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NeuroOne® Announces First Clinical Case Using Evo® sEEG Electrode Performed at Mayo Clinic

Retrieved on: 
Wednesday, May 10, 2023

EDEN PRAIRIE, Minn., May 10, 2023 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that its first clinical case using the Evo® sEEG electrode was performed by Dr. Jamie Van Gompel at Mayo Clinic. Using a non-robotic stereotactic frame system, Evo electrodes were implanted successfully and met the Company’s product performance objectives.

Key Points: 
  • Using a non-robotic stereotactic frame system, Evo electrodes were implanted successfully and met the Company’s product performance objectives.
  • We are ecstatic with the initial performance of our Evo sEEG electrodes which confirmed the results of many years of testing on the device.
  • While we previously used the device intraoperatively, this was the first clinical case that was cleared by the FDA for less than 30 day use.
  • NeuroOne believes there is a significant opportunity to expand market adoption of sEEG technology with broad U.S. distribution of its Evo product line.

NeuroOne® Announces U.S. Commercial Launch of Evo® sEEG Electrodes

Retrieved on: 
Tuesday, May 2, 2023

EDEN PRAIRIE, Minn., May 02, 2023 (GLOBE NEWSWIRE) -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced the commercial launch of the Evo® sEEG electrode product line in the United States. Zimmer Biomet holds exclusive worldwide distribution rights to NeuroOne’s Evo Cortical and sEEG product lines, and the Evo product line is expected to utilize Zimmer Biomet’s ROSA One® Brain, a robotic platform that assists surgeons in planning and performing complex minimally invasive neurosurgical procedures.

Key Points: 
  • Dave Rosa, CEO of NeuroOne, commented, “The commercial launch of the Evo sEEG platform represents one of the most impactful milestones in our Company’s history.
  • Epilepsy mapping procedures primarily utilize sEEG electrodes due to their less invasive insertion procedure, but less than 5% of people with drug-resistant epilepsy who are surgical candidates receive diagnostic procedures using sEEGs.
  • NeuroOne believes there is a significant opportunity to expand market adoption of sEEG technology with broad U.S. distribution of its Evo product line.
  • NeuroOne’s Evo sEEG electrode technology offers stereoelectroencephalography recording, brain stimulation and future capabilities for spinal cord stimulation, and ablation solutions targeted for patients suffering from epilepsy, chronic back pain, and Parkinson’s disease.

NeuroOne® Ships Initial Zimmer Biomet Order for its Evo® sEEG System for Less than 30 Day Use

Retrieved on: 
Wednesday, November 30, 2022

EDEN PRAIRIE, Minn., Nov. 30, 2022 /PRNewswire/ --  NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it shipped the first commercial order to Zimmer Biomet for its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.  Zimmer Biomet is the exclusive worldwide distribution partner for the NeuroOne Evo Cortical and sEEG electrode product lines.

Key Points: 
  • Zimmer Biomet is the exclusive worldwide distribution partner for the NeuroOne Evo Cortical and sEEG electrode product lines.
  • We look forward to commercialization of this exciting technology in the future in partnership with Zimmer Biomet
    The Evo sEEG System represents the Company's second FDA 510(k) cleared product.
  • sEEG electrodes are the predominant technology used in these procedures due to their less invasive placement and subsurface location.
  • The Company's Evo Cortical and sEEG Electrodes are a portfolio of hi-definition thin film electrodes.

NeuroOne® to Ring Nasdaq Stock Market Closing Bell on November 22

Retrieved on: 
Tuesday, November 22, 2022

EDEN PRAIRIE, Minn., Nov. 22, 2022 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced today that it will ring the Nasdaq closing bell today Tuesday, November 22, 2022, to commemorate its recent corporate milestone achievement for the Evo® thin film electrode platform.

Key Points: 
  • EDEN PRAIRIE, Minn., Nov. 22, 2022 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced today that it will ring the Nasdaq closing bell today Tuesday, November 22, 2022, to commemorate its recent corporate milestone achievement for the Evo thin film electrode platform.
  • The NeuroOne closing bell ceremony will be broadcast live starting at 3:50 p.m. Eastern Time from Nasdaq MarketSite in New York City's Times Square.
  • Following an introduction by Nasdaq, NeuroOne CEO Dave Rosa will deliver brief remarks and then ring the bell at4:00 p.m. alongside other members of theNeuroOneteam.
  • We are excited to celebrate this victory at Nasdaq's iconic bell ringing ceremony."

NeuroOne® Receives FDA 510(k) Clearance to Market its Evo® sEEG System for Less than 30 Day Use

Retrieved on: 
Tuesday, October 25, 2022

EDEN PRAIRIE, Minn., Oct. 25, 2022 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Evo sEEG Electrode technology for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

Key Points: 
  • On August 9, 2022, the Company announced it had resubmitted its 510(k) application to the FDA for less than 30 day use, which included additional biocompatibility testing as requested by the FDA.
  • On October 20, 2022, the Company received an FDA clearance letter stating that the Evo sEEG System is substantially equivalent to the predicate device and may be marketed in the United States.
  • "I am extremely proud of the entire NeuroOne team and their relentless pursuit of this clearance.
  • The Evo sEEG System represents the Company's second FDA 510(k) cleared product.

NeuroOne® Submits Special 510(k) to FDA for Evo® sEEG Electrode

Retrieved on: 
Tuesday, August 9, 2022

EDEN PRAIRIE, Minn., Aug. 9, 2022 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company submitted a special 510(k) to the U.S. Food and Drug Administration ("FDA") on August 8th for its sEEG electrode to extend the duration of use from less than 24 hours to less than 30 day use. A special 510(k), according to FDA guidance, is usually reviewed within 30 days of receipt, rather than the 90 days for a traditional 510(k).

Key Points: 
  • A special 510(k), according to FDA guidance, is usually reviewed within 30 days of receipt, rather than the 90 days for a traditional 510(k).
  • Dave Rosa, Chief Executive Officer of NeuroOne, states, "Our employees and contractors worked exceptionally hard to expedite the testing and resubmission of our sEEG electrode 510(k) application ahead of our timeline.
  • 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."
  • Forwardlooking statements may include statements regarding the timing of the FDA's review of the Company's special 510(k) submission; and the ability to obtain FDA clearance of the Company's sEEG electrode for

NeuroOne® Announces $3.5 Million Accelerated Milestone Payment from Zimmer Biomet for Evo® sEEG Electrode

Retrieved on: 
Wednesday, August 3, 2022

EDEN PRAIRIE, Minn., Aug. 3, 2022 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company entered into an amendment to its Exclusive Development and Distribution Agreement with Zimmer Biomet, Inc. ("Zimmer") that will provide the Company with a $3.5 million accelerated payment within 10 business days which relates to certain milestone payments.  In addition, Zimmer Biomet will receive a Warrant to purchase 350,000 shares of the Company's common stock, with an exercise price of $3.00 per share.

Key Points: 
  • In addition, Zimmer Biomet will receive a Warrant to purchase 350,000 shares of the Company's common stock, with an exercise price of $3.00 per share.
  • Dave Rosa, Chief Executive Officer of NeuroOne, states, "I want to thank Zimmer for all their support to date and their confidence in our business, technology and future endeavors.
  • Under the Exclusive Development and Distribution Agreement signed by both parties in July 2020, Zimmer Biomet has exclusive global distribution rights to distribute the Company's Cortical and sEEG diagnostic electrode technology.
  • Forwardlooking statements may include statements regarding the future of NeuroOne's partnership with Zimmer, NeuroOne's receipt of the $3.5 million payment, and NeuroOne's need for short-term financing.

NeuroOne Provides Evo® sEEG Update

Retrieved on: 
Monday, May 16, 2022

EDEN PRAIRIE, Minn., May 16, 2022 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces that the U.S. Food and Drug Administration (the "FDA") has completed its review of the Company's appeal for 510(k) clearance for its Evo® sEEG Electrode for less than 30-day use.  In a letter to the Company dated May 13, 2022, the FDA stated that they were upholding their decision that the device is not substantially equivalent for extended use based on their analysis of the methodology used for exhaustive extraction testing.

Key Points: 
  • EDEN PRAIRIE, Minn., May 16, 2022 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (NASDAQ: NMTC) ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announces that the U.S. Food and Drug Administration (the "FDA") has completed its review of the Company's appeal for 510(k) clearance for its Evo sEEG Electrode for less than 30-day use.
  • The FDA also stated that the Company may submitanew510(k) withnewevidence,specificallyasit relates to the subacute toxicity endpoint, to support a finding of substantial equivalence.
  • In September 2021 the Company received FDAclearance to market the Evo sEEG Electrode for temporary (less than 24 hours) use with equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.
  • These forwardlooking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forwardlooking statements for any reason, even if new information becomes available in the future.

NeuroOne Reports First Quarter Fiscal Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, February 14, 2022

Dave Rosa, CEO of NeuroOne commented, "During and subsequent to our fiscal first quarter, we made significant advancements across our product portfolio.

Key Points: 
  • Dave Rosa, CEO of NeuroOne commented, "During and subsequent to our fiscal first quarter, we made significant advancements across our product portfolio.
  • R&D expense in the first quarter of fiscal 2022 was$1.1 million, compared with$0.9 million in the same period of fiscal 2021.
  • SG&A expense in the first quarter of fiscal 2022 was$1.7 million, compared with$1.2 million in the prior year period.
  • Net loss was$2.8 millionfor the first quarter of fiscal 2022, compared to a net loss of$2.0 million in the first quarter of fiscal 2021.

NeuroOne® Medical Technologies Corporation Receives FDA 510(k) Clearance for its Evo® sEEG Electrode

Retrieved on: 
Tuesday, September 7, 2021

The Evo sEEG electrode represents the Company's second FDA 510(k) cleared product, providing a full line of electrode technology to address an estimated worldwide market of $100M for patients requiring diagnostic brain mapping procedures.

Key Points: 
  • The Evo sEEG electrode represents the Company's second FDA 510(k) cleared product, providing a full line of electrode technology to address an estimated worldwide market of $100M for patients requiring diagnostic brain mapping procedures.
  • It has become the predominant technology used in these procedures due to its less invasive placement and subsurface location.
  • The Company's Evo Cortical and sEEG Electrodes are a portfolio of hi-definition thin film electrodes.
  • NeuroOne received FDA clearance for its Evo cortical technology inNovember 2019.