NeuroOne Medical Technologies Corporation has reported financial results for the first quarter of fiscal year 2026, revealing significant momentum in product adoption and providing revenue guidance for the full fiscal year. The company expects product revenue to reach at least $10.5 million in fiscal 2026, representing an increase of at least 17% compared to the previous year's $9.1 million. This growth projection follows a quarter where nearly 50% of all ablations performed since the OneRF® Ablation System product launch in 2024 occurred during Q1 2026, demonstrating accelerating market adoption.
The company's technological expansion continues with the FDA 510(k) clearance for the OneRF® Trigeminal Nerve Ablation System to treat facial pain, which was received ahead of schedule. NeuroOne has successfully completed nine cases using this system for trigeminal neuralgia, with all patients reportedly pain free. This represents entry into a completely new market for the company beyond its established brain ablation applications. Management has advanced discussions with potential tier-one strategic partners for multiple new 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.
NeuroOne's intellectual property portfolio has expanded with key patents secured in the U.S. and Europe, bringing the total to 13 issued and pending patents in the U.S. and 4 internationally. The company's drug delivery system targeting is expected to be commercially available for use in investigational clinical studies or animal studies in Q3 fiscal 2026, representing expedited progress from previous timelines. Additional development programs include scheduled long-term animal studies for percutaneous paddle electrode for spinal cord stimulation beginning in Q2 fiscal 2026 and confirmation of the Basivertebral Nerve Ablation System's validity based on advisory board feedback.
Financial results for Q1 fiscal 2026 show product revenue of $2.9 million, a slight decrease from $3.3 million in the same quarter of the prior year due to an initial stocking order from Zimmer in Q1 fiscal 2025. However, sequential product revenue increased 5.5% from $2.7 million in Q4 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, with research and development expense increasing to $1.4 million from $1.2 million in the prior year quarter.
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. NeuroOne ended the quarter with cash and cash equivalents of $3.6 million and working capital of $6.8 million, with no debt outstanding. The company believes it is funded through fiscal 2026, potentially longer if certain milestones are achieved. For more information about NeuroOne's technology platform and product families, visit https://nmtc1.com.
Operational highlights include progress toward ISO 13485 certification for Outside the U.S. distribution with a second audit scheduled for April 2026. The company's sEEG-based drug delivery program is ahead of schedule by six months, with commercial readiness expected in Q3 fiscal 2026 for investigational clinical or animal studies. NeuroOne is establishing a physician advisory board to evaluate treatment of glioblastomas and focusing on brain tumors, gene and cell-based therapies. The company continues diligence discussions with two organizations regarding potential partnerships for this program.
For the OneRF® Ablation System in the brain, a record number of patients were treated in Q1 fiscal 2026, with first cases for the post-market patient registry expected in July 2026. Doctors from the Mayo Clinic in Jacksonville, Florida provided positive experience feedback at the American Epilepsy Society Meeting in December 2025. The company has appointed Jason Mills to the Board of Directors in December 2025, adding veteran medical technology executive experience to strengthen governance and strategic direction.
