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 ...

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]

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]

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][4] - The company is known for its TULSA-PRO® technology, which combines real-time MRI, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control for treating prostate diseases [4] Upcoming Investor Event - Profound will host a hybrid investor event on April 28, 2025, during the American Urological Association's Annual Meeting in Las Vegas, NV [1] - The event will feature presentations from the management team and leading physicians discussing TULSA-PRO®, peri-operative results from the Level 1 CAPTAIN post-market study, the upcoming TULSA-AI® module for BPH, and the TULSA+ program [2] TULSA-PRO® Technology - TULSA-PRO® is designed to treat a wide range of prostate diseases, including low-, intermediate-, and high-risk prostate cancer, as well as benign prostatic hyperplasia (BPH) [4] - The procedure is incision- and radiation-free, performed in a single session, and aims to preserve urinary continence and sexual function while effectively targeting prostate tissue [4] Sonalleve® Technology - Profound is also commercializing Sonalleve®, a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases [5] - The technology has received CE marking and FDA approval under a Humanitarian Device Exemption for specific treatments, with ongoing exploration for additional markets [5]

Core Viewpoint - Profound Medical Corp. is under investigation for potential securities fraud following the disclosure of a revenue overstatement of $472,000 in Q1 2024, leading to a significant drop in stock price [2][3]. Group 1: Company Financials - Profound Medical Corp. identified an error that overstated revenue by $472,000 in the first quarter of 2024 [2]. - The company announced that its quarterly reports for the first three quarters of 2024 should no longer be relied upon and intends to file restated interim financial statements [2]. Group 2: Stock 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 [3]. Group 3: Legal Investigation - Pomerantz LLP is investigating claims on behalf of investors regarding potential securities fraud or unlawful business practices by Profound and its officers and/or directors [1].