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. The new code is 00503Z4 Construction of Brain Using Stereoelectroencephalographic Radiofrequency Ablation, Percutaneous Approach. This code allows hospital reporting of inpatient procedures that are performed using the OneRF Ablation system, which has FDA 510(k) clearance for creation of radiofrequency ("RF") lesions in nervous tissue for functional surgical procedures.

ICD-10-PCC codes play a critical role in the healthcare system, ensuring efficient and accurate documentation, billing, and analysis. The code goes into effect beginning October 1, 2024. The OneRF Ablation System is NeuroOne's first device with a therapeutic indication and its third FDA 510(k) -cleared device.

NeuroOne now boasts a full line of thin film electrode technology to address patients requiring diagnostic brain mapping procedures as well as RF ablation using the same sEEG electrode. In addition to the OneRF Ablation System, NeuroOne's other FDA-cleared devices include the Evo®? cortical and sEEG electrode product lines which are used primarily for stimulation, recording and monitoring of electrical activity in the brain for less than 30 days.

NeuroOne estimates the current brain ablation market to be at least $100 million worldwide and growing rapidly, with the potential to grow multifold based on large addressable patient populations with unmet clinical needs.