Financial Data and Key Metrics Changes - For the three months ended March 31, 2025, the company reported $13.3 million in cash, reflecting an operating cash flow of $2.3 million for the quarter, resulting in a monthly cash burn of approximately $800,000, down from $1.1 to $1.2 million last year [5][6] - The company forecasts a monthly cash burn of about $1 million to sustain operations through the milestones set for the remainder of the year, indicating a strong balance sheet with over a year’s worth of cash available [6] Business Line Data and Key Metrics Changes - The company has received FDA clearance for its embossed total TKA system, marking a significant milestone in its operations [8] - A pilot placement program has been initiated with a major institution in the U.S., involving approximately four surgeons to demonstrate the system's clinical performance [9] Market Data and Key Metrics Changes - The orthopedic surgery market is highly consolidated, with Stryker holding a significant market share of approximately 70% with its Mako robot, which presents a competitive landscape for the company [14][15] - The company aims to capitalize on the demographic shift in orthopedic surgeons, with a significant portion expected to retire by 2031, potentially allowing for increased market share [16] Company Strategy and Development Direction - The company is focused on commercializing what it believes to be the first autonomous saw-based cutting robot for total knee arthroplasty, positioning itself at the forefront of a paradigm shift in orthopedic surgery [13] - The strategy includes a slow and methodical rollout of the system to ensure high service levels and surgeon support, with plans for accelerated commercial growth once a solid foundation is established [10][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future, highlighting the potential impact of robotic precision and efficiency in orthopedic surgeries, while acknowledging the need for continued validation through live patient surgeries [11][18] - The company is actively exploring capital opportunities to accelerate growth, indicating strong interest from investors as it prepares for clinical trials and pilot placements [61][62] Other Important Information - The company has made substantial hardware and software improvements since its last submission to the FDA, enhancing the system's capabilities [9][49] - The first live patient surgeries with the Emboss system are expected to occur in the summer or early fall of 2025, representing a key inflection point for the company [18] Q&A Session Summary Question: Can you provide more detail on timelines for the U.S. and India? - The company expects to conduct live patient surgeries in India within 90 business days and anticipates the first placement in the U.S. to occur in Q2 or early Q3 2025 [24][25] Question: What differentiators will allow Monogram to compete with Stryker? - The company aims to focus on accuracy, safety, and minimal surgeon skill required for execution, with plans to leverage AI for landmark identification to enhance system performance [30][31][34] Question: Can you elaborate on system enhancements? - Significant enhancements have been made to the feed rate and cutting speed of the robot, with ongoing internal testing to ensure safety and effectiveness [48][49] Question: Is the domestic launch a full commercial launch or a trial? - The domestic launch is termed a pilot launch, allowing for real-world evaluation and surgeon feedback before a broader rollout [51][52] Question: What are the capital needs for upcoming trials and commercialization? - The company is exploring additional capital to accelerate growth, with a focus on derisking the opportunity through successful live patient surgeries [61][63]