Table of Contents OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39032 PROFOUND MEDICAL CORP. UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 (Exact Name of Registrant as Specified in its Charter) Ontario, Canada Not Applica ...

TORONTO, May 08, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, AI-powered, incision-free therapies for the ablation of diseased tissue, today reported unaudited financial results for the first quarter ended March 31, 2025. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with U.S. generally accepte ...

TORONTO, April 30, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today announced that management will present an update on the Company’s business at the 2025 Bloom Burton & Co. Healthcare Investor Conference on Tuesday, May 6, 2025 at 1:30 p.m. Eastern Time at the Metro Toronto Convention Centre. The presentatio ...

– First Level 1 study comparing an emerging technology head-to-head with RP in men with prostate cancer – – TULSA had no blood loss and no overnight stay, along with reduced post-procedure pain, and more rapid recovery to baseline activities and overall health – TORONTO, April 29, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, AI-powered, incision-free therapies for the a ...

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]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices by Profound Medical Corp and its officers or directors [1] Group 1: Financial Disclosure - On March 7, 2025, Profound disclosed an error that overstated revenue by $472,000 in Q1 2024, leading to the conclusion that its quarterly reports for the first three quarters of 2024 should no longer be relied upon [3] - Profound intends to file restated interim financial statements as soon as practicable following the identification of the error [3] Group 2: Market Reaction - Following the news of the revenue overstatement, Profound's stock price fell by $0.43 per share, or 5.9%, closing at $6.86 per share on March 7, 2025 [4]

Core Viewpoint - Profound Medical Corp. is set to announce its first quarter 2025 financial results on May 8, 2025, and will host a conference call to discuss these results and business developments [1][2]. Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing and marketing customizable, incision-free therapies for the ablation of diseased tissue [3]. Product Offerings - The company is commercializing TULSA-PRO®, a technology that integrates real-time MRI, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control, aimed at treating various prostate conditions [4]. - TULSA-PRO® is designed to be a mainstream treatment for prostate cancer and benign prostatic hyperplasia (BPH), offering a "one-and-done" procedure that is incision- and radiation-free, with quick recovery times [4]. - Profound is also marketing Sonalleve®, a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases, with potential applications in non-invasive ablation of abdominal cancers [5].

Core Viewpoint - The Schall Law Firm is investigating Profound Medical Corp. for potential violations of securities laws related to misleading statements and undisclosed information affecting investors [1][2]. Group 1: Investigation Details - The investigation centers on whether Profound Medical Corp. issued false or misleading statements and failed to disclose critical information to investors [2]. - On March 7, 2025, Profound disclosed an error that overstated revenue by $472,000 in Q1 2024, leading to the conclusion that its quarterly reports for the first three quarters of 2024 are no longer reliable [2]. - Following this announcement, shares of Profound fell by 5.9% on the same day [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who suffered losses are encouraged to contact the firm for a free discussion of their rights [3].

Group 1 - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of investors of Profound Medical Corp. regarding potential securities fraud by certain officers and/or directors of the company [1] - Profound Medical Corp. disclosed an error in an SEC filing on March 7, 2025, which overstated revenue by $472,000 in Q1 2024, leading to the conclusion that its quarterly reports for the first three quarters of 2024 are no longer reliable [2] - Following the announcement of the revenue overstatement, shares of Profound Medical Corp. fell by 5.9% on the same day [2]

Group 1 - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of investors of Profound Medical Corp. regarding potential securities fraud by certain officers and/or directors of the company [1] - Profound Medical Corp. disclosed an error in an SEC filing on March 7, 2025, which overstated revenue by $472,000 in Q1 2024, leading to the conclusion that its quarterly reports for the first three quarters of 2024 are no longer reliable [2] - Following the announcement of the revenue overstatement, shares of Profound Medical Corp. fell by 5.9% on the same day [2] Group 2 - Wolf Haldenstein has a strong reputation in prosecuting securities class actions and derivative litigation across various courts in the United States, with multiple offices and a recognized expertise in shareholder litigation [3]