Regulatory Approvals and Clearances - The company has received 510(k) clearance for three devices from the FDA, including the Evo cortical electrode technology, Evo sEEG electrode technology, and OneRF ablation system[25]. - The company received FDA 510(k) clearance for its thin film cortical electrode technology in December 2019, targeting the epilepsy diagnosis market[66]. - The Evo sEEG electrode technology received FDA clearance on October 20, 2022, for temporary use in subsurface brain monitoring[67]. - The OneRF Ablation System is the only FDA cleared radiofrequency ablation system in the U.S. for both diagnostic and therapeutic use, launched in April 2024[68]. - On December 6, 2023, the company obtained FDA 510(k) clearance for the OneRF Ablation System, enabling the creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures[84]. - The company plans to submit additional 510(k) clearance applications for other ablation applications and neurological drug delivery in the future[84]. - The FDA aims to complete its review of a 510(k) notification within 90 calendar days, although clearance often takes longer[170]. - If a device is not deemed "substantially equivalent," the sponsor must fulfill the more rigorous PMA approval process or seek reclassification through the De Novo process[171]. - The FDA review of a PMA application generally takes between one and three years, but may take significantly longer[177]. - The FDA can impose significant regulatory fines or penalties for failure to submit the requisite applications for modifications to existing devices[172]. - Clinical trials are typically required to support a PMA application and must comply with FDA regulations, including IDE approval[180]. - The FDA may require post-market surveillance studies and can enforce compliance through periodic inspections[188]. - Failure to comply with regulatory requirements can result in sanctions such as fines, product recalls, and operational restrictions[189]. Market and Financial Overview - The epilepsy market in the U.S. has approximately 3,000,000 patients annually, with an additional 200,000 diagnosed each year, costing the U.S. $15.5 billion per year[37]. - The average cost for diagnostic technology per procedure could exceed $10,000, with ablation devices costing over $15,000[38]. - The global market for spinal cord stimulation (SCS) is estimated to be valued between $2.5 billion and $3 billion[51]. - Over half of the back pain market is comprised of patients with failed back surgery syndrome (FBSS)[52]. - The company estimates that clinical trials for its implantable devices will require an investment of over $2,000,000 due to anticipated rigorous regulatory approval processes[101]. - The company received a Nasdaq notification regarding non-compliance with the minimum bid price requirement due to the closing bid price being below $1.00 per share for 30 consecutive business days[129]. - The company believes that many of the indications pursued with its technologies are currently reimbursed on a widespread basis by Medicare, Medicaid, and private insurance companies[138]. - Research and development expenses were $5.1 million for the year ended September 30, 2024, compared to $6.9 million for the year ended September 30, 2023, indicating a decrease of approximately 26%[142]. - The 2024 Private Placement resulted in total gross proceeds of approximately $2.65 million from the sale of 2,944,446 shares and warrants[128]. Product Development and Technology - The company aims to develop an all-in-one solution that combines diagnostic and therapeutic capabilities for epilepsy treatment[38]. - The company is developing spinal cord stimulation technology to address chronic back pain from failed back surgery syndrome, with initial animal implants completed[34]. - The company is pursuing 510(k) clearance for a future neurological drug delivery technology intended to deliver drugs or gene therapy while recording brain activity[32]. - The company plans to expand its product offerings to include less invasive solutions for treating various neurological disorders[35]. - The company believes its proprietary thin film technology will provide more accurate detection of irregular brain activity compared to existing technologies[42]. - The technology is expected to improve diagnostic accuracy by recording at higher fidelity than current EEG technologies[63]. - The company aims to develop percutaneous placed electrodes for spinal cord and peripheral stimulation, potentially reducing the invasiveness of procedures[69]. - The company is investigating applications of artificial intelligence in conjunction with its scalable electrode technology[75]. - The electrodes are designed to be ultra-thin, allowing for less invasive placement through smaller incisions compared to traditional craniotomy procedures[77]. - The company is developing a device for brain monitoring and drug delivery, with successful proof of concept confirmed through bench top and animal experiments[94]. - The company has completed the design phase for its OneRF Ablation System, with the verification phase finished in June 2023 and manufacturing transfer beginning in July 2023[98]. Partnerships and Collaborations - The company has partnered with Mayo Clinic and Cleveland Clinic for pre-clinical studies, demonstrating reduced immunological response and improved flexibility of its polyimide electrodes compared to standard silicone electrodes[102][105]. - The company is actively seeking strategic partnerships and collaborations to expedite market entry for its spinal cord stimulator electrodes, which are still in early development[101]. - The company plans to explore partnerships for drug delivery systems that integrate with its sEEG technology[74]. Compliance and Legal Considerations - Compliance with the Anti-Kickback Statute and Stark Law is critical, as violations could lead to exclusion from Medicare and Medicaid programs[200][201]. - The False Claims Act allows for penalties ranging from $5,500 to $11,000 for each false claim, plus triple damages for the federal government[204]. - The company must allocate significant resources to comply with the Physician Payment Sunshine Act, which requires annual reporting of financial arrangements with healthcare providers[210]. - The evolving nature of healthcare regulations may impact the company's provider and training arrangements, potentially leading to non-compliance issues[203]. Competition and Market Position - The company faces competition from established players like Medtronic and Integra Life Sciences, which have greater resources and market presence, potentially impacting innovation speed[143][146]. - The current success rate for seizure-free postoperative conditions remains at 50%, which may limit patient willingness to undergo invasive surgical procedures[143]. - The company’s financial performance may be negatively impacted if government and third-party payors do not provide adequate coverage and reimbursement for its products[139]. Intellectual Property - The company relies on a combination of patents, trademarks, copyrights, and trade secrets to protect its intellectual property, which is a strategic priority[150]. - The company’s patent estate includes three issued U.S. patents and several pending applications, with issued patents expiring between 2040 and 2043, which may impact future competitive positioning[151].

Core Insights - NeuroOne Medical Technologies Corporation has amended its distribution agreement with Zimmer Biomet, granting exclusive rights for the distribution of the OneRF™ Ablation System in the US and certain international markets, which is expected to enhance sales revenue and profitability for the company [1][2][4] Group 1: Financial Implications - NeuroOne will receive an upfront payment of $3 million and has the potential to earn additional milestone payments based on performance criteria [2] - The agreement is anticipated to generate significant revenue and improve profitability for NeuroOne [2] Group 2: Product Overview - The OneRF Ablation System is the only FDA-cleared radiofrequency ablation system in the US for both diagnostic and therapeutic use, successfully used in various ablation cases since its limited launch in April [3] - The system has demonstrated the ability to identify and ablate brain tissue responsible for seizure activity, potentially reducing hospital stays, number of surgeries, and adverse events while enhancing patient safety through temperature control [3] Group 3: Strategic Partnership - The expanded agreement with Zimmer Biomet is viewed as a significant catalyst for NeuroOne, leveraging Zimmer Biomet's leadership in robotic technology and extensive distribution channels [4] - The partnership aims to build on the existing agreement for NeuroOne's Cortical and sEEG diagnostic electrode technology, with plans for product launch in the near future [4] Group 4: Company Background - NeuroOne is focused on developing minimally invasive and high-definition solutions for various neurological disorders, including epilepsy and Parkinson's disease, with potential applications in other areas such as depression and chronic pain [5]

Core Points - NeuroOne Medical Technologies Corporation will participate in The ThinkEquity Conference on October 30, 2024, in New York, focusing on innovations in surgical care for neurological disorders [1][3] - Ron McClurg, CFO of NeuroOne, will present at 9:00 am ET and the company will conduct one-on-one investor meetings throughout the day [1][2] - The ThinkEquity Conference is a platform for institutional investors and industry professionals, featuring over 70 company presentations and 500+ one-on-one meetings in the past [3] Company Overview - NeuroOne is a developmental stage medical technology company dedicated to minimally invasive and high-definition solutions for EEG recording, brain stimulation, and ablation for neurological disorders [3] - The company aims to improve patient outcomes and reduce procedural costs for conditions such as epilepsy, Parkinson's disease, and chronic pain, with potential applications in depression and artificial intelligence [3]

NEW YORK, Oct. 02, 2024 (GLOBE NEWSWIRE) -- P10, Inc. (NYSE: PX), a leading private markets solutions provider, today announced Enhanced Community Development, a part of P10 subsidiary Enhanced Capital Group LLC, was awarded a $65 million allocation from the New Markets Tax Credits (NMTC) program administered by the U.S. Treasury Department's Community Development Financial Institutions Fund. Under the program, the U.S. Treasury Department allocated a total of $5 billion to 104 Community Development Entitie ...

Forty-four ablations performed successfully in one patient Patient currently reportedly seizure free with improvements in mood and memory EDEN PRAIRIE, Minn., Sept. 10, 2024 (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 the OneRF Ablation System was recently used in a breakthrough patient pr ...

NeuroOne Medical Technologies Corporation (NASDAQ:NMTC) Q3 2024 Earnings Conference Call August 14, 2024 4:30 PM ET Company Participants Dave Rosa - Chief Executive Officer Ron McClurg - Chief Financial Officer Conference Call Participants Operator Good day, ladies and gentlemen. Welcome to the NeuroOne Medical Technologies Corporation Third Quarter of Fiscal Year 2024 Financial Results Conference Call. Today's call will be conducted by the company's Chief Executive Officer, Dave Rosa; and Ron McClurg, the ...

Exhibit 99.1 NeuroOne® Reports Third Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update EDEN PRAIRIE, Minn., August 14, 2024 (GlobeNewswire) -- 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 fiscal year 2024 ended June 30, 2024. Third Quarter Fiscal Ye ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 Form 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-40439 | --- | --- | --- | --- | --- | |--------------------------------------------------|-------|-------|-------|-- ...

EDEN PRAIRIE, Minn., Aug. 12, 2024 (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, will host a conference call and webcast on August 14, 2024, at 4:30 PM Eastern Time to discuss financial results for its third quarter of fiscal year 2024 ended June 30, 2024, and provide a corporate update. Conference Call and Webc ...

Contact: Specific procedure code positions OneRF™ Ablation System for broader adoption and awareness throughout the healthcare system "We are pleased that CMS has provided an ICD-10-PCS code that describes our OneRF procedure, which we believe will drive better recognition of our technology and greater utilization within the healthcare system," said Dave Rosa, CEO of NeuroOne. "In our view, CMS approval of our new code is a critical step in facilitating broader market acceptance of our technology's potentia ...