NeuroOne Medical Technologies follows the old American proverb, “if at first you don’t succeed, try, try again.”
The Eden Prairie, Minnesota-based company this week submitted a special 510(k) request to the FDA for its Evo sEEG to extend the duration of use for up to 30 days. The device is currently cleared for use for less than 24 hours, and the FDA rejected the company’s previous offer for long-term use of the device. The sEEG device is used for recording, monitoring and stimulation of electrical signals at the subterranean level of the brain.
A special 510(k) submission is usually reviewed within 30 days, instead of the 90 days for a traditional 510(k) submission.
“Our employees and contractors have been working hard to expedite the testing and resubmission of our 510(k) sEEG electrode application ahead of our schedule,” said NeuroOne CEO Dave Rosa. . “We are delighted with the results provided by an accredited independent testing facility and look forward to continuing the dialogue with the FDA regarding this submission to reach a positive conclusion.”
In May, the FDA upheld the not substantially equivalent decision after the company appealed the ruling. The agency also informed the company that it may submit a new 510(k) with new evidence specifically with respect to the subacute toxicity biocompatibility endpoint.
NeuroOne develops minimally invasive and high definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremor, chronic pain due to back surgery failures and other associated neurological disorders.
NeuroOne secures $3.5 million accelerated payment from Zimmer Biomet
The 510(k) special submission follows news last week that NeuroOne has 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 agreement, Zimmer Biomet received a warrant to purchase 350,000 shares of NeuroOne, with an exercise price of $3 per share.
“I want to thank Zimmer for all of their support to date and their confidence in our business, our technology and our future plans,” said Rosa. “This agreement achieves several goals for NeuroOne, the most important being to provide additional capital to our short-term balance sheet without the need for highly dilutive financing, and to further strengthen our ongoing partnership with Zimmer.”
The companies first signed the agreement in July 2020, granting Zimmer Biomet exclusive worldwide distribution rights to distribute NeuroOne’s cortical and sEEG diagnostic electrode technology.
“We look forward to continuing our relationship with NeuroOne as we advance our mission to relieve pain and improve the quality of life for people around the world,” said Brian Hatcher, President, Trauma Division, CMFT, Foot and ankle at Zimmer Biomet.
Earlier this year, NeuroOne performed a first bench-top long-term stimulation test of its thin-film electrode technology. The company said the tests measured the electrodes’ ability to deliver the number of electrical stimulation pulses needed to meet approximately 5 years of use using an active accelerated aging test model. The results demonstrated the potential to deliver chronic stimulation at typical stimulation settings currently used to treat patients with chronic back pain due to multiple back surgery failures, NeuroOne said.