Core Insights - Profound Medical Corp. will announce its fourth quarter and full year 2025 financial results on March 5, 2026, followed by a conference call to discuss the results and business developments [1][2]. Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing and marketing innovative interventional MRI (iMRI) procedures [3]. Product Offerings - The company is commercializing TULSA-PRO, a technology that integrates real-time MRI, AI-enhanced planning, and robotically-driven ultrasound for treating prostate diseases. The TULSA Procedure is designed to preserve urinary continence and sexual function while effectively targeting prostate tissue [4]. - TULSA-PRO is CE marked, Health Canada approved, and has received 510(k) clearance from the U.S. FDA [4]. - Profound is also marketing Sonalleve, a therapeutic platform approved for treating uterine fibroids and other conditions. It has received CE marking and FDA approval under a Humanitarian Device Exemption for specific treatments [5].

Core Insights - Profound Medical Corp. has been awarded the 2025/2026 Mount Logan Award for its achievements in interventional MRI procedures, particularly for the TULSA Procedure [1][2] Company Achievements - The company has treated its 4,000th TULSA Procedure patient and secured new U.S. reimbursement codes from Medicare, enhancing its market position [2] - Profound Medical has established strategic partnerships to expand global patient access to its technologies [2] - The TULSA Procedure is a significant advancement in prostate care, utilizing robotically controlled ultrasound and real-time MRI thermography for precise treatment [2][5] Technology Overview - The TULSA Procedure employs a unique method of delivering ultrasound from within the urethra to heat prostate tissue to 'kill temperature' (55-57°C), minimizing side effects and ensuring no procedural blood loss [2][5] - The procedure is incision-free, requires no overnight hospital stay, and allows for a quick recovery, making it a compelling option for patients [5] Market Position and Future Plans - Currently, there is only one TULSA-PRO system installed in Canada, but the company aims to increase installations following the regain of exclusive distribution rights in the country [3] - Profound Medical is deploying a direct sales team in North America and partnering with strategic distribution partners to enhance its global reach [3] Additional Products - Profound Medical is also commercializing Sonalleve, a therapeutic platform approved for treating uterine fibroids and other conditions, with potential applications in non-invasive cancer treatments [6]

Core Insights - Profound Medical Corp. has achieved a significant milestone with the completion of its 500th Sonalleve Procedure at PRO FAMILIA Specialist Hospital in Poland, reflecting the growing adoption of non-surgical treatment options for uterine conditions [1][2] - The Sonalleve technology offers a non-invasive alternative for treating uterine fibroids and adenomyosis, providing targeted relief without incisions, blood loss, or the need for overnight hospital stays [1][2] - The company is also focused on the commercialization of TULSA-PRO, which is designed for prostate disease treatment, emphasizing its unique ability to minimize side effects associated with traditional surgical methods [3][5] Company Overview - Profound Medical Corp. is a commercial-stage medical device company that specializes in AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [4] - The company is actively commercializing two main products: TULSA-PRO for prostate conditions and Sonalleve for gynecologic disorders, both of which utilize advanced imaging and therapeutic technologies [5][7] Product Details - Sonalleve has been operational in Europe, China, and Southeast Asia, with over 4,000 women treated for uterine conditions, demonstrating effective pain and symptom relief while preserving fertility [2][3] - TULSA-PRO employs real-time MRI guidance and is designed to treat a wide range of prostate diseases, ensuring preservation of urinary continence and sexual function [5][6] - Both Sonalleve and TULSA-PRO have received various regulatory approvals, including CE marking and FDA clearance, indicating their compliance with safety and efficacy standards [6][7]

Core Insights - Profound Medical Corp. is a commercial-stage medical device company focused on AI-powered, MRI-guided, incision-free therapies for ablation of diseased tissue [1][3] Company Overview - Profound Medical is known for its TULSA-PRO technology, which integrates real-time MRI, AI-enhanced planning, and robotic 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 procedure is incision-free, radiation-free, and typically completed in a single session, with patients experiencing quick recovery [4] - TULSA-PRO has received CE marking, Health Canada approval, and 510(k) clearance from the FDA [4] Additional Products - Profound Medical is also commercializing Sonalleve, a platform approved for treating uterine fibroids, adenomyosis, and pain from bone metastases, among other conditions [5] - Sonalleve has received CE marking and FDA approval under a Humanitarian Device Exemption for specific treatments and is being explored for additional applications in cancer therapy [5] Upcoming Events - The company will participate in the Lake Street Life-Sciences Invitational on February 4-5 in Scottsdale, AZ, and the BTIG 13th Annual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on February 10-11 in Snowbird, UT [6]

Company Overview - Profound Medical (PROF) shares increased by 9.5% to close at $8.34, with trading volume significantly higher than usual, contrasting with a 0.3% loss over the past four weeks [1] - The rise in share price followed the successful treatment of a prostate cancer patient at Mount Sinai Hospital using the TULSA-PRO system, which integrates advanced technologies for treatment [2] Financial Performance - The company is projected to report a quarterly loss of $0.28 per share, reflecting a year-over-year decline of 40%, while revenues are expected to reach $8 million, marking a 91.4% increase from the previous year [3] - The consensus EPS estimate for the upcoming quarter has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [4] Industry Context - Profound Medical operates within the Zacks Medical - Drugs industry, where Rigel Pharmaceuticals (RIGL) also holds a Zacks Rank of 3 (Hold) and has seen a 3.4% decrease in its share price [4][5] - Rigel's consensus EPS estimate for its upcoming report is $1.17, representing a 46.3% increase from the previous year, with its stock also experiencing a decline of 6.7% over the past month [5]

Core Insights - Mount Sinai Hospital has successfully treated its first prostate cancer patient using the TULSA-PRO system, marking a significant advancement in prostate care with AI-powered, MRI-guided therapy [1][4] Group 1: TULSA Procedure Overview - The TULSA Procedure™ utilizes robotically controlled directional ultrasound to heat prostate tissue to 'kill temperature' (55-57°C), while protecting surrounding nerves, resulting in no procedural blood loss and a quicker recovery [2][9] - This procedure is designed to treat a range of prostate diseases, including prostate cancer and benign prostatic hyperplasia (BPH), with minimal side effects such as urinary incontinence and erectile dysfunction [2][8] Group 2: Collaboration and Leadership - Mount Sinai is the first health system in the New York Metro Area to offer the TULSA Procedure, establishing itself as a leader in robotic surgical care [4] - The collaboration between the Department of Urology and the Department of Interventional Radiology at Mount Sinai aims to pave the way for future studies and guidelines in prostate cancer and BPH treatment using TULSA-PRO [5] Group 3: Technology and Market Potential - TULSA-PRO combines real-time MRI, AI-enhanced planning, and temperature feedback control, positioning it as a potential mainstream treatment for various prostate conditions [8] - The procedure is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA, indicating its regulatory compliance and market readiness [9]

Core Insights - Profound Medical Corp. has successfully increased its TULSA-PRO installed base to 78 systems by the end of 2025, surpassing its target of 75 installations [1] - The qualified sales pipeline for TULSA-PRO has expanded to 97 new systems, indicating strong market interest and potential for future sales [2] - The CEO of Profound Medical anticipates that the growing installed base will lead to higher patient treatment rates and an increase in high-margin recurring revenue, driven by the TULSA Procedure's effectiveness in treating a wide range of prostate diseases while preserving patient functions [3] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing and marketing AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [4] - The TULSA-PRO system utilizes advanced technology, including real-time MRI, AI-enhanced planning, and temperature feedback control, to provide precise treatment for various prostate conditions [5] - Profound is also commercializing Sonalleve, a therapeutic platform approved for treating uterine fibroids and other conditions, and is exploring additional treatment markets for this technology [6]

Core Insights - Profound Medical Corp. has achieved a significant milestone with the launch of its TULSA-PRO system at The Johns Hopkins Hospital, marking the beginning of non-clinical-trial treatments for prostate cancer using this advanced technology [1][3] Company Overview - Profound Medical is a commercial-stage medical device company focused on developing and marketing AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [4] Technology and Procedure - The TULSA Procedure™ utilizes robotically controlled directional ultrasound to treat prostate cancer and benign prostatic hyperplasia (BPH) by heating prostate tissue to 'kill temperature' (55-57°C) while preserving surrounding nerves [2][5] - Real-time MRI thermography allows for continuous visualization and temperature adjustments during the procedure, resulting in no procedural blood loss, no overnight hospital stay, and a quicker recovery for patients [2][5] Clinical Development and Approval - Johns Hopkins University played a crucial role in the clinical development of TULSA-PRO, participating in pivotal clinical trials that led to FDA clearance and further studies to validate its efficacy [3] - TULSA-PRO is CE marked, Health Canada approved, and has received 510(k) clearance from the U.S. FDA, indicating its regulatory compliance and readiness for commercialization [5] Market Potential - The TULSA Procedure has the potential to become a mainstream treatment for a wide range of prostate conditions, including low-, intermediate-, and high-risk prostate cancer, as well as BPH and salvage therapy for radio-recurrent localized prostate cancer [5]

Core Viewpoint - Profound Medical Corp. has successfully completed a private placement of common shares, raising approximately US$6.45 million to support its business expansion and development efforts [1][2]. Group 1: Offering Details - The company issued a total of 921,428 common shares at a price of US$7.00 per share [1]. - The shares are subject to a hold period of four months plus one day from the closing date under Canadian securities laws [2]. - The net proceeds from the offering will be allocated for sales and marketing expansion, working capital, research and development, strategic transactions, and general corporate purposes [2]. Group 2: Regulatory Information - The securities offered have not been registered under the U.S. Securities Act and cannot be sold in the U.S. without registration or an applicable exemption [3]. - The company plans to file a registration statement with the U.S. Securities and Exchange Commission within four months from the closing date of the offering [3]. Group 3: Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on AI-powered, MRI-guided, incision-free therapies for tissue ablation [5]. - The company is commercializing TULSA-PRO, a technology designed for the treatment of various prostate conditions, which is CE marked, Health Canada approved, and FDA 510(k) cleared [6]. - Profound is also developing Sonalleve, a therapeutic platform for treating uterine fibroids and other conditions, which has received CE marking and FDA approval under a Humanitarian Device Exemption [7].

Core Viewpoint - Profound Medical Corp. has increased the size of its private placement to raise up to US$6.45 million, accommodating a long-term existing investor [1]. Group 1: Offering Details - The Offering will consist of up to 921,428 common shares priced at US$7.00 per share [1]. - The common shares will be subject to a hold period of four months plus one day from the closing date, which is expected to occur on or prior to December 30, 2025 [2]. Group 2: Use of Proceeds - The net proceeds from the Offering will be utilized for expansion of sales and marketing, working capital, research and development, strategic transactions, and general corporate purposes [2]. Group 3: Company Overview - Profound Medical Corp. is a commercial-stage medical device company that develops AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [4]. - The company is commercializing TULSA-PRO, a technology that combines real-time MRI, AI-enhanced planning, and ultrasound for prostate disease treatment [5]. - Profound is also commercializing Sonalleve, a therapeutic platform for treating uterine fibroids and other conditions, with approvals in multiple jurisdictions [6].