OUR NEW PROFILE IS: (NASDAQ: NMTC)
NeuroOne® Announces $3.5 Million Accelerated Milestone Payment from Zimmer Biomet for Evo® sEEG Electrode
NMTC Has Closed Green the Past 5 Sessions and Has Been on the Move the Past Few Months
NMTC IS UP OVER 100% SINCE JULY AND SHOWING NO SIGN OF SLOWING DOWN!!!
We have another exciting profile for you to get on your radar this morning.
Pull up NMTC Immediately.
NeuroOne Medical Technologies Corporation is a developmental stage company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs.
Brain Monitoring – Understanding What Allows Us To Sense, Move, Think And Feel. (1)
86 BILLION NEURONS
Neurons communicate through electrical and chemical signals. The specific properties of the neurons composing a brain area and their connections with neurons in other brain areas, define the function of a brain area (e.g. language, vision, movement).
Monitoring Neural Activity
THEY CAN RECORD ELECTRICAL SIGNALS
There are different ways to record and monitor neural activity. Their solution is to provide electrodes that are placed on top of or within the brain and capture the activity of a group of neurons located underneath/around each contact. The signals recorded are called intracranial electroencephalogram (iEEG) or electrocorticography (ECoG) signals. The shape, amplitude and frequency of these electrical signals provide a readout of the activity of that brain area.
Monitoring Neurological Disorders
Neurological diseases may be associated with disturbances in neural activity and connectivity between brain areas. The changes in the shape, amplitude and frequency of recorded electrical signals may be used to identify areas with altered activity.
Epilepsy is the disease associated with spontaneously recurring seizures. A seizure is a sudden, uncontrolled electrical disturbance in the brain. It can cause changes in behavior, movements or feelings, and in levels of consciousness. There are different types of seizures and their characterization and classification helps guide the treatment.
There are more than twenty seven FDA-approved drugs for the treatment of seizures. However, in ~1/3 of the patient’s medication fails to control their seizures. These patients are candidates for surgical options.
Evo® Cortical Electrode
Cortical or subdural electrodes are used in electrocorticography (ECoG) or intracranial electroencephalography (iEEG) surgeries to monitor, record and stimulate the surface of the brain for up to 30 days. The company’s Evo cortical electrode portfolio consists of various contact configurations of strip and grid electrodes. (Rx only)
The Evo Advantage
Decreased Immunological Response – The Evo Electrode is over 7 times thinner than a silicone electrode. The flexibility and reduced volume should reduce pain and edema.
The Evo’s polyimide substrate has properties like increased flexibility, reduced volume, and decreased immunological response, which should reduce signal artifacts.
Single Tail Design – The single thin tail design allows the implanted electrode tail to be tunneled through one incision which should reduce infection risk and procedure time.
Reduced Cable Management – A disposable cable assembly is sent with each Evo Electrode as an electrode kit, removing the need to source the correct cables for each electrode being used in surgery. Also, hospital resources are freed from the management of sterilizing and storing individual electrode cable assemblies.
How NeuroOne’s Thin Film Electrode Technology is Different
In comparison to currently available technologies, our electrodes are manufactured with polyimide thin film. Our electrodes are designed to reduce trauma to the brain by allowing a less invasive implant due to the flexibility, thinness and reduced weight of the electrode.
Furthermore, the potential to significantly increase the resolution of brain recordings may enable the usage of powerful computing techniques, such as machine learning and artificial intelligence.
Caution: US Federal law restricts this device to sell by or on the order of a physician
Two FDA-Cleared Devices and Counting
Are you beginning to understand that NeuroOne is not just “another” MedTech company? In fact, their Evo Cortical and sEEG Electrodes are both FDA approved!
What they are doing right now has incredible implications for the future of the medical industry.
So much so that the technologies below could be commonplace and in wide use across the globe.
NeuroOne® Reports Third Quarter Fiscal Year 2022 Financial Results and Provides Corporate Update
EDEN PRAIRIE, Minn., Aug. 11, 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 its operating results for the third quarter of fiscal year 2022 ended June 30, 2022.
Third Quarter and Recent Business Updates
- Zimmer Biomet agreed to an accelerated $3.5M milestone payment for Evo® sEEG electrode; Zimmer received a warrant to purchase 350,000 shares of NeuroOne’s common stock at $3.00 per share.
- Re-submitted special 510(k) to FDA for <30 day use for the Evo sEEG electrode.
- Completed ablation system prototypes, including RF generator from RBC Medical and NeuroOne’s electrodes and accessories, ahead of schedule and successfully tested the first fully integrated sEEG/RF ablation system.
- Achieved major milestone with first sEEG electrode case for intraoperative brain mapping at the subsurface level of the brain performed at Emory University.
- Qualified second source for manufacturing for both the Evo cortical and sEEG electrodes.
- Completed validation and placed orders for a new cable assembly which will provide significant cost reduction.
- Established advisory board of leading anesthesiologists and neurosurgeons for spinal cord stimulation program.
- Completed design verification to extend shelf life for Evo cortical electrodes to three years.
- Presented at the HC Wainwright Global Investment Conference and the NobleCon 18 Investor Conference.
- Exhibited the Evo Cortical electrode family in partnership with Zimmer Biomet at the American Association of Neurological Surgeons Annual Scientific Meeting and the American Society for Stereotactic and Functional Neurosurgery Biennial Meeting.
- The first peered-reviewed paper presenting the biocompatibility results for NeuroOne subdural thin film electrodes was published in the Frontiers of Neuroscience journal on April 29, 2022.
- The Company’s Evo sEEG implantation accuracy study was accepted as a podium presentation at the Biennial Meeting of the World Society for Stereotactic & Functional Neurosurgery, to be held in South KoreaSeptember 4-7 2022.
Dave Rosa, CEO of NeuroOne commented, “The Company made great strides in the third fiscal quarter of 2022 and subsequent six weeks. Significant progress was made in testing our Evo sEEG electrode and on August 9th we re-submitted to the FDA a special 510(k) seeking clearance for <30 day use. In addition, we were excited to have the first Evo sEEG case performed by Dr. Robert Gross of Emory University for less than 24 hour use. We were also successful in reducing costs by completing validation of a new cable assembly and extending shelf life of the Evo Cortical electrode product lines. A backup supplier for our electrodes was also qualified providing additional insurance for our supply chain. Regarding our ablation system which we have named OneRF™ we successfully completed bench top testing for the entire system.
Finally, we are excited that Zimmer Biomet agreed to an accelerated $3.5Mmilestone payment for the Evo® sEEG electrode.” Rosa continued, “This amendment to our agreement provides NeuroOne with near term capital without the need for a highly dilutive financing and reinforces our ongoing partnership with Zimmer Biomet.”
Upcoming Targeted Milestones
- Evo sEEG Depth Diagnostic Electrode
- OneRF(RF ablation system)
- Partner with a research organization to develop electrode for new clinical indication.
- Chronic Use Electrode
Third Quarter of Fiscal 2022 Financial Results
Product revenue was $32,000 in the third quarter of fiscal 2022, compared to product revenue of $40,000 in the third quarter of fiscal 2021. Collaboration revenue was delayed in the third quarter of fiscal 2022 due to the FDA decision, compared to collaboration revenue of $17,000 in the third quarter of fiscal 2021. Collaboration revenue is derived from the Zimmer Development Agreement and represents the portion of the upfront initial development fee payment eligible for revenue recognition as of June 30, 2022.
Total operating expenses in the third quarter of fiscal 2022 were $2.8 million, compared with $3.0 million in the prior year third quarter. R&D expense in the third quarter of fiscal 2022 was $1.2 million, compared with $0.9 million in the same period of fiscal 2021. SG&A expense in the third quarter of fiscal 2022 was $1.5 million, compared with $2.1 million in the prior year third quarter.
Net loss for the third quarter of fiscal 2022 was $2.8 million, compared to a net loss of $3.0 million in the third quarter of fiscal 2021.
As of June 30, 2022, the Company had cash of approximately $10.2 million, compared to $6.9 million as of September 30, 2021, the end of the Company’s most recent fiscal year. The Company had no debt outstanding as of June 30, 2022.
NeuroOne® Announces $3.5 Million Accelerated Milestone Payment from Zimmer Biomet for Evo® sEEG Electrode
Amendment provides Zimmer Biomet with 350,000 warrants with exercise price of $3.00 per share
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.
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. This agreement accomplishes multiple objectives for NeuroOne, most importantly by providing additional capital to our balance sheet in the short-term without the need for a highly dilutive financing, and further reinforcing our ongoing partnership with Zimmer.”
Brian Hatcher, President of the Trauma, CMFT, Foot and Ankle Division of Zimmer said, “We look forward to continuing the relationship with NeuroOne as we advance our mission to alleviate pain and improve the quality of life for people around the world.” 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.
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