Core Insights - Profound Medical Corp. has announced the successful completion of its 100th TULSA Procedure™ at Dallas Medical Center, marking a significant milestone in the adoption of its innovative prostate treatment technology [1][2] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, MRI-guided, incision-free therapies for treating diseased tissue, particularly in prostate care [1][3] - The company's flagship product, the TULSA-PRO system, allows for precise, real-time MRI-guided prostate therapy, enhancing treatment personalization and minimizing side effects associated with traditional surgical methods [4][6] Technology and Innovation - The TULSA Procedure utilizes robotically controlled directional ultrasound to heat prostate tissue to 'kill temperature' (55-57°C), while protecting surrounding anatomy, resulting in no procedural blood loss and quicker recovery times [2][4] - Real-time MRI thermography enables continuous visualization and autonomous temperature adjustments during the procedure, allowing for tailored therapy for each patient [2][4] Market Adoption and Growth - Following a transition to a Medicare model, the TULSA Procedure's adoption increased by 500%, indicating strong market demand and interest from urologists across Texas and surrounding states [2] - The innovative model developed by Texas Prostate bridges private-pay practices and Medicare-participating hospitals, facilitating broader access to advanced prostate care [2] Additional Products - Profound Medical also markets Sonalleve, an MRI-guided therapy for non-surgical treatment of various conditions, including pain palliation for bone metastases and gynecologic issues, which also emphasizes incision-free treatment and faster recovery [5][7] Regulatory Approvals - Profound Medical's technologies, including TULSA-PRO and Sonalleve, are approved in major global markets, including the United States, Europe, Canada, and several other countries, expanding access to innovative treatment options [6][7]

Core Insights - The CAPTAIN trial demonstrates that the TULSA Procedure shows significant improvement over robotic radical prostatectomy (RP) in preserving erectile function and urinary continence at 6 months post-treatment [1][3][5] Group 1: Trial Overview - CAPTAIN trial successfully exceeded its enrollment target, treating 211 patients across 20 sites in the U.S., two in Canada, and one in Europe by August 2025 [2] - The trial aims to compare the safety and efficacy of the TULSA Procedure with RP in men with localized, intermediate-risk prostate cancer [7] Group 2: Clinical Outcomes - At 6 months, 50% of patients preserved both erectile function and urinary continence after TULSA compared to 24% after RP, with a statistically significant p-value of <0.05 [3] - TULSA preserved pad-free continence in 84% of men, while only 49% achieved this after RP [3] - Patient-reported erectile function was preserved in 56% of TULSA patients compared to 47% after RP [3] Group 3: Perioperative Measures - TULSA showed zero blood loss compared to 150 mL after RP, with a significant p-value of <0.001 [3] - Patients undergoing TULSA had a shorter recovery time, missing an average of 10 days from work compared to 19 days for RP [3] Group 4: Complications and Safety - The rate of serious complications within 90 days was significantly lower for TULSA at 0.7% compared to 6.3% for RP [3] - No patients required ICU admission after TULSA, while 1.6% did after RP [3] Group 5: Future Outlook - Secondary oncologic outcomes from the TULSA Procedure are expected to be reported later this year, which will provide further insights into its efficacy [4][5] - The trial positions the TULSA Procedure as a potential standard of care in prostate cancer treatment, pending further results [5][6]

Core Insights - Profound Medical Corp. is set to present the first clinical outcomes from the Level 1 post-market CAPTAIN trial, comparing the TULSA Procedure™ with robotic radical prostatectomy for localized prostate cancer at the EAU 2026 Congress on March 13, 2026 [1][2] Company Overview - Profound Medical Corp. is a commercial-stage medical device company specializing in AI-powered, MRI-guided, incision-free therapies for ablation of diseased tissue [1][5] - The company's flagship platform, TULSA-PRO, allows for precise, incision-free prostate therapy, enabling real-time treatment confirmation and personalized strategies for prostate care [6] - Profound also offers Sonalleve, an MRI-guided therapy for non-surgical treatment of various conditions, including pain palliation for bone metastases and gynecologic issues [7] Upcoming Events - A press release summarizing the CAPTAIN presentation will be issued after the event, followed by an investor webinar at 11:30 a.m. EDT on March 13, 2026, where Dr. Klotz will discuss the clinical relevance of the data [3][4] - Profound management will participate in one-on-one investor meetings at the 38th Annual Roth Conference from March 22-24, 2026 [4] Market Approval - Profound's technologies, including TULSA-PRO and Sonalleve, are approved in major global markets, including the United States, Europe, Canada, and several other countries [8][9]

Financial Data and Key Metrics Changes - For Q4 2025, the company recorded revenue of $6 million, a 43% increase from CAD 4.2 million in Q4 2024, with $2.3 million from recurring revenue and $3.7 million from one-time capital equipment sales [4][5] - Gross margin in Q4 2025 was 67%, down from 71% in Q4 2024, primarily due to product mix and introductory pricing in new markets [5] - The net loss for Q4 2025 was CAD 8.2 million or CAD 0.27 per share, compared to a net loss of approximately CAD 4.9 million or CAD 0.20 per share in Q4 2024 [5][6] Business Line Data and Key Metrics Changes - The company had 78 TULSA-PRO sites as of December 31, 2025, with a growing sales pipeline of 110 new systems in various stages of the sales process [21] - The TULSA-PRO system is seeing broader adoption across both academic and community hospitals, driven by increased awareness of its clinical benefits and established reimbursement pathways [22] Market Data and Key Metrics Changes - TULSA reimbursement was confirmed for 2026 at Urology level seven, with expectations for private insurance coverage decisions in the second half of 2026 [22][24] - The company is experiencing significant interest in image-guided interventions, which is expected to drive growth [24] Company Strategy and Development Direction - The company aims to establish TULSA as a third distinct category in prostate cancer treatment, capable of treating the whole gland or specific regions while minimizing side effects [27][28] - Strategic partnerships are being developed globally, with recent agreements in Saudi Arabia and Australia already yielding sales [25][26] - The introduction of the TULSA-AI Volume Reduction module is expected to enhance BPH treatment efficiency and expand the total addressable market significantly [35][44] Management's Comments on Operating Environment and Future Outlook - Management believes the company is on a path to profitable growth, with expectations of declining cash burn and eventual cash flow positivity as revenues grow [6][24] - The company anticipates high double-digit to low triple-digit revenue growth in 2026, supported by the expansion of TULSA-PRO sites and increased procedure volumes [24][46] Other Important Information - The CAPTAIN trial, a significant clinical study, is expected to provide important data that could accelerate reimbursement timelines and enhance the credibility of TULSA [9][76] - The company is also exploring opportunities with its Sonalleve technology, which is being used for various treatments, including for uterine fibroids and pancreatic cancer [42][43] Q&A Session Summary Question: Update on private payers and reimbursement - Management reported that the number of patients going through private payers is increasing, with typical payments between 1.5 to 2.5 times Medicare rates, and over 90% of rejections are being tracked for potential reversals [48][49] Question: Dynamics of non-capital revenue decline - Management noted that while there was a sequential decline in non-capital revenue, overall usage is increasing, and the mix is expected to shift towards recurring revenue as the install base grows [54][60] Question: Expectations for 2026 revenue growth - Management did not provide specific guidance but indicated confidence in achieving high double-digit to low triple-digit growth, with an expected increase in the number of sites [66][70] Question: Progress on TULSA installations - Management confirmed that installations are progressing well, with expectations for increased installations throughout the year [84] Question: BPH module usage - At least 10 sites are currently using the BPH module, with expectations for rapid growth in usage by mid-year [91] Question: International expansion progress - Management highlighted increased attention in international markets and the signing of distributor agreements to facilitate growth [92]

Financial Data and Key Metrics Changes - For Q4 2025, the company recorded revenue of $6 million, a 43% increase from CAD 4.2 million in the same period last year [4][5] - Gross margin in Q4 2025 was 67%, down from 71% in Q4 2024, primarily due to product mix and introductory pricing in new markets [5][6] - The net loss for Q4 2025 was CAD 8.2 million or CAD 0.27 per share, compared to a net loss of CAD 4.9 million or CAD 0.20 per share in Q4 2024 [6] Business Line Data and Key Metrics Changes - Recurring revenue for Q4 2025 was $2.3 million, while one-time sales of capital equipment accounted for $3.7 million [4] - The company had 78 TULSA-PRO sites as of December 31, 2025, with a growing sales pipeline of 110 new systems in various stages of the sales process [22] Market Data and Key Metrics Changes - The company is seeing broader adoption of TULSA-PRO across both academic and community hospitals, driven by increased awareness of clinical benefits and established reimbursement pathways [22][24] - TULSA reimbursement was confirmed for 2026 at Urology level 7, with expectations for private insurance coverage decisions in the second half of 2026 [24] Company Strategy and Development Direction - The company aims to establish TULSA as a third distinct category in prostate cancer treatment, capable of treating the whole gland or specific regions while minimizing side effects [28][29] - Strategic partnerships with distributors in Saudi Arabia and Australia are expected to enhance market presence and sales [26][27] - The introduction of the TULSA-AI Volume Reduction module is anticipated to streamline BPH treatment and expand the total addressable market significantly [36][45] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitable growth, projecting a path to cash flow positivity as revenues grow and margins remain high [7][25] - The company expects to reach high double-digit to low triple-digit revenue growth in 2026, supported by new clinical data and product offerings [25][47] Other Important Information - The CAPTAIN trial, a significant clinical study, is set to present its first outcomes at the European Association of Urology meeting, which may influence reimbursement timelines [15][76] - The company is also exploring opportunities with its Sonalleve technology for treating conditions like adenomyosis and pancreatic cancer [43][44] Q&A Session Summary Question: Update on private payers and reimbursement - Management reported that the number of patients going through private payers is increasing, with typical payments between 1.5 to 2.5 times Medicare rates, and over 90% of rejections are being tracked for potential reversals [49][50] Question: Dynamics of non-capital revenue decline - Management noted that while there was a sequential decline in non-capital revenue, overall usage is increasing, and the mix is expected to shift towards recurring revenue as the install base grows [55][56] Question: Expectations for 2026 revenue growth - Management did not provide specific guidance but indicated confidence in achieving a range of 90% to 110% growth based on the number of new sites and product offerings [66][71] Question: Progress on TULSA installations - Management confirmed that installations are progressing well, with expectations for increased installations in the first quarter and throughout the year [85] Question: Use of the BPH module - At least 10 sites are currently using the BPH module, with expectations to increase to 30-40 sites by mid-year [92] Question: International expansion progress - Management highlighted growing interest in international markets and recent distributor agreements, with introductory pricing aimed at facilitating market entry [93]

Financial Data and Key Metrics Changes - For Q4 2025, the company recorded revenue of $6 million, a 43% increase from CAD 4.2 million in Q4 2024 [4][5] - Gross margin in Q4 2025 was 67%, down from 71% in Q4 2024, primarily due to product mix and introductory pricing in new markets [5] - The net loss for Q4 2025 was CAD 8.2 million or CAD 0.27 per share, compared to a net loss of CAD 4.9 million or CAD 0.20 per share in Q4 2024 [5][6] - As of December 31, 2025, the company had cash of $59.7 million, with expectations of declining cash burn and eventual cash flow positivity [6] Business Line Data and Key Metrics Changes - Recurring revenue for Q4 2025 was $2.3 million, while one-time sales of capital equipment accounted for $3.7 million [4] - The company had 78 TULSA-PRO sites as of December 31, 2025, with a growing sales pipeline of 110 new systems [20] Market Data and Key Metrics Changes - The company is seeing broader adoption of TULSA-PRO across both academic and community hospitals, driven by increased awareness of clinical benefits and established reimbursement pathways [20] - TULSA reimbursement was confirmed for 2026 at Urology level 7, with expectations of coverage decisions from private insurance carriers in the second half of 2026 [21] Company Strategy and Development Direction - The company aims to establish TULSA as a third distinct category in prostate cancer treatment, offering both whole-gland and focal treatment options [25][26] - The strategy includes focusing on existing MR installations and achieving an install base of 200 TULSA-PRO sites, with plans for compatibility with new Siemens interventional MR technology [37] - The introduction of the TULSA-AI Volume Reduction module is expected to enhance BPH treatment efficiency and expand the total addressable market [33][42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving high double-digit to low triple-digit revenue growth, supported by upcoming catalysts and a strong sales pipeline [22][43] - The company is on a path to profitable growth, with projections indicating that revenues of $80 million to $85 million could lead to profitability [76] Other Important Information - The CAPTAIN trial, a significant clinical study, is expected to provide important data that could influence reimbursement timelines and treatment paradigms [72][74] - The company is also exploring opportunities with its Sonalleve technology, which is being used for various treatments, including for adenomyosis and pancreatic cancer [40][41] Q&A Session Summary Question: Update on private payers and reimbursement - Management noted that the number of patients going through private payers is increasing, with typical payments between 1.5 to 2.5 times Medicare rates, and over 90% of rejections are being tracked for potential reversal [44][46] Question: Dynamics of non-capital revenue decline - Management clarified that the 20% growth mentioned was year-over-year, not quarter-over-quarter, and that the mix of capital versus recurring revenue is expected to shift as the install base grows [49][50] Question: Expectations for 2026 revenue growth - Management did not provide specific guidance but indicated confidence in achieving a range of 90% to 110% growth based on site additions and overall market dynamics [62][63] Question: Progress on CAPTAIN trial data release - Management expects that early dissemination of CAPTAIN trial data will enhance confidence in reimbursement decisions and emphasized the integrity of the trial data [72][74] Question: Cash flow positivity timeline - Management indicated a trend of decreasing cash burn, projecting that reaching revenues of $80 million to $85 million would lead to cash flow positivity [76] Question: Installation pacing for TULSA systems - Management suggested that installations would increase throughout the year, with a standardized approach to announcing numbers expected [82][83] Question: Usage of the BPH module - At least 10 sites have started using the BPH module, with expectations for rapid growth in adoption [89] Question: International expansion progress - Management confirmed ongoing interest in international markets, with distributor agreements in place and a careful strategy for growth outside the U.S. [91][92]

Core Insights - Profound Medical Corp. reported a record revenue of $6.0 million for Q4 2025, reflecting a 43% year-over-year growth and a 13% sequential increase [2][5] - The company anticipates reaching approximately 120 TULSA-PRO installations by the end of 2026, up from 78 as of December 31, 2025, driven by a growing sales pipeline [2] - Profound's technologies, particularly the TULSA Procedure, are gaining traction in treating various prostate diseases, with a significant portion of patients treated for prostate cancer [2][21] Business Highlights - The TULSA-PRO qualified sales pipeline includes 110 new systems in various stages of the sales process [2] - In Q4 2025, 67% of patients treated were for prostate cancer, with a diverse range of cancer grades and treatment intentions [2] - The company launched the TULSA-AI Volume Reduction module, aimed at optimizing BPH treatment, which is expected to triple the total available market for prostate disease to about 600,000 patients annually [3][2] Financial Performance - For the full year 2025, Profound recorded total revenue of approximately $16.1 million, up from $10.7 million in 2024 [10] - The gross margin for Q4 2025 was 67%, down from 71% in the prior year, attributed to product mix and introductory pricing in new markets [6] - The net loss for Q4 2025 was approximately $8.2 million, compared to a net loss of $4.9 million in Q4 2024 [9] Operating Expenses - Total operating expenses for Q4 2025 were approximately $11.4 million, slightly up from $11.3 million in the prior year, primarily due to increased headcount and sales force [8] - For the full year 2025, operating expenses totaled approximately $52.6 million, compared to $40.1 million in 2024, driven by increased enrollment in clinical trials and higher material costs [12] Liquidity and Share Capital - As of December 31, 2025, Profound had cash reserves of approximately $59.7 million [14] - The company completed a $36.0 million registered direct offering and a $6.45 million private placement to strengthen its balance sheet [7] Leadership Changes - Frank Baylis has been appointed to the Board of Directors, succeeding Kris Shah, who resigned [14][18]

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]