NeuroOne Medical Technologies Corporation reported financial results for the first quarter of fiscal year 2026, highlighting growing adoption of its medical technology and expansion into new treatment markets. 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. Nearly 50% of all ablations performed since the OneRF® Ablation System product launch in 2024 occurred during the first quarter of fiscal 2026, indicating accelerating adoption of the technology.
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 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. These developments could significantly expand NeuroOne's market reach beyond its current neurological focus.
Management emphasized progress across all target markets leveraging the OneRF® platform technology. 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, said Dave Rosa, CEO of NeuroOne. The company's patent portfolio now includes 13 issued and pending patents in the U.S. and 4 internationally, strengthening its intellectual property position. Operational highlights include expedited progress on the sEEG-based drug delivery system, now expected to be commercially available for investigational clinical studies or animal studies in Q3 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. Doctors from the Mayo Clinic in Jacksonville, Florida provided positive experience with the system at Zimmer's booth during the American Epilepsy Society Meeting in December 2025. For the spinal cord stimulation percutaneous paddle lead program, the company is initiating a 6-month animal study in the second quarter of fiscal 2026 in preparation for first-in-man studies. The system was displayed and papers were presented at the Business of Pain Meeting and NANS meetings. Multiple advisory board meetings with leading pain specialists have confirmed the validity of the Basivertebral Nerve Ablation System for lower back pain.
First quarter fiscal 2026 financial results showed product revenue of $2.9 million, compared to $3.3 million in the same quarter of the prior year. The slight decrease was attributed to an 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 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.
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. More information about the company is available at https://nmtc1.com.
