NeuroOne Medical Technologies (NASDAQ:NMTC) reported first-quarter fiscal 2026 product revenue of $2.9 million, down from $3.3 million a year earlier as the prior-year period included an initial stocking order tied to the launch of its OneRF brain ablation system. On a sequential basis, revenue increased 5.5% from $2.7 million in the fourth quarter of fiscal 2025, which management said reflected continued momentum and restocking activity.
Chief Executive Officer Dave Rosa said the company expects fiscal 2026 sales of at least $10.5 million, representing a minimum 17% increase from fiscal 2025. Rosa described progress across multiple programs, including adoption of its OneRF brain ablation platform, an early commercial launch of a trigeminal nerve ablation system, and accelerated timelines in its drug delivery initiative.
OneRF brain ablation: adoption, registry plans, and international steps
Management also highlighted a patient outcome story involving a professional pianist from Chicago who, according to the company, was able to resume his career following an ablation performed with NeuroOne’s system. Rosa said NeuroOne is establishing a registry to capture patient outcomes over time, and the company hopes to enroll its first patient by the end of the third fiscal quarter.
Commercially, the company said the OneRF system was exhibited at Zimmer Biomet’s booth at the American Epilepsy Society meeting in December, including commentary from physicians at the Mayo Clinic in Jacksonville, Florida, who discussed their experience with the technology at the booth. Rosa also said NeuroOne sees potential for international opportunity and is working toward ISO 13485 certification as an initial step toward international commercialization.
Trigeminal nerve ablation: limited launch and licensing discussions
On the OneRF trigeminal nerve ablation system, Rosa reiterated that NeuroOne received FDA 510(k) clearance in August 2025 to treat facial pain by ablating the trigeminal nerve. During the first quarter of fiscal 2026, the company initiated a limited commercial launch and reported that the first two patients were treated at University Hospitals Cleveland, with both patients reporting pain relief.
Rosa said nine total patients have been treated at three centers to date, and all were reported pain-free. He emphasized that the company’s probe is intended to be placed once due to multiple contacts on the device, contrasting it with traditional ablation systems that may require multiple placements and potentially lead to additional discomfort and longer procedures. Based on early results, NeuroOne expects to complete the limited launch by the end of Q2 fiscal 2026.
In response to an analyst question, Rosa said the nine cases were conducted at three centers, one of which was associated with Dr. Sanjeet Grewal, a neurosurgeon and collaborator whom Rosa noted had recently died unexpectedly. Rosa added that NeuroOne is in diligence discussions with a strategic partner to potentially license the trigeminal technology and aims to conclude the discussions quickly, but said the company would be prepared to commercialize the product itself if it does not move forward.
Drug delivery and pain programs: accelerated timelines and advisory work
NeuroOne said it accelerated its drug delivery program and now expects to have devices available for commercial use in investigational clinical studies or animal studies in Q3 fiscal 2026—about six months sooner than previously expected. Management said it is organizing an advisory board of oncology experts focused on challenging brain tumors such as glioblastomas to help guide use of the system for therapy delivery to the brain. The company also said it continues discussions with pharmaceutical and biotechnology companies regarding use of the device for animal and/or investigational human studies for gene and cell therapies, and it is evaluating partnership opportunities with two organizations interested in using the platform for experimental therapies in neurological conditions.
Rosa also provided updates on two lower back pain technologies:
- Percutaneously placed paddle electrode: Designed for broader, customizable stimulation with less energy consumption and intended to be inserted through a 14-gauge needle without an incision. The company plans to initiate a long-term animal study “next month” in preparation for its first human implant and said it is in diligence discussions with strategic organizations regarding interest in the platform.
- Basivertebral nerve ablation system: NeuroOne held multiple advisory board meetings with pain experts during the quarter to confirm product requirements and validate potential benefits versus existing technologies. Rosa said the company plans to leverage its existing OneRF generator and sEEG probe for this application and is in discussions with potential partners. The next development step is identifying manufacturing firms for required access tools.
Quarterly financial results: margin, expenses, and cash
Chief Financial Officer Ron McClurg said first-quarter fiscal 2026 product gross profit was $1.6 million, or 54.2% of revenue, compared with $1.9 million, or 58.9% of revenue, in the year-ago quarter. On a sequential basis, product gross profit increased 2.6% from $1.5 million in the fourth quarter of fiscal 2025.
The company reported no license revenue in the quarter, compared with $3.0 million in license revenue in the first quarter of fiscal 2025, which McClurg said was derived from an expanded exclusive distribution agreement with Zimmer related to the OneRF product in October 2024. Net loss in the first quarter of fiscal 2026 was $1.4 million, or a loss of $0.03 per share, compared with net income of $1.8 million, or $0.06 per share, in the prior-year quarter.
Total operating expenses were $3.3 million versus $3.2 million a year earlier. Research and development expense increased to $1.4 million from $1.2 million, while selling, general and administrative expense decreased 7.7% to $1.9 million from $2.0 million.
As of December 31, 2025, NeuroOne had $3.6 million in cash and cash equivalents, down from $6.6 million as of September 30, 2025. Working capital was $6.8 million versus $7.9 million at fiscal year-end. McClurg said the company had no debt outstanding and stated that NeuroOne is funded through fiscal 2026, potentially longer if key milestones are met.
Commercial execution with Zimmer and upcoming investor engagement
During the Q&A, management said it does not have visibility into the number of centers or physicians where Zimmer is present domestically, nor regional adoption trends for OneRF. McClurg characterized the quarter’s revenue as primarily restocking and ongoing sales into the market following Zimmer’s initial stocking order in the first quarter of fiscal 2025.
Rosa also said that under the companies’ agreement, Zimmer is responsible for marketing and sales costs, while NeuroOne provides training and reasonable field support. McClurg said the company expects SG&A to remain “fairly flat” for the remainder of fiscal 2026, while R&D may fluctuate depending on project phases, including near-term spending tied to accelerated drug delivery work and animal studies.
NeuroOne also announced the appointment of Jason Mills to its board of directors. Rosa said Mills is Executive Vice President of Strategy for Penumbra, Inc., which Rosa noted was recently acquired by Boston Scientific for $14.5 billion, and previously served as a managing director at Canaccord Genuity.
Looking ahead, Rosa said the company will attend the Oppenheimer 36th Annual Healthcare MedTech and Services Conference and invited investors to meet with management March 16 through 19, with a presentation scheduled for March 17 at 1:20 p.m. Eastern Time.
Rosa closed the call by expressing condolences for the “unexpected loss” of Dr. Sanjeet Grewal, calling him a valued collaborator and friend to the company.
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.
