Profound Medical (PROF) came out with a quarterly loss of $0.36 per share versus the Zacks Consensus Estimate of a loss of $0.29. This compares to loss of $0.26 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -24.14%. A quarter ago, it was expected that this company would post a loss of $0.30 per share when it actually produced a loss of $0.20, delivering a surprise of 33.33%.Over the last four quarters, the company has surpas ...

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]

Financial Data and Key Metrics Changes - For Q1 2025, the company recorded revenue of $2.6 million, an increase of 82% from $1.4 million in Q1 2024 [7] - Gross margin improved to 71% in Q1 2025 from 60% in Q1 2024 [7] - Total operating expenses rose to $13 million in Q1 2025 from $8.7 million in Q1 2024 [7] - 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 [8] Business Line Data and Key Metrics Changes - Recurring revenue accounted for $1.8 million, while one-time sales of capital equipment contributed $820,000 to total revenue in Q1 2025 [7] Market Data and Key Metrics Changes - The TULSA PRO had a strong presence at medical meetings, including the American Urological Association meeting, where initial data from the CAPTAIN trial was presented [9][10] - The CAPTAIN trial is the first successful randomized controlled trial comparing TULSA technology to robotic radical prostatectomy, highlighting TULSA's advantages [10][11] Company Strategy and Development Direction - The company is focusing on expanding the TULSA technology's adoption through clinical data and patient satisfaction, which is expected to drive demand [15][27] - The introduction of the TULSA AI volume reduction module aims to enhance efficiency and expand the total addressable market for BPH treatments [17][18] - The TULSA Plus program is designed to provide a comprehensive solution for urologists, facilitating the adoption of TULSA technology [20][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growing pipeline and the impact of Medicare reimbursement on patient engagement and revenue [58] - The transition to a capital model in 2025 is expected to lead to back-end loaded revenue growth, with a focus on building relationships with top cancer centers [49][66] Other Important Information - The company is leveraging AI technology to improve treatment efficiency and patient outcomes, which is expected to enhance market competitiveness [17][27] - The TULSA PRO is positioned as a key player in the interventional MRI space, with a focus on urology and prostate disease treatment [20][25] Q&A Session Summary Question: Feedback on CAPTAIN data post-AUA conference - Management received positive feedback from teaching hospitals and physicians, indicating that the data will help drive adoption and guideline development [33][35] Question: Plans for presenting CAPTAIN data to commercial insurers - Conversations with insurers have begun, and there is optimism about obtaining policies for TULSA treatments as awareness of Medicare reimbursement grows [36][37] Question: Activity at the AUA booth - The booth activity was highly successful, with significant interest from physicians and positive feedback on the volume reduction module [39][40] Question: Guidance for the year and revenue growth expectations - Management remains confident in achieving 70% to 75% revenue growth compared to 2024, despite a back-end loaded revenue model [45][49] Question: Sales force readiness and resources - The company has established a comprehensive sales team and is making progress in training and market development [52][53] Question: Engagement with Medicare and Medicaid patients - Initial revenue impacts from Medicare reimbursement were limited, but there is growing confidence in the pipeline and patient engagement as billing and payments begin to materialize [58] Question: Marketing plans and materials - The company is ramping up digital marketing efforts and plans to utilize satisfied patients, including ex-NFL players, to promote TULSA [60][62] Question: Timing for TULSA Plus availability and economic model - The TULSA Plus model is expected to be compatible by the end of Q3 2025, with ongoing discussions about economic benefits from partnerships with MRI manufacturers [79][81]

[Business Highlights](index=1&type=section&id=Business%20Highlights) Profound Medical achieved 82% Q1 2025 revenue growth, driven by TULSA procedure flexibility and new Urology APC Level 7 codes, with plans for TULSA-AI and TULSA+ launches in H2 2025 - Q1 2025 revenue grew **82%** compared to Q1 2024[4](index=4&type=chunk) - The company's new Urology APC **Level 7** codes provide a competitive advantage with higher payment levels and applicability in more settings (hospitals, ASCs, imaging centers, offices) compared to peers at **Level 6**[3](index=3&type=chunk) - Profound plans to launch two new offerings in the second half of 2025: the **TULSA-AI** module for BPH and the **TULSA+** total interventional-MRI solution[3](index=3&type=chunk) TULSA-PRO Patient Treatment Mix (Q1 2025) | Category | Breakdown | | :--- | :--- | | **Indication** | 82% Prostate Cancer, 10% Hybrid (Cancer & BPH), 8% Salvage | | **Cancer Grade** | 11% GG1, 64% GG2, 17% GG3, 8% GG4 & GG5 | | **Ablation Type** | 33% Whole Gland, 31% Sub-total, 18% Hemi-ablation, 18% Focal | | **Prostate Size** | 6% <20cc, 38% 20-40cc, 39% 40-60cc, 13% 60-100cc, 4% >100cc | - Initial data from the **CAPTAIN trial** presented at AUA 2025 showed that MRI-guided TULSA offered statistically significant improvements in post-operative experience versus robotic radical prostatectomy, including no blood loss, no overnight stay, and reduced pain[4](index=4&type=chunk) [Financial Performance](index=2&type=section&id=Financial%20Performance) Profound Medical's Q1 2025 revenue reached **$2.6 million** with **71%** gross margin, but increased operating expenses led to a **$10.7 million** net loss, ending with **$46.4 million** cash [Q1 2025 Financial Summary](index=2&type=section&id=Summary%20First%20Quarter%202025%20Results) Profound's Q1 2025 revenue grew **82%** to **$2.6 million**, with gross margin at **71%**, but operating expenses rose **49%** to **$13.0 million**, resulting in a **$10.7 million** net loss Q1 2025 vs Q1 2024 Financial Highlights | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenue** | $2.6M | $1.4M | +82% | | - Recurring Revenue | $1.8M | $1.4M | +28% | | - Capital Equipment | $0.8M | $0 | N/A | | **Gross Margin** | 71% | 60% | +11 p.p. | | **Operating Expenses** | $13.0M | $8.7M | +49% | | **Net Loss** | $10.7M | $6.6M | +62% | | **Net Loss per Share** | $0.36 | $0.27 | +33% | - The increase in operating expenses was driven by investments to expand the commercial organization, increased variable compensation, accelerated R&D, and higher travel and conference costs[7](index=7&type=chunk) [Liquidity and Share Capital](index=2&type=section&id=Liquidity%20and%20Outstanding%20Share%20Capital) Profound Medical maintained **$46.4 million** in cash as of March 31, 2025, with **30,053,142** common shares outstanding as of May 8, 2025 Liquidity and Share Capital Overview | Item | Amount | As of Date | | :--- | :--- | :--- | | Cash | $46.4 million | March 31, 2025 | | Common Shares Outstanding | 30,053,142 | May 8, 2025 | [Condensed Consolidated Balance Sheets](index=3&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) Profound's total assets decreased to **$60.9 million** by March 31, 2025, primarily due to reduced cash, leading to a decline in shareholders' equity to **$50.8 million** Balance Sheet Summary (in thousands USD) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash | $46,433 | $54,912 | | Total Current Assets | $59,912 | $69,065 | | **Total Assets** | **$60,864** | **$70,234** | | Total Current Liabilities | $5,295 | $6,565 | | **Total Liabilities** | **$10,074** | **$9,812** | | **Total Shareholders' Equity** | **$50,790** | **$60,422** | [Condensed Consolidated Statements of Operations](index=4&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS%20AND%20COMPREHESIVE%20LOSS) Q1 2025 revenue rose to **$2.6 million** and gross profit to **$1.9 million**, but increased operating expenses, especially SG&A, resulted in an **$11.2 million** operating loss and **$10.7 million** net loss Statement of Operations (in thousands USD) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | $2,621 | $1,439 | | Gross Profit | $1,853 | $866 | | Research and development | $4,808 | $3,945 | | Selling, general and administrative | $8,211 | $4,798 | | **Total operating expenses** | **$13,019** | **$8,743** | | **Operating loss** | **($11,166)** | **($7,877)** | | **Net loss** | **($10,724)** | **($6,585)** | | **Loss per share** | **$0.36** | **$0.27** | [Condensed Consolidated Statements of Cash Flows](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20CASH%20FLOWS) Q1 2025 saw **$8.3 million** net cash used in operations, leading to an **$8.5 million** decrease in cash, ending the quarter with **$46.4 million** Cash Flow Summary (in thousands USD) | Cash Flow Activity | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($8,283) | ($4,529) | | Net cash provided by (used in) financing activities | ($290) | $20,456 | | **Net increase (decrease) in cash** | **($8,573)** | **$15,927** | | **Cash, end of period** | **$46,433** | **$41,180** | [Corporate Information and Products](index=2&type=section&id=About%20Profound%20Medical%20Corp.) Profound Medical is a medical device company focused on incision-free therapies, primarily TULSA-PRO for prostate diseases and Sonalleve for uterine fibroids and bone metastases - **TULSA-PRO** is the company's primary commercialized technology, combining real-time MRI, AI-enhanced planning, and robotically-driven ultrasound to treat the entire prostate disease spectrum from cancer to BPH[13](index=13&type=chunk) - **Sonalleve** is a therapeutic platform commercialized for uterine fibroids and palliative pain treatment of bone metastases, with potential for expansion into other areas like abdominal cancers[15](index=15&type=chunk) - The company will host a conference call at **4:30 pm ET** to discuss the financial results, with a live webcast available on its investor relations website[11](index=11&type=chunk)

[PART I. Financial Information](index=4&type=section&id=PART%20I.%20Financial%20Information) [Item 1. Condensed Consolidated Financial Statements](index=4&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements) Q1 2025 unaudited financials show total assets at $60.9 million, revenue at $2.6 million, and a net loss of $10.7 million [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $60.9 million as of March 31, 2025, primarily due to a reduction in cash, while shareholders' equity declined to $50.8 million Condensed Consolidated Balance Sheet Highlights (USD in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash | $46,433 | $54,912 | | Total current assets | $59,912 | $69,065 | | **Total assets** | **$60,864** | **$70,234** | | **Liabilities & Equity** | | | | Total current liabilities | $5,295 | $6,565 | | **Total liabilities** | **$10,074** | **$9,812** | | **Total shareholders' equity** | **$50,790** | **$60,422** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q1 2025 revenue grew 82% to $2.6 million, but operating expenses increased 49% to $13.0 million, leading to a net loss of $10.7 million Q1 2025 vs. Q1 2024 Performance (USD in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Revenue | $2,621 | $1,439 | | Gross Profit | $1,853 | $866 | | Total Operating Expenses | $13,019 | $8,743 | | Operating Loss | ($11,166) | ($7,877) | | Net Loss | ($10,724) | ($6,585) | | Basic and Diluted Net Loss per Share | ($0.36) | ($0.27) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $8.3 million in Q1 2025, resulting in an $8.5 million decrease in cash, ending at $46.4 million Cash Flow Summary (USD in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($8,283) | ($4,529) | | Net cash provided by (used in) financing activities | ($290) | $20,456 | | **Net increase (decrease) in cash** | **($8,573)** | **$15,927** | | **Cash, end of period** | **$46,433** | **$41,180** | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2025 revenue growth driven by product mix, increased operating expenses, and ongoing remediation of a material weakness in revenue recognition controls [Overview](index=18&type=section&id=Overview) Profound Medical is a medical device company specializing in MRI-guided therapeutic systems like TULSA-PRO for prostate ablation and Sonalleve for uterine fibroids - The company's lead product, **TULSA-PRO**, is approved by CE, Health Canada, and FDA for incision-free prostate tissue ablation[51](index=51&type=chunk)[52](index=52&type=chunk) - The **Sonalleve** platform is commercialized for uterine fibroids and bone metastases, with approvals in Europe, China, and an FDA Humanitarian Device Exemption[53](index=53&type=chunk) - A hybrid recurring revenue model is employed in the U.S., while a capital sales model is used internationally in Europe and Asia[54](index=54&type=chunk)[55](index=55&type=chunk) [Results of Operations](index=20&type=section&id=Results%20of%20Operations) Q1 2025 revenue increased 82% to $2.6 million with improved gross margin, while R&D and SG&A expenses rose significantly due to headcount and commercialization efforts Q1 2025 vs Q1 2024 Operational Changes (USD in thousands) | Item | Q1 2025 | Q1 2024 | Change $ | Change % | | :--- | :--- | :--- | :--- | :--- | | Revenue | $2,621 | $1,439 | $1,182 | 82% | | Gross Profit | $1,853 | $866 | $987 | 114% | | Gross Margin | 71% | 60% | - | - | | R&D Expenses | $4,808 | $3,945 | $863 | 22% | | SG&A Expenses | $8,211 | $4,798 | $3,413 | 71% | - The increase in R&D expenses was primarily due to increased headcount, higher enrollment for the **CAPTAIN trial**, and greater material expenditures[64](index=64&type=chunk) - SG&A increase was driven by higher sales force commissions, increased travel for conferences, and costs for the 'Pro-Talk Live' educational event[66](index=66&type=chunk) [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2025, cash and equivalents totaled $46.4 million, deemed sufficient for 12 months, following a credit agreement amendment and partial use of public offering proceeds - Cash and cash equivalents totaled **$46,433 thousand** as of March 31, 2025, expected to fund operations for at least the next 12 months[69](index=69&type=chunk)[70](index=70&type=chunk) - On March 3, 2025, the company amended its credit agreement with CIBC, converting the existing loan into a new revolving line of credit maturing in March 2027[31](index=31&type=chunk)[74](index=74&type=chunk) Use of Proceeds from 2024 Public Offering (as of March 31, 2025, in thousands) | Use of Proceeds | Spending to Date | | :--- | :--- | | TULSA-PRO commercialization | $7,060 | | Sonalleve development and commercialization | $2,541 | | Working capital and general corporate purposes | $2,560 | | **Total** | **$12,161** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section on market risk disclosures is not applicable for the registrant - The company indicates that Quantitative and Qualitative Disclosures About Market Risk are not applicable[86](index=86&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls were effective as of March 31, 2025, but remediation continues for a material weakness in internal control over financial reporting related to revenue recognition - Management concluded that disclosure controls and procedures were effective as of March 31, 2025[88](index=88&type=chunk) - A material weakness in internal control over financial reporting was identified as of December 31, 2024, concerning ineffective controls over revenue recognition contract terms[90](index=90&type=chunk)[92](index=92&type=chunk) - Remediation efforts, including hiring CPAs and engaging consultants, began in Q1 2025 and are expected to conclude in 2025[93](index=93&type=chunk) [PART II. Other Information](index=30&type=section&id=PART%20II.%20Other%20Information) [Item 1. Legal Proceedings](index=30&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to have a material adverse effect - The company is not currently involved in any legal proceedings anticipated to have a material adverse impact[97](index=97&type=chunk) [Item 1A. Risk Factors](index=30&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred to the risk factors previously disclosed in the 2024 Annual Report on Form 10-K - No material changes have occurred to the risk factors described in the 2024 Annual Report on Form 10-K[98](index=98&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities were reported during the period - None reported[99](index=99&type=chunk) [Item 5. Other Information](index=30&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted, modified, or terminated Rule 10b5-1 trading plans in Q1 2025 - No directors or executive officers adopted, modified, or terminated any Rule 10b5-1 trading plans in Q1 2025[102](index=102&type=chunk) [Item 6. Exhibits](index=31&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including certifications and Inline XBRL documents - The report includes a list of filed exhibits, such as certifications pursuant to the Sarbanes-Oxley Act and XBRL data files[103](index=103&type=chunk)

Core Insights - Profound Medical Corp. reported a significant revenue growth of 82% in Q1 2025 compared to Q1 2024, reaching approximately $2.6 million [5][6] - The company continues to expand its market presence with its TULSA technology, which is positioned uniquely in the prostate disease treatment market [3][4] - Gross margin improved to 71% in Q1 2025, up from 60% in the same period last year, attributed to higher manufacturing efficiency [7] Business Highlights - The revenue growth trajectory aligns with internal expectations, and the AUA 2025 meeting was successful for the company [3] - TULSA's economic proposition is enhanced by new Urology APC Level 7 codes, which offer higher reimbursement rates compared to competitors [3] - The company plans to roll out the TULSA-AI module for benign prostatic hyperplasia (BPH) and the TULSA+ total interventional-MRI solution in the second half of 2025 [3] Financial Performance - Q1 2025 revenue was approximately $2.6 million, with $1.8 million from recurring non-capital revenue and $820,000 from one-time capital equipment sales [6] - Operating expenses increased to approximately $13.0 million in Q1 2025, up from $8.7 million in the prior year, primarily due to expansion efforts [8] - The net loss for Q1 2025 was approximately $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] Market and Product Development - The TULSA-PRO technology is designed for a wide range of prostate disease treatments, emphasizing its precision and effectiveness [14] - Initial perioperative data from the CAPTAIN randomized trial showed TULSA's advantages over robotic radical prostatectomy, including no blood loss and quicker recovery [4][5] - Profound is also exploring additional markets for its Sonalleve platform, which is approved for treating uterine fibroids and palliative pain [15]

Core Insights - Profound Medical Corp. is a commercial-stage medical device company focused on customizable, incision-free therapies for ablation of diseased tissue [3] Company Overview - Profound Medical is commercializing TULSA-PRO®, a technology that integrates real-time MRI, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control for prostate disease treatment [4] - The TULSA procedure is designed to treat a range of prostate conditions, including low-, intermediate-, and high-risk prostate cancer, benign prostatic hyperplasia (BPH), and salvage therapy for radio-recurrent localized prostate cancer [4] - TULSA is a single-session procedure that preserves urinary continence and sexual function while effectively targeting prostate tissue through precise heating [4] - Profound is also commercializing Sonalleve®, a therapeutic platform for treating uterine fibroids and palliative pain from bone metastases, with approvals in multiple regions including CE marking and FDA clearance [5] Upcoming Events - Management will present a business update at the 2025 Bloom Burton & Co. Healthcare Investor Conference on May 6, 2025 [1] - The presentation will be available for live broadcast and archived on the company's website [2]

Core Insights - The CAPTAIN trial is the first Level 1 study comparing the TULSA procedure with radical prostatectomy (RP) in men with intermediate-risk prostate cancer, showing TULSA's advantages in safety and patient experience [1][4][7] - Initial perioperative data indicates TULSA has no blood loss, shorter hospital stays, and reduced post-procedure pain compared to RP, leading to quicker recovery [1][5][6] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, incision-free therapies for tissue ablation [1][8] - The TULSA-PRO system combines real-time MRI, AI-enhanced planning, and ultrasound technology for precise treatment of prostate conditions [9] Clinical Trial Details - The CAPTAIN trial recruited 201 patients across 20 sites in the U.S., Canada, and Europe, with 69% receiving TULSA and 31% RP [3][7] - The primary endpoints include preservation of erectile potency and urinary continence at one year, and freedom from additional treatment or cancer-related death by three years [7] Key Findings - TULSA showed a median blood loss of 0 mL compared to 100 mL for RP, and a median length of stay of 0.29 days versus 1.24 days for RP [5] - Patient-reported outcomes indicated significantly lower pain levels and better quality of life for TULSA patients compared to those undergoing RP [5][6] Market Implications - The positive outcomes from the CAPTAIN trial are expected to drive patient demand and influence insurance coverage policies, as Level 1 trials are considered the gold standard in evidence-based research [6]

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]