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
NMTC has no debt outstanding as of March 31, 2023
NeuroOne® Successfully Completes Initial Animal Implant of Novel Thin Film Paddle Lead for Spinal Cord Stimulation
Product revenue was $466,000 in the fiscal second quarter 2023, compared to product revenue of $37,000 in the fiscal second quarter 2022. For the first six months of fiscal 2023, product revenue was $581,000, compared to $70,000 for the same period in fiscal 2022. Collaboration revenue was $1.46 million in the first six months of fiscal 2023, compared to collaboration revenue of $6,000 in the first six months of fiscal 2022
NeuroOne® Announces First Clinical Case Using Evo® sEEG Electrode
NeuroOne® Submits 510(k) Application to FDA for OneRF™ Ablation System
NeuroOne Medical Technologies Corp
Potential for transformative improvement in neurosurgery as first known sEEG-guided RF system thatrecords andablates nervous tissue with the added benefit of temperature control
EDEN PRAIRIE, Minn., June 12, 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, announced today its submission of a 510(k) application to the U.S. Food and Drug Administration (FDA) for its OneRF™ Ablation System. This technology uses the already implanted sEEG electrodes to record brain activity and allow for ablation of nervous tissue when connected to a proprietary radio frequency (RF) generator. If cleared by the FDA, NeuroOne’s OneRF 510(k) submission represents the first step in bringing to market an innovative RF ablation system in the field of neurology and neurosurgery.
As the Company’s first therapeutic device, OneRF is a combination system that includes both diagnostic and therapeutic capabilities. The system utilizes a customized RF generator with real-time temperature monitoring capabilities, allowing clinicians to have greater control over temperature management during the ablation. Designed to both record brain activity and ablate nervous tissue using the same electrode, the system is designed to offer the potential for a safer clinical option for patients as well as lower costs by reducing the number of invasive procedures and hospital stays for patients. NeuroOne estimates the current brain ablation market to be at least $100M worldwide and growing rapidly, with the potential to grow multiple fold based on large addressable patient populations with unmet clinical needs.
Dave Rosa, CEO of NeuroOne, commented, “This is a monumental day for NeuroOne as it represents the first known FDA 510(k) submission of an sEEG electrode intended to record brain activity and also be used as an RF probe to ablate nervous tissue. In addition, it marks the Company’s first complete system combining hardware, software, and our novel electrode technology. Over the past few years, we have been excited with the feedback we have received from our advisory board as well as the performance of the system in animal feasibility studies. We also believe this system has applications beyond ablation of nervous tissue in the brain, offering a larger opportunity than we initially envisioned. I am proud of our entire team and their efforts which allowed us to complete this before the end of June as planned.”
NeuroOne anticipates receiving initial feedback from the FDA no later than August 7th, 2023.
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Hello Everyone,
We have another biotech profile that we want you to put on your radar heading into Mondays session.
This one is sitting just above a buck right now but is known for big multi-session swings.
The last time we looked at it we saw it jump 18% overnight!
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® Announces First Clinical Case Using Evo® sEEG Electrode in Robotic #Neurosurgery: Evo sEEG electrode used with Zimmer Biomet’s ROSA One® Brain during procedure at @ClevelandClinic.
— NeuroOne Medical Technologies Corporation (@N1MTC) May 17, 2023
NeuroOne® Announces First Clinical Case Using Evo® sEEG Electrode in Robotic Neurosurgery
Evo sEEG electrode used with Zimmer Biomet’s ROSA One® Brainduringprocedure at Cleveland Clinic
EDEN PRAIRIE, Minn., May 17, 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 first clinical case using the Evo® sEEG electrode in robotic neurosurgery. Performed by Dr. William Bingaman at Cleveland Clinic, the procedure was the first to utilize NeuroOne’s Evo sEEG electrode, exclusively marketed in the U.S. by Zimmer Biomet, with Zimmer Biomet’s ROSA One® Brain, a robotic platform that assists surgeons in planning and performing complex minimally invasive neurosurgical procedures.
Dave Rosa, CEO of NeuroOne, commented, “This clinical case utilizing our minimally invasive and high-definition electrode technology with ROSA One Brain is a major milestone in NeuroOne’s partnership with Zimmer Biomet. Now that Zimmer Biomet has commenced U.S. distribution of our Evo sEEG electrodes, this case study confirms the synergistic use of our product with Zimmer Biomet’s robotics platform which was the foundation of our interest to partner with Zimmer Biomet.”
The Evo sEEG electrode technology offers stereoelectroencephalography recording, brain stimulation and future development of ablation solutions targeted for patients suffering from multiple neurological conditions. In October 2022, NeuroOne received FDA 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.
NeuroOne® Reports Second Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update
EDEN PRAIRIE, Minn., May 11, 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 announces its operating results for the fiscal second quarter 2023 ended March 31, 2023.
Fiscal SecondQuarter 2023 and Recent Business Updates
Evo® sEEG:
Announced the commercial launch of the Evo sEEG electrode product line in the United States with exclusive distribution partner Zimmer Biomet. The new technology potentially provides NeuroOne with a new revenue stream.
The first clinical case using the Evo® sEEG electrode was performed at the Mayo Clinic using a stereotactic frame system. Another procedure using the Evo® sEEG electrode in robotic neurosurgery was performed at a different medical facility. This procedure was the first to utilize NeuroOne’s Evo sEEG electrode with Zimmer Biomet’s ROSA One® Brain, a robotic platform that assists surgeons in planning and performing complex yet minimally invasive neurosurgical procedures.
Fulfilled five shipments of sEEG product to Zimmer Biomet in preparation for launch.
Completed initial training for the sEEG product line to select Zimmer Biomet sales personnel.
Presented the Evo sEEG system alongside Zimmer Biomet at the American Association of Neurological Surgeons (AANS) annual meeting.
OneRF™Ablation:
Successfully completed usability testing for OneRF with 15 neurosurgeons.
Successfully completed execution of internal device verification and validation protocols for the final OneRF Ablation System.
Spinal Cord Stimulation Program:
Successfully completed an initial animal implant of novel thin film paddle leads for spinal cord stimulation (SCS). The devices are intended for the treatment of patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back, and leg pain. A percutaneous (through a needle) delivery system for paddle leads is also under development and has been successfully bench-tested.
Drug Delivery Program:
Successfully completed feasibility bench top testing of first drug delivery and recording system prototype.
Other Updates:
Expanded IP portfolio with new U.S. patent titled “Improved Neural Depth Probes and Related Systems and Methods” 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.
Expanded management team with the appointment of Anthony Millar as Vice-President of Operations.
Oral presentation delivered at the North American Neuromodulation Society (NANS) annual meeting titled “Electrochemical Characterization of the First FDA-Cleared Thin-Film Electrodes for Recording and Stimulation of Brain Activity.”
Dave Rosa, CEO of NeuroOne, commented, “We were excited to officially announce the commercial release of our Evo sEEG electrode and look forward to a successful launch with Zimmer Biomet. In addition, we continued to make critical progress with the OneRF ablation system design verification testing and remain on track to submit a 510(k) to FDA for OneRF in the second calendar quarter of 2023. We made meaningful progress with our spinal cord stimulation program, as well as our recording and drug delivery system. We also filled a key executive role and are excited to have Anthony Millar join our team as our VP of Operations.”
Upcoming Targeted Milestones
Evo sEEG:
Successful market launch of Evo sEEG system.
Expand sales training of the sEEG product line to Zimmer personnel.
OneRF:
Complete design verification and validation testing for OneRF confirming that the full feature system meets its design specifications and is fully functional.
Submit a 510(k) application to the FDA for OneRF ablation system in the second quarter of calendar year 2023.
Initiate transfer of OneRF to production activities.
Perform in vivo animal study with six neurosurgeons utilizing the complete OneRF ablation system.
Presentation of OneRF® Ablation System preclinical study at Neurological Disorders Summit (NDS-2023) Italy, June 2023.
SCS Program:
Complete bench top testing of percutaneous implantation of thin film paddle electrode in spinal cord model by a physician.
Complete first animal study to assess biocompatibility of NeuroOne’s thin film electrode in the spinal cord.
Drug Delivery Program:
Complete testing of drug delivery and recordings in a small animal model.
Fiscal SecondQuarter 2023 Financial Results
Product revenue was $466,000 in the fiscal second quarter 2023, compared to product revenue of $37,000 in the fiscal second quarter 2022. For the first six months of fiscal 2023, product revenue was $581,000, compared to $70,000 for the same period in fiscal 2022. Collaboration revenue was $1.46 million in the first six months of fiscal 2023, compared to collaboration revenue of $6,000 in the first six months of fiscal 2022. Collaboration revenue was derived from the Zimmer Development Agreement and represents the portion of the exclusivity and milestone fee payments eligible for revenue recognition during the respective periods.
Total operating expenses in the fiscal second quarter 2023 were $3.5 million, compared with $3.0 million in the same period of the prior fiscal year. Research and Development expense in the fiscal second quarter 2023 was $1.7 million compared with $1.2 million in the same period of fiscal 2022. Selling General and Administrative expense in the fiscal second quarter 2023 was $1.8 million compared with $1.8 million in the prior year period. For the first six months of fiscal 2023, total operating expenses were $6.8 million, compared with $5.8 million in the same period of the prior fiscal year. R&D expense in the first six months of fiscal 2023 was $3.3 million compared with $2.3 million in the same period of fiscal 2022. SG&A expense in the first six months of fiscal 2023 was $3.5 million compared with $3.6 million in the prior year period.
Net loss was $3.5 million for the fiscal second quarter 2023, compared to a net loss of $3.1 million in the prior year period. Net loss for the first six months of fiscal 2023 was $5.3 million compared with $5.9 million in the same period of fiscal 2022.
As of March 31, 2023, the Company had cash, cash equivalents, and short-term investments of $4.6 million, compared to $11.1 million as of September 30, 2022. The Company had working capital of $4.8 million as of March 31, 2023, compared to working capital of $9.1 million as of September 30, 2022.
The Company had no debt outstanding as of March 31, 2023.
NeuroOne® Successfully Completes Initial Animal Implant of Novel Thin Film Paddle Lead for Spinal Cord Stimulation
Company is also developing a percutaneous (through a needle) delivery system for paddle leads
EDEN PRAIRIE, Minn., March 16, 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 announced the successful completion of an initial animal implant of its novel thin film paddle leads for spinal cord stimulation. The devices are intended for the treatment of patients with chronic back pain due to multiple failed back surgery syndrome, intractable low back and leg pain.
The study evaluated the feasibility of implanting a variety of sizes and shapes of ultra-thin paddle leads in a sheep model. A mini laminectomy surgical approach was used to gain access to the epidural space for device placement. All devices were easily advanced to the target location in under one minute. A competitive silicone-based lead was also placed for comparison purposes. The NeuroOne lead fit comfortably in the epidural space and the veterinary surgeon reported no concerns regarding the placement of the lead.
These results demonstrated feasibility for placement of a thin film paddle lead intended to treat chronic back pain due to multiple failed back surgeries. More testing will be completed to optimize the design and placement. The Company is also developing a percutaneous (through a needle) paddle lead placement system which would eliminate the need for an incision in the patient’s back. The preliminary bench top testing for this percutaneous approach has also been successfully completed.
Dave Rosa, CEO of NeuroOne, commented, “This represents a major milestone for the Company as we continue our development of innovative devices that provide therapeutic properties coupled with recording capabilities. The market opportunity for spinal cord stimulation is large and growing. We believe our technology can fill a market need for improved patient outcomes due in part to its potential ability to place a paddle device through a needle, provide a larger stimulation surface area of the spinal cord, better conformability with the tissue and improve battery life of devices, reducing the frequency of patient’s need to recharge or replace the battery.”
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
Neurons
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
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.
Evo® Cortical Electrode* (less than 30-day use)
NeuroOne offers a 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.
• 7 times thinner and 8 times lighter than typical silicone electrodes1 • Reduced artifact and improved signal quality2
• Reduced inflammation based on published testing by Mayo Clinic3
Evo® sEEG Electrode* (less than 30-day use)
The Evo sEEG electrode technology offers stereoelectroencephalography recording, spinal cord stimulation, brain stimulation and ablation solutions. The first clinical case using the Evo sEEG electrode was performed intraoperatively by Dr. Robert Gross at Emory University for brain mapping at the subsurface level of the brain.
• Designed to be less invasive – reduced risk of brain plunge, may require fewer brain insertions • Improved signal quality vs. other devices1
• Proven implant accuracy1
• Automated manufacturing, precise and consistent quality1
*Caution U.S. Federal law restricts this device to sale by, or on the order of, a physician.
1NeuroOne data on file 2Bower R., et al. December 2017. Multi-Resolution intracranial EEG rodent recording system. (Abst. 2.062) 2017. American Epilepsy Society 3Worrell, G. et. al. December 2019. Commercial Scale Production of Thin-Film electrode arrays for Clinical Intracranial EEG. (Abst. 1.154), 2019. American Epilepsy Society)
OneRFTM Therapeutic Ablation Electrode System
OneRF is a developing technology that utilizes existing implanted sEEG diagnostic electrodes for RF ablation in nervous (brain) tissue to create tissue lesion(s). It is designed to be a safer and less expensive combination electrode, intended to improve patient outcomes, reduce procedures and overall treatment cost.
NeuroOne® Announces First Clinical Case Using Evo® sEEG Electrode Performed at @MayoClinic.
— NeuroOne Medical Technologies Corporation (@N1MTC) May 10, 2023
NeuroOne® Announces First Clinical Case Using Evo® sEEG Electrode
Evo sEEG electrodes used for brain mapping in epilepsy surgery
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.
Dave Rosa, CEO of NeuroOne, commented, “We would like to thank Dr. Van Gompel and his surgical team at Mayo for this ‘first in the world’ opportunity. 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. We look forward to continued success with the launch of the technology as we continue the roll out of the technology through our distribution partner, Zimmer Biomet.”
NeuroOne provides a full line of electrode technology to address an estimated worldwide market of $100 million for patients requiring diagnostic brain mapping procedures. 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.
Mayo Clinic has a financial interest in the technology referenced in this press release. Mayo Clinic will use any revenue it receives to support its not-for-profit mission in patient care, education and research.
MAJOR CATALYSTS
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.
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.
RON MCCLURG
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.
MARK CHRISTIANSON
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.
STEVE MERTENS
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.
CAMILO DIAZ-BOTIA
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.
CHAD WILHELMY
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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