NeuroOne Medical Technologies (NASDAQ:NMTC) executives highlighted what they called a “record” fiscal 2025 and a company “inflection point” during the company’s fourth-quarter earnings call, pointing to sharp product revenue growth, improved margins, and multiple pipeline and regulatory milestones across its brain ablation, facial pain, lower back pain, and drug delivery initiatives.
Fiscal 2025 financial results: revenue growth and margin improvement
Chief Executive Officer Dave Rosa said fiscal 2025 was the most successful year in the company’s history, driven largely by expanded commercialization of the OneRF brain ablation system through distributor Zimmer Biomet.
McClurg also noted the company generated $3.0 million in license revenue in fiscal 2025 (not included in product revenue), which he said was derived from the expanded exclusive distribution agreement with Zimmer Biomet. There was no license revenue in fiscal 2024.
Margins improved alongside higher volume. Fourth-quarter product gross profit was $1.5 million, or 55.8% of revenue, compared with $0.1 million, or 51.8%, in the year-ago quarter. For fiscal 2025, product gross profit increased to $5.1 million, or 56.5% of revenue, from $1.1 million, or 31.3%, in fiscal 2024.
Operating expenses, profitability trends, and liquidity
NeuroOne also emphasized cost discipline. Total operating expenses declined to $2.9 million in the fiscal fourth quarter, down from $3.0 million a year earlier. R&D expenses were $1.1 million, flat year over year, while SG&A expenses were $1.8 million, also flat.
For the full year, total operating expenses decreased 5% to $12.4 million, including a 2% decline in R&D to $5.0 million and a 7% reduction in SG&A to $7.4 million.
Net loss narrowed materially. McClurg said fourth-quarter net loss improved 52% to $1.6 million, or $0.03 per share, compared with $3.4 million, or $0.11 per share, in the prior-year quarter. For fiscal 2025, net loss improved 71% to $3.6 million, or $0.09 per share, versus $12.3 million, or $0.46 per share, in fiscal 2024.
On the balance sheet, the company ended fiscal 2025 with $6.6 million in cash and cash equivalents (up from $1.5 million a year earlier), $7.9 million in working capital (up from $2.4 million), and no debt outstanding. Management also referenced an $8.2 million capital raise during the year. McClurg added that NeuroOne is funded through at least fiscal 2026, “potentially longer if key milestones are hit.”
Commercial traction and registry plans for OneRF brain ablation
Rosa attributed the surge in fourth-quarter product revenue to the ongoing rollout of the OneRF brain ablation system at additional sites through Zimmer Biomet. He said reported clinical outcomes have been positive, with no adverse events to date, and added that the company’s temperature control probe is performing as intended by providing an added safety mechanism to prevent excessive temperatures during procedures.
The company also discussed a OneRF registry intended to gather performance data. Rosa said NeuroOne recently met with participating sites at the American Epilepsy Society meeting in early December, where centers provided comments and suggestions. He cautioned that timing depends on each hospital’s internal processes, including institutional review board approvals and site contracting, which “can vary by center.” In the Q&A, he said he did not expect the paperwork and site approvals to be completed until Q2.
NeuroOne said it attended multiple industry meetings during fiscal Q4 2025 through the call date, including:
- Society for Neuroscience
- Congress of Neurological Surgeons
- American Epilepsy Society meeting, which included Mayo Clinic physician testimonials at the Zimmer Biomet booth
New indications and pipeline: trigeminal neuralgia, lower back pain, and drug delivery
Rosa highlighted an August FDA 510(k) clearance for the OneRF trigeminal nerve ablation system to treat facial pain by ablating the trigeminal nerve. He said the company planned a limited commercial launch in the fourth quarter of calendar 2025 and reported that the first two patients were successfully treated at University Hospitals Cleveland. According to Rosa, both patients reported pain relief without complications, and the procedures supported the company’s contention that its multi-contact probe can reduce the need for multiple placements compared with traditional systems.
In the Q&A, Rosa said three additional centers have indicated they have cases planned, though timing depends on ancillary equipment and, at one site, generator installation. He said there is a “good chance” more cases will be completed this month. He also said the two Cleveland cases were performed back to back and reiterated that trigeminal neuralgia procedures can be scheduled in advance, which can make logistical support easier than brain ablations that may require a waiting period while seizure foci are identified.
On distribution strategy, Rosa said Zimmer Biomet’s expanded agreement includes distribution beyond diagnostic SEEG electrodes to include the brain ablation system. However, he clarified that Zimmer Biomet does not currently have distribution rights for facial pain, and that back-pain discussions involve strategics that do not include Zimmer Biomet, noting Zimmer previously divested its spine business. Rosa also said there is interest from a strategic partner to potentially license the facial pain technology.
For lower back pain, Rosa described two active development programs:
- Percutaneously placed paddle electrode for spinal cord stimulation, deliverable through a 14-gauge needle and designed to expand for broader, customizable stimulation with less energy consumption. Management said it is finishing chronic animal studies and expects to initiate additional long-term studies in fiscal Q2 2026, with a goal of partnering with an established spinal cord stimulation company rather than developing pulse generators internally.
- Basivertebral nerve ablation (BVNA), initiated in fiscal Q4 2025. Rosa said the program aims to leverage the existing OneRF generator and a probe to ablate the basivertebral nerve, supported by an advisory board of pain specialists. Next steps include animal studies and continued R&D testing, including confirming the generator can create the lesion sizes clinicians expect and sourcing necessary accessories.
NeuroOne also discussed physician and industry interest in its drug delivery program using SEEG platform electrode technology. Rosa said two organizations have approached the company about potential partnerships for gene therapy, cell therapy, and glioblastoma drug delivery development, and the company has reported initial sales of preclinical devices to a large pharmaceutical company for testing. In response to an analyst question, Rosa said the company expects to be able to ship additional preclinical units around mid-year, with current work focused on manufacturing and process validation.
Rosa said NeuroOne’s fiscal 2026 growth expectations do not include revenue from trigeminal neuralgia ablation, strategic agreements for pain management technology, or drug delivery partnerships or sales.
Compliance, patents, and upcoming investor outreach
Management said Nasdaq granted NeuroOne a 180-day extension until May 4, 2026, to regain compliance with the Nasdaq minimum bid price rule, and the company will continue monitoring its closing bid price during the extension period.
On intellectual property, Rosa said the company received U.S. Patent and Trademark Office notices of allowance covering manufacturing methods for depositing contact material onto its electrode and another covering its proprietary temperature control probe when used with its SEEG electrode. He also said NeuroOne received its first granted European patent for the temperature probe and now has 17 issued and pending patents, largely developed and owned in-house.
Rosa said the company plans to provide fiscal 2026 financial guidance once it receives a final forecast from Zimmer Biomet and noted NeuroOne will attend the J.P. Morgan Healthcare Conference in January, inviting meetings with investors and analysts on January 12, 13, or 14.
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.
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