NeuroOne Announces Distribution Deal With Zimmer Biomet For Evo™ Cortical Electrode; Reduces Majority of Debt While Strengthening Balance Sheet

August 06 12:50 2020

NeuroOne Medical Technologies Corporation (OTC: NMTC) finalized a development and distribution deal with Zimmer Biomet (NYSE: ZBH) to market its Evo™ Cortical Electrode (Evo), the Company’s first FDA 510(k)-cleared product. The Evo Cortical Electrode is indicated for recording, monitoring and stimulating brain tissue for up to 30 days. The technology, utilizing sophisticated automated manufacturing processes, offers a thin-film lightweight design, high resolution capabilities, reduced immunological response—as demonstrated in pre-clinical studies—and the potential to be placed in a minimally invasive manner. 

The terms of the deal announced in July provide Zimmer Biomet with exclusive global rights to distribute Evo, which is the result of collaborations between NeuroOne and the University of Wisconsin-Madison’s Alumni Research Foundation and the Mayo Foundation for Medical Education and Research. 

Innovative Thin Film Evo Cortical Electrode 

The deal with Zimmer Biomet is the second milestone for this innovative electrode, with the first coming from FDA 510(k) clearance, announced in December of 2019. Evo cortical electrodes are designed to be less invasive, improve the surgical experience and enhance mapping capabilities for people suffering from neurological disorders. In pre-clinical studies conducted by the Mayo Clinic, Evo demonstrated a reduction in the brain’s immunological response, which should increase patient comfort and reduce signal artifacts associated with the brain electrode interface. This technology is expected to generate significant interest from neurologists and neurosurgeons managing patients with epilepsy and brain tumors.

Zimmer’s involvement is expected to allow NeuroOne to focus its resources on the pursuit of additional applications of its technology and meeting initial launch order requests to initiate product commercialization.

In connection with the Zimmer distribution agreement, NeuroOne received an upfront payment, with the potential to receive back-end payments upon meeting certain milestones. 

Second Product Seeking FDA 510(k) Clearance in Q4

The next product being developed by NeuroOne is a stereoelectroencephalography (sEEG) depth electrode, which NeuroOne anticipates submitting for FDA 510(k) clearance by the end of 2020. The sEEG depth electrode is an expansion of NeuroOne’s thin film electrode platform that can access deep cortical structures (where its Evo cortical electrodes are only on the surface). Additionally, it can be implanted through tiny twist holes instead of a craniotomy. This design feature may lead to fewer complications, less post-operative pain, and shorter length of stay in the hospital. Like Evo, the new sEEG depth electrode will be indicated for recording, monitoring and stimulating brain tissue for up to 30 days.

Beyond the Evo electrode portfolio, NeuroOne’s development pipeline includes an ablation electrode to record and remove targeted problematic brain tissue, a spinal cord stimulation electrode, and a deep brain stimulation electrode. Intended applications for these innovative devices include helping with epilepsy, Parkinson’s Disease, dystonia, essential tremors, and chronic back pain due to failed surgeries. 

These innovative thin film technologies leverage new research conducted by scientists using deep brain stimulation to treat psychological and mental disorders. To date, published clinical data has helped generate a spike in interest from respected biotech leaders and technology entrepreneurs.

To drive future development of its proven product pipeline, NeuroOne has created an advisory board of seven prominent artificial intelligence experts to assist in the technology’s planning, development, and functional application. Artificial intelligence is expected to be an integral part of the company’s next generation of electrode technology.

Balance Sheet Strengthened In July

In July, the Company retired approximately $3.3 million of debt, allowing the Company to transition towards planning commercialization, building its financial infrastructure, and focusing on additional product development. 

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