Milestone reflects accelerating adoption of innovative, non-surgical treatment options for uterine conditionsTORONTO, Feb. 05, 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, announced today that PRO FAMILIA Specialist Hospital in Rzeszów, Poland has completed its 500th Sonalleve® Procedure. The MRI-guid ...

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 ...

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].

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]