EDEN PRAIRIE, Minn., Feb. 04, 2025 (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 it has regained compliance with the Nasdaq Capital Market’s continued listing standard for the minimum share price requirements under Nasdaq Listing Rule 5550(a)(2). The Company received a letter on February 3, ...

Core Viewpoint - NeuroOne Medical Technologies Corporation reported a significant increase in revenue for the first quarter of fiscal 2025, driven by collaboration revenue and product sales, indicating strong growth potential in the medical technology sector focused on neurological disorders [1][2][3]. Revenue Highlights - Total revenue for the first quarter of fiscal 2025 is expected to reach a record $6.2 million, a substantial increase from $1.0 million in the same quarter of fiscal 2024 [2]. - The revenue includes a one-time upfront payment of $3.0 million from a collaboration with Zimmer Biomet, which is part of an expanded distribution agreement for the OneRF™ Ablation System [2][4]. - Product revenues are projected to increase by 227% to $3.2 million in the first quarter of fiscal 2025, compared to $1.0 million in the first quarter of fiscal 2024 [3]. Future Guidance - For the full fiscal year 2025, the company maintains its guidance for product revenues, excluding collaboration revenues, to be between $8.0 million and $10.0 million, with product gross margins expected to range from 47% to 51% [3]. Business Operations - The increase in expected revenue is attributed to higher-than-anticipated product sales as the partner, Zimmer Biomet, builds inventory and implements NeuroOne's products and technology with customers [4]. - A virtual investor webinar is scheduled to discuss business operations and recent updates, including the collaboration with Zimmer Biomet [5][6]. Company Overview - NeuroOne Medical Technologies Corporation focuses on developing minimally invasive and high-definition solutions for neurological disorders, aiming to improve patient outcomes and reduce procedural costs [8].

Core Viewpoint - NeuroOne Medical Technologies Corporation is set to provide an overview of its business model and anticipated revenue growth for fiscal year 2025, following a significant increase in product revenue in fiscal year 2024 [1][2]. Group 1: Business Model and Revenue Growth - The company has recently expanded its exclusive distribution agreement with Zimmer Biomet, a leading medical device manufacturer [2]. - Product revenue for fiscal year 2024 grew by 77% to $3.5 million, and the company expects revenue to rise to between $8 million and $10 million in fiscal year 2025, indicating a growth of 132% to 190% [2]. Group 2: Upcoming Investor Webinar - A virtual investor webinar is scheduled for January 10, 2025, where the CEO will present the business model and recent achievements, followed by a Q&A session [3]. - Participants are encouraged to join at least five minutes early to ensure timely participation [3]. Group 3: Company Overview - NeuroOne is focused on developing minimally invasive and high-definition solutions for EEG recording, brain stimulation, and ablation for various neurological disorders, aiming to improve patient outcomes and reduce procedural costs [5]. - The company may also explore applications in other areas such as depression, mood disorders, and artificial intelligence [5].

Business Model and Revenue Projections - The company will hold a virtual roadshow webinar to discuss its business operations and recent updates, including an overview of its business model and recent milestone achievements [1][2] - The company recently expanded its exclusive distribution agreement with Zimmer Biomet, one of the world's largest medical device manufacturers [2] - Product revenue grew by 77% to $3.5 million in fiscal year 2024, and is expected to increase to between $8 and $10 million in fiscal year 2025, representing a growth of 132% to 190% [2] Webinar Details - The webinar will include a presentation followed by a Q&A session, accessible via webcast or dial-in numbers [3] - The webinar is scheduled for Thursday, January 9, 2025, at 11:00 a.m. Eastern Standard Time [3] - A playback of the call will be available through January 23, 2025 [4] Company Overview - NeuroOne Medical Technologies Corporation is focused on developing minimally invasive and hi-definition solutions for EEG recording, brain stimulation, and ablation for patients with neurological disorders such as epilepsy, Parkinson's disease, and chronic pain [5] - The company is also exploring applications in other areas including depression, mood disorders, pain, incontinence, high blood pressure, and artificial intelligence [5] Forward-Looking Statements - The press release contains forward-looking statements regarding the company's future performance, including expectations for significant product revenue growth and margin expansion in fiscal year 2025 [6] - These statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially [6][7]

Financial Data and Key Metrics Changes - Product revenue for Q4 2024 was $1.3 million, a decrease from $1.7 million in Q4 2023 due to the cancellation of a purchase order to transition manufacturing to the new OneRF product line [17] - Product revenue for the full fiscal year 2024 increased by 77% to $3.5 million compared to $2 million in fiscal year 2023 [18] - Total operating expenses decreased by 12% to $3 million in Q4 2024 compared to $3.4 million in Q4 2023 [18] - The net loss for Q4 2024 was $3.3 million, compared to a net loss of $3.1 million in Q4 2023 [19] - The company expects product revenue for fiscal year 2025 to range between $8 million and $10 million, representing an increase of 132% to 190% compared to fiscal year 2024 [21] Business Line Data and Key Metrics Changes - The OneRF Ablation System is the first and only FDA cleared system for both reporting electrical activity and ablation of nervous tissue [5] - The company has completed OneRF Ablation procedures on 12 patients, with all patients either seizure-free or experiencing significant reductions in seizure occurrences [8] - 24 epilepsy centers have requested proposals to acquire the technology, doubling from the previous quarter [8] Market Data and Key Metrics Changes - The new ICD-10-PCS code for the OneRF ablation procedure became effective on October 1, 2024, facilitating accurate data collection and reimbursement claims [9] Company Strategy and Development Direction - The company aims to pursue additional applications for RF Ablation outside of the brain, targeting conditions like trigeminal neuralgia [10] - The OneRF Ablation System is seen as a platform technology for multiple indications, providing competitive differentiation [11] - The company is exploring partnerships for its spinal cord stimulation and drug delivery technologies [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in driving revenue growth and margin improvement in 2025, supported by the recent partnership with Zimmer Biomet [6][24] - The company is optimistic about the commercialization of the trigeminal nerve indication potentially in calendar year 2025 [24] Other Important Information - The company completed a $2.65 million private placement and had cash and cash equivalents of $1.5 million as of September 30, 2024 [20] - The company had no debt outstanding as of September 30, 2024 [20] Summary of Q&A Session - No specific questions or answers were provided in the content regarding the Q&A session.

Revenue Growth - Product revenue increased 77% to $3.5 million in fiscal year 2024, compared to $2.0 million in fiscal year 2023[3] - The company expects product revenue to range between $8 million and $10 million in fiscal year 2025, representing an increase of between 132% and 190% compared to fiscal year 2024[5] - Product revenue increased significantly from $1,952,441 in 2023 to $3,453,003 in 2024, representing a growth of about 77.0%[34] Operating Expenses - Operating expenses decreased 12% to $3.0 million in Q4 fiscal year 2024, compared to $3.4 million in the same quarter of the prior year[3] - Total operating expenses decreased 6% to $13.0 million in fiscal year 2024, compared to $13.9 million in fiscal year 2023[18] - Operating expenses decreased from $13,866,955 in 2023 to $12,966,876 in 2024, a reduction of about 6.5%[34] Profitability and Loss - Net loss for fiscal year 2024 was $12.3 million, compared to a net loss of $11.9 million in fiscal year 2023[20] - Net loss for the period was $12,318,110 in 2024, compared to a net loss of $11,859,491 in 2023, indicating a slight increase in losses[34] Assets and Liabilities - Total current assets decreased from $7,312,925 in 2023 to $4,630,925 in 2024, a decline of approximately 36.8%[31] - Total liabilities surged from $1,847,910 in 2023 to $4,547,927 in 2024, an increase of approximately 146.5%[31] - Cash and cash equivalents dropped from $5,322,493 in 2023 to $1,460,042 in 2024, a decline of approximately 72.5%[31] - Total stockholders' equity decreased significantly from $6,249,404 in 2023 to $822,013 in 2024, a decline of approximately 87.8%[31] Product Development - The exclusive distribution agreement with Zimmer Biomet included a $3 million upfront payment and is expected to drive significant revenue and margin expansion[4] - The OneRF™ Ablation System has performed RF ablation procedures on 12 patients, with positive outcomes reported[9] - The company plans to submit a 510(k) application for a new trigeminal nerve ablation product in the first half of fiscal year 2025[7] Gross Margin - Product gross margin is expected to range between 47% and 51% in fiscal year 2025, compared to 31% in fiscal year 2024[5] - Product gross profit improved from $456,517 in 2023 to $1,079,667 in 2024, an increase of about 136.5%[34] Shareholder Information - The number of shares used in per share calculations increased from 18,121,108 in 2023 to 26,762,392 in 2024, reflecting a rise of about 47.9%[34] - Accounts payable rose from $685,104 in 2023 to $1,029,206 in 2024, an increase of approximately 50.2%[31]

Core Insights - NeuroOne Medical Technologies Corporation has expanded its exclusive distribution agreement with Zimmer Biomet, receiving a $3 million upfront payment, which is expected to significantly drive revenue and expand margins [1][2][3] Financial Highlights - Product revenue for fiscal year 2024 increased by 77% to $3.5 million from $2.0 million in fiscal year 2023 [2][9] - Operating expenses decreased by 12% to $3.0 million in Q4 2024 compared to $3.4 million in Q4 2023 [2][10] - The company expects product revenue for fiscal year 2025 to range between $8 million and $10 million, representing an increase of 132% to 190% compared to fiscal year 2024 [2][13] Operational Updates - The OneRF™ Ablation System has been placed in five prominent epilepsy centers, with positive outcomes reported from procedures performed on 12 patients [5] - The company is progressing discussions with strategic partners for additional use cases and has plans to submit a 510(k) application for a new trigeminal nerve ablation product in the first half of 2025 [4][6] Management Commentary - The CEO highlighted the partnership with Zimmer Biomet as a key driver for future revenue growth and margin expansion, with expectations of at least $8 million in revenue for fiscal year 2025 [3] Cash Position - As of September 30, 2024, the company had cash and cash equivalents of $1.5 million, down from $5.3 million a year earlier, but remains debt-free [12]

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]