Clinical validation from the Busch Center highlights the proven, scalable innovation driving a paradigm shift in prostate care — delivering precision treatment and better patient outcomesTORONTO, Oct. 16, 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 unveiled new, real-world data from the inter ...

TORONTO, Oct. 14, 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 announced that management will present an update on the Company’s business at the Stifel 2025 Healthcare Conference on Tuesday, November 11, 2025 at 1:20 p.m. Eastern Time in NYC. The presentation will be broadcast live and archive ...

To release full third quarter 2025 financial results on November 13th; conference call to followTORONTO, Oct. 07, 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 announced preliminary unaudited revenues for the third quarter of 2025. Unless specified otherwise, all amounts in this press release a ...

New program delivers TULSA Procedure’s precision treatment - minimal side effects, no overnight hospital stay – to Medicare patients across TexasTORONTO, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company developing AI-powered, incision-free therapies for ablating diseased tissue, announced today the launch of a first-of-its-kind TULSA program by Texas Prostate and Dallas Medical Center to meet the growing ...

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]

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].

Core Viewpoint - Profound Medical Corp. is set to announce its second quarter 2025 financial results on August 14, 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, AI-enhanced planning, and robotically-driven transurethral ultrasound for the treatment of prostate diseases. The TULSA procedure is designed to preserve urinary continence and sexual function while effectively targeting prostate tissue [4]. - TULSA is a single-session, incision-free procedure that operates at temperatures of 55-57°C, with no associated bleeding or hospital stay required, allowing for quick recovery [4]. - Profound is also marketing Sonalleve, a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases. It has received CE marking and FDA approval under a Humanitarian Device Exemption for specific treatments [5].

Core Viewpoint - Profound Medical Corp. has successfully conducted the first commercial treatment for benign prostatic hyperplasia (BPH) using the new TULSA-AI Volume Reduction Module, enhancing the TULSA-PRO system's capabilities for incision-free therapies [1][4]. Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing and marketing customizable, AI-powered, incision-free therapies for the ablation of diseased tissue [1][7]. - The TULSA-PRO system combines real-time MRI, AI-enhanced planning, and ultrasound technology to treat various prostate diseases, including BPH and prostate cancer [8]. Treatment Details - The TULSA procedure is a "one-and-done" treatment that is incision- and radiation-free, performed in a single session lasting a few hours, with no bleeding or hospital stay required [3][8]. - The new TULSA-AI Volume Reduction module streamlines the procedure, allowing for personalized treatment plans and reducing total skin-to-skin time to an expected 60-90 minutes [5][6]. Clinical Efficacy - A recent Phase II study showed significant improvements in urinary function and quality of life for BPH patients treated with TULSA, with the International Prostate Symptom Score (IPSS) decreasing from 17 to 4 and maximum urine flow rate increasing from 11.1 to 18.3 mL/s [4]. - 96% of patients who were on BPH medications prior to the TULSA procedure discontinued their use after treatment [4]. Market Potential - The introduction of the TULSA-AI Volume Reduction module is expected to expand the total addressable market for prostate disease patients from 200,000 to 600,000 annually [7].

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 - 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]