NeuroOne has said that its US Food and Drug Administration (FDA) cleared device has seen success across a number of ablation procedures since its limited release in April of 2024. Credit: Shutterstock / Alexander Supertramp

Minnesota-based medical device firm NeuroOne Medical Technologies has announced an amendment to its deal with Zimmer Biomet that will provide Zimmer Biomet with the exclusive rights to distribute NeuroOne’s OneRF system for an upfront payment of $3m.

The company’s OneRF ablation system is designed to use implanted stereo electroencephalograph (sEEG) electrodes so to record brain activity for the treatment of conditions such as multifocal epilepsy among other neurological disorders.

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NeuroOne has said that its US Food and Drug Administration (FDA) cleared device has seen success across a number of ablation procedures since its limited release in April of 2024. Now, the agreement with Zimmer Biomet means the OneRF system will see greater distribution across the US.

Dave Rosa, president, and CEO of NeuroOne, said: “The expanded agreement with Zimmer Biomet to include distribution of our OneRF Ablation System is a significant catalyst for the Company.

“We are confident that the partnership will allow NeuroOne to leverage Zimmer Biomet’s leadership position in robotic technology and extensive distribution channels both in the United States and abroad. As the world’s first FDA-cleared system for both diagnostic and therapeutic procedures, our ablation system provides clear advantages over existing competitive electrode technologies. We look forward to continuing to expand the indications for use in the future.”

Designed to reduce hospitalisations as well as the number of surgeries and adverse events, NeuroOne says that the OneRF system deal is expected to bring improved revenue into both firms with set milestone payments for certain performance criteria. The company has also said that to date, all the ablations have been performed at the patient’s bedside saving additional operating costs while allowing the patient to be diagnosed and treated in one hospitalisation instead of multiple visits.

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Brian Hatcher, president of Zimmer Biomet said, “We are excited to expand the relationship with NeuroOne to include the OneRF Ablation System, which builds on our existing agreement to distribute NeuroOne’s Cortical and sEEG diagnostic electrode technology, and we look forward to launching this product in the near future.”

Aside from the NeuroOne OneRF system, the company previously announced the completion of the first robotic neurosurgery case using its Evo sEEG electrode, part of a robotic platform designed to aid surgeons in the planning and execution of complex minimally invasive neurosurgical procedures.