Neuroone Medical Technologies (NMTC) Status Update summary

Fiscal 2025 Strategic Plan and Business Overview

• Focus on expanding the OneRF ablation system, advancing the product pipeline, and targeting multi-billion-dollar neurological and pain management markets, including epilepsy and Parkinson's.

• Transforming diagnosis and treatment of neurological disorders with FDA-cleared thin-film electrode technology and patented multi-purpose electrodes.

• Exclusive partnerships with Zimmer Biomet and Mayo Clinic support commercialization, clinical research, and board representation.

• Three FDA 510(k) cleared electrode families for brain use, with additional patent applications and regulatory submissions planned for 2025.

• Drug delivery and spinal cord stimulation platforms in development, with successful feasibility studies and future growth targets.

Product and Technology Updates

• OneRF is the only sEEG electrode with FDA clearance for both diagnostic and therapeutic use, enabling single-hospitalization procedures.

• Multi-purpose electrodes reduce surgeries and hospitalizations by enabling recording, ablation, and stimulation with a single device.

• Evo Cortical and SEEG electrodes distributed by Zimmer Biomet offer improved signal clarity and reduced noise.

• OneRF Ablation System allows single-procedure diagnosis and therapy, with a new ICD-10-PCS code effective October 2024.

• Spinal cord paddle lead and SEEG-based drug delivery system in development, with FDA submission planned.

Commercialization and Strategic Partnerships

• Zimmer Biomet partnership expanded to include distribution rights for OneRF Ablation System, with $3M licensing fee and potential milestone payments.

• Full sales force training for Zimmer Biomet expected to take 3-4 more months.

• Mayo Clinic collaboration includes pre-clinical and clinical research, board representation, and first commercial use of Evo electrodes.

• Ongoing discussions with potential partners for pain management and drug delivery applications.

• Pursuing additional strategic partnerships and non-dilutive licensing agreements.