NeuroOne Wins ISO 13485 Certification, Opening International Markets for OneRF Ablation Platforms
核心洞察
NeuroOne received ISO 13485 certification, enabling international commercialization of its OneRF Brain and Trigeminal Neuralgia (搜索) Ablation Systems and Evo diagnostic lines.
Third-quarter fiscal 2026 product revenue reached $2.0 million, up 16% year over year, with product orders of $2.7 million, up 43%.
The Journal of Neurosurgery published a Mayo Clinic Jacksonville study showing OneRF procedures may be performed without interfering with implanted neuromodulation hardware.
NeuroOne Medical Technologies (搜索) (NASDAQ: NMTC) has received ISO 13485 certification, the international quality management standard required to market medical devices outside the United States, the company announced during its third-quarter fiscal 2026 earnings call. The certification, achieved earlier than projected, clears the way for international commercialization of the OneRF Brain Ablation System (搜索), the OneRF Trigeminal Neuralgia (搜索) Ablation System, and the Evo Cortical and sEEG diagnostic product lines.
"I am very proud to announce that we received our certification recently, which now provides the opportunity to enter international markets," said Dave Rosa, NeuroOne's Chief Executive Officer.
Commercial Results and Manufacturing Constraints
Product revenue for the third quarter of fiscal 2026 was $2.0 million, a 16% increase from $1.7 million in the same quarter of fiscal 2025, driven by higher sales of OneRF products. New product orders totaled $2.7 million for the quarter, representing 43% year-over-year growth and outpacing recognized revenue, leaving a backlog of $1.7 million as of June 30, 2026.
Gross margin expanded to 59.9% of product revenue, compared with 53.9% a year earlier, which the company attributed to a more favorable sales mix toward higher-margin products. Total operating expenses rose to $3.6 million from $2.8 million, including $1.4 million in research and development and $2.2 million in selling, general and administrative costs. Net loss for the quarter was $2.0 million, or $0.28 per diluted share, compared with a net loss of $1.5 million, or $0.22 per diluted share, in the prior-year period. The result was favorably impacted by a $0.4 million gain from a fair value change in warrant liability.
NeuroOne guided to fiscal 2026 recognized revenue of $9.2 million to $10.5 million against aggregate product orders of approximately $11.2 million. Rosa said the gap reflects manufacturing constraints rather than demand, noting that supplier lead times "can take as long as 6 months" and that the $11.2 million order figure "is very unlikely to happen" as recognized revenue. The company is qualifying a second manufacturing site, described as substantially larger than its current facility, expected to come online in the first part of 2027.
Mayo Clinic Study Expands Treatable Population
The Journal of Neurosurgery published a retrospective observational study conducted by the Mayo Clinic in Jacksonville, Florida, titled "Stereoelectroencephalography-guided radiofrequency Thermocoagulation in patients with implanted Neuromodulation devices, a patient series." The study evaluated the OneRF Brain Ablation System (搜索) in patients with implanted neuromodulation devices and concluded that the procedures may be performed without interfering with existing hardware while providing meaningful seizure reduction.
Rosa said the finding expands the pool of treatable patients to include those with existing neuromodulation implants. The company also expects to enroll the first patient in a brain ablation post-market registry by the end of September 2026.
For the OneRF Trigeminal Nerve Ablation System (搜索), Rosa cited a patient recently treated with the device who was featured in a television interview on Cleveland 19 News, an affiliate of CBS. The patient described living with trigeminal neuralgia (搜索) as worse than experiencing childbirth ten times and said the condition made her feel "like a zombie"; she reported being pain-free following treatment. NeuroOne estimates the U.S. market for trigeminal neuralgia disposables, excluding hardware, at $40 million, with the majority of cases performed at approximately 30 centers. The company is interviewing independent distributors to support commercialization beyond geographies covered by its partnership with Zimmer Biomet.
StereoCED Targets Intracranial Drug Delivery Bottleneck
David Wambecke, NeuroOne's Chief Business Officer, presented the company's robotic-assisted intracranial drug delivery platform, StereoCED (搜索), which is designed to leverage neurosurgical equipment and workflows already established in leading hospitals. He said current brain-delivery procedures can run 8 to 12 hours in the operating room and rely entirely on intraoperative MRI guidance, and that StereoCED has the potential to significantly reduce procedure times through simultaneous multi-trajectory delivery without requiring hospitals to purchase an entirely new robotic platform.
Wambecke highlighted the FDA's June decision to reverse its earlier position and allow uniQure to submit an accelerated approval BLA for AMT-130 in Huntington's disease (搜索) based on existing 3-year clinical data. If approved, AMT-130 could become the first commercially approved blockbuster therapy delivered directly into the brain, with Wall Street analysts projecting global peak sales exceeding $2 billion while flagging commercial risk tied to the complex, lengthy procedure.
NeuroOne anticipates StereoCED (搜索) will be ready for investigational human clinical studies by the end of September, and possibly sooner for animal research. The company has announced collaborations with the University of Minnesota in epilepsy (搜索) and with Mayo Clinic in diffuse midline glioma (搜索); first animal studies were scheduled to begin this month, with data from both programs expected this fall. Rosa said the University of Minnesota work pertains to focal epilepsy, with preclinical testing expected in the next quarter and a potential Phase I in patients if efficacy is demonstrated. NeuroOne also expects its first device sale to a pharmaceutical company for a nonhuman primate study later this year.
BVNA Back Pain Program Advances Toward 510(k)
For its Basivertebral Nerve Ablation (BVNA) system for chronic lower back pain (搜索), NeuroOne completed user design requirements and initiated preclinical testing during the quarter. The company reconfirmed that the regulatory pathway is likely a 510(k) submission and expects to file with the FDA in the second half of calendar 2027. Rosa noted that clearance for the OneRF Trigeminal Nerve Ablation System (搜索) took approximately four months, and that the company has succeeded with both of its prior 510(k) submissions. The BVNA strategy leverages the existing OneRF generator, temperature accessory and ablation electrode while outsourcing access tools through outside vendors or potential distribution partners.
Financial Position
NeuroOne reported cash and cash equivalents of $2.0 million as of June 30, 2026, down from $6.6 million as of September 30, 2025, alongside $1.1 million in accounts receivable expected to convert to cash in the fourth quarter. Working capital stood at $3.7 million, compared with $7.9 million at the end of fiscal 2025, and the company reported no debt outstanding. NeuroOne raised $0.4 million through its at-the-market offering program during the quarter and an additional $1.0 million on July 13, 2026 through the issuance of 400,346 shares. Following the end of the quarter, the company's lead investor increased its holdings from 7.4% to 12.5%. All share and per-share amounts reflect a 1-for-6 reverse stock split that began trading on a split-adjusted basis on the NASDAQ Capital Market on April 16, 2026.