Core Insights - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, incision-free therapies for tissue ablation [3][4] Company Overview - Profound Medical Corp. is engaged in the commercialization of TULSA-PRO®, a technology that integrates real-time MRI, AI-enhanced planning, and robotically-driven ultrasound for prostate disease treatment [4] - The TULSA Procedure™ is designed to treat various prostate conditions, including low-, intermediate-, and high-risk prostate cancer, benign prostatic hyperplasia (BPH), and salvage therapy for radio-recurrent localized prostate cancer [4] - The TULSA Procedure is characterized as a "one-and-done" treatment, performed in a single session without incisions or radiation, with a typical duration of a few hours [4] - The procedure utilizes precise sound absorption technology to heat targeted prostate tissue to 55-57°C, preserving urinary continence and sexual function [4] - TULSA-PRO has received CE marking, Health Canada approval, and 510(k) clearance from the U.S. FDA [4] Additional Products - Profound is also commercializing Sonalleve®, a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases [5] - Sonalleve has received CE marking and approval from the China National Medical Products Administration for non-invasive treatment of uterine fibroids, as well as FDA approval under a Humanitarian Device Exemption for osteoid osteoma treatment [5] - The company is exploring further treatment applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy [5] Upcoming Events - Management will present a business update at the Stifel 2025 Healthcare Conference on November 11, 2025, at 1:20 p.m. Eastern Time [1][2]

[Filing Details](index=1&type=section&id=Filing%20Details) This section provides the fundamental identification and status information for the Form 8-K filing [General Information](index=1&type=section&id=General%20Information) This section provides the basic identification details of the Form 8-K filing, including the registrant's name, jurisdiction, address, and contact information, along with the date of the report - Company Name: **PROFOUND MEDICAL CORP.**[1](index=1&type=chunk) - Date of Report: **October 7, 2025**[1](index=1&type=chunk) - Jurisdiction of Incorporation: **Ontario, Canada**[1](index=1&type=chunk) [Securities and Filing Status](index=1&type=section&id=Securities%20and%20Filing%20Status) This section details the registrant's securities information, specifically common shares traded on Nasdaq, and confirms its status regarding emerging growth company provisions Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Shares | PROF | The Nasdaq Stock Market | - Emerging growth company status: **Not an emerging growth company (indicated by unchecked box)**[3](index=3&type=chunk) [Corporate Event Disclosure](index=2&type=section&id=Corporate%20Event%20Disclosure) This section discloses significant corporate events, including financial results and related exhibits [Item 2.02 - Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition.) Profound Medical Corp. announced its preliminary unaudited financial results for the three months ended September 30, 2025, along with a business update, via a press release furnished as Exhibit 99.1. The information is not considered 'filed' for Section 18 purposes of the Exchange Act - Event: Announcement of preliminary unaudited financial results for the three months ended **September 30, 2025**, and a business update[4](index=4&type=chunk) - Date of Announcement: **October 7, 2025**[4](index=4&type=chunk) - Source: **Press release furnished as Exhibit 99.1**[4](index=4&type=chunk) - Filing Status: The information in Item 2.02 (including Exhibit 99.1) is **furnished, not deemed 'filed'** for purposes of Section 18 of the Securities Exchange Act of 1934[5](index=5&type=chunk) [Item 9.01 - Financial Statements and Exhibits](index=2&type=section&id=Item%209.01.%20Financial%20Statements%20and%20Exhibits.) This section lists the exhibits accompanying the Form 8-K filing, primarily the press release detailing the financial results and business update, and the interactive data file Exhibits Filed | Exhibit No. | Description | | :---------- | :---------------------------------------------------------- | | 99.1 | Press Release dated October 7, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=SIGNATURE) This section formally authenticates the report through the authorized signatory [Authorization and Signatory](index=3&type=section&id=Authorization%20and%20Signatory) The report is formally signed on behalf of Profound Medical Corp. by its Chief Financial Officer, Rashed Dewan, confirming compliance with the Securities Exchange Act of 1934 requirements - Signatory: **Rashed Dewan**, Chief Financial Officer[10](index=10&type=chunk) - Date of Signature: **October 7, 2025**[10](index=10&type=chunk)

Core Viewpoint - Profound Medical Corp. anticipates significant revenue growth for Q3 2025, with preliminary estimates indicating revenues between $5.2 million and $5.3 million, representing an increase of 84% to 87% compared to the same period last year [2][3] Financial Performance - For the quarter ended September 30, 2025, Profound expects total revenues in the range of $5.2 million to $5.3 million, up from $2.8 million in Q3 2024 [2] - The gross margin for Q3 2025 is projected to be approximately 72%, an increase from 64% in the prior year [2] Business Developments - The installed base of the TULSA-PRO system has grown to 67 units, up from 60, with expectations to reach at least 75 by the end of the year due to a strong capital sales pipeline [3] - The TULSA Procedure is positioned as a potential mainstream treatment for various prostate conditions, emphasizing its incision-free and radiation-free nature [6] Upcoming Events - The company will release its full Q3 2025 financial results on November 13, 2025, followed by a conference call at 4:30 p.m. ET to discuss the results and business developments [4]

Core Insights - The article discusses the experience of an investor who utilized earnings reports to identify potential winning stocks during the pandemic, highlighting a methodical approach to investing [1]. Group 1: Investment Strategy - The investor's strategy involves studying earnings reports and transcripts to find indicators of future growth [1]. - Specific stocks identified as future winners include OPRX, OTRK, FUBO, and PLUG, showcasing the effectiveness of this analytical approach [1].

Core Viewpoint - Profound Medical Corp. has launched a new TULSA program in collaboration with Texas Prostate and Dallas Medical Center, providing Medicare patients in Texas access to the TULSA Procedure, a minimally invasive treatment for prostate cancer and benign prostatic hyperplasia (BPH) without the need for surgery [1][2][3] Group 1: TULSA Procedure Overview - The TULSA Procedure offers effective prostate treatment with minimal side effects compared to traditional surgery, such as incontinence or erectile dysfunction [2] - The procedure is performed using the TULSA-PRO system, which combines real-time MRI guidance, AI-enhanced planning, and robotically-driven ultrasound to precisely ablate targeted prostate tissue [5] - TULSA is a single-session, incision-free procedure that allows patients to return home the same day, with no procedural blood loss and a significantly lower risk of complications [3][5] Group 2: Medicare Coverage and Accessibility - Medicare coverage for the TULSA Procedure was granted in January 2025, allowing it to be performed in various settings, including Hospital Outpatient and Ambulatory Surgical Centers [2] - The collaboration with Dallas Medical Center enables Texas Prostate to perform TULSA procedures exclusively at this facility, enhancing patient access to this advanced treatment [2][3] Group 3: Company Background and Future Potential - Profound Medical Corp. is a commercial-stage medical device company focused on developing incision-free therapies for diseased tissue ablation [4] - The TULSA Procedure has the potential to become a mainstream treatment for a wide range of prostate diseases, including low-, intermediate-, and high-risk prostate cancer, as well as BPH [5] - The TULSA-PRO system is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA, indicating its regulatory compliance and readiness for market [5]

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 Corp. is developing and marketing innovative medical technologies, including TULSA-PRO and Sonalleve, aimed at treating various medical conditions [3][4][5] TULSA-PRO Technology - TULSA-PRO combines real-time MRI, AI-enhanced planning, and robotically-driven ultrasound for precise treatment of prostate diseases, including cancer and benign prostatic hyperplasia [4] - The TULSA procedure is incision-free, radiation-free, and performed in a single session, with a treatment temperature of 55-57°C, ensuring minimal recovery time for patients [4] - TULSA-PRO has received CE marking, Health Canada approval, and 510(k) clearance from the FDA [4] Sonalleve Technology - Sonalleve is a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases, with CE marking and FDA approval under a Humanitarian Device Exemption [5] - The technology is also approved by the China National Medical Products Administration for non-invasive treatment of uterine fibroids [5] - Profound is exploring additional treatment markets for Sonalleve, including non-invasive ablation of abdominal cancers [5] Upcoming Event - Management will participate in the Lake Street Capital Markets "BIG9" Conference on September 11, 2025, in New York City, with one-on-one investor meetings scheduled [1][2]

Company Overview - Profound Medical Corp. (NASDAQ: PROF) develops the TULSA-PRO system designed for the ablation of malignant or benign prostate tissue [1] - The TULSA-PRO system is applicable for treating prostate diseases, including cancer and benign prostatic hyperplasia (BPH) [1] Industry Context - The development of advanced medical technologies like the TULSA-PRO system reflects ongoing innovation in the treatment of prostate diseases [1]

Financial Data and Key Metrics Changes - For Q2 2025, the company received total orders of over $3 million and recorded revenue of $2.2 million, with $1.6 million from recurring revenue and $650,000 from one-time capital equipment sales [6][7] - Gross margin in Q2 2025 was 73%, up from 64% in Q2 2024 [6] - Total operating expenses in Q2 2025 were $15.4 million, compared to $9.3 million in Q2 2024 [6] - The net loss for Q2 2025 was $15.7 million, or $0.52 per share, compared to a net loss of $6.9 million, or $0.28 per share, in Q2 2024 [7] Business Line Data and Key Metrics Changes - The company is transitioning from a placement model to a capital model, which is expected to lead to a backend-loaded revenue operation [8][9] - The sales pipeline includes close to 500 prospects, with over 100 leads engaged and 80 qualified leads in the verification, negotiation, and contracting stages [10][11] Market Data and Key Metrics Changes - The U.S. sales team has been streamlined to focus on organizational sales to corporatized hospitals, emphasizing the importance of intangible attributes like grit and perseverance in sales success [12][13] - The company aims to increase the number of active sites in the U.S., with a target of at least 75 by the end of the year [61] Company Strategy and Development Direction - The CAPTAIN trial has been fully recruited, which is expected to drive adoption of the TULSA procedure and influence treatment guidelines [15][16] - The pilot release of the new TULSA AI volume reduction software is anticipated to enhance efficiency in BPH procedures, moving TULSA from a niche to a mainstream treatment option [19][20] - The company is optimistic about the integration of TULSA with new interventional MR technologies, which could enhance its market position [63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 70% to 75% revenue growth in 2025 compared to 2024, despite short-term revenue shortfalls due to delays in capital sales [8][22] - Positive feedback from physicians regarding the CAPTAIN trial completion is expected to enhance adoption and pipeline growth [36][37] - The company anticipates that as more data is published, it will lead to new guidelines requiring that TULSA be presented as a treatment option alongside traditional methods [23] Other Important Information - The company has approximately $35.2 million in cash as of June 30, 2025 [7] - The initial clinical outcomes from the CAPTAIN trial are expected to be presented at major medical meetings in December [19][94] Q&A Session Summary Question: Can you provide insights on the sales contribution from recurring and capital perspectives? - Management indicated that the revenue mix is expected to shift from recurring to capital revenue as the installed base grows, with a long-term goal of 70% recurring and 30% capital revenue [29][30] Question: What feedback are you receiving from physicians regarding the CAPTAIN trial? - High positive feedback has been received, particularly regarding the completion of the trial, which is seen as a significant achievement in the field [36][37] Question: How does the proposed reimbursement rule for BPH treatments affect TULSA? - The company maintained favorable reimbursement levels compared to other BPH procedures, which positions TULSA advantageously in the market [44][45] Question: What is the current number of active TULSA placements in the U.S.? - There are about 60 active sites, with plans to install three more, aiming for at least 75 by year-end [61] Question: How is the soft launch of the volume reduction module for BPH going? - Initial feedback has been excellent, with procedure times averaging closer to 60 minutes, which is a significant improvement [90][91]

[Profound Medical Announces Second Quarter 2025 Financial Results](index=1&type=section&id=Profound%20Medical%20Announces%20Second%20Quarter%202025%20Financial%20Results) This report details Profound Medical's financial and operational performance for the second quarter of 2025, highlighting key business developments and financial results [Business Highlights](index=1&type=section&id=Business%20Highlights) Profound Medical reported continued growth in TULSA-PRO system utilization and a robust sales pipeline in Q2 2025. Key developments included positive clinical trial data for TULSA, the launch of the TULSA-AI Volume Reduction Module, and strategic partnerships, despite some short-term delays in capital sales [TULSA-PRO System Utilization and Sales Pipeline](index=1&type=section&id=TULSA-PRO%20System%20Utilization%20and%20Sales%20Pipeline) TULSA-PRO procedure volumes increased sequentially, and the sales pipeline expanded with numerous new systems in advanced stages - TULSA-PRO 'same store' procedure volumes increased by **10% sequentially from Q1-2025**[2](index=2&type=chunk) - The TULSA-PRO qualified sales pipeline now includes **80 new systems** in the 'Verify, Negotiate and Contracting' stages[2](index=2&type=chunk) [Patient Demographics and Treatment Intent](index=1&type=section&id=Patient%20Demographics%20and%20Treatment%20Intent) Analysis of TULSA-PRO patient data reveals primary use for prostate cancer, with a significant portion for hybrid treatments and varying cancer grades TULSA-PRO Patient Treatment Breakdown (Q2 2025) | Category | Percentage | | :-------------------------------- | :--------- | | Prostate cancer only | 79% | | Hybrid (cancer & BPH) | 17% | | Salvage | 3% | | BPH only | 1% | TULSA-PRO Patient Cancer Grade Breakdown (Q2 2025) | Cancer Grade | Percentage | | :------------- | :--------- | | GG1 | 4% | | GG2 | 53% | | GG3 | 28% | | GG4 & GG5 | 15% | TULSA-PRO Patient Intention-to-Treat Breakdown (Q2 2025) | Intention-to-Treat | Percentage | | :------------------- | :--------- | | Whole gland | 48% | | Sub-total (> half gland) | 26% | | Hemi-ablations or focal therapy | 26% | [Clinical Data and Research](index=1&type=section&id=Clinical%20Data%20and%20Research) Initial CAPTAIN trial data indicates TULSA's significant perioperative benefits over robotic radical prostatectomy - Initial perioperative data from the CAPTAIN randomized trial showed MRI-guided TULSA provided statistically significant improvement in post-operative experience compared to robotic radical prostatectomy (RP), with **no blood loss, no overnight stay, reduced pain, and faster recovery**[2](index=2&type=chunk) [Product Development and Strategic Partnerships](index=1&type=section&id=Product%20Development%20and%20Strategic%20Partnerships) Profound launched the TULSA-AI Volume Reduction Module and is on track with Siemens Healthineers for a combined prostate solution - The first commercial BPH treatment using the new TULSA-AI Volume Reduction Module was successfully conducted in June 2025, with a full launch expected in **Q4-2025**[2](index=2&type=chunk)[3](index=3&type=chunk) - Profound and Siemens Healthineers remain on track to initiate sales of their combined total prostate solution (TULSA-PRO and Magnetom Free.Max MR scanner) before the end of **2025**[3](index=3&type=chunk) [Corporate Governance and Brand Advocacy](index=1&type=section&id=Corporate%20Governance%20and%20Brand%20Advocacy) Shareholders approved all matters at the AGM, and a former NFL player was appointed Global Ambassador for TULSA-PRO - All matters presented at the Annual General and Special Meeting of Shareholders in May 2025 were approved, and **six nominees** were elected to the board of directors[2](index=2&type=chunk) - Leonard Wheeler, a former NFL player and TULSA procedure recipient, was named Global Ambassador for TULSA-PRO in June 2025 to drive global awareness and advocacy[2](index=2&type=chunk) [CEO Commentary and 2025 Outlook](index=2&type=section&id=CEO%20Commentary%20and%202025%20Outlook) CEO noted short-term capital sales delays in Q2 2025 but reaffirmed the target of 70% to 75% year-over-year revenue growth for 2025 - CEO Arun Menawat noted short-term delays in completing a few TULSA-PRO capital sales in Q2 2025, which would have pushed total revenues over **$3 million**[3](index=3&type=chunk) - The Company continues to target total year-over-year revenue growth in the approximate range of **70% to 75% for 2025**, driven by a growing sales pipeline and strong procedure volume growth[3](index=3&type=chunk) [Summary Second Quarter 2025 Financial Results](index=2&type=section&id=Summary%20Second%20Quarter%202025%20Financial%20Results) Profound Medical's Q2 2025 revenue remained flat year-over-year at $2.2 million, with recurring revenue showing a slight increase. Gross margin improved significantly to 73%, but operating expenses rose substantially due to increased headcount, trial enrollment, and sales force expansion, leading to a higher net loss [Revenue Performance](index=2&type=section&id=Revenue%20Performance) Q2 2025 total revenue remained stable year-over-year at $2.2 million, with recurring non-capital revenue slightly increasing Q2 2025 Revenue Breakdown (USD in thousands) | Category | Q2 2025 | Q2 2024 | Change (YoY) | | :-------------------- | :------ | :------ | :----------- | | Recurring - non-capital | $1,561 | $1,460 | +$101 | | Capital equipment | $650 | $773 | -$123 | | **Total Revenue** | **$2,211** | **$2,233** | **-$22** | - Total revenue for Q2 2025 was approximately **$2.2 million**, essentially unchanged from the prior year period[4](index=4&type=chunk) [Gross Margin Analysis](index=2&type=section&id=Gross%20Margin%20Analysis) Gross margin significantly improved to 73% in Q2 2025, driven by enhanced manufacturing efficiency Q2 2025 Gross Margin | Period | Gross Margin | | :----- | :----------- | | Q2 2025 | 73% | | Q2 2024 | 64% | - Gross margin expanded to **73%** in Q2 2025 from **64%** in the prior year period, primarily due to higher manufacturing efficiency rates[5](index=5&type=chunk) [Operating Expenses](index=2&type=section&id=Operating%20Expenses) Operating expenses increased substantially to $15.4 million in Q2 2025 due to higher headcount, trial enrollment, and sales force expansion Q2 2025 Total Operating Expenses (USD in thousands) | Period | Total Operating Expenses | | :----- | :----------------------- | | Q2 2025 | $15,424 | | Q2 2024 | $9,263 | - Total operating expenses increased to approximately **$15.4 million** in Q2 2025 from **$9.3 million** in Q2 2024, driven by increased headcount, CAPTAIN trial enrollment, sales force expansion, commissions, and infrastructure costs[6](index=6&type=chunk) [Net Loss and Per Share Data](index=2&type=section&id=Net%20Loss%20and%20Per%20Share%20Data) Net loss for Q2 2025 significantly widened to $15.7 million, resulting in a higher loss per common share Q2 2025 Net Loss and EPS | Period | Net Loss (USD in thousands) | EPS | | :----- | :-------------------------- | :---- | | Q2 2025 | $15,695 | $0.52 | | Q2 2024 | $6,919 | $0.28 | - Net loss for Q2 2025 was approximately **$15.7 million**, or **$0.52 per common share**, compared to **$6.9 million**, or **$0.28 per common share**, in Q2 2024[7](index=7&type=chunk) [Liquidity and Outstanding Share Capital](index=2&type=section&id=Liquidity%20and%20Outstanding%20Share%20Capital) As of June 30, 2025, Profound Medical held $35.2 million in cash. The number of common shares outstanding increased slightly since the end of 2024 Liquidity and Share Capital | Metric | As of June 30, 2025 | As of August 14, 2025 | | :------------------------ | :------------------ | :-------------------- | | Cash | ~$35.2 million | N/A | | Common Shares Outstanding | 30,053,142 | 30,053,142 | - As of June 30, 2025, Profound had cash of approximately **$35.2 million**[8](index=8&type=chunk) [About Profound Medical Corp.](index=3&type=section&id=About%20Profound%20Medical%20Corp.) Profound Medical is a commercial-stage medical device company specializing in incision-free therapies for diseased tissue ablation. Its primary technologies are TULSA-PRO for prostate diseases and Sonalleve for uterine fibroids and palliative pain [Company Profile](index=3&type=section&id=Company%20Profile) Profound Medical is a commercial-stage medical device company focused on developing and marketing customizable, AI-powered, incision-free tissue ablation therapies - Profound Medical Corp. is a commercial-stage medical device company developing and marketing customizable, AI-powered, incision-free therapies for diseased tissue ablation[1](index=1&type=chunk)[11](index=11&type=chunk) [TULSA-PRO Technology Overview](index=3&type=section&id=TULSA-PRO%20Technology%20Overview) TULSA-PRO is an MRI-guided, robotically-driven transurethral ultrasound system for prostate disease, offering incision- and radiation-free treatment - TULSA-PRO combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control for treating the entire prostate disease spectrum[12](index=12&type=chunk) - The TULSA procedure is incision- and radiation-free, performed in a single session, and aims to preserve urinary continence and sexual function while ablating targeted prostate tissue[12](index=12&type=chunk) - TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA[12](index=12&type=chunk) [Sonalleve Technology Overview](index=3&type=section&id=Sonalleve%20Technology%20Overview) Sonalleve is a therapeutic platform CE marked for uterine fibroids and palliative pain, with FDA approval for osteoid osteoma and ongoing exploration for other cancers - Sonalleve is a therapeutic platform CE marked for uterine fibroids and palliative pain treatment of bone metastases, and approved in China for uterine fibroids[13](index=13&type=chunk) - Sonalleve also has FDA approval under a Humanitarian Device Exemption for osteoid osteoma and is being explored for non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This section outlines the forward-looking nature of certain statements in the release, including expectations for technology efficacy, TULSA-PRO sales, 2025 revenue growth, and commercialization strategy. It cautions that actual results may differ due to various known and unknown risks inherent in the medical device industry and market conditions - Forward-looking statements include expectations regarding the efficacy of Profound's technology, timing of TULSA-PRO system sales, full-year 2025 revenue growth (**70-75%**), and U.S. commercialization strategy[14](index=14&type=chunk) - Such statements are subject to known and unknown risk factors and uncertainties, including those related to the medical device industry, regulatory approvals, reimbursement, economic factors, and competition[14](index=14&type=chunk) [Conference Call Details](index=2&type=section&id=Conference%20Call%20Details) Profound Medical invited interested parties to a conference call on August 14, 2025, at 4:30 pm ET to discuss the Q2 2025 results, with pre-registration required for telephone participation and a live webcast available on the company's website - A conference call was scheduled for **August 14, 2025, at 4:30 pm ET** to discuss the Q2 2025 results[10](index=10&type=chunk) - Participants could pre-register for dial-in or access a live broadcast and archive on Profound's website[10](index=10&type=chunk) [Condensed Consolidated Financial Statements](index=4&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Profound Medical Corp., including the Balance Sheets, Statements of Operations and Comprehensive Loss, and Statements of Cash Flows, providing detailed financial performance and position for Q2 2025 and the six months ended June 30, 2025, compared to prior periods [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets show a decrease in cash and total shareholders' equity from December 31, 2024, to June 30, 2025 Condensed Consolidated Balance Sheets (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | **Assets** | | | | Cash | $35,195 | $54,912 | | Total current assets | $48,811 | $69,065 | | Total assets | $49,668 | $70,234 | | **Liabilities** | | | | Total current liabilities | $5,724 | $6,565 | | Total liabilities | $10,409 | $9,812 | | **Shareholders' Equity** | | | | Total shareholders' equity | $39,259 | $60,422 | - Cash decreased from **$54.9 million** at December 31, 2024, to **$35.2 million** at June 30, 2025[17](index=17&type=chunk) - Total shareholders' equity decreased from **$60.4 million** at December 31, 2024, to **$39.3 million** at June 30, 2025[17](index=17&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statements show increased total revenue for the six months ended June 30, 2025, but also a significant rise in net loss Condensed Consolidated Statements of Operations and Comprehensive Loss (USD in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Revenue | $2,211 | $2,233 | $4,832 | $3,672 | | Gross profit | $1,618 | $1,421 | $3,471 | $2,287 | | Total operating expenses | $15,424 | $9,263 | $28,443 | $18,006 | | Operating loss | $13,806 | $7,842 | $24,972 | $15,719 | | Net loss attributed to shareholders | $15,695 | $6,919 | $26,419 | $13,504 | | Basic and diluted net loss per common share | $0.52 | $0.28 | $0.88 | $0.55 | - For the six months ended June 30, 2025, total revenue increased to **$4.8 million** from **$3.7 million** in the prior year period, while net loss increased to **$26.4 million** from **$13.5 million**[18](index=18&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow statements indicate a substantial increase in net cash used in operating activities for the six months ended June 30, 2025 Condensed Consolidated Statements of Cash Flows (USD in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(22,027) | $(10,748) | | Net cash provided by (used in) financing activities | $(290) | $19,853 | | Net increase (decrease) in cash and cash equivalents | $(22,317) | $9,105 | | Cash, end of period | $35,195 | $34,079 | - Net cash used in operating activities significantly increased to **$22.0 million** for the six months ended June 30, 2025, compared to **$10.7 million** in the prior year period[19](index=19&type=chunk) - Cash at the end of the period was **$35.2 million**, a decrease from **$54.9 million** at the beginning of the period (December 31, 2024, from balance sheet) but comparable to **$34.1 million** at June 30, 2024[19](index=19&type=chunk)[17](index=17&type=chunk)

Core Insights - Profound Medical Corp. reported its second quarter financial results for 2025, highlighting growth in TULSA-PRO system utilization and a strong sales pipeline, despite experiencing short-term delays in capital sales [1][3]. Business Highlights - Utilization of TULSA-PRO systems increased, with "same store" procedure volumes rising by 10% sequentially from Q1-2025 [2]. - The sales pipeline for TULSA-PRO has expanded to 80 new systems in various stages of the sales process [2]. - Patient demographics treated with TULSA-PRO in Q2-2025 included 79% for prostate cancer, 17% for hybrid conditions, and 3% for salvage therapy [2]. - The company hosted an investor event at the AUA 2025, showcasing positive initial data from the CAPTAIN trial, which indicated TULSA's advantages over robotic radical prostatectomy [2]. - Leonard Wheeler was appointed as Global Ambassador for TULSA-PRO to enhance awareness and advocacy [2]. - The TULSA-AI Volume Reduction Module was successfully launched for BPH treatment, with a full launch expected in Q4-2025 [3]. Financial Performance - Revenue for Q2-2025 was approximately $2.2 million, with $1.6 million from recurring non-capital revenue and $650,000 from capital equipment sales [4]. - Gross margin improved to 73% in Q2-2025, up from 64% in the prior year, attributed to higher manufacturing efficiency [5]. - Total operating expenses rose to approximately $15.4 million, compared to $9.3 million in the previous year, driven by increased headcount and trial enrollment [6]. - The net loss for Q2-2025 was approximately $15.7 million, or $0.52 per share, compared to a loss of $6.9 million, or $0.28 per share, in Q2-2024 [7]. Liquidity and Share Capital - As of June 30, 2025, the company had cash reserves of approximately $35.2 million [8]. - The total number of common shares outstanding was 30,053,142 as of August 14, 2025 [8].