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]

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]

Company Overview - Profound Medical Corp. (NASDAQ: PROF) develops the TULSA-PRO system designed for the ablation of malignant or benign prostate tissue [1] - The TULSA-PRO system is applicable for treating prostate diseases, including cancer and benign prostatic hyperplasia (BPH) [1] Industry Context - The development of advanced medical technologies like the TULSA-PRO system reflects ongoing innovation in the treatment of prostate diseases [1]

Financial Data and Key Metrics Changes - For Q2 2025, the company received total orders of over $3 million and recorded revenue of $2.2 million, with $1.6 million from recurring revenue and $650,000 from one-time capital equipment sales [6][7] - Gross margin in Q2 2025 was 73%, up from 64% in Q2 2024 [6] - Total operating expenses in Q2 2025 were $15.4 million, compared to $9.3 million in Q2 2024 [6] - The net loss for Q2 2025 was $15.7 million, or $0.52 per share, compared to a net loss of $6.9 million, or $0.28 per share, in Q2 2024 [7] Business Line Data and Key Metrics Changes - The company is transitioning from a placement model to a capital model, which is expected to lead to a backend-loaded revenue operation [8][9] - The sales pipeline includes close to 500 prospects, with over 100 leads engaged and 80 qualified leads in the verification, negotiation, and contracting stages [10][11] Market Data and Key Metrics Changes - The U.S. sales team has been streamlined to focus on organizational sales to corporatized hospitals, emphasizing the importance of intangible attributes like grit and perseverance in sales success [12][13] - The company aims to increase the number of active sites in the U.S., with a target of at least 75 by the end of the year [61] Company Strategy and Development Direction - The CAPTAIN trial has been fully recruited, which is expected to drive adoption of the TULSA procedure and influence treatment guidelines [15][16] - The pilot release of the new TULSA AI volume reduction software is anticipated to enhance efficiency in BPH procedures, moving TULSA from a niche to a mainstream treatment option [19][20] - The company is optimistic about the integration of TULSA with new interventional MR technologies, which could enhance its market position [63] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 70% to 75% revenue growth in 2025 compared to 2024, despite short-term revenue shortfalls due to delays in capital sales [8][22] - Positive feedback from physicians regarding the CAPTAIN trial completion is expected to enhance adoption and pipeline growth [36][37] - The company anticipates that as more data is published, it will lead to new guidelines requiring that TULSA be presented as a treatment option alongside traditional methods [23] Other Important Information - The company has approximately $35.2 million in cash as of June 30, 2025 [7] - The initial clinical outcomes from the CAPTAIN trial are expected to be presented at major medical meetings in December [19][94] Q&A Session Summary Question: Can you provide insights on the sales contribution from recurring and capital perspectives? - Management indicated that the revenue mix is expected to shift from recurring to capital revenue as the installed base grows, with a long-term goal of 70% recurring and 30% capital revenue [29][30] Question: What feedback are you receiving from physicians regarding the CAPTAIN trial? - High positive feedback has been received, particularly regarding the completion of the trial, which is seen as a significant achievement in the field [36][37] Question: How does the proposed reimbursement rule for BPH treatments affect TULSA? - The company maintained favorable reimbursement levels compared to other BPH procedures, which positions TULSA advantageously in the market [44][45] Question: What is the current number of active TULSA placements in the U.S.? - There are about 60 active sites, with plans to install three more, aiming for at least 75 by year-end [61] Question: How is the soft launch of the volume reduction module for BPH going? - Initial feedback has been excellent, with procedure times averaging closer to 60 minutes, which is a significant improvement [90][91]