NeuroOne Medical Technologies Corporation has issued a corporate update highlighting accelerating commercial momentum, including record procedure volume for its OneRF® ablation system and early clinical success in treating trigeminal neuralgia. The company is strategically advancing its platform technology into three new market segments—drug delivery, basivertebral nerve ablation (BVNA), and spinal cord stimulation—each representing what the company believes to be an addressable U.S. market exceeding $1 billion annually.
The company's brain ablation program, commercialized through an exclusive distribution partnership with Zimmer Biomet, delivered its strongest quarter since launch in Q1 fiscal 2026. Nearly 50% of all ablations performed with the system since its 2024 introduction were completed in that single quarter, indicating growing clinical adoption. Under the distribution agreement, Zimmer Biomet covers all marketing and sales costs, meaning incremental procedures directly benefit NeuroOne's margin structure. Physicians from the Mayo Clinic in Jacksonville shared positive clinical experiences at the American Epilepsy Society meeting in December 2025.
Following FDA 510(k) clearance in August 2025, NeuroOne's OneRF® Trigeminal Nerve Ablation System has been used in nine cases across three centers, with all patients reportedly pain-free. Trigeminal neuralgia affects an estimated 150,000 new patients annually in the United States. The company is completing a limited market release and evaluating both direct commercialization and a strategic licensing partnership, with active diligence discussions underway. A transaction could generate incremental revenue beyond existing 2026 guidance and potentially a non-dilutive licensing fee.
The company's confidence is supported by patient outcomes, including a professional pianist from Chicago who resumed his career and a teenage girl who became seizure-free for over a year following treatment with the OneRF® system. The company estimates the market opportunity for its currently approved commercial applications exceeds $200 million in the U.S., but sees significantly larger potential in new areas. The strategic interest in these larger markets is evidenced by transactions like Boston Scientific's acquisition of Relievant Medsystems, the developer of the Intracept® BVNA system, for approximately $850 million upfront in late 2023. The company believes its platform technology can be leveraged to develop highly differentiated products for the BVNA market that offer strong competition against existing technologies.
NeuroOne's sEEG-based drug delivery program is now six months ahead of its original schedule, targeting commercial readiness for use in investigational clinical or animal studies by the end of Q3 fiscal 2026. The initial focus is on glioblastoma and gene and cell-based therapies. The company is in active discussions with two potential partners and is establishing a physician advisory board. For its basivertebral nerve ablation program, the company has held multiple advisory board meetings with pain specialists and is in advanced discussions with multiple potential strategic partners. The strategy is capital-efficient, leveraging the existing OneRF® generator and probes while outsourcing access tools.
The company has also initiated a six-month animal study for its spinal cord stimulation percutaneous paddle lead in preparation for a first-in-man study, with potential strategic partners engaged in diligence discussions. The system was presented at the Business of Pain and NANS meetings, generating early physician interest. The solution utilizes a percutaneously-placed thin-film paddle electrode designed to be placed by both pain management doctors and neurosurgeons, potentially expanding access compared to current invasive surgical placement.
Financially, NeuroOne reported strong Q1 fiscal 2026 results with zero debt, $3.6 million in cash and cash equivalents, $2.7 million in accounts receivable, and $6.8 million in working capital as of December 31, 2025. Product gross margin was 54.2%, with gross profit growing sequentially. The company is guiding to at least $10.5 million in product revenue for fiscal year 2026, a minimum 17% increase over fiscal 2025. This guidance does not include potential contributions from the trigeminal nerve ablation system or potential non-dilutive cash from active partnership discussions.
The company has also announced the appointment of David Wambeke as Chief Business Officer in March 2026. Wambeke will lead the drug delivery device program and oversee investor relations. To demonstrate alignment with shareholders, he purchased 1,000,000 shares of NeuroOne common stock in a private placement. NeuroOne has also filed a proxy statement for its Annual Meeting of Stockholders on April 3, 2026, requesting shareholder approval for a potential reverse stock split to maintain compliance with Nasdaq listing requirements. The company emphasizes this is a structural compliance mechanism that does not affect shareholder ownership percentage or total market capitalization.
With four FDA 510(k) clearances, a growing intellectual property portfolio, and a commercial infrastructure through Zimmer Biomet, NeuroOne believes it is positioned for several strategic and commercial inflection points beginning in 2026 across its expanding pipeline. The company's platform approach allows it to efficiently develop new products for large, high-unmet-need markets while maintaining financial discipline and leveraging strategic partnerships.
