Financial Data and Key Metrics Changes - For the six months ended June 30, 2025, revenue was approximately $1.25 million, down from $1.75 million in the same period in 2024, reflecting a decrease of about 29% [12] - Gross profit for the first half of 2025 was $349,000 compared to $799,000 in the prior year, resulting in a gross margin of 28% versus 46% in 2024 [12] - Total operating expenses decreased to $7.39 million from $7.68 million a year ago, indicating efforts to optimize spending [13] - The net loss for the first half of 2025 was $6.95 million or $0.12 per share, compared to a net loss of $6.69 million or $0.14 per share in the same period last year [13] Business Line Data and Key Metrics Changes - The company is experiencing a positive shift in adoption in Europe, particularly in breast cancer cryoablation, driven by clinical evidence and increased usage [8][9] - The ProSense technology was featured prominently at several high-impact medical forums, indicating growing interest and adoption [9] Market Data and Key Metrics Changes - The company believes there is a significant opportunity to change the paradigm of breast cancer care for an estimated 46,000 women in the U.S. annually [7] - The FDA has requested a post-market study to be conducted after marketing authorization, which the company is actively preparing for [8] Company Strategy and Development Direction - The company aims to strengthen its financial position and has successfully closed a $10 million rights offering, which was significantly oversubscribed [10] - The company plans to leverage upcoming medical conferences to drive awareness and adoption of its technology [16] Management's Comments on Operating Environment and Future Outlook - Management remains optimistic about receiving FDA approval before the end of 2025 and believes that this could accelerate the company's growth trajectory [4][10] - The company is preparing for commercialization efforts in 2026, contingent on receiving FDA clearance [25] Other Important Information - As of June 30, 2025, the company had $5.38 million in cash, cash equivalents, and short-term deposits, which included a $2 million loan from a major shareholder [14] - The company is actively working on a post-market study involving 400 patients across 30 sites, which is expected to conclude within three years [20] Q&A Session Summary Question: What is the nature of the additional information that FDA requested? - The FDA requested important information regarding the post-market study, including a list of potential participating sites and a recruitment plan [19] Question: Will the additional information lead to an increase in the budget for the trial? - The final budget will be decided once there is a full understanding with the FDA regarding all requests [21][23] Question: Are you still expecting late 2026 for CPT one code from AMA? - The company plans to start recruitment for commercialization as soon as clearance is received and will apply for CPT one code thereafter [25][26] Question: Has the submission for the post-market study been accepted by the FDA? - Yes, the submission has been accepted, and the FDA is currently reviewing the protocol [29][30] Question: Is the current cash position sufficient to fund operations through FDA clearance? - The company currently has enough funding to get through FDA authorization, but final costs will be assessed once the budgeting for the post-market study is finalized [51][52]