NeuroOne Archives - Medical Design Sourcing

First clinical case performed with NeuroOne Evo sEEG, Zimmer Biomet Rosa One Brain

The Evo sEEG [Photo courtesy of NeuroOne]NeuroOne Medical Technologies (Nasdaq:NMTC) today announced the first clinical case performed with its Evo sEEG in robotic neurosurgery.

Dr. William Bingaman performed the procedure with the electrode — exclusively marketed by Zimmer Biomet — at Cleveland Clinic. It marks the first procedure to utilize NeuroOne’s Evo sEEG with Zimmer Biomet’s Rosa One Brain.

The Rosa One Brain, a robotic platform, assists surgeons in planning and performing complex, minimally invasive neurosurgical procedures.

Eden Prairie, Minnesota-based NeuroOne commercially launched its Evo sEEG electrode line in the U.S. earlier this month. The electrodes provide up to 30 days of recording, monitoring and stimulation of electrical signals at the subsurface level of the brain.

NeuroOne’s electrodes provide a similar function at the subsurface level of the brain compared to cortical electrodes. However, they util…

NeuroOne launches Evo sEEG electrodes in the U.S.

The Evo sEEG [Photo courtesy of NeuroOne]NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it commercially launched its Evo sEEG electrode line in the U.S.

Zimmer Biomet holds exclusive worldwide distribution rights to the Evo Cortical and sEEG product lines. NeuroOne expects the line to utilize Zimmer Biomet’s Rosa One Brain robotic surgery platform for neurosurgical procedures. Zimmer paid $3.5 million to NeuroOne under the deal in August 2022. That came after an up-front payment of $2 million in 2020. NeuroOne began shipping commercial orders in the deal in November 2022.

“The commercial launch of the Evo sEEG platform represents one of the most impactful milestones in our company’s history,” said NeuroOne CEO Dave Rosa. “Paired with Zimmer Biomet’s ROSA One Brain robotic platform and broad distribution network, we believe the Company is well positioned in the market given the synergies that exist between our novel thin film ele…

NeuroOne completes animal implant of thin film lead for spinal cord stimulation

NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it completed an initial animal implant of its novel thin film paddle leads.

These leads enable spinal cord stimulation (SCS). NeuroOne intends for the devices to treat patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back pain and leg pain.

Eden Prairie, Minnesota-based NeuroOne’s implant came as part of a feasibility study. The company is evaluating a variety of sizes and shapes of ultra-thin paddle leads in a sheep model. It used a mini laminectomy surgical approach to access the epidural space for device placement.

The company said all devices easily advanced to the target location in under one minute. NeuroOne placed a competitive silicone-based lead for comparison purposes. It reported that its own lead fit “comfortably in teh epidural space.” The veterinary surgeon reported no concerns regarding the lead’s placement.…

NeuroOne completes feasibility study of OneRF ablation system

NeuroOne Medical today announced it completed a feasibility study of its OneRF ablation system.

The feasibility study evaluated the OneRF ablation system that uses existing sEEG diagnostic electrodes for brain tissue lesioning. Researchers completed the study in an animal model. The research combined the sEEG electrodes with a proprietary RF generator. In addition, there was a unique temperature control accessory that monitored and maintained ablation temperatures. The temperature control accessory allows doctors to set the temperature and time for each ablation procedure.

Dr. Van Gompel and his team implanted five sEEG electrodes. They performed electrophysiological records and completed a total of 10 RF ablations using different settings for temperature and time. An MRI scan confirmed all ablations in the feasibility study.

“This technology potentially represents a major improvement in the field, as it is the first known sEEG-guided RF system to …

NeuroOne begins shipping 30-day sEEG electrodes to Zimmer Biomet

The NeuroOne Evo sEEG [Photo courtesy of NeuroOne]NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that shipped its first commercial order in an agreement with Zimmer Biomet (NYSE:ZBH).

Zimmer Biomet holds an exclusive development and distribution agreement with NeuroOne for its thin film technology. It already sells NeuroOne’s earlier cortical strip and grid electrode devices. Over a year ago, Zimmer Biomet placed initial stocking orders with NeuroOne to sell the Evo sEEG device to neurosurgeons.

Zimmer paid $3.5 million to NeuroOne under the deal in August. That came after an up-front payment of $2 million in 2020.

“This shipment represents a monumental accomplishment for the company,” said NeuroOne CEO Dave Rosa. “Without the persistence of our staff and manufacturing partners, we could not have reached this point. We look forward to commercialization of this exciting technology in the future in partnership with Zimmer Biomet…

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.

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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…