Financial Data and Key Metrics Changes - The company experienced a decline in revenue growth quarter over quarter in the U.S. over the last six quarters, attributed to hospital capacity and workflow management issues [4] - Gross margin took a step back in the quarter but the company maintained full-year guidance of 74% gross margin, expecting an acceleration to above 75% in the second half [47][48] Business Line Data and Key Metrics Changes - International performance has exceeded expectations with double-digit growth across major European markets, not solely driven by China [3][34] - The U.S. commercial footprint has expanded significantly, but growth has been slower than anticipated due to operational constraints [7][10] Market Data and Key Metrics Changes - The total addressable market (TAM) in the U.S. for severe emphysema patients is estimated at 500,000, with only about 10,000 procedures expected in 2025, indicating significant room for growth [10][8] - The company is seeing strong interest from the physician community and patient advocacy, which is expected to drive future growth [3][8] Company Strategy and Development Direction - The company is focusing on initiatives like AeriSeal® and the AeriSeal® Convert2 clinical trial, which is expected to expand the patient base by 20% once approved [5][55] - There is a strong emphasis on educating community pulmonologists to improve referral networks and streamline the patient treatment process [18][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in overcoming short-term operational challenges and expects to see sustained growth from initiatives implemented [12][24] - The company anticipates that international markets will continue to grow, with a significant opportunity in China and Japan, particularly with the upcoming commercial launch [34][43] Other Important Information - The company has tightened its operating expense guidance to $128 to $130 million for the year, focusing on maintaining cash burn while funding growth initiatives [48][49] - Management highlighted strong cash management practices, which have been crucial in navigating the current operational landscape [63] Q&A Session Summary Question: When do we see U.S. growth translate into more sustained and meaningful growth? - Management expects growth to begin translating now, with ongoing initiatives starting to show results [7] Question: How much of the slowdown in the U.S. is structural versus temporary? - Management believes the slowdown is primarily due to operational constraints rather than market saturation [10] Question: How sustainable are the trends in StratX® volume? - Management indicated that they expect sustained growth over time, with early indicators showing positive results [22][24] Question: What are the timelines for commercial launch in Japan? - The company is currently enrolling patients for a study and expects a significant ramp in 2026, with broader commercial launch anticipated in 2027 [43][46] Question: How does AeriSeal® help address challenges in the U.S.? - AeriSeal® is expected to expand the TAM and provide treatment options for patients who currently do not qualify for existing procedures [55][56] Question: How is the company managing competition from new device entrants? - Management acknowledged the interest in the market but expressed confidence in their established data and experience with existing products [51][52]