NeuroOne Medical Technologies Corporation has released financial results for the first quarter of fiscal year 2026 ended December 31, 2025, alongside substantial business updates highlighting clinical progress and market expansion. The company expects product revenue to reach at least $10.5 million in fiscal year 2026, representing a minimum 17% increase compared to the $9.1 million reported in fiscal 2025.
Clinical achievements formed a significant portion of the update, with nearly 50% of all ablations performed since the OneRF® Ablation System product launch in 2024 occurring during the first quarter of fiscal 2026. Following FDA 510(k) clearance for the OneRF® Trigeminal Nerve Ablation System to treat facial pain, the company successfully completed nine cases to date, with all patients reportedly pain free. This represents entry into a completely new market for NeuroOne beyond its existing neurological applications.
The company 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. All three systems would represent new market opportunities for the company. NeuroOne has also expanded its intellectual property portfolio, now holding 13 issued and pending patents in the U.S. and four internationally.
Dave Rosa, CEO of NeuroOne, stated that momentum from fiscal 2025 has accelerated into the first quarter, with progress across all target markets leveraging the OneRF® platform technology. Rosa noted the record number of ablations performed in the quarter demonstrates continued expansion and real-world benefits of the technology. The company has scheduled chronic animal studies for its percutaneous paddle electrode system for lower back pain to begin next quarter and confirmed the validity of its basivertebral nerve ablation system through advisory board meetings with leading pain specialists.
Operational highlights include 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 the OneRF® Ablation System in the brain, a record number of patients were treated in the first quarter, with the first cases for the post-market patient registry expected to be completed in July 2026. Doctors from the Mayo Clinic in Jacksonville, Florida provided positive experience with the system at the American Epilepsy Society Meeting in December 2025.
Financial results for the first quarter showed product revenue of $2.9 million, compared to $3.3 million in the same quarter of the prior year. The decrease was 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, compared to $1.9 million, or 58.9% of revenue, in the same quarter of the prior fiscal year.
Total operating expenses were $3.3 million in the first quarter of fiscal 2026, compared to $3.2 million in the same quarter of the prior year. Research & Development expense increased to $1.4 million from $1.2 million, while Selling, General & Administrative expense decreased 7.7% to $1.9 million from $2.0 million. Net loss for the quarter was $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. The prior year's net income included license revenue of $3.0 million related to the distribution license granted to Zimmer for the OneRF® brain ablation system.
As of December 31, 2025, the company had cash and cash equivalents of $3.6 million, compared to $6.6 million as of September 30, 2025. NeuroOne believes it is funded through fiscal 2026, potentially longer if certain milestones are achieved. The company had working capital of $6.8 million and no debt outstanding as of December 31, 2025. For more information about NeuroOne's technology platform and product families, visit https://nmtc1.com.
