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 - 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 the company, with record product sales growth of 163% to $9.1 million [3] - In Q4 2025, product revenue increased 907% to $2.7 million compared to $0.3 million in Q4 2024 [14] - Product gross margins improved to 55.8% in Q4 2025 from 51.8% in Q4 2024 [5] - 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 the same quarter of the prior year [16] - Total operating expenses decreased 2% to $2.9 million in Q4 2025 compared to $3.0 million in Q4 2024 [15] 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 [6] - The OneRF brain ablation system continues to gain traction, with positive clinical outcomes reported [11] Market Data and Key Metrics Changes - The company is pursuing several market opportunities as potential revenue drivers, particularly in drug delivery and pain management [5] - Interest from strategic partners in using the technology for various therapies indicates a growing market potential [6] Company Strategy and Development Direction - The company plans to provide financial guidance for fiscal year 2026 after receiving a forecast from distribution partner Zimmer Biomet [4] - The strategy includes expanding the product portfolio and pursuing international commercial expansion through ISO 13485 certification [4] - The company aims to leverage existing technologies for new applications in pain management and drug delivery [30] 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 [17] - The company anticipates significant growth opportunities in drug delivery and pain management platforms [7] Other Important Information - The company raised $8.2 million in capital, strengthening its balance sheet [3] - As of September 30, 2025, the company had cash and cash equivalents of $6.6 million, compared to $1.5 million a year earlier [16] - The company has 17 issued and pending patents, enhancing its intellectual property portfolio [12] 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 ancillary equipment [19][20] Question: Were the two procedures done back to back? - Yes, both cases were performed back to back, which allows for better scheduling and support [21][22] Question: Will there be more orders from the large pharma player for drug delivery? - Additional orders are expected around mid-year as the company prepares to ship preclinical devices [23] Question: What is the status of the epilepsy registry? - The registry is expected to be established by Q2, pending internal approvals from participating sites [24] Question: What strategies are being implemented to raise patient awareness? - The company is partnering with organizations like CURE and the Epilepsy Foundation to increase visibility [25][26] 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 [27][33] Question: How is the company navigating the reimbursement landscape? - The company is utilizing established reimbursement codes, which have not hindered adoption by neurosurgeons [34][35]