NeuroOne Medical Technologies (NASDAQ:NMTC) executives outlined the company’s thin-film electrode platform, recent commercial traction, and upcoming milestones during an Oppenheimer conference presentation featuring CEO Dave Rosa and CFO Ron McClurg.
Thin-film platform positioned for multiple neurological indications
Rosa said NeuroOne has developed and commercialized a “true thin film electrode platform technology” designed to deliver multiple functions with the same device across a range of neurological conditions. He listed intended uses including epilepsy, Parkinson’s disease, back pain, and drug delivery for gene and cell therapies in development, as well as potential applications for brain tumor drugs.
Rosa described two key differentiators: a thin-film design that allows less invasive placement (including through a 14-gauge needle) and the ability to perform both diagnostic and therapeutic functions with the same device. He said the combined approach could reduce surgeries and hospitalizations and potentially improve outcomes, adding that NeuroOne “remain[s] the only FDA 510(k) cleared device for both diagnostic and therapeutic use.”
Partnerships with Mayo Clinic and Zimmer Biomet
Rosa said the Mayo Clinic relationship began after clinicians there—Dr. Greg Worrell and Dr. Jamie Van Gompel—evaluated NeuroOne prototypes and became interested in their potential. He added that Mayo personnel have been involved in testing newer devices and more recently in using NeuroOne’s drug delivery platform.
NeuroOne’s 2020 partnership with Zimmer Biomet covers exclusive U.S. distribution rights and certain international geographies, Rosa said. He noted the company has received $8.5 million in licensing fees under the arrangement. On adoption, Rosa said utilization has been increasing and that in the most recent quarter, “almost half” of all patients who have received ablations since launch were treated in that quarter. The company is also pursuing ISO 13485 certification as part of preparations for international distribution.
Product portfolio: revenue driver and pipeline programs
Rosa walked through the company’s cleared products and development programs, emphasizing that they share a common thin-film platform.
- Evo sEEG and cortical electrodes: Rosa said these were among NeuroOne’s first FDA 510(k)-cleared products and were commercialized through Zimmer Biomet for diagnostic use, but he said they have been “cannibalized to a great extent” by the OneRF brain ablation system.
- OneRF Ablation System (brain): Rosa said this is the company’s primary revenue contributor and is the only FDA 510(k)-cleared technology that supports both diagnostic and therapeutic use with the same device. He said it was designed to reduce surgeries and hospitalizations and includes a proprietary temperature probe intended to enhance safety. Rosa stated that in epilepsy procedures there have been “no reported procedural adverse events,” and that most patients are reported to be seizure-free or have a significant reduction in seizures. He also described a capability for post-ablation confirmation of seizure activity and “touch-up” ablation if needed. NeuroOne has initiated a registry to share results and, Rosa noted, issued a press release about a PubMed-published study describing Cleveland Clinic doctors’ initial experience with the technology.
- OneRF Trigeminal Nerve Ablation System: Rosa said the system is intended for trigeminal neuralgia and reduces the need for multiple insertions required by some competing approaches by enabling a single implantation to locate the pain-triggering point. He said NeuroOne has completed nine cases in a limited market release and that all patients were reportedly pain-free. Rosa added he expected the limited market release to conclude by the end of the month, after which the company would be positioned to expand distribution.
- Spinal cord percutaneous paddle lead: Rosa said the program targets lower back pain with pain traveling down the legs. He contrasted NeuroOne’s percutaneous paddle design with thin-wire stimulation leads, saying the larger paddle footprint can provide broader stimulation using less energy, potentially reducing battery recharging frequency, while enabling customization of stimulation placement. He said the company is in chronic animal studies and is targeting readiness for first-in-human implants by year-end. NeuroOne is also seeking a partner with an existing FDA PMA-approved platform to shorten the commercialization timeline.
- Basivertebral nerve ablation (BVNA): Rosa said the company is developing a BVNA system leveraging its ablation platform for lower back pain, with multiple contacts enabling multiple ablations and offering a larger “sweet spot” for pain specialists. He said he has been told the procedure is among the fastest-growing lower back pain procedures and that NeuroOne believes the regulatory path will be 510(k). He noted that Boston Scientific and Stryker have systems on the market for this application and said NeuroOne is in partnership discussions.
- Drug delivery device: Rosa said this technology can record brain activity before, during, and after delivery of gene or cell therapies infused through a center lumen, and can also stimulate tissue. He said it can be placed using Zimmer Biomet’s robotic system without requiring MRI for placement, has a low profile, and can support placement of many devices if needed. He added NeuroOne designed it for use across animal models, allowing companies to use the device from early development through human studies and commercialization.
Financial snapshot and outlook
McClurg said that as of December 31 (the company’s most recent filed 10-Q), NeuroOne had $3.6 million in cash and $2.7 million in accounts receivable that has since been collected, with no debt on the balance sheet. He reported fiscal first-quarter product revenue of $2.9 million, up 5.5% sequentially, and gross margin of 54.2%, with gross profit up 2.6% sequentially.
He said internal modeling indicates the company can fund operations through the end of its fiscal year ending September 2026 with cash on hand, excluding any potential partnership-related proceeds. McClurg also reiterated that NeuroOne has publicly stated it expects product revenue of at least $10.5 million this year, representing a minimum 17% increase over the prior year. He noted that ISO 13485 certification is a step toward addressing international revenue opportunities and said that would “most likely” occur in the next fiscal year.
Registry data, drug delivery considerations, and partnership timing
During Q&A, Oppenheimer’s Suraj Kalia asked about the OneRF registry and whether NeuroOne plans to track seizure-burden outcomes over time and translate results into publications. Rosa said the company is collecting those data and emphasized the importance of evidence to support neurologist referrals. He reiterated the company’s reported safety experience to date and said NeuroOne aims to publish results, including potentially incorporating retrospective data from treated patients, while the new registry is designed for forward-looking patients.
Asked about drug delivery limitations related to molecule size or viscosity, Rosa said pharma companies developing therapies will need to test compatibility with the device. He said NeuroOne has conducted bench testing and that Mayo Clinic has tested therapies as well, adding that so far NeuroOne has not encountered cases where molecule characteristics were too challenging, while acknowledging the possibility across the broader range of therapies.
On the cadence of potential partnerships across programs including BVNA, trigeminal neuralgia, and drug delivery, Rosa said he believes partnership activity could occur “this year,” adding that companies are at varying stages of diligence and that he sees “an extremely strong possibility” of one or more relationships occurring in 2026.
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.
