Financial Data and Key Metrics Changes - For Q1 2025, the company reported revenue of $2.6 million, an increase of 82% from $1.4 million in Q1 2024 [7][8] - Gross margin improved to 71% in Q1 2025 from 60% in Q1 2024 [8] - Total operating expenses rose to $13 million in Q1 2025 from $8.7 million in Q1 2024 [8] - The net loss for Q1 2025 was $10.7 million, or $0.36 per share, compared to a net loss of $6.6 million, or $0.27 per share, in Q1 2024 [9] Business Line Data and Key Metrics Changes - Recurring revenue accounted for $1.8 million of total revenue, while $820,000 came from one-time capital equipment sales [7] - The TULSA PRO technology was highlighted for its strong presence at medical meetings, particularly the American Urological Association meeting [10] Market Data and Key Metrics Changes - The CAPTAIN clinical trial data was presented, showing TULSA's effectiveness compared to robotic radical prostatectomy, which is expected to drive adoption [10][11] - The introduction of the TULSA AI volume reduction module is anticipated to enhance procedure efficiency and expand the total addressable market [19] Company Strategy and Development Direction - The company aims to leverage the CAPTAIN trial results to drive mainstream adoption of TULSA technology [29] - The TULSA Plus program is designed to facilitate adoption by providing a comprehensive solution for urologists [21][24] - The company is focusing on expanding its commercial organization to support growth and enhance market presence [20][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline and the impact of Medicare reimbursement on future revenue growth [58][59] - The company is optimistic about the increasing patient demand and the positive feedback from the medical community regarding TULSA technology [36][41] Other Important Information - The TULSA AI volume reduction module is set for limited release in June 2025, with a full release planned for Q4 2025 [19] - The company is actively engaging with commercial insurers to secure reimbursement policies for TULSA procedures [38][39] Q&A Session Summary Question: Feedback on CAPTAIN data post-AUA conference - Management received positive feedback from teaching hospitals eager to adopt the data for mainstream use [36][37] Question: Plans for presenting to commercial insurers - Conversations with insurers have begun, and there is optimism about securing reimbursement policies [38][39] Question: Activity at the AUA booth - The level of interest from physicians was high, and the feedback on the volume reduction module was tremendous [41][42] Question: Guidance for the year - The company remains on track for 70% to 75% growth compared to 2024, with a back-end loaded revenue model [46][50] Question: Sales resources and team readiness - The sales team is fully ramped up, with specialized teams in place for health economics and market access [51][53] Question: Engagement of Medicare and Medicaid patients - Initial impacts of reimbursement were limited, but there is growing engagement and billing activity from hospitals [58][59] Question: Marketing plans and materials - The company is ramping up digital marketing efforts and plans to utilize satisfied patients as advocates [60][62] Question: Capital revenue details - Most capital revenue came from new sites, with some conversions from existing sites [73][74] Question: Timing for TULSA Plus availability - The TULSA Plus model is expected to be compatible by the end of Q3 2025, with specific deals to be announced [78][79]

Financial Data and Key Metrics Changes - For Q1 2025, the company reported revenue of $2.6 million, an increase of 82% from $1.4 million in Q1 2024 [7][8] - Gross margin improved to 71% in Q1 2025 from 60% in Q1 2024 [8] - Total operating expenses rose to $13 million in Q1 2025 from $8.7 million in Q1 2024 [8] - The net loss for Q1 2025 was $10.7 million, or $0.36 per share, compared to a net loss of $6.6 million, or $0.27 per share, in Q1 2024 [9] Business Line Data and Key Metrics Changes - Recurring revenue accounted for $1.8 million of total revenue, while $820,000 came from one-time capital equipment sales [7] - The TULSA PRO technology was highlighted for its strong presence at medical meetings, particularly the American Urological Association meeting [10] Market Data and Key Metrics Changes - The CAPTAIN clinical trial data was presented, showing TULSA's effectiveness compared to robotic radical prostatectomy, which is expected to drive adoption [10][11] - The introduction of the TULSA AI volume reduction module is anticipated to expand the total addressable market for BPH treatments [19] Company Strategy and Development Direction - The company aims to leverage the CAPTAIN trial data to drive mainstream adoption of TULSA technology and establish guidelines for its use [29] - The TULSA Plus program is designed to facilitate adoption by providing a comprehensive solution for urologists [21][24] - The company is focusing on expanding its commercial organization to support growth and enhance market access [52] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the pipeline and the impact of Medicare reimbursement on future revenue growth [58][59] - The company is optimistic about the increasing patient demand and the positive feedback from the medical community regarding TULSA technology [36][41] Other Important Information - The TULSA AI volume reduction module is expected to be released in Q4 2025, enhancing the efficiency of BPH procedures [19][31] - The company is actively engaging with commercial insurers to secure reimbursement policies for TULSA treatments [38][39] Q&A Session Summary Question: Feedback on CAPTAIN data post-AUA conference - Management received positive feedback from teaching hospitals eager to adopt the data for mainstream use [36][37] Question: Plans for presenting CAPTAIN data to commercial insurers - Conversations with insurers have begun, and there is optimism about securing reimbursement policies [38][39] Question: Activity at the AUA booth - The level of interest from physicians was high, and the introduction of the volume reduction module received tremendous feedback [41][42] Question: Guidance for the year and revenue growth expectations - Management remains confident in achieving 70% to 75% revenue growth compared to 2024, with a back-end loaded pipeline [46][49] Question: Status of sales resources and team ramp-up - The sales team is fully ramped, with specialized teams in place for health economics and market access [52][54] Question: Engagement of Medicare and Medicaid patients - Initial impacts of reimbursement were limited, but there is growing confidence in the pipeline and patient engagement [58][59] Question: Marketing plans and patient engagement - The company is ramping up digital marketing efforts and plans to utilize satisfied patients as advocates for TULSA [60][62] Question: Capital revenue details for the quarter - Most capital revenue came from new sites, with some conversions from existing sites [73][74] Question: Timing and benefits of the TULSA Plus program - The TULSA Plus program is expected to be compatible by the end of Q3 2025, with ongoing discussions about economic models [78][81]

Summary of ProFound Medical (PROF) Update / Briefing April 29, 2025 Company Overview - ProFound Medical focuses on TULSA (Transurethral Ultrasound Ablation) technology for prostate cancer and benign prostatic hyperplasia (BPH) treatment [1][2] Key Industry Insights - TULSA is positioned as a mainstream treatment option for personalized prostate ablation, both malignant and benign [1] - The company has successfully enrolled in the CAPTAIN level one randomized control trial for prostate cancer, demonstrating strong clinical outcomes [1][4] Core Points and Arguments Prostate Cancer Treatment - The CAPTAIN trial has shown that TULSA PRO eliminates blood loss and overnight hospital stays, with TULSA patients averaging 0.29 days in the hospital compared to 1.24 days for robotic prostatectomy patients [10][11] - TULSA PRO patients reported statistically significant less pain and better overall health compared to those undergoing robotic prostatectomy [12][13] - The trial included 201 patients, with 194 treated or scheduled for treatment, indicating strong recruitment and interest in TULSA technology [5][6] BPH Treatment - ProFound Medical is introducing a new TULSA AI volume reduction module aimed at making TULSA a mainstream option for BPH patients [2][48] - The company estimates a total addressable market (TAM) of $5 billion for prostate cancer and BPH treatments, with a significant portion expected to be recurring revenue [48] Technological Advancements - The introduction of AI modules aims to improve clinical outcomes, reduce treatment time, and enhance workflow efficiency [50] - Features like the thermal boost module and contouring assistant are designed to ensure comprehensive treatment coverage and improve procedural efficiency [52][54] Patient Experience and Satisfaction - High patient satisfaction is indicated by an 88.5% recommendation rate for TULSA among patients, alongside a low regret score of 5.2 [15] - The TULSA procedure is noted for its precision, allowing for targeted treatment while minimizing damage to surrounding tissues, thus preserving erectile function and urinary control [80][81] Additional Important Insights - The CAPTAIN trial is the first of its kind to successfully randomize patients between TULSA and robotic prostatectomy, addressing previous challenges in trial design [5][8] - The company emphasizes the importance of patient demand in driving the adoption of surgical robots and TULSA technology [2][3] - ProFound Medical's focus on real-world outcomes and longitudinal tracking of patient data positions it favorably within the competitive landscape of prostate cancer treatments [44][65] Conclusion - ProFound Medical is at a pivotal point in establishing TULSA as a leading treatment option for both prostate cancer and BPH, supported by strong clinical data, technological advancements, and a focus on patient satisfaction and outcomes [1][4][48]