TORONTO, Jan. 27, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce its participation in the following investor events in February. Lake Street Life-Sciences Invitational: Profound is scheduled to participate in a series of one-on-one meetings February 4th-5th in Scottsdale, AZ.BTIG ...

Mount Sinai advances prostate care with AI-powered therapy designed to preserve continence and sexual function The Mount Sinai Hospital is ranked No. 6 nationally for Urology by US News & World Report® for 2025-26 TORONTO, Jan. 15, 2026 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce t ...

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].

Core Viewpoint - Profound Medical Corp. has successfully closed a registered direct offering of 5,142,870 common shares at a price of $7.00 per share, generating approximately $36 million in gross proceeds before fees and expenses [1][3]. Financing Details - The offering was structured as a straightforward equity investment with no warrant coverage, led by healthcare-dedicated investors alongside existing shareholders [2]. - The gross proceeds from the offering are intended for expansion of sales and marketing, working capital, research and development, strategic transactions, and general corporate purposes [3]. Placement Agent - Konik Capital Partners, LLC acted as the exclusive placement agent for the offering [4]. Regulatory Information - The offering was made under an effective shelf registration statement on Form S-3, declared effective by the SEC on December 4, 2025 [5]. Future Plans - In addition to the registered direct offering, the company plans to complete a private placement to certain Canadian purchasers, expected to close on or before December 30, 2025, subject to necessary approvals [7]. Company Overview - Profound Medical Corp. is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [8]. - The company is commercializing TULSA-PRO, a technology that combines real-time MRI, AI-enhanced planning, and ultrasound for prostate disease treatment [9]. - Profound is also marketing Sonalleve, a therapeutic platform for treating uterine fibroids and other conditions, which has received various regulatory approvals [10].

Core Viewpoint - Profound Medical Corp. announced a registered direct offering of 5,142,857 common shares at $7.00 per share, aiming for gross proceeds of up to $40 million, including a subsequent private placement of up to 571,428 shares at the same price [1][3][6] Group 1: Offering Details - The registered direct offering is structured as an equity investment with no warrant coverage, led by healthcare-dedicated investors [2] - Gross proceeds from the offering are expected to be approximately $36 million before deducting fees and expenses [3] - The private placement aims for up to $4 million in gross proceeds, with shares subject to a four-month hold period [6] Group 2: Use of Proceeds - The net proceeds from the offering will be utilized for sales and marketing expansion, working capital, research and development, strategic transactions, and general corporate purposes [3] Group 3: Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on AI-powered, MRI-guided therapies for tissue ablation [7] - The company is commercializing TULSA-PRO, a technology for treating various prostate conditions, which is incision-free and has a quick recovery time [8] - Profound is also developing Sonalleve, a platform for treating uterine fibroids and other conditions, with approvals in multiple jurisdictions [9]

Core Insights - The CAPTAIN trial is the first randomized controlled trial comparing MRI-guided transurethral ultrasound ablation (TULSA) to robotic radical prostatectomy (RP), successfully recruiting to target [1][4] - Dr. Pejman Ghanouni received the Cum Laude award for his presentation on the CAPTAIN trial at the RSNA Annual Meeting, highlighting the significance of the study [1][2] - The TULSA Procedure offers a quicker recovery time compared to robotic RP, with patients feeling better the day after the procedure, while robotic RP patients take nearly three weeks [3] Company Overview - Profound Medical Corp. specializes in AI-powered, MRI-guided, incision-free therapies for tissue ablation, with a focus on the TULSA Procedure [1][5] - The TULSA-PRO system is the only AI-powered, MRI-guided robotic system for prostate therapy, allowing real-time monitoring and personalized treatment [3][6] - Profound is also commercializing Sonalleve, a therapeutic platform for various conditions, including uterine fibroids and bone metastases [7] CAPTAIN Trial Details - The CAPTAIN trial is a multi-center study comparing the safety and efficacy of TULSA with RP in men with organ-confined, intermediate-risk prostate cancer [4] - As of January 2025, 210 patients were randomized, with 69% receiving TULSA and 31% receiving RP, ensuring balanced baseline characteristics [4] - The trial commenced in 2022 across 20 sites in the U.S., two in Canada, and one in Europe, with the last patient treatment occurring in August 2025 [4]

Core Insights - Profound Medical Corp. is launching the TULSA-AI Volume Reduction module for treating benign prostatic hyperplasia (BPH) at the RSNA meeting, enhancing the TULSA Procedure's versatility and potential for mainstream adoption [1][4] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on AI-powered, MRI-guided, incision-free therapies for ablation of diseased tissue [9][10] - The TULSA Procedure™ is the only incision-free option for prostate cancer and BPH, utilizing real-time MRI guidance for precision [3][10] Product Details - The TULSA-AI Volume Reduction module allows for efficient stacking of multiple prostate cases in one day, improving workflow and reducing procedure times [3][4] - The TULSA Procedure has shown significantly reduced risks of sexual function loss and incontinence compared to traditional methods, with superior outcomes in blood loss, length of stay, post-operative pain, and recovery time [3][4] Market Potential - The launch of the TULSA-AI module is expected to triple Profound's total available market in prostate disease to approximately 600,000 patients annually [4] - The TULSA Procedure is positioned to become a mainstream treatment across various prostate disease conditions, including low-, intermediate-, and high-risk prostate cancer, as well as BPH [10] Event Participation - Profound Medical will showcase the TULSA-AI Volume Reduction module and present new clinical data at the RSNA and SUO meetings [5][6][7]