This section highlights FDA-related milestones and regulatory updates for drugs developed by NeuroOne Medical Technologies (NMTC).
Over the past two years, NeuroOne Medical Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ICD-10 and OneRF. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
ICD-10 - FDA Regulatory Timeline and Events
ICD-10 is a drug developed by NeuroOne Medical Technologies for the following indication: For sEEG RF Ablation.
This drug is approved by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ICD-10
- Announced Date:
- June 20, 2024
- Indication:
- For sEEG RF Ablation
Announcement
NeuroOne Medical Technologies Corporation announced that the Centers for Medicare and Medicaid Services (CMS) has approved and granted a new ICD-10-PCS (International Classification of Diseases, 10th Revision, Procedure Coding System) code for the OneRF™ Ablation procedure.
AI Summary
NeuroOne Medical Technologies Corporation announced that the Centers for Medicare and Medicaid Services (CMS) has approved a new ICD-10-PCS code for its OneRF™ Ablation procedure. The new code, 00503Z4, defines the procedure as the "Destruction of Brain Using Stereoelectroencephalographic Radiofrequency Ablation, Percutaneous Approach." This update, effective October 1, 2024, will enable hospitals to accurately report and document inpatient procedures performed with the FDA-cleared OneRF™ Ablation System.
By standardizing how the procedure is recorded and billed, this CMS decision is expected to boost recognition and adoption of NeuroOne’s innovative technology. The improved coding could contribute to enhanced patient outcomes, potentially reducing hospital stays and the number of surgeries for those suffering from neurological disorders.
Read Announcement- Drug:
- ICD-10
- Announced Date:
- June 20, 2024
- Estimated Event Date Range:
- October 1, 2024 - October 1, 2024
- Target Action Date:
- October 01, 2024
- Indication:
- For sEEG RF Ablation
Announcement
NeuroOne Medical Technologies Corporation announced that ICD-10-PCS code for first to market, FDA-cleared thin-film, sEEG-guided RF ablation system effective October 1, 2024
AI Summary
NeuroOne Medical Technologies Corporation announced that the Centers for Medicare and Medicaid Services has approved a new ICD-10-PCS code for its OneRF™ Ablation System. This FDA-cleared, thin‐film, sEEG-guided RF ablation system will have its associated procedure code take effect on October 1, 2024. The new code allows hospitals to accurately document and bill for inpatient procedures that use this innovative technology to create radiofrequency lesions in nervous tissue, enhancing patient safety during neurosurgical procedures.
CEO Dave Rosa emphasized that the code’s approval is a key milestone that will drive broader adoption and market acceptance of the new system. He believes this advance will help reduce hospital stays, the number of surgeries, and adverse events, further establishing NeuroOne’s commitment to improving outcomes in neurosurgical care.
Read Announcement
OneRF - FDA Regulatory Timeline and Events
OneRF is a drug developed by NeuroOne Medical Technologies for the following indication: Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- OneRF
- Announced Date:
- April 23, 2025
- Indication:
- Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures.
Announcement
- NeuroOne Medical Technologies Corporation announced that has filed its 510(k) submission to the FDA for trigeminal nerve ablation earlier than previous guidance.
AI Summary
NeuroOne Medical Technologies Corporation has moved forward with its plans by filing a 510(k) submission to the FDA for its trigeminal nerve ablation technology earlier than expected. The submission, now scheduled for May 2025, uses the company’s proprietary OneRF Ablation System. This system is designed as a minimally invasive treatment that uses radiofrequency energy to target the trigeminal nerve, which is responsible for severe facial pain in patients suffering from trigeminal neuralgia. The earlier submission date could help speed up the review process, potentially allowing NeuroOne to begin generating revenue from this treatment later in 2025 if approved. This step is part of the company’s broader mission to develop hi-definition, minimally invasive solutions for pain relief and neurological conditions.
Read Announcement- Drug:
- OneRF
- Announced Date:
- March 11, 2025
- Estimated Event Date Range:
- May 1, 2025 - May 31, 2025
- Target Action Date:
- May 01, 2025
- Indication:
- Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures.
Announcement
NeuroOne Medical Technologies Corporation a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, has accelerated the anticipated timeline of its 510(k) submission to the FDA for trigeminal nerve ablation to May 2025, which leverages the Company's patented OneRF® Technology Platform. The Company had previously projected a submission by the end of June 2025.
AI Summary
NeuroOne Medical Technologies Corporation has moved up its planned 510(k) submission to the FDA for a new trigeminal nerve ablation system to May 2025. This device uses the Company’s patented OneRF® Technology Platform to treat trigeminal neuralgia, a condition that causes severe facial pain. The minimally invasive procedure uses radiofrequency energy to eliminate abnormal tissues along the trigeminal nerve, potentially offering a valuable new option for patients suffering from chronic facial pain. By accelerating its schedule by about two months, NeuroOne aims to be positioned for earlier FDA clearance and earlier revenue generation if approved. The company’s swift submission demonstrates its commitment to advancing surgical care methods and improving patient outcomes in the field of neurological disorders.
Read Announcement- Drug:
- OneRF
- Announced Date:
- September 10, 2024
- Indication:
- Ablation System for creation of radiofrequency ("RF") lesions in nervous tissue for functional neurosurgical procedures.
Announcement
NeuroOne Medical announced that the OneRF Ablation System was recently used in a breakthrough patient procedure at the University Hospitals in Cleveland to successfully complete forty four ablations in one patient.
AI Summary
NeuroOne Medical recently announced a breakthrough procedure at University Hospitals in Cleveland using its OneRF Ablation System. The system was used to perform 44 ablations in one patient over a two-day period. Guided by sEEG recordings that identified the patient’s epileptic zones, six implanted electrodes delivered the ablations. This unique procedure exceeded the typical range found in clinical literature and was well-tolerated by the patient.
The patient is now reported to be seizure-free, with improvements in mood and memory. Both Dr. Michael Staudt, who led the procedure, and NeuroOne’s CEO praised the system’s performance and safety. They believe that the success of this case may lead to more widespread use of the OneRF Ablation System in treating patients with challenging neurological conditions.
Read Announcement
Free NMTC Stock Alerts