Financial Data and Key Metrics Changes - Total operating expenses for Q3 2025 were $11.5 million, a 35% decrease from $17.8 million in Q3 2024 [11] - GAAP net loss for Q3 2025 was $11.1 million, or $1.86 per share, compared to a GAAP net loss of $17.1 million, or $2.90 per share in Q3 2024 [11] - Non-GAAP adjusted net loss for Q3 2025 was $11.3 million, or adjusted net loss of $1.91 per share, compared to $17 million, or $2.87 per share in Q3 2024 [12] - Cash burn rate for Q3 2025 was approximately $10.5 million, with an expectation of full year 2025 cash burn to be around $50 million [12] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2025 were $8 million, down from $10.8 million in Q3 2024 [11] - General and administrative expenses for Q3 2025 were $3.2 million, compared to $5.7 million in Q3 2024 [11] - Sales and marketing expenses for Q3 2025 were $350,000, down from $1.2 million in Q3 2024 [11] Company Strategy and Development Direction - The main priority is achieving design freeze of the production equivalent system by year-end 2026, which is essential for clinical entry and commercialization [6][9] - The company is focusing on reducing cash burn through targeted outsourcing and structural changes while preserving core technology [7][9] - A consulting firm has been engaged to perform a gap analysis and assist with outsourcing strategies, expected to be completed by the end of November [8][10] Management's Comments on Operating Environment and Future Outlook - Management remains committed to transforming surgical care and emphasizes transparency in communication regarding progress and challenges [14] - The company is actively exploring opportunities to bolster its balance sheet and reduce cash burn for 2026 [12][13] - There is confidence in driving a material reduction in cash burn going forward while maintaining momentum toward design freeze [12][13] Other Important Information - The company strengthened its balance sheet with approximately $5.9 million in gross proceeds from a registered direct offering [9] - The company plans to share updates about the development of its platform through social media and its investor relations website [10] Q&A Session Summary Question: Confirmation of timeline for system built to standard for regulatory testing and clinical use - Management confirmed that the timeline for design freeze is still targeted for mid-2026, and they are working to mitigate any disruptions from outsourcing initiatives [17][18] Question: Additional details on the PREDV system and outsourcing initiative - Management clarified that the outsourcing initiative is not a restart but aims to improve manufacturability and reduce costs while maintaining the timeline [20][21] Question: Development builds and surgeon testing - Management stated that they have been conducting regular testing with surgeons, including cadaver labs, and have seen improvements in system stability and efficiency [28][30] Question: Consulting engagement duration and cost - The consulting engagement with PA Consulting is expected to be short and completed by the end of the month, with a fixed fee that was deemed reasonable [35][36] Question: Status with hospital and health system partners - Management reported strong ongoing relationships with hospital partners, with active communication and surgeon engagement [38][39]

Core Insights - OpenAI anticipates a significant increase in cash consumption, projecting it to reach $115 billion from 2023 to 2029, which is approximately $80 billion higher than previous estimates [1] - The company also expects its revenue for 2030 to be about 15% higher than earlier forecasts [1]