NeuroOne Medical Technologies FY Conference Summary Company Overview - **Company**: NeuroOne Medical Technologies Corporation - **Ticker**: NasdaqCM: NMTC - **Technology**: Developed a thin film electrode platform technology for various neurological conditions including epilepsy, Parkinson's disease, back pain, and drug delivery for gene and cell therapies [3][4] Core Points and Arguments - **Device Portfolio**: - Four devices with FDA 510(k) clearance: three for brain-related applications and one for facial pain [4] - Key products include the OneRF Ablation System, which is the only FDA-cleared device for both diagnostic and therapeutic use [8][9] - The OneRF Trigeminal Nerve Ablation System targets trigeminal neuralgia, a condition with a high suicide rate among patients [10][11] - The spinal cord percutaneous paddle lead is designed for lower back pain, offering broader stimulation with less energy [12][13] - Basivertebral nerve ablation (BVNA) technology is in development, targeting lower back pain procedures [14][15] - Drug delivery technology capable of recording brain activity and stimulating tissue during therapy [16][17] - **Market Opportunity**: - Multi-billion dollar market potential for all devices, with spinal cord stimulation generating $3-4 billion in revenue [6] - Epilepsy, drug delivery, and basivertebral nerve ablation are expected to grow into billion-dollar businesses [6] - **Partnerships**: - Current partnerships with Mayo Clinic and Zimmer Biomet, with potential for additional collaborations [4][5] - Received $8.5 million in licensing fees from Zimmer Biomet for exclusive distribution rights [5] - **Financial Overview**: - Cash on hand as of December 31: $3.6 million, with accounts receivable of $2.7 million [20] - Product revenue for the fiscal first quarter: $2.9 million, a 5.5% sequential increase [20] - Expected product revenue for the year: at least $10.5 million, a minimum of 17% increase over the prior year [21] - **Upcoming Catalysts**: - Continued revenue growth for the RF brain ablation system [23] - Full launch of trigeminal nerve ablation system expected next quarter [23] - Potential licensing agreements and commercialization for drug delivery [23] Additional Important Content - **Regulatory Path**: - Preparing for ISO 13485 certification to facilitate international distribution [6][21] - The regulatory path for BVNA is expected to be a 510(k) [15] - **Safety and Efficacy**: - No reported adverse events in epilepsy procedures using the OneRF system, with many patients experiencing significant seizure reduction [9][28] - A registry has been established to collect data on patient outcomes, which is critical for expanding device utilization [27][29] - **Leadership Experience**: - Team includes professionals with experience from major medical device companies, enhancing credibility and expertise [18] - **Future Outlook**: - Strong potential for partnerships in 2026, with ongoing discussions for various technologies [32] This summary encapsulates the key aspects of NeuroOne Medical Technologies as discussed in the conference, highlighting its innovative technology, market potential, financial health, and strategic direction.

Core Viewpoint - NeuroOne Medical Technologies Corporation is hosting a virtual investor webinar to discuss future operations and financial results, including revenue guidance for 2026 [1]. Group 1: Company Overview - The call is led by CEO Dave Rosa and CFO Ron McClurg, indicating a focus on leadership communication with investors [1]. - The company emphasizes that the conference call will include forward-looking statements regarding its future performance and financial outlook [2]. Group 2: Financial Guidance - NeuroOne is providing revenue guidance for 2026, which is a key focus of the discussion during the webinar [1]. - The management's beliefs and assumptions as of the call date will underpin the financial projections shared [1].

NeuroOne Medical Technologies Conference Call Summary Company Overview - **Company**: NeuroOne Medical Technologies Corporation (NasdaqCM: NMTC) - **Industry**: Medical Technology, specifically focused on neurological devices Key Points and Arguments Company Goals and Technology - The company aims to deliver a thin-film electrode platform technology for various neurological conditions, including epilepsy, Parkinson's disease, and back pain [3][4] - NeuroOne has achieved FDA clearance for four devices, three for brain applications and one for facial pain [4] - Unique technology features include less invasive placement through small needles and the ability to perform both diagnostic and therapeutic functions [5] Partnerships - Current partnerships include: - **Mayo Clinic**: Involved in initial testing and development of thin-film technology [6] - **Zimmer Biomet**: Exclusive distribution partner for brain-related devices, with $8.5 million received in licensing fees [6][7] - The company is exploring additional partnerships to expand its market reach [4] Market Opportunities - The devices target multi-billion-dollar markets, with spinal cord stimulation already generating over $3 billion annually [7][16] - Other markets, such as drug delivery and epilepsy, have the potential to grow into billion-dollar businesses [8] Product Portfolio - Key products include: - **OneRF Ablation System**: First FDA-cleared device for both diagnostic and therapeutic use, aimed at reducing seizures [10][11] - **OneRF Trigeminal Nerve Ablation System**: Targets trigeminal neuralgia, with initial cases showing all patients pain-free [13][14] - **Basivertebral Nerve Ablation Technology**: Designed for lower back pain, expected to have a shorter regulatory path [19][20] - **Drug Delivery Platform**: Designed to record brain activity and deliver therapeutic agents directly [21][22] Financial Overview - As of the fiscal first quarter, the company reported: - **Cash on hand**: $3.6 million - **Product revenue**: $2.9 million, a 5.5% sequential increase - **Gross margin**: 54.2% [26] - Revenue guidance for fiscal 2026 is at least $10.5 million, excluding potential revenue from new products and international sales [27][61] Upcoming Catalysts - Key upcoming events include: - Revenue growth from the OneRF brain ablation system [28] - Full launch of the trigeminal nerve ablation system [28] - Commercialization of the drug delivery system [28] - Securing ISO certification for international market access [28] Leadership and Experience - The leadership team has experience from major companies like Boston Scientific and Medtronic, which is critical for the company's development [24][25] - Recent appointment of David Wambach is expected to expedite drug delivery development due to his pharma experience [56][57] Regulatory Pathways - The basivertebral nerve ablation system is expected to follow a straightforward 510(k) regulatory path [66] - The spinal cord stimulation device may require a more complex PMA pathway unless partnered with an existing company [67] Adoption and Market Challenges - Adoption of the OneRF brain ablation system is influenced by neurologists' conservative nature and concerns about safety [63][64] - The company is working on sharing clinical results to increase interest and adoption [64][65] Additional Important Information - The company is in discussions for potential licensing agreements for all discussed devices, indicating a proactive approach to market expansion [29][54] - The focus on glioblastoma treatment represents a significant opportunity for improving patient outcomes [39][40] This summary encapsulates the key points from the NeuroOne Medical Technologies conference call, highlighting the company's strategic direction, product offerings, financial outlook, and market opportunities.

Financial Data and Key Metrics Changes - The company reported product revenue of $2.9 million in Q1 2026, down from $3.3 million in Q1 2025, but up 5.5% from $2.7 million in Q4 2025 [11][12] - The net loss for Q1 2026 was $1.4 million, or a loss of $0.03 per share, compared to a net income of $1.8 million, or $0.06 per share, in Q1 2025 [13] - Cash and cash equivalents as of December 31, 2025, were $3.6 million, down from $6.6 million as of September 30, 2025 [13][14] Business Line Data and Key Metrics Changes - The OneRF brain ablation system saw nearly half of all ablations performed since its launch in Q1 2026, indicating strong market adoption [4] - The OneRF trigeminal nerve ablation system initiated a limited commercial launch in Q1 2026, with nine patients treated across three centers, all reporting pain relief [5][21] Market Data and Key Metrics Changes - The company is working towards receiving ISO 13485 certification to facilitate international commercialization of its technology [5] - The company is in discussions with strategic partners for potential licensing of the trigeminal nerve ablation technology [7][22] Company Strategy and Development Direction - The company projects fiscal year 2026 sales to be at least $10.5 million, representing a minimum 17% increase from fiscal year 2025 [3] - The company is establishing a registry to capture patient outcomes from the OneRF brain ablation system, aiming to enroll the first patient by the end of Q3 2026 [4] - The company is accelerating its drug delivery program, expecting devices for commercial use in investigational studies by Q3 2026, six months ahead of schedule [7][8] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued positive momentum from fiscal year 2025 and the progress across various programs [3][16] - The company is prepared to commercialize the trigeminal nerve ablation technology independently if strategic discussions do not conclude favorably [22] Other Important Information - The company appointed Jason Mills to its board of directors, who brings significant experience in strategy and business development [10] - The company had no debt outstanding as of December 30, 2025, and is funded through fiscal 2026 [14][15] Q&A Session Summary Question: Update on trigeminal nerve ablation cases and interest from Zimmer - The nine cases were performed at three centers, with all patients reporting pain relief. Discussions with strategic partners are ongoing, but the company is prepared to commercialize independently if necessary [21][22] Question: Expectations for operating expenses for the rest of the year - SG&A expenses are expected to remain flat, while R&D expenses may fluctuate based on project phases [25] Question: Clinical feedback from neurologists or surgical teams - Feedback indicates success in reducing seizures or eliminating them, with procedures being performed at patients' bedsides [33][35] Question: Sales and marketing responsibilities with Zimmer - Zimmer is responsible for all marketing and sales costs, while the company provides training and field support [37] Question: Revenue breakdown for Q1 - Most revenue was from restocking, following the initial stocking order in Q1 2025 [38]

Financial Data and Key Metrics Changes - The company reported product revenue of $2.9 million in Q1 fiscal 2026, down from $3.3 million in Q1 fiscal 2025, but up 5.5% from $2.7 million in Q4 fiscal 2025 [11][12] - The net loss for Q1 fiscal 2026 was $1.4 million, or a loss of $0.03 per share, compared to a net income of $1.8 million, or $0.06 per share, in the same quarter of the prior year [13] - Cash and cash equivalents as of December 31, 2025, were $3.6 million, down from $6.6 million as of September 30, 2025 [13][14] Business Line Data and Key Metrics Changes - The OneRF brain ablation system saw nearly half of all ablations performed since its launch in Q1 fiscal 2026, indicating strong market penetration [4] - The OneRF trigeminal nerve ablation system initiated a limited commercial launch, treating nine patients across three centers, all reporting pain relief [5][6] Market Data and Key Metrics Changes - The company is working towards receiving ISO 13485 certification to facilitate international commercialization of its technology [5] - The company attended the American Epilepsy Society meeting, showcasing its technology and receiving positive feedback from medical professionals [4] Company Strategy and Development Direction - The company is projecting fiscal year 2026 sales to be at least $10.5 million, representing a minimum 17% increase from fiscal year 2025 [3] - The company is in discussions with strategic partners for potential licensing of its trigeminal nerve ablation technology and is prepared to commercialize independently if necessary [7][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued positive momentum from fiscal year 2025 and the progress across various programs [3][16] - The company is focused on accelerating its drug delivery program, expecting devices for commercial use in investigational studies by Q3 fiscal 2026, six months ahead of schedule [7][8] Other Important Information - The company appointed Jason Mills to its board of directors, bringing valuable experience from his previous roles in strategy and investment banking [10] - The company had no debt outstanding as of December 30, 2025, indicating a strong financial position [14][15] Q&A Session Summary Question: Update on trigeminal nerve ablation cases and interest from Zimmer - The nine cases were performed at three centers, with all patients reporting pain relief. Discussions with strategic partners are ongoing, but the company is ready to commercialize independently if needed [21][22] Question: Expectations for operating expenses for the rest of the year - SG&A expenses are expected to remain flat, while R&D expenses may fluctuate based on project phases [25] Question: Clinical feedback from neurologists or surgical teams - Feedback indicates success in reducing or eliminating seizures, with procedures being performed at patients' bedsides, enhancing ease of use [33][35] Question: Sales and marketing responsibilities with Zimmer - Zimmer is responsible for all marketing and sales costs, while the company provides training and field support [37] Question: Revenue breakdown for Q1 - Most revenue was from restocking, following the initial stocking order in the previous fiscal year [38]

Financial Data and Key Metrics Changes - The company reported product revenue of $2.9 million in Q1 2026, a decrease from $3.3 million in Q1 2025, but a sequential increase of 5.5% from $2.7 million in Q4 2025 [11] - Product gross profit was $1.6 million, or 54.2% of revenue, in Q1 2026, compared to $1.9 million, or 58.9% of revenue, in the same quarter of the prior year [12] - The net loss for Q1 2026 was $1.4 million, or a loss of $0.03 per share, compared to net income of $1.8 million, or $0.06 per share, in Q1 2025 [13] Business Line Data and Key Metrics Changes - The OneRF brain ablation system saw nearly half of all ablations performed since its launch in Q1 2026, indicating strong market adoption [4] - The OneRF trigeminal nerve ablation system initiated a limited commercial launch in Q1 2026, with nine patients treated across three centers, all reporting pain relief [5][6] Market Data and Key Metrics Changes - The company is working towards receiving ISO 13485 certification to facilitate international commercialization of its technology [5] - The company attended the American Epilepsy Society meeting, showcasing its technology and receiving positive feedback from medical professionals [4] Company Strategy and Development Direction - The company is projecting fiscal year 2026 sales to be at least $10.5 million, representing a minimum 17% increase from fiscal year 2025 [3] - The company is in discussions with strategic partners for potential licensing of its technology and aims to conclude these discussions quickly [6] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued positive momentum from fiscal year 2025 and the progress across all programs [3] - The company is focused on capturing long-term outcomes through a registry for patients treated with its systems, which will help validate the technology's effectiveness [4][31] Other Important Information - The company appointed Jason Mills to its board of directors, bringing valuable experience from his previous roles in strategy and investment banking [10] - As of December 31, 2025, the company had cash and cash equivalents of $3.6 million and no outstanding debt [13][14] Q&A Session Summary Question: Update on trigeminal nerve ablation cases - The nine cases were performed at three centers, with all patients reporting pain relief. Discussions are ongoing with strategic partners for commercialization [20][21] Question: Expectations for operating expenses - SG&A expenses are expected to remain flat for the rest of the year, while R&D expenses may fluctuate based on project phases [23][25] Question: Clinical feedback from neurologists - Feedback indicates success in reducing seizures or eliminating them, with procedures being performed at patients' bedsides [30][32] Question: Sales and marketing responsibilities - Zimmer is responsible for all marketing and sales costs, while the company provides training and field support [35]

Revenue Performance - The company expects product revenue to reach at least $10.5 million in fiscal year 2026, representing an increase of at least 17% compared to $9.1 million in fiscal year 2025[3]. - Product revenue for Q1 fiscal 2026 was $2.9 million, a slight decrease from $3.3 million in Q1 fiscal 2025, but a 5.5% increase from $2.7 million in Q4 fiscal 2025[10]. - Product revenue for Q4 2025 was $2,892,635, a decrease of 11.7% from $3,274,167 in Q4 2024[24]. - License revenue was $0 in Q4 2025, compared to $3,000,000 in Q4 2024[24]. Profitability and Loss - Product gross profit in Q1 fiscal 2026 was $1.6 million, or 54.2% of revenue, compared to $1.9 million, or 58.9% of revenue, in the same quarter of the prior year[11]. - Product gross profit decreased to $1,567,828 in Q4 2025 from $1,926,889 in Q4 2024, reflecting a decline of 18.6%[24]. - The net loss for Q1 fiscal 2026 was $1.4 million, or ($0.03) per share, compared to net income of $1.8 million, or $0.06 per share, in Q1 fiscal 2025[13]. - The company reported a net loss of $1,437,890 in Q4 2025, compared to a net income of $1,785,322 in Q4 2024[24]. - Basic and diluted net loss per share for Q4 2025 was $(0.03), down from $0.06 in Q4 2024[24]. Operating Expenses - Total operating expenses were $3.3 million in Q1 fiscal 2026, slightly up from $3.2 million in the same quarter of the prior year[12]. - Total operating expenses increased to $3,275,135 in Q4 2025 from $3,215,682 in Q4 2024, an increase of 1.9%[24]. - Research and development expenses rose to $1,389,680 in Q4 2025, up from $1,172,228 in Q4 2024, an increase of 18.5%[24]. - Selling, general and administrative expenses decreased to $1,885,455 in Q4 2025 from $2,043,454 in Q4 2024, a decrease of 7.7%[24]. Cash and Working Capital - The company had cash and cash equivalents of $3.6 million as of December 31, 2025, down from $6.6 million as of September 30, 2025[15]. - The company had no debt outstanding as of December 31, 2025, and working capital decreased to $6.8 million from $7.9 million as of September 30, 2025[15]. Product Development and Partnerships - The company successfully completed nine trigeminal neuralgia cases with all patients reportedly pain-free, following FDA 510(k) clearance for the OneRF Trigeminal Nerve Ablation System[3]. - The company is advancing discussions with potential tier-one strategic partners for multiple new products, including the Basivertebral Nerve Ablation System and percutaneous paddle lead for lower back pain[3]. - The company is on track to have its drug delivery system commercially available for investigational clinical studies or animal studies by Q3 fiscal 2026, ahead of schedule by six months[3].

Revenue and Profit - Product revenue for the three months ended December 31, 2025, was $2,892,635, a decrease of $381,532 compared to $3,274,167 in the same period of 2024[154] - Product gross profit for the same period was $1,567,828, down from $1,926,889, reflecting a decrease of $359,061[154] - License revenue was $0 for the three months ended December 31, 2025, compared to $3,000,000 in the same period of 2024, a decrease of $3,000,000[154] - Product revenue for the three months ended December 31, 2025, was $2.9 million, with a gross profit of $1.6 million and a gross profit percentage of 54.2%[155] - License revenue was $3.0 million for the three months ended December 31, 2024, but no license revenue was generated during the same period in 2025[157] Expenses - Total operating expenses increased to $3,275,135 for the three months ended December 31, 2025, from $3,215,682 in 2024, an increase of $59,453[154] - Selling, general and administrative expenses were $1,885,455 for the three months ended December 31, 2025, down from $2,043,454 in 2024, a decrease of $157,999[154] - Research and development expenses increased to $1,389,680 for the three months ended December 31, 2025, from $1,172,228 in 2024, an increase of $217,452[154] - Selling, general and administrative expenses decreased to $1.9 million for the three months ended December 31, 2025, from $2.0 million in the prior year[158] - Research and development expenses increased to $1.4 million for the three months ended December 31, 2025, compared to $1.2 million in the same period of 2024[159] Net Loss and Financial Position - The net loss for the three months ended December 31, 2025, was $1,437,890, compared to a net income of $1,785,322 in the same period of 2024, a change of $3,223,212[154] - As of December 31, 2025, the accumulated deficit was $80.0 million, primarily due to research and development expenses and other operational costs[136] - The net loss for the three months ended December 31, 2025, was $1.4 million, which included non-cash expenses and a net cash use of approximately $1.9 million due to changes in operating assets and liabilities[188] - The company experienced a net decrease in cash of $3.0 million for the three months ended December 31, 2025, compared to a decrease of $325,692 in the same period of 2024[187] Cash Flow and Financing - As of December 31, 2025, cash and cash equivalents totaled approximately $3.6 million, raising concerns about the company's ability to continue as a going concern[164][179] - The company anticipates significant cash requirements for ongoing product development and commercialization operations, including royalty obligations[173] - The company entered into an underwriting agreement in April 2025, resulting in net proceeds of approximately $8.2 million from the sale of 16 million shares of common stock[166] - The company has issued 5,544,489 shares under the ATM Program for gross proceeds of $8.0 million through December 31, 2025[171] - The company has a delayed draw term loan facility of up to $3.0 million, which was terminated in November 2024 without any amounts drawn[172] - The company expects to satisfy its short-term and long-term obligations through cash on hand and future revenue from commercial sales[176] - Net cash used in operating activities was $3.1 million for the three months ended December 31, 2025, compared to a net cash provided of $0.2 million in the same period of 2024[188][189] - Net cash used in investing activities was $41,000 for the three months ended December 31, 2025, compared to $24,000 in the same period of 2024, both related to purchases of property and equipment[190] - Net cash provided by financing activities was $148,000 for the three months ended December 31, 2025, primarily from the exercise of warrants amounting to $174,000[191] Operational Developments - The company initiated a limited market release of the OneRF TN Ablation System in December 2025[139] - The company has received FDA 510(k) clearance for four devices, including the Evo Cortical and OneRF Ablation System[133] Accounting and Financial Reporting - The financial statements are prepared in accordance with U.S. generally accepted accounting principles, requiring estimates and judgments that can affect reported amounts[194] - The company has not had significant variable consideration adjustments related to product revenue, indicating stable revenue recognition practices[195] - The warrants issued in connection with the August 2024 Private Placement are classified as liabilities and will be adjusted for fair value changes until certain conditions are met[196] Cash Flow Dynamics - The increase in accounts receivable was linked to the Zimmer Distribution Agreement, impacting cash flow negatively[188][189] - The company reported a decrease in accrued expenses and accounts payable, which also contributed to the cash flow dynamics observed[188]

Financial Data and Key Metrics Changes - Fiscal year 2025 marked the most successful year in the history of the company, with record product sales growth of 163% to $9.1 million [3] - Fourth quarter product revenue increased 907% to $2.7 million compared to $0.3 million in the same quarter of fiscal 2024 [15] - Product gross margins improved to 55.8% in Q4 2025 from 51.8% in Q4 2024, with a full-year gross margin of 56.5% compared to 31.3% in fiscal 2024 [15][16] - Net loss in Q4 2025 improved by 52% to $1.6 million, or $0.03 per share, compared to a net loss of $3.4 million, or $0.11 per share, in Q4 2024 [17] - Cash and cash equivalents increased to $6.6 million as of September 30, 2025, from $1.5 million a year earlier [17] Business Line Data and Key Metrics Changes - The company received FDA 510(k) clearance for the OneRF trigeminal nerve ablation system and advanced the development of spinal cord stimulation electrodes for lower back pain [4] - The drug delivery program using SEEG platform electrode technology has garnered significant physician interest, with potential partnerships for gene therapy and glioblastoma drug delivery [5][6] - The company reported its first preclinical drug delivery device sales to a large pharmaceutical company [6] Market Data and Key Metrics Changes - The OneRF brain ablation system, marketed by Zimmer Biomet, continues to gain traction, with positive clinical outcomes reported [12] - The company is pursuing several market opportunities as potential revenue drivers, particularly in drug delivery and pain management [5][8] Company Strategy and Development Direction - The company plans to provide financial guidance for fiscal year 2026 after receiving a final forecast from its distribution partner, Zimmer Biomet [4] - The strategy includes leveraging existing technologies for new applications, such as the basivertebral nerve ablation system for lower back pain [9][38] - The company aims to strengthen its patent portfolio, with 17 issued and pending patents [13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in driving increased revenue from the OneRF ablation system and preparing for future international sales [14] - The company anticipates significant growth opportunities in drug delivery and pain management platforms, with a focus on FDA clearance for new products [8][18] Other Important Information - The company has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price rule [4] - Total operating expenses decreased by 2% in Q4 2025 compared to the same quarter in the previous year [16] Q&A Session Summary Question: Will there be more procedures for facial pain before year-end? - Management indicated that three other centers have planned cases, pending some ancillary equipment [22] Question: Were the two procedures done back to back? - Yes, both cases were performed back to back, which allows for better scheduling of future cases [23] Question: What is the status of the drug delivery program with the large pharma player? - Additional orders are expected mid-year for preclinical testing, with ongoing efforts to validate manufacturing processes [25] Question: What is the timing for establishing the epilepsy registry? - The registry is expected to be established by Q2 2026, pending internal approvals from participating sites [28] Question: How is the company navigating the reimbursement landscape? - The company is utilizing established reimbursement codes, and the cost advantages of its technology have not hindered adoption [44]

Financial Data and Key Metrics Changes - Fiscal year 2025 was the most successful year in the history of NeuroOne Medical Technologies, with record product sales growth of 163% to $9.1 million [3][16] - In Q4 2025, product revenue increased 907% to $2.7 million compared to $0.3 million in Q4 2024, with product gross margins improving to 55.8% from 51.8% [5][16] - Total operating expenses decreased by 2% to $2.9 million in Q4 2025, and net loss improved by 52% to $1.6 million, or $0.03 per share [17][18] Business Line Data and Key Metrics Changes - The company received FDA 510(k) clearance for the OneRF trigeminal nerve ablation system and advanced the development of spinal cord stimulation electrodes for lower back pain [4][10] - The drug delivery program using SEEG platform electrode technology has garnered significant physician interest, with initial sales reported to a large pharmaceutical company [6][7] Market Data and Key Metrics Changes - The company is pursuing several market opportunities, including partnerships for gene therapy and glioblastoma drug delivery development [6][7] - The OneRF brain ablation system is gaining traction with accounts as it is released to additional sites, with positive clinical outcomes reported [12] Company Strategy and Development Direction - The company plans to provide financial guidance for fiscal year 2026 after receiving a final forecast from distribution partner Zimmer Biomet [4] - NeuroOne aims to leverage existing technologies and partnerships to expand its product offerings in pain management and drug delivery [9][40] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in driving increased revenue from the OneRF ablation system and preparing for future international sales [15][19] - The company anticipates strong growth prospects and plans to execute its strategy effectively [15][19] Other Important Information - The company raised $8.2 million in capital, strengthening its balance sheet [3] - NeuroOne has received a 180-day extension from Nasdaq to regain compliance with minimum bid price requirements [4] Q&A Session Summary Question: Will there be more procedures for facial pain before year-end? - Management indicated that there are three other centers planning cases, pending some equipment installations [22][23] Question: Were the initial procedures back to back? - Yes, both cases were performed back to back, and scheduling for future cases is expected to be more convenient [24] Question: Will there be more orders from the large pharma player for drug delivery? - Additional orders are anticipated around mid-year as the company prepares to ship more preclinical devices [26] Question: What is the timing for establishing the epilepsy registry? - The registry is expected to be established by Q2 2026, pending site approvals [28][29] Question: What strategies are in place for raising patient awareness? - The company is partnering with organizations like the Epilepsy Foundation to enhance visibility and share patient success stories [30][32] Question: Can you elaborate on the distribution agreement with Zimmer Biomet? - The agreement has expanded to include the brain ablation system, with potential for further growth [41][42] Question: How is the company navigating the reimbursement landscape? - The company is utilizing established reimbursement codes, and the cost advantages of its technology have not hindered adoption [43][45]