NeuroOne Reports Record Procedure Volume and Advances Toward Billion-Dollar Market Opportunities

NeuroOne Medical Technologies Corporation has issued a comprehensive corporate update highlighting accelerating commercial momentum and significant progress across its neurological disorder treatment platform. The company reported record OneRF procedure volume in the first fiscal quarter of 2026 and early clinical success with its trigeminal neuralgia treatment, while advancing toward three new market opportunities each representing over $1 billion in potential annual revenue in the United States.

The company's confidence stems from clinical evidence demonstrating transformational patient outcomes. Following treatment with the OneRF ablation system, a professional pianist from Chicago resumed his career and a teenage girl who experienced an average of 10 seizures nightly became seizure-free for over a year. The first nine patients treated for trigeminal neuralgia, one of medicine's most severe pain conditions, are all reportedly pain-free following FDA 510(k) clearance last August. These outcomes reinforce the company's conviction in the long-term potential of its platform technology.

Beyond currently approved commercial applications representing over $200 million in U.S. market opportunity, NeuroOne is targeting three significant expansion areas. Drug delivery, basivertebral nerve ablation, and spinal cord stimulation each represent addressable markets that could exceed $1 billion annually. The strategic interest in these larger opportunities is evidenced by transactions such as Boston Scientific's acquisition of Relievant Medsystems for approximately $850 million upfront plus additional contingent payments, representing roughly a 12× multiple of expected revenue at the time. The category has also attracted new product launches from companies such as Stryker, further validating the clinical need and expanding the long-term market opportunity.

Commercialization progress continues to validate NeuroOne's approach. The brain ablation program, commercialized through an exclusive distribution partnership with Zimmer Biomet, delivered its strongest quarter since launch in Q1 fiscal 2026, with nearly 50% of all ablations performed since introduction in 2024 completed in that single quarter alone. Physicians from the Mayo Clinic in Jacksonville shared positive clinical experience with the system at the American Epilepsy Society meeting in December. The company is also making progress toward ISO 13485 certification, a requirement for international distribution.

The drug delivery system is now six months ahead of its original development schedule, targeting commercial readiness for use in investigational clinical studies or animal studies by the end of Q3 fiscal 2026. The company is focused initially on glioblastoma, an aggressive form of brain cancer with median survival measured in months, as well as gene and cell-based therapies. Multiple advisory board meetings with leading pain specialists have confirmed the clinical rationale and design principles of the Basivertebral Nerve Ablation system for chronic low back pain. The company has initiated a six-month animal study in preparation for a first-in-man study for its spinal cord stimulation percutaneous paddle lead, with potential strategic partners engaged in diligence discussions to accelerate the path to commercialization.

Financially, NeuroOne reported strong positioning with growing revenues and ample working capital. As of December 31, 2025, the company carries zero debt with $3.6 million in cash and cash equivalents, $2.7 million in accounts receivable, and $6.8 million in working capital. Product gross margin was 54.2% in Q1, with gross profit growing sequentially while SG&A declined 7.7% year-over-year. The company is guiding to at least $10.5 million in product revenue for fiscal year 2026, a minimum 17% increase over fiscal year 2025, though this guidance does not include any contribution from the recent trigeminal nerve ablation clearance.

The company has filed a proxy statement in connection with its Annual Meeting of Stockholders to be held on April 3, 2026, requesting stockholder approval for a reverse stock split to maintain compliance with Nasdaq's continued listing requirements. Management emphasized this is a structural compliance mechanism rather than a reflection of operational performance, noting that maintaining the Nasdaq listing preserves liquidity, supports price discovery, provides access to institutional capital, and keeps the company positioned to pursue licensing and strategic transactions currently in progress.

NeuroOne's investment thesis centers on a platform that works in markets where it matters, with partners that validate the technology and patients experiencing results. The company has secured four FDA 510(k) clearances and maintains a growing intellectual property portfolio of 13 U.S. patents issued or pending plus four internationally. With revenue growing and capital needs expected to decline, the largest commercial opportunities in BVNA, drug delivery, and spinal cord stimulation represent several important strategic and commercial inflection points beginning in 2026.