NeuroOne Medical Technologies Corporation has reported financial results for the first quarter of fiscal year 2026, revealing substantial progress across its medical technology platforms for neurological disorders. The company projects product revenue of at least $10.5 million for the full fiscal year, representing a minimum 17% increase compared to fiscal 2025. This growth projection follows a quarter where nearly 50% of all ablations since the OneRF® Ablation System product launch in 2024 were performed, indicating accelerating adoption of the company's technology.
The company's expansion into new treatment markets represents a significant development in neurological care. Following FDA 510(k) clearance for the OneRF® Trigeminal Nerve Ablation System to treat facial pain, NeuroOne has successfully completed nine cases to date, with all patients reportedly pain free. This clearance came ahead of schedule and validates the OneRF® technology platform while offering alternatives to pharmaceutical and invasive surgical treatments for facial pain. The company is evaluating distribution strategies for this system, with limited market release expected by the end of the second quarter of fiscal 2026.
NeuroOne has advanced discussions with potential tier-one strategic partners for multiple systems, including the Trigeminal Neuralgia Ablation System for facial pain, Basivertebral Nerve Ablation System for lower back pain, and percutaneous paddle lead for lower back pain. These partnerships could accelerate growth in completely new markets for the company. The Basivertebral Nerve Ablation System has been validated through multiple advisory board meetings with leading pain specialists who confirmed the system's benefits. More information about the company's technology portfolio can be found at https://nmtc1.com.
Operational milestones include progress on the sEEG-Based Drug Delivery Program, which is expected to be commercial-ready for use in investigational clinical studies or animal studies in the third quarter of fiscal 2026, six months ahead of schedule. The company is establishing a physician advisory board to evaluate treatment of glioblastomas and focusing on brain tumors, gene and cell-based therapies. For spinal cord stimulation, NeuroOne is initiating a 6-month animal study in the second quarter of fiscal 2026 in preparation for first-in-man studies, with the system having been displayed at professional meetings including the Business of Pain Meeting and NANS meetings.
Financial results for the first quarter show product revenue of $2.9 million, a 5.5% sequential increase from the fourth quarter of fiscal 2025. Product gross profit was $1.6 million, or 54.2% of revenue, while total operating expenses were $3.3 million. The company reported a net loss of $1.4 million, or ($0.03) per share, compared to net income of $1.8 million in the same quarter of the prior year. NeuroOne ended the quarter with cash and cash equivalents of $3.6 million and believes it is funded through fiscal 2026, potentially longer if certain milestones are achieved.
CEO Dave Rosa emphasized the company's momentum, stating that progress across all target markets leveraging the OneRF® platform technology has accelerated. "With a record number of ablations performed in the first quarter of fiscal 2026, we've demonstrated the continued expansion and real-world benefits of our technology," Rosa said. The company's intellectual property portfolio has expanded to include 13 issued and pending patents in the U.S. and 4 internationally, strengthening its competitive position in the neurological treatment market.
