NeuroOne Reports Strong Q1 2026 Adoption and Expansion into New Pain Treatment Markets

NeuroOne Medical Technologies Corporation reported significant progress in its first quarter fiscal 2026 results, with the company expecting product revenue of at least $10.5 million for the full fiscal year, representing a minimum 17% increase over fiscal 2025. The company's OneRF® Ablation System demonstrated accelerating adoption, with nearly 50% of all ablations since the product's 2024 launch performed in the first quarter of fiscal 2026 alone. This momentum follows the FDA 510(k) clearance for the OneRF® Trigeminal Nerve Ablation System to treat facial pain, where NeuroOne has successfully completed nine cases to date, with all patients reportedly pain free.

The company's expansion into new markets represents a significant development in pain treatment alternatives. Following the FDA clearance received ahead of schedule, NeuroOne has advanced discussions with potential tier-one strategic partners for multiple systems targeting completely new markets. These include the OneRF® Trigeminal Neuralgia Ablation System for facial pain, Basivertebral Nerve Ablation System for lower back pain, and percutaneous paddle lead for lower back pain. The company confirmed the validity and potential opportunity for the Basivertebral Nerve Ablation System based on multiple meetings with advisory board pain specialists, while key opinion leaders validated the system's benefits.

NeuroOne's intellectual property portfolio continues to expand, with the company securing key patents in the U.S. and Europe that now include 13 issued and pending patents in the U.S. and 4 internationally. The drug delivery system targeting is expected to be commercially available for use in investigational clinical studies or animal studies in Q3 fiscal 2026 due to expedited progress, six months ahead of schedule. The company is establishing a physician advisory board to evaluate the treatment of glioblastomas, focusing on brain tumors, gene and cell-based therapies, with FDA regulatory pathway strategy in process.

Operational highlights include a record number of patients treated with the OneRF® brain ablation system in Q1 fiscal 2026, with doctors from the Mayo Clinic in Jacksonville, Florida providing positive experience with the system at Zimmer's booth at the American Epilepsy Society Meeting in December 2025. The company continues to make progress on ISO 13485 certification for Outside the U.S. distribution, with a second audit scheduled in April 2026 with their notified body. For the spinal cord stimulation percutaneous paddle lead program, NeuroOne is initiating a 6-month animal study in the second quarter of fiscal 2026 in preparation for first-in-man study, with the system displayed and papers presented at the Business of Pain Meeting and NANS meetings.

Financial results for the first quarter show product revenue of $2.9 million, compared to $3.3 million in the same quarter of the prior year, with the slight decrease attributed to the initial stocking order from Zimmer that occurred in the first quarter of fiscal 2025. On a sequential basis, product revenue increased 5.5% compared to $2.7 million in 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, or $0.06 per share, in the same quarter of the prior year, with the prior year including license revenue of $3.0 million related to the distribution license granted to Zimmer.

As of December 31, 2025, NeuroOne had cash and cash equivalents of $3.6 million, compared to $6.6 million as of September 30, 2025, with the company believing it is funded through fiscal 2026, potentially longer if certain milestones are hit. Working capital stood at $6.8 million, with no debt outstanding. The company's progress across multiple therapeutic areas demonstrates the expanding application of its OneRF® platform technology, offering alternatives to pharmaceutical and invasive surgical treatments for neurological disorders and pain conditions. Management expressed confidence in delivering technologies that offer both patient and physician benefits compared to competing systems, with limited market release for the OneRF® Trigeminal Nerve Ablation System expected to be completed by the end of the second quarter of fiscal 2026.