Financial Data and Key Metrics Changes - The company ended the year with a cash balance of 13 million preferred D raise [7][9]. - Monthly cash burn has been maintained at around 1.1 million [91]. Business Line Data and Key Metrics Changes - The company has 27 full-time employees and leverages outsourced engineering talent as needed, scaling back on outsourcing in Q4 as the BNB project wound down [9]. - The company is focused on developing a robotic system for orthopedic surgeries, particularly knee replacements, which is expected to see increased adoption in the future [12][14]. Market Data and Key Metrics Changes - Robotic utilization in total knee replacements is currently low, but forecasts suggest that one out of two knee replacements could be robotic within the next five years [17]. - The company believes that the market is currently digesting robotics as a growth driver, with significant potential for future growth [14][15]. Company Strategy and Development Direction - The company aims to develop a fully autonomous robotic system for orthopedic surgeries, which is expected to be competitive in the market [24][37]. - The strategy includes addressing the market pain points in robotic knee surgery and expanding into other clinical applications with a high degree of freedom robotic arm [37]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming milestones and the strong balance sheet, indicating readiness to enter the next stage of development [9][10]. - The company is awaiting FDA clearance for its robotic system, with the timeline largely out of its control, but has made every effort to address the FDA's questions [41][119]. Other Important Information - The company is working with the Indian Regulatory Agency to initiate a clinical trial, with training already conducted for the involved surgeons [42][43]. - The upgraded end effector for the robotic system has exceeded expectations in terms of performance, with cutting speeds now competitive with manual surgery [71][72]. Q&A Session Summary Question: What is the anticipated duration of the trial in India once approvals are received? - Management indicated that from clearance to the first surgery would take about two months, with patient enrollment expected to start four weeks after clearance [56][60]. Question: What is the cash burn for this quarter and the outlook for 2025? - The cash burn rate has been reduced to approximately $1.1 million per month, with expectations to maintain this level going forward [91][96]. Question: How will the FDA's recent budget cuts affect clinical trials? - Management confirmed that the FDA's orthopedic devices branch has not indicated any impact from budget cuts on their application review process [105][106]. Question: What happens after FDA approval regarding robot deployment in hospitals? - Management stated that there would be a ramp-up period for working capital and system upgrades before launching the product in hospitals [112][113].
Monogram Orthopaedics (MGRM) - 2024 Q4 - Earnings Call Transcript