NeuroOne Medical Technologies (NASDAQ:NMTC) reported third-quarter fiscal 2026 product revenue of $2.0 million, up 16% from $1.7 million in the prior-year quarter, as sales of its OneRF products increased. The medical-device company also reported $2.7 million in new product orders during the quarter, representing 43% year-over-year growth.
Chief Executive Officer Dave Rosa said the company expects aggregate fiscal 2026 product orders of about $11.2 million. Recognized revenue is projected to range from $9.2 million to $10.5 million, depending on manufacturing and shipment timing. NeuroOne had a product-order backlog of $1.7 million as of June 30, 2026.
Margins Expand as Expenses and Loss Increase
Total operating expenses increased to $3.6 million from $2.8 million in the prior-year period. Research and development expense rose to $1.4 million from $1.2 million, while selling, general and administrative expense increased to $2.2 million from $1.6 million, reflecting higher headcount and sales and marketing costs.
NeuroOne posted a net loss of $2.0 million, or $0.23 per basic share and $0.28 per diluted share, compared with a $1.5 million loss, or $0.19 per basic share and $0.22 per diluted share, in the third quarter of fiscal 2025. The latest-quarter loss included a favorable $0.4 million gain related to the fair-value change in the company’s warrant liability.
As of June 30, NeuroOne had $2.0 million in cash and cash equivalents, down from $6.6 million at Sept. 30, 2025. The company reported $3.7 million of working capital and no debt outstanding. It raised $0.4 million through its at-the-market program during the quarter and subsequently raised another $1.0 million on July 13 through the issuance of 400,346 shares.
Manufacturing Capacity and International Market Plans
Rosa said the company is working with suppliers to expedite production and address remaining backlog by the end of the fourth calendar quarter of 2026. He said supplier lead times can extend as long as six months and that product-mix changes can create constraints because the company generally builds to order.
NeuroOne is pursuing qualification of a second manufacturing site, which Rosa said is expected to come online in the first part of 2027. The additional facility is expected to expand manufacturing capacity and potentially reduce lead times.
The company also said it recently received ISO 13485 certification, an international quality-management standard that Rosa said provides an opportunity to enter international markets with the OneRF Brain Ablation System, OneRF Trigeminal Nerve Ablation System, and Evo cortical and SEEG diagnostic product lines.
NeuroOne plans to work with distribution partner Zimmer Biomet to assess international markets where Zimmer Biomet has existing customer relationships and where economics are favorable. For territories that remain exclusive to NeuroOne, the company said it will consider independent distribution partnerships. Rosa noted that requirements vary by geography, with some markets requiring additional documentation, submissions or clinical data.
Product and Clinical Updates
Rosa highlighted a recently published Mayo Clinic Jacksonville retrospective observational study involving NeuroOne’s OneRF Brain Ablation System in patients with implanted neuromodulation devices. According to Rosa, the Journal of Neurosurgery article concluded that the procedures may be performed without interfering with existing hardware while providing meaningful seizure reduction.
For the OneRF Trigeminal Nerve Ablation System, Rosa cited a patient’s television interview following treatment in which the patient reported being pain-free. He said the company estimates the U.S. market for related disposable products, excluding hardware, at $40 million. NeuroOne plans to use current staff and independent distributors to expand commercialization, noting that most cases are performed at roughly 30 centers.
Rosa said the company is interviewing potential distributors for the trigeminal product and intends to hire them once agreements are finalized. He also said Zimmer Biomet remains interested in the product, but NeuroOne plans to continue moving forward independently rather than wait for partnership discussions to conclude.
StereoCED and Back-Pain Program Development
Chief Business Officer David Wambeke discussed the company’s StereoCED intracranial drug-delivery platform, which is designed to use existing neurosurgical equipment and workflows. The robotic-assisted system is intended to allow simultaneous multi-trajectory delivery and potentially reduce procedure times, according to Wambeke.
Wambeke said NeuroOne expects StereoCED to be ready for investigational human clinical studies by the end of September, and potentially sooner for animal research. The company has announced preclinical collaborations with the University of Minnesota in focal epilepsy and Mayo Clinic in diffuse midline glioma. Initial animal studies are scheduled to begin this month, with data from both programs expected this fall.
Rosa said the University of Minnesota work will first involve preclinical testing of a therapy developed by the institution. If that testing demonstrates efficacy, the program could advance to a Phase I patient study.
NeuroOne also expects its first device sale to a pharmaceutical company for a non-human primate study later this year. Rosa said StereoCED could be used in preclinical, clinical and commercial settings, though pharmaceutical companies with ongoing clinical studies may be reluctant to change delivery technologies during those trials.
Separately, NeuroOne completed user design requirements and began preclinical testing for its basivertebral nerve ablation, or BVNA, system for back pain. The company expects to leverage its existing OneRF generator, temperature accessory and ablation electrode while outsourcing access tools. Rosa said NeuroOne reconfirmed that the anticipated regulatory route is likely a 510(k) submission and expects to submit for FDA clearance in the second half of calendar 2027.
About NeuroOne Medical Technologies (NASDAQ:NMTC)
NeuroOne Medical Technologies Corp. is a medical device company focused on developing advanced neural interface technologies for diagnostic and therapeutic applications in neurosurgery and neurology. The company’s core mission is to improve patient outcomes through next-generation electrode systems that enable high-resolution neural recording and targeted stimulation. By leveraging proprietary thin-film microelectrode arrays, NeuroOne aims to offer clinicians unprecedented single-unit precision during brain mapping procedures.
The company’s flagship platform, the EVO™ system, integrates thin-film neural electrodes with intraoperative monitoring hardware and software.
