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NeuroOne Tries Again for Long-Term sEEG Clearance

Image courtesy of designer491 / Alamy Stock Photo Hand written words "try again" with green underline and check mark.
After FDA shot down the company's earlier bid for extended use of the device, NeuroOne has now filed a special 510(k) submission.

NeuroOne Medical Technologies is following the old American proverb, "if at first you don't succeed, try, try again."

The Eden Prairie, MN-based company submitted a special 510(k) to FDA this week for its Evo sEEG extend the duration of use up to 30 days. The device is currently cleared to be used for less than 24 hours, and FDA shot down the company's earlier bid for long-term use of the device. The sEEG device is used for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

A special 510(k) submission is usually reviewed within 30 days, rather than the 90 days for a traditional 510(k) submission.

"Our employees and contractors worked exceptionally hard to expedite the testing and resubmission of our sEEG electrode 510(k) application ahead of our timeline," said NeuroOne CEO Dave Rosa. "We are excited with the results provided by an accredited independent test facility and look forward to continuing the dialogue with FDA regarding this submission to reach a successful conclusion."

In May, FDA uphold the not substantially equivalent decision after the company had appealed the ruling. The agency also informed the company it could submit a new 510(k) with new evidence specifically as it relates to the subacute toxicity biocompatibility endpoint.

NeuroOne develops minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson's disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders.

NeuroOne gets $3.5M accelerated payment from Zimmer Biomet

The special 510(k) submission follows last week's news that NeuroOne received a $3.5 million accelerated milestone payment from Zimmer Biomet for its Evo sEEG Electrode. The companies amended their exclusive development and distribution agreement. As part of the deal, Zimmer Biomet received a warrant to buy 350,000 shares of NeuroOne stock, with an exercise price of $3 a share.

"I want to thank Zimmer for all their support to date and their confidence in our business, technology, and future endeavors," Rosa said. "This agreement accomplishes multiple objectives for NeuroOne, most importantly by providing additional capital to our balance sheet in the short-term without the need for a highly dilutive financing, and further reinforcing our ongoing partnership with Zimmer."

The companies first signed the agreement in July 2020, giving Zimmer Biomet exclusive global distribution rights to distribute NeuroOne's cortical and sEEG diagnostic electrode technology.

"We look forward to continuing the relationship with NeuroOne as we advance our mission to alleviate pain and improve the quality of life for people around the world," Brian Hatcher, president of the trauma, CMFT, foot and ankle division at Zimmer Biomet said.

Earlier this year, NeuroOne completed an initial bench top, long-term stimulation testing of its thin film electrode technology. The company said the tests measured the electrodes’ ability to deliver the number of electrical stimulation pulses required to meet about 5 years of use using an active accelerated aging test model. The results demonstrated the potential to provide chronic stimulation at typical stimulation parameters currently used to treat patients suffering with chronic back pain due to multiple failed back surgeries, NeuroOne said.

TAGS: Neurological
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