NeuroOne Archives - Page 2 of 2 - Medical Design Sourcing

FDA clears NeuroOne’s Evo sEEG electrode for 30-day use

The Evo sEEG uses NeuroOne’s hi-definition thin-film electrodes technology. [Photo courtesy of NeuroOne]NeuroOne today announced it received expanded FDA 510(k) clearance to market its Evo sEEG Electrode technology for temporary use with brain recording, monitoring and stimulation equipment.

Eden Prairie, Minnesota-based NeuroOne previously announced it resubmitted its 510(k) application for up to 30-day use. The resubmission included additional biocompatibility testing as requested by the FDA.

The new FDA clearance covers temporary use for up to 30 days with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

“I am extremely proud of the entire NeuroOne team and their relentless pursuit of this clearance. Despite the challenges we faced, our team remained focused and persistent in driving this successful conclusion. This is clearly our most exc…

How NeuroOne and Zimmer Biomet will partner on robotic brain surgery

The NeuroOne Evo sEEG [Photo courtesy of NeuroOne]

NeuroOne is preparing its depth electrode technology for commercialization through Zimmer Biomet (NYSE: ZBH) while waiting for FDA feedback on its latest submission.

NeuroOne’s Evo stereoelectroencephalography (sEEG) device won FDA 510(k) clearance in September 2021 for recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

That clearance was for temporary use (less than 24 hours), and NeuroOne applied in November to extend the duration of use to less than 30 days. The FDA denied that application in May, but said the company could try again with new subacute toxicity biocompatibility evidence.

NeuroOne CEO Dave Rosa [Photo courtesy of NeuroOne]

“We ran into a methodology issue or disagreement with them on the last test that we performe…

NeuroOne submits special FDA 510(k) application for Evo sEEG electrode

NeuroOne (Nasdaq:NMTC) announced today that it submitted a special FDA 510(k) application for its sEEG electrode.

Eden Prairie, Minnesota-based NeuroOne’s special submission aims to extend the duration of use for its Evo sEEG electrode from less than 24 hours to less than 30-day use.

The company said in a news release that, according to FDA guidance, a special 510(k) submission is usually reviewed within 30 day of receipt as opposed to the 90 day period for a traditional 510(k) submission.

In May, the FDA stated that it would uphold its decision that the Evo device is “not substantially equivalent for extended use” based on its analysis of the methodology used for exhaustive extraction testing. NeuroOne said the FDA told the company it could submit a new 510(k) with new evidence.

Evo received FDA 510(k) clearance for the temporary (less than 24 hours) recording, monitoring and stimulation of electrical signals at the subsurface l…

Zimmer Biomet speeds up investments in NeuroOne

NeuroOne Medical Technologies (Nasdaq: NMTC) announced today that it will receive an accelerated $3.5 million milestone payment from Zimmer Biomet.

The milestone payment is related to Eden Prairie, Minnesota–based NeuroOne’s Evo sEEG electrode technology, which last year received FDA 510(k) clearance for temporary (less than 24 hours) recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

Under an agreement inked in July 2020, Zimmer Biomet (NYSE: ZBH) has exclusive rights to distribute the NeuroOne’s cortical and sEEG diagnostic electrode technology worldwide. The agreement amendments announced today also gave ZB a warrant to purchase 350,000 shares of NeuroOne’s common stock at an exercise price of $3.00 per share. (NMTC shares are up by about a third to $1.56 apiece this morning; MassDevice‘s MedTech 100 Index is up slightly.)

“This agreement accomplishes multiple objectives for …

NeuroOne announces first clinical case using Evo sEEG electrodes

NeuroOne Medical Technologies today announced the first clinical case using its Evo sEEG electrodes.

The procedure was performed at Emory University by Dr. Robert Gross for intraoperative brain mapping at the subsurface level of the brain, according to the Eden Prairie, Minnesota-based company.

“This first clinical case use represents a major milestone achievement of one of our primary objectives for the company. We are grateful to Dr. Gross and his staff and were excited to hear of the positive experience he had using the electrode,” NeuroOne CEO Dave Rosa said in a news release. “We look forward to continuing to gain clinical experience with the electrode as we prepare to submit a special 510(k) to FDA in August for clearance to commercialize the product for less than 30 days use.”

NeuroOne received FDA 510(k) clearance to market the Evo sEEG electrode technology for temporary use in less than 24 hours for use with recording, mo…

FDA clears NeuroOne’s Evo sEEG electrode

NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode technology.

Eden Prairie, Minnesota-based NeuroOne’s Evo sEEG electrode technology received clearance for temporary (less than 24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain, according to a news release.

Get the full story at our sister site, Mass Device.

FDA clears NeuroOne’s Evo sEEG electrode

NeuroOne Medical Technologies (NMTC) announced that it received FDA 510(k) clearance for its Evo sEEG electrode technology.

Eden Prairie, Minnesota-based NeuroOne’s Evo sEEG electrode technology received clearance for temporary (less than 24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain, according to a news release.

The Evo sEEG electrode represents the second FDA-cleared product from NeuroOne its Evo cortical electrode technology in November 2019. The company develops surgical care options for patients suffering from neurological disorders.

NeuroOne’s sEEG electrodes, contrary to cortical electrodes, provide a similar function at the subsurface level of the brain while using a much less invasive process as it does not require the removal of the top portion of the patient’s skull.

The company anticipates a la…

NeuroOne gains NASDAQ listing

NeuroOne Medical Technologies (OTC:NMTC) announced that it was approved to uplist and begin trading on the Nasdaq market.

Eden Prairie, Minn.-based NeuroOne expects trading to commence today at the open of the market, with the company trading under the “NMTC” ticker, according to a news release.

The developer of surgical care options for patients suffering from neurological disorders will continue to trade on the OTC markets until trading commences on the Nasdaq.

“The team at NeuroOne has worked relentlessly for the past four years to position the company to accomplish this major milestone,” NeuroOne CEO Dave Rosa said in the release. “Nasdaq has an established reputation for being an exchange associated with emerging growth stocks and we believe our uplisting will elevate the company’s corporate profile with current and prospective investors, and the financial community as a whole.

“As the company continu…

NeuroOne Medical appoints new CFO

NeuroOne Medical Technologies (OTC:NMTC) announced today that it appointed Ronald McClurg as its chief financial officer.

McClurg, a veteran of 30 years in the space of financial leadership, has held the role of CFO for companies including Orthomet, Incisive Surgical, Video Sentry and Insignia Systems, having begun his career in public accounting at Ernst and Young, according to a news release.

“Over the past quarter, the company has made great progress in achieving key milestones and building our infrastructure,” NeuroOne president & CEO Dave Rosa said in the release. “With our future goal to uplist to a major national securities exchange, it became critical to add a seasoned senior financial executive such as Ron.

“His broad experience with both public and private companies as well as his familiarity with medical device companies make him an ideal fit for the role of CFO at NeuroOne. We are very fortunate to have him as part…