I hope that you have been paying attention to the markets. I am seeing new opportunities pop up now on a regular basis now that weren’t there just a few weeks back.
Take a look at this chart. You can see that it is no stranger to monster moves and wild swings.
The last time we looked at it, this one opened at 1.05 and about 2 weeks later it tapped 2.80.
Pull up NMTC Immediately.
NMTC is a medical technology company focused on the development and commercialization of a minimally invasive and high-definition/high-precision electrode technology platform used for acute diagnostics and chronic treatment across a wide range of neurologic conditions including epilepsy, Parkinson’s disease, dystonia, essential tremors, and chronic pain due to failed back surgeries. NeuroOne’s electrodes offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering combination diagnostic and therapeutic functions such as EEG recording and tissue ablation and/or chronic stimulation. In addition to NeuroOne’s FDA-cleared EVO® diagnostic electrodes, a combination recording and radiofrequency (RF) ablation technology, OneRF®, is currently under development as the Company’s first therapeutic device. Other research and development programs include revolutionary new thin-film-based (chronic) electrodes for spinal cord stimulation (SCS) and deep brain stimulation (DBS), and the potential application of the Company’s technology for artificial intelligence and machine learning.
NeuroOne® Awarded U.S. Patent Covering Novel and Proprietary Thin Film Electrode Platform
New patent adds value to NeuroOne’s growing patent portfolio in the U.S. and abroad
EDEN PRAIRIE, Minn., March 7, 2023 /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 it has been awarded a patent from the United States Patent and Trademark Office relating to its novel and proprietary electrode technology.
The patent, titled “Improved Neural Depth Probes and Related Systems and Methods,” adds to NeuroOne’s intellectual property portfolio, and is focused on a layered thin film neural depth electrode. The electrode could have potential applications in a wide variety of neurological procedures for both diagnostic and therapeutic use. Conditions that could potentially benefit from this technology include epilepsy, Parkinson’s disease, chronic back pain due to failed back surgeries, and mood- based disorders associated with depression, severe OCD, etc.
In addition to this patent, NeuroOne’s patent portfolio includes three licensed patents, eight pending U.S. applications, and several foreign applications covering a wide variety of thin-film electrode technologies, including both neural and spinal cord electrodes having unique properties to optimize the functionality and minimized profile of those electrodes, enabling less invasive surgeries. More specifically, the inventions described in the patent applications include electrodes and related devices with drug delivery capabilities, spinal cord stimulation electrodes, ablation electrodes, and electrodes with temperature sensing features.
Dave Rosa, CEO of NeuroOne, comments, “NeuroOne is committed to protecting our groundbreaking electrode technology with respect to device claims and proprietary manufacturing processes. With a plethora of patent applications both in the U.S. and overseas relating to procedures in epilepsy, Parkinson’s disease, chronic back pain and drug/gene delivery, we believe the Company is well positioned to impact a number of key neurological conditions with patent-protected novel electrodes. We look forward to continued success with our patent applications.”
LETTER TO SHAREHOLDERS
Dear fellow shareholders,
In fiscal 2022 we made terrific strides in advancing our game-changing cortical, strip, grid and sEEG electrode technology for broad diagnostic and therapeutic applications. Today, NeuroOne provides a full line of electrode technology to address an estimated worldwide market of $100 million for patients requiring diagnostic brain mapping procedures. Our focus remains on patients suffering from epilepsy, chronic back pain, and Parkinson’s disease.
NeuroOne’s robust product suite has recently expanded beyond our first disruptive product introduction, the Evo® Cortical Electrode, to include our second FDA 510(k) cleared product, the Evo® sEEG Depth Electrode system, which is ready for commercial launch in the current calendar quarter. During 2022 we also made substantial development progress with our first combination system which includes both diagnostic and ablation capabilities.
The purpose of this letter is to share with you fiscal year 2022 and subsequent key highlights along with multiple exciting catalysts for NeuroOne in fiscal 2023.
Fiscal Year 2022 and Subsequent Highlights
Clearly our most exciting and important accomplishment as a company to date was receiving U.S. Food and Drug Administration (FDA) 510(k) clearance for our Evo® sEEG product portfolio.
FDA 510(k) clearance enables us to market the Evo sEEG (stereoelectroencephalography) 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. With this milestone, the full diagnostic functionality of our EVO sEEG System is complete.
The first commercial order of Evo sEEG Electrodes for temporary (less than 30 days) use was shipped to Zimmer Biomet, another major achievement for our Company. Our manufacturing ramp and commercialization strategies are in place for near-term market introduction in collaboration with our distribution and development partner Zimmer Biomet (NYSE: ZBH).
Significant progress was made in the development of our OneRFTM therapeutic ablation electrode system. Milestones completed include i) testing of hardware and software
prototypes for the accompanying RF generator, ii) the design and
testing of the OneRF system accessories, and iii) a second successfulanimal feasibility study at the Mayo Clinic. Designed to both record
brain activity and ablate nervous tissue using the same electrode, our
system offers the potential for a safer and less expensive combination electrode,
intended to improve patient outcomes, reduce procedures and overall treatment
cost. This system will potentially be our first therapeutic device, representing the next major phase in our Company’s development.
We completed initial testing and advanced the development of electrodes for chronic stimulation and recording. Our initial target is the spinal cord stimulation market, a $3 billion market in the U.S. alone. We are designing our devices to utilize percutaneous delivery systems (non- surgical placements) that require less battery energy and expanded tissue coverage as compared to standard electrodes placed percutaneously1. Since our electrodes are intended to be implanted for long-term use, theyhave advanced insulation against
fluid permeation and greater durability than devices intended for less than 30 days use. Prominent key opinion leaders joined our new Physician Advisory Board to help guide our development of both the electrode and device delivery system(s).
We increased our financial runway and maintain capital resources to support upcoming commercial and development catalysts. In August 2022 we received an accelerated $3.5 million payment from Zimmer Biomet related to certain milestone events, as part of an amendment to our distribution and development agreement. Earlier in fiscal year 2022 we completed a public offering, raising gross proceeds of $13.4 million.
Additional partners were qualified for manufacturing. With an expanded supply chain, we are well- equipped to meet increased product demand with the market launch of the Evo sEEG.
We bolstered our management team by hiring key positions in Research and Development and Quality Control. Our leadership team holds deep expertise in thin film electrode technology research and development, marketing, finance, quality control, regulatory affairs, and business development. The Company also benefits from a world-class board of directors and esteemed scientific and physician advisory boards.
1 North RB, Kidd DH, Olin JC, Sieracki JM. Spinal cord stimulation electrode design: prospective, randomized, controlled trial comparing percutaneous and laminectomy electrodes-part I: technical outcomes. Neurosurgery. Aug 2002;51(2):381-9; discussion 389-90.
NeuroOne joined the University of Minnesota in a National Institutes of Health (NIH) grant submission. NIH funding would support our joint development of a chronic cortical electrode capable of both recording and stimulation. We believe this device will provide new opportunities for clinical studies in many areas, including chronic pain, substance use disorder, depression, obsessive compulsive disorder, and other mental health conditions.
Our corporate and scientific teams presented and promoted NeuroOne at numerous high-profile events in the U.S. and overseas. Our data was presented to the scientific community at the Neuroelectronic Interfaces Gordon Research Conference, Congress of Neurological Surgeons, Society for Neuroscience, and American Epilepsy Society meetings. We exhibited our Evo electrode product family with Zimmer Biomet at the Congress of Neurological Surgeons annual meeting and the American Epilepsy Society annual meeting. The Evo sEEG implantation accuracy study was featured in a podium presentation at the Biennial Meeting of the World Society for Stereotactic &Functional Neurosurgery, held in South Korea. Our full team participated in a Nasdaq Stock Market Closing Bell ceremony to celebrate our Evo sEEG FDA 510(k) clearance milestone.Fiscal Year 2023 Potential Catalysts
Commercial launch of Evo sEEG Electrodes. We expect to begin the commercial launch of our Evo sEEG electrodes with Zimmer Biomet in the first calendar quarter of 2023. We have already shipped the first commercial order and will continue to build up inventory to meet product forecasts and additional orders in house.
Continuing ablation electrode development. OneRF is on track for submission of a 510(k) application to the FDA in the second quarter of calendar year 2023.
Continuing spinal cord stimulation (SCS) electrode development. In 2023, we will continue to refine our chronic spinal cord electrode design based on customer feedback and conduct additional pre- clinical bench and/or animal tests to further validate our value proposition.
Exploration of additional partnerships. We believe there may be opportunities to establish mutually beneficial relationships with companies that could leverage our core technology. Our technology enables, complements, and/or competes with a number of companies that are in the market or attempting to enter the market with diagnostic or therapeutic technologies to treat brain related disorders. In addition, our technology may have application in cardiovascular, orthopedic, and pain related indications that could benefit from a high-fidelity thin film electrode product that can provide stimulation and/or ablation therapies.
Exploration of new indications. As mentioned previously, we are excited about working with the University of Minnesota to develop an electrode that could be used as part of a closed loop cortical system that has the potential to provide both recording and therapeutic stimulation for multiple indications, one of which includes mental health conditions, an exciting market that is exploring more effective treatments in addition to pharmacological care.
In closing, the NeuroOne team made great progress in fiscal 2022 on multiple fronts including commercialization, product development, and financing. We are in a strong position to continue executing meaningful advances in electrode technology for a variety of neurological applications.
NeuroOne® Reports First Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update.
Evo® Cortical ElectrodeNeuroOne offers a breakthrough thin-film electrode for the diagnosis of various neurological conditions. Evo’s high- definition, minimally invasive technology delivers major advantages over the limitations of legacy silicone-based electrodes, hampered by the lack of innovation and progress in electrode technology, that are still widely used today.o Over 7 times thinner and 8 times lighter than comparable silicone electrodes used in legacy products. o Flexibility, thinness, and reduced weight facilitates potential for minimally invasive placement.o Reduced inflammation as compared to silicon-based legacy electrodes based on published testing by Mayo.Evo cortical electrode technology has received 510(k) clearance from the FDA for recording, monitoring, and stimulating brain tissue for up to 30 days.
Evo® sEEG Electrode
The Evo sEEG electrode technology offers stereoelectrocencephalography recording, spinal cord stimulation, brain stimulation and ablation solutions. The first clinical case using the Evo sEEG electrode was recently performed by Dr. Robert Gross at Emory University for intraoperative brain mapping at the subsurface level of the brain.
The sEEG electrode has received FDA 510(k) clearance from the FDA for use of less than 24 hours. A 510(k) for Evo sEEG electrode technology for up to 30 day use has been submitted to the FDA.
Brain Monitoring – Understanding What Allows Us To Sense, Move, Think And Feel
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.
“Electrochemical Characterization of the First FDA-Cleared Thin-Film Electrodes for Recording and Stimulation of Brain Activity”
NeuroOne® Receives FDA 510(k) Clearance to Market its Evo® sEEG System for Less than 30 Day Use
Company focused on manufacturing ramp for commercialization in partnership with Zimmer Biomet
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.
The Company’s Evo Cortical and sEEG Electrodes are a portfolio of hi-definition thin film electrodes. Potential advantages include increased signal clarity and reduced noise; better tactile feedback during insertion into brain tissue; and faster order fulfillment due to an automated manufacturing process.
As previously reported, NeuroOne is also advancing a pipeline of therapeutic electrode technologies for brain tissue ablation and chronic stimulation use for DBS (deep brain stimulation) and spinal cord stimulation for chronic back pain. These therapeutic electrode technologies represent addressable markets valued between $500 million and $6 billion.
Disruptive next-generation diagnostic electrodes advancing a new era in neuroscience; foundational technology initially developed in collaboration with Mayo Clinic, a shareholder of the Company.
Strategic partnership with Zimmer Biomet (NYSE:ZBH, ~$27B mkt cap) to exclusively commercialize and distribute EVO® diagnostic electrodes; accelerated payment of $3.5 million received in August 2022.
Potential to penetrate large disease populations including epilepsy, Parkinson’s disease, and spinal cord stimulation, with total addressable markets of $1+ billion, $5+ billion, and $10+ billion, respectively.
Multi-billion market opportunity for combination devices; potential for technology adaptation and entry into AI and machine learning markets.
Platform technology with licensing potential for applications in urinary incontinence, pain management, hypertension, depression, and other related neurological disorders.
Ample capital resources to support upcoming commercial and development catalysts including the commercial launch of the Evo sEEG diagnostic line, and further development of OneRF and a thin-film-based SCS electrode system.
Leadership with deep expertise in medical device technology, marketing, and business development; world-class board of directors; esteemed scientific and physician advisory boards.
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.
NeuroOne® Successfully Completes Feasibility Study with its OneRF™ Ablation System
Animal study completed under the guidance of Dr. Jamie Van Gompel at the Mayo Clinic in Rochester, MN
Company on track to submit OneRF 510(k) application to the FDA in the second quarter of calendar year 2023
EDEN PRAIRIE, Minn., Dec. 6, 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 successfully completed a feasibility study with its OneRF™ ablation system, a developing technology that utilizes existing implanted sEEG diagnostic electrodes for brain tissue lesioning.
The study evaluated the Company’s new RF ablation system in an animal model. The study used NeuroOne’s FDA cleared sEEG electrodes combined with a proprietary RF generator and a unique temperature control accessory that monitors and maintains the temperature at which the ablation is performed. This allows clinicians to set temperature and time for each ablation. Dr. Van Gompel and his team implanted five sEEG electrodes, performed electrophysiological recordings, and then completed a total of ten RF ablations using different settings for temperature and time. All ablations were confirmed by an MRI scan.
“This technology potentially represents a major improvement in the field, as it is the first known sEEG-guided RF system to monitor and adjust settings based on temperature throughout the ablation. The addition of this feature may improve the safety of the procedure. We are extremely excited regarding the continued progress with the OneRF ablation system and believe it could have a significant impact in setting a new gold standard for these procedures, if successful. We look forward to the FDA submission of the device in the second calendar quarter of 2023.” said Dave Rosa, CEO of NeuroOne.
As previously reported, NeuroOne is also advancing a pipeline of therapeutic electrode technologies for chronic stimulation use for DBS (deep brain stimulation) and spinal cord stimulation for chronic back pain. These therapeutic electrode technologies represent addressable markets valued between $500 million and $6 billion.
Mr. Rosa is an entrepreneur with three decades of experience in the medical device industry spanning a variety of technologies and products. In addition to CEO roles with early-stage medical device companies, Mr. Rosa’s background also includes senior roles with C.R. Bard Inc., Boston Scientific Inc., and St. Jude Medical, where his responsibilities included marketing, product development and business development. He has been named as an inventor on multiple medical device patents, serves on seven corporate boards, and has raised $200M in the capital markets. Mr. Rosa holds an MBA from Duquesne University and a BS in Commerce and Engineering from Drexel University.
Chief Financial Officer
Mr. McClurg has over 30 years of financial leadership experience with private and public companies. Prior to joining NeuroOne, Mr. McClurg was VP – Finance & Administration and Chief Financial Officer of Incisive Surgical, Inc., a privately-held medical device manufacturer, and Chief Financial Officer and Treasurer of Wavecrest Corporation, a privately-held manufacturer of electronic test instruments for the semiconductor industry. Mr. McClurg also served as Chief Financial Officer for several publicly-held companies, including Video Sentry Corporation, Insignia Systems, Inc., and Orthomet, Inc. Currently, he serves as a director for a privately held company. He began his career in public accounting with Ernst & Young, where he earned his CPA certificate. He holds a Bachelor of Business Administration degree in accounting from the University of Wisconsin – Eau Claire.
Co-Founder, Business Development Director, Medical Sales Liaison
In excess of 15 years of executive sales, sales management, marketing, and project management experience with development stage companies. Prior to NeuroOne, Mr. Christianson held the positions of North American Sales Manager for Cortec Corporation, a manufacturer of specialty chemical products, and Regional Sales Manager for PMT Corporation, a leading manufacturer of products for neurosurgery, orthopedics and plastic surgery. He holds an accounting degree from Augsburg College.
Chief Technology Officer
Prior to joining NeuroOne, Mertens was Sr. Vice President of R&D and Operations at Nuvaira, a privately held lung denervation company developing minimally invasive products for obstructive lung diseases. Before that, Mertens was a Senior Vice President of Research and Development for Boston Scientific, where he guided a wide range of technologies through product development for the cardiology, electrophysiology, and peripheral vascular markets.
Mertens began his medical device career working in engineering, quality control, and manufacturing roles at SciMed Life Sciences. Mertens holds a Bachelor of Science degree in Chemical Engineering from the University of Minnesota and a master’s degree in Business Administration from the University of St. Thomas.
Director of Electrode Development
Dr. Camilo Diaz-Botia is a highly experienced neural engineer whose work has focused on the development of technologies for bidirectional communication with the nervous system. He has authored and co-authored multiple peer reviewed scientific articles published in journals including Journal of Neural Engineering, Neuron, and Lab-on-a-Chip.
Most recently, Dr. Diaz-Botia worked for Neuralink where he led and mentored the process engineering team to deliver projects with unique microfabrication processes. Under his direction, the team built and designed novel processes for integration of thin film neural probes with brain machine interface systems.
Dr. Diaz-Botia earned a B.S. in Electrical Engineering from Universidad Nacional de Colombia and a Ph.D. in Bioengineering from the joint program at the University of California Berkeley and the University of California San Francisco. During his graduate studies, he conducted research on microfabricated thin film neural interfaces for chronic implants developing electrocorticography arrays with silicon carbide, a material suitable for long-term performance in harsh environments, and electrode arrays for minimally invasive subcortical recordings.
Vice President of Quality Control and Regulatory Affairs
Chad Wilhelmy joined NeuroOne with 20 years of medical device experience developing, implementing, and leading quality management systems. Prior to joining NeuroOne, he held top leadership roles at HLT Medical as the Vice President of Quality and at Sunshine Heart as the Senior Director of Quality. He has driven quality strategies from early-stage development to commercial distribution with both the FDA and Notified Body. Chad earned a Bachelor of Science degree from the University of Wisconsin – Stout in Engineering Technology with an emphasis in Quality.
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