Core Insights - Profound Medical Corp has entered an exclusive distribution agreement with Al Faisaliah Medical Systems Co for its TULSA-PRO and Sonalleve technologies in Saudi Arabia, facilitating access to the Middle East healthcare market [1][6] Company Overview - Profound Medical Corp is a commercial-stage medical device company specializing in AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [9] - The company focuses on two main products: TULSA-PRO for prostate disease and Sonalleve for uterine conditions [4][11] Product Details - TULSA-PRO is designed for treating prostate diseases, utilizing MRI guidance and ultrasound to heat tissue to 'kill temperature' (55-57°C) without incisions or radiation [3][10] - Over 4,000 men have undergone the TULSA Procedure, with 67 TULSA-PRO systems installed as of October 2025 [3] - Sonalleve is primarily sold as a one-time capital sale and is gaining traction outside the U.S., with ten devices operational in Europe, China, and Southeast Asia, treating over 4,000 women for conditions like adenomyosis and uterine fibroids [4][11] Market Strategy - The company is deploying a direct sales team in North America while partnering with strategic distributors globally to enhance market penetration [5] - The partnership with Al Faisaliah Medical Systems is expected to leverage their expertise in introducing advanced medical technologies in Saudi Arabia [6][7] Regulatory and Reimbursement Updates - The U.S. Centers for Medicare & Medicaid Services established reimbursement for the TULSA procedure under the outpatient prospective payment system, effective January 1, 2025 [3] - TULSA-PRO has received necessary regulatory approvals, including CE marking, Health Canada approval, and FDA clearance [10]

Profound Medical Conference Call Summary Company Overview - **Company**: Profound Medical (NasdaqCM: PROF) - **Industry**: Medical Technology, specifically focused on prostate cancer and benign prostatic hyperplasia (BPH) treatment Key Points and Arguments Product and Technology - **TULSA PRO System**: A prostate ablation system that aims to provide outcomes comparable to standard surgical and radiation treatments while significantly improving quality of life for patients [3][4] - **Revenue Growth**: The company reported an impressive **85% revenue growth** in Q3, with the TULSA installed base expanding to **67 systems** [4][9] - **Adoption Rates**: The adoption of TULSA technology is increasing, with expectations to reach at least **75 installations** by the end of the year [9][26] - **AI-Driven Treatment Plans**: The system utilizes AI to create personalized treatment plans, enhancing the efficiency and effectiveness of procedures [8][22] Market Position and Competition - **Market Dynamics**: The primary competition comes from traditional radical prostatectomy and radiation therapies, with TULSA positioned as a unique ablative option [10][13] - **Clinical Outcomes**: Early data suggests that TULSA may improve clinical outcomes compared to traditional methods, with significant reductions in recovery time and side effects [20][22] - **Target Market**: The majority of patients require whole gland treatment, with TULSA capable of addressing both whole gland and focal therapy needs [12][13] Financial Outlook - **Revenue Projections**: The company anticipates significant revenue growth, projecting **$55 million** in recurring revenue per patient once reaching **200 sites** [34] - **Reimbursement Impact**: The introduction of reimbursement codes is expected to drive adoption, with hospitals beginning to see profitability from TULSA treatments [26][25] Future Developments - **BPH Software Launch**: A full launch of BPH software is expected soon, which will expand the treatment capabilities of TULSA and increase the total addressable market (TAM) [14][16] - **Interventional MRI Integration**: The company is exploring integration with interventional MRI technology, which could enhance the capabilities and applications of TULSA [24][34] - **Sonalleve Technology**: Profound Medical is also developing the Sonalleve system, which has been used in treating various conditions outside the U.S. and is expected to evolve into a recurring revenue model similar to TULSA [39][40] Clinical Trials and Data - **Kapton Trial**: A significant clinical trial comparing TULSA technology with robotic prostatectomy is underway, with promising early results regarding safety and recovery times [19][20] - **Patient Feedback**: Positive testimonials from patients highlight the impact of TULSA on their quality of life, reinforcing the product's value proposition [3][4] Commercial Strategy - **Site Expansion**: The company is actively expanding its network of treatment sites, with plans to increase from **67 to 75 sites** by year-end [26][27] - **Sales Pipeline**: The sales pipeline is robust, with a high probability of closing deals with potential sites, primarily due to established clinical and economic data [28][29] Challenges and Considerations - **Adoption Barriers**: The main challenges to adoption are related to hospital workflows and training rather than clinical efficacy or economic viability [49][50] - **Market Readiness**: Hospitals require time to adapt to new reimbursement codes and integrate TULSA into their treatment offerings [26][27] Additional Important Information - **Patient Demographics**: The majority of patients treated fall within higher-grade cancer categories, indicating a focus on more severe cases [21] - **AI Advancements**: Continuous improvements in AI technology are expected to further streamline procedures and enhance treatment outcomes [22][41] This summary encapsulates the key insights from the Profound Medical conference call, highlighting the company's innovative technology, market positioning, financial outlook, and future growth strategies.

TORONTO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets artificial intelligence (“AI”)-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce that it has regained exclusive distribution rights for TULSA-PRO® in Canada from Knight Therapeutics Inc. (“Knight”). The TULSA Procedure™, performed using the TULSA-PRO system, is used by ...

Core Insights - Profound Medical Corp. has introduced new real-world data from the Busch Center, showcasing the effectiveness and versatility of the TULSA Procedure in treating various prostate diseases, marking a significant advancement in prostate care [1][5] 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 [6][7] TULSA Procedure Details - The TULSA Procedure utilizes a unique incision-free, MRI-guided approach to treat prostate cancer and benign prostatic hyperplasia (BPH), with over 500 procedures completed at the Busch Center [1][2] - The procedure has shown successful outcomes in complex cases, with a significant portion of patients experiencing good cancer control and minimal side effects [2][4] - Approximately 75% of cases at the Busch Center involved customized ablations covering more than 90% of the prostate volume, demonstrating the procedure's adaptability [3] Clinical Outcomes - In a retrospective analysis, the TULSA Procedure resulted in a PSA reduction from 6.7 to 0.9 ng/mL, with 93% of patients showing no evidence of residual disease, while maintaining pad-free continence in 100% of men and erectile function in 82% [4] - The procedure is particularly effective for patients with high-risk disease, utilizing intraoperative MRI guidance and real-time thermography for precision control [3][5] Technology and Innovation - The TULSA-PRO system is the only AI-powered, MRI-guided robotic system for prostate treatment, allowing for real-time visualization and customization of therapy [5][7] - The procedure is designed to be a "one-and-done" treatment, performed in a single session without the need for hospitalization, leading to quick recovery for patients [7] Market Potential - The TULSA Procedure has the potential to become a mainstream treatment for a wide range of prostate diseases, including low-, intermediate-, and high-risk prostate cancer, as well as BPH and salvage therapy for radio-recurrent localized prostate cancer [7]

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 [3]. Key Technologies - The company is commercializing TULSA-PRO, a technology that integrates real-time MRI, AI-enhanced planning, and robotically-driven transurethral ultrasound for prostate disease treatment. 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 TULSA Procedure is characterized as a "one-and-done" treatment performed in a single session, taking a few hours, with no bleeding, no hospital stay required, and quick recovery reported by patients [4]. Regulatory Approvals - TULSA-PRO has received CE marking, Health Canada approval, and 510(k) clearance from the U.S. FDA [4]. - Profound is also commercializing Sonalleve, which is CE marked for treating uterine fibroids and palliative pain from bone metastases, and has received FDA approval under a Humanitarian Device Exemption for treating osteoid osteoma [5]. Future Prospects - The company is exploring additional treatment markets for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy [5]. Upcoming Events - Management will present an update on the company's business at the Stifel 2025 Healthcare Conference on November 11, 2025 [1].

Core Insights - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, incision-free therapies for tissue ablation [3][4] Company Overview - Profound Medical Corp. is engaged in the commercialization of TULSA-PRO®, a technology that integrates real-time MRI, AI-enhanced planning, and robotically-driven 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 TULSA Procedure is characterized as a "one-and-done" treatment, performed in a single session without incisions or radiation, with a typical duration of a few hours [4] - The procedure utilizes precise sound absorption technology to heat targeted prostate tissue to 55-57°C, preserving urinary continence and sexual function [4] - TULSA-PRO has received CE marking, Health Canada approval, and 510(k) clearance from the U.S. FDA [4] Additional Products - Profound is also commercializing Sonalleve®, a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases [5] - Sonalleve has received CE marking and approval from the China National Medical Products Administration for non-invasive treatment of uterine fibroids, as well as FDA approval under a Humanitarian Device Exemption for osteoid osteoma treatment [5] - The company is exploring further treatment applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy [5] Upcoming Events - Management will present a business update at the Stifel 2025 Healthcare Conference on November 11, 2025, at 1:20 p.m. Eastern Time [1][2]

[Filing Details](index=1&type=section&id=Filing%20Details) This section provides the fundamental identification and status information for the Form 8-K filing [General Information](index=1&type=section&id=General%20Information) This section provides the basic identification details of the Form 8-K filing, including the registrant's name, jurisdiction, address, and contact information, along with the date of the report - Company Name: **PROFOUND MEDICAL CORP.**[1](index=1&type=chunk) - Date of Report: **October 7, 2025**[1](index=1&type=chunk) - Jurisdiction of Incorporation: **Ontario, Canada**[1](index=1&type=chunk) [Securities and Filing Status](index=1&type=section&id=Securities%20and%20Filing%20Status) This section details the registrant's securities information, specifically common shares traded on Nasdaq, and confirms its status regarding emerging growth company provisions Securities Registered | Title of each class | Trading Symbol(s) | Name of each exchange on which registered | | :------------------ | :---------------- | :---------------------------------------- | | Common Shares | PROF | The Nasdaq Stock Market | - Emerging growth company status: **Not an emerging growth company (indicated by unchecked box)**[3](index=3&type=chunk) [Corporate Event Disclosure](index=2&type=section&id=Corporate%20Event%20Disclosure) This section discloses significant corporate events, including financial results and related exhibits [Item 2.02 - Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02.%20Results%20of%20Operations%20and%20Financial%20Condition.) Profound Medical Corp. announced its preliminary unaudited financial results for the three months ended September 30, 2025, along with a business update, via a press release furnished as Exhibit 99.1. The information is not considered 'filed' for Section 18 purposes of the Exchange Act - Event: Announcement of preliminary unaudited financial results for the three months ended **September 30, 2025**, and a business update[4](index=4&type=chunk) - Date of Announcement: **October 7, 2025**[4](index=4&type=chunk) - Source: **Press release furnished as Exhibit 99.1**[4](index=4&type=chunk) - Filing Status: The information in Item 2.02 (including Exhibit 99.1) is **furnished, not deemed 'filed'** for purposes of Section 18 of the Securities Exchange Act of 1934[5](index=5&type=chunk) [Item 9.01 - Financial Statements and Exhibits](index=2&type=section&id=Item%209.01.%20Financial%20Statements%20and%20Exhibits.) This section lists the exhibits accompanying the Form 8-K filing, primarily the press release detailing the financial results and business update, and the interactive data file Exhibits Filed | Exhibit No. | Description | | :---------- | :---------------------------------------------------------- | | 99.1 | Press Release dated October 7, 2025 | | 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | [Signatures](index=3&type=section&id=SIGNATURE) This section formally authenticates the report through the authorized signatory [Authorization and Signatory](index=3&type=section&id=Authorization%20and%20Signatory) The report is formally signed on behalf of Profound Medical Corp. by its Chief Financial Officer, Rashed Dewan, confirming compliance with the Securities Exchange Act of 1934 requirements - Signatory: **Rashed Dewan**, Chief Financial Officer[10](index=10&type=chunk) - Date of Signature: **October 7, 2025**[10](index=10&type=chunk)

Core Viewpoint - Profound Medical Corp. anticipates significant revenue growth for Q3 2025, with preliminary estimates indicating revenues between $5.2 million and $5.3 million, representing an increase of 84% to 87% compared to the same period last year [2][3] Financial Performance - For the quarter ended September 30, 2025, Profound expects total revenues in the range of $5.2 million to $5.3 million, up from $2.8 million in Q3 2024 [2] - The gross margin for Q3 2025 is projected to be approximately 72%, an increase from 64% in the prior year [2] Business Developments - The installed base of the TULSA-PRO system has grown to 67 units, up from 60, with expectations to reach at least 75 by the end of the year due to a strong capital sales pipeline [3] - The TULSA Procedure is positioned as a potential mainstream treatment for various prostate conditions, emphasizing its incision-free and radiation-free nature [6] Upcoming Events - The company will release its full Q3 2025 financial results on November 13, 2025, followed by a conference call at 4:30 p.m. ET to discuss the results and business developments [4]

Core Insights - The article discusses the experience of an investor who utilized earnings reports to identify potential winning stocks during the pandemic, highlighting a methodical approach to investing [1]. Group 1: Investment Strategy - The investor's strategy involves studying earnings reports and transcripts to find indicators of future growth [1]. - Specific stocks identified as future winners include OPRX, OTRK, FUBO, and PLUG, showcasing the effectiveness of this analytical approach [1].

Core Viewpoint - Profound Medical Corp. has launched a new TULSA program in collaboration with Texas Prostate and Dallas Medical Center, providing Medicare patients in Texas access to the TULSA Procedure, a minimally invasive treatment for prostate cancer and benign prostatic hyperplasia (BPH) without the need for surgery [1][2][3] Group 1: TULSA Procedure Overview - The TULSA Procedure offers effective prostate treatment with minimal side effects compared to traditional surgery, such as incontinence or erectile dysfunction [2] - The procedure is performed using the TULSA-PRO system, which combines real-time MRI guidance, AI-enhanced planning, and robotically-driven ultrasound to precisely ablate targeted prostate tissue [5] - TULSA is a single-session, incision-free procedure that allows patients to return home the same day, with no procedural blood loss and a significantly lower risk of complications [3][5] Group 2: Medicare Coverage and Accessibility - Medicare coverage for the TULSA Procedure was granted in January 2025, allowing it to be performed in various settings, including Hospital Outpatient and Ambulatory Surgical Centers [2] - The collaboration with Dallas Medical Center enables Texas Prostate to perform TULSA procedures exclusively at this facility, enhancing patient access to this advanced treatment [2][3] Group 3: Company Background and Future Potential - Profound Medical Corp. is a commercial-stage medical device company focused on developing incision-free therapies for diseased tissue ablation [4] - The TULSA Procedure has the potential to become a mainstream treatment for a wide range of prostate diseases, including low-, intermediate-, and high-risk prostate cancer, as well as BPH [5] - The TULSA-PRO system is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA, indicating its regulatory compliance and readiness for market [5]