company launched the RED device in 2025, which is designed to evaluate neuromuscular function in patients with chronic constipation. Additionally, Neuraxis has received a Category I CPT code for its PENFS procedures, effective January 1, 2026, which is expected to enhance reimbursement prospects and facilitate broader adoption of its products. The company has established its IB-Stim device in approximately 80 children's hospitals across the U.S., targeting a market with significant unmet needs in pediatric gastrointestinal disorders.
Neuraxis has also focused on enhancing its internal controls and compliance measures, particularly in light of identified material weaknesses in its financial reporting processes. The company has taken steps to address these issues by hiring additional accounting personnel and implementing a dedicated internal control manager. As of December 31, 2025, Neuraxis had 24 full-time employees, reflecting its commitment to building a robust operational framework to support future growth.
Looking ahead, Neuraxis aims to continue its expansion into new markets and indications, including post-concussion syndrome and fibromyalgia pain. The company is actively pursuing additional FDA clearances for its products and plans to leverage its existing clinical data to support these efforts. However, Neuraxis acknowledges the challenges it faces, including the need for ongoing regulatory compliance and the potential impact of market competition on its growth trajectory. The company’s future capital requirements will depend on its ability to secure additional funding and achieve widespread insurance coverage for its products, which remains a top priority.
About Neuraxis, INC
Neuraxis, Inc. develops neuromodulation medical devices targeting pediatric and adult gastrointestinal and neurological conditions. Its core products include FDA-cleared non-invasive nerve stimulation systems for functional abdominal pain, IBS, and related disorders. The company leverages proprietary patents, clinical research, and strategic licensing to provide evidence-based, non-drug therapies that improve patient outcomes, primarily serving hospitals, clinics, and healthcare providers in the US and globally.
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