NeuroOne Archives - Medical Design Sourcing

NeuroOne stock is down on Q4 revenue misses

NeuroOne Medical Technologies (Nasdaq:NMTC) shares took a hit today on fourth-quarter results that fell shy of the consensus sales forecast.

Shares of NMTC fell 8.2% at $1.58 apiece in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — dipped 0.2%.

The Eden Prairie, Minnesota-based company posted losses of $3.1 million for the three months ended Sept. 30, 2023. That marked a more than two-fold bottom-line slide from losses of $1.4 million a year ago. However, the company brought in more than 10 times the revenue it did for the same period a year ago, reporting $742,000 in sales.

NeuroOne reported $1.952 million in sales for the full year, compared to just $171,000 in 2022.

Still, the $742,000 fell $58,000 short of Wall Street’s projections for $800,000 in revenue for the fourth quarter.

Recent highlights include FDA clearance for the company&#…

FDA clears neuro ablation tech from NeuroOne

NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that the FDA granted 510(k) clearance to its OneRF ablation system.

Clearance makes OneRF the first FDA-cleared, thin-film, sEEG-guided radiofrequency (RF) system capable of recording electrical activity and ablating nervous tissue. The system, which also features temperature control, became the third FDA-cleared device at NeuroOne. It’s the first therapeutic device made by the Eden Prairie, Minnesota-based company.

The technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator. NeuroOne’s electrodes provide a similar function at the subsurface level of the brain compared to cortical electrodes. They utilize a much less invasive process that eliminates the need to remove the top portion of the skull, though.

NeuroOne initially submitted OneRF for FDA clearance in June. Last…

NeuroOne is pursuing drug delivery with neural probes

NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it received a patent for drug delivery with neural probe devices.

The United States Patent and Trademark Office (USPTO) issued the patent titled “Agent-Delivering Neural Probe Devices and Related Systems and Methods.” It covers novel electrodes that can operate as a standard neural electrode that delivers a treatment agent to a target area of the brain.

A step into the drug delivery space would mark further progress for NeuroOne, which develops thin-film electrode technologies.

The company already has a patent portfolio that includes both neural and spinal cord electrodes. Their unique structures optimize the functionality and minimized profile of those electrodes.

Get the full story at our sister site, Drug Delivery Business News.

NeuroOne picks former Cardiovascular Systems VP as new COO

NeuroOne Medical Technologies (Nasdaq:NMTC) announced that it appointed Christopher R. Volker as its chief operating officer (COO).

Volker joins the Eden Prairie, Minnesota-based neurotech company from Abbott. He previously served as VP and GM of international at Cardiovascular Systems (CSI), which Abbott acquired earlier this year.

“Chris’ appointment further strengthens our executive leadership team and deepens our capabilities as we build for future commercial growth and expansion into other clinical applications,” said NeuroOne CEO Dave Rosa. “We are excited to benefit from his broad experience in business development, commercial expansion, finance and health economics, and reimbursement.”

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

The company is als…

NeuroOne expects FDA nod for neuro ablation tech next year

NeuroOne (Nasdaq:NMTC) announced today that it responded to FDA questions regarding the 510(k) submission of its OneRF ablation system.

Eden Prairie, Minnesota–based NeuroOne submitted OneRF for FDA clearance in June. It’s the company’s first therapeutic device.

The technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator.

NeuroOne’s electrodes provide a similar function at the subsurface level of the brain compared to cortical electrodes. They utilize a much less invasive process that eliminates the need to remove the top portion of the skull, though.

When the company announced its submission, it said it expected feedback from the FDA by Aug. 7, 2023. It said today that it expects to receive additional communications from the FDA in 30 days or less. NeuroOne retains hope for completed discussions soon followed by a commercial la…

NeuroOne prices $5.25M public offering

NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it priced an underwritten registered public offering.

Eden Prairie, Minnesota-based NeuroOne’s offering includes 5.25 million shares of common stock priced at $1 per share. All shares included in the offering will be sold by the company. NeuroOne also granted the underwriter a 30-day option to purchase up to an additional 787,500 shares. Those common stock shares come at the public offering price less the underwriting discount.

NeuroOne expects the gross proceeds to total approximately $5.25 million. The company scheduled the offering to close on or about July 27, subject to customary conditions.

Proceeds are earmarked for a trio of uses. First, NeuroOne aims to use funds to support the commercial launch of the Evo sEEG electrode line in the U.S. The company began its launch with Zimmer Biomet in May. Zimmer Biomet holds exclusive worldwide distribution…

NeuroOne submits RF ablation system for FDA 510(k) clearance

NeuroOne Medical Technologies (Nasdaq:NMTC) announced today that it submitted an FDA 510(k) application for its OneRF ablation system.

This technology uses already-implanted sEEG electrodes to record brain activity and enable the ablation of nervous tissue. It connects to a proprietary radiofrequency (RF) generator. NeuroOne’s electrodes provide a similar function at the subsurface level of the brain compared to cortical electrodes. However, they utilize a much less invasive process. That process eliminates the need to remove the top portion of the skull.

NeuroOne said FDA clearance would mark the first step in bringing an RF ablation system to market for neurology and neurosurgery. It’s the company’s first therapeutic device. The company 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 b…

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…