Core Insights - Dr. Y. Mark Hong has achieved a significant milestone by performing 200 TULSA Procedures™ independently, establishing a new model for MRI-guided prostate therapy [1][2][3] - The TULSA Procedure utilizes Profound Medical's TULSA-PRO system, which is AI-powered and allows for precise ablation of prostate tissue while preserving surrounding structures [2][6] - The TULSA Procedure is a non-invasive treatment option that has shown high success rates, rapid recovery, and minimal complications, positioning it as a potential first-line treatment for prostate cancer [4][7] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, MRI-guided, incision-free therapies for tissue ablation [5] - The TULSA-PRO system combines real-time MRI, AI-enhanced planning, and robotic ultrasound technology, making it a unique offering in the prostate treatment market [6] - Profound is also exploring additional markets for its Sonalleve platform, which is CE marked and FDA approved for various non-invasive treatments [8]

Core Insights - Profound Medical Corp. has achieved a significant milestone with the TULSA Procedure, marking the first 200 procedures performed independently by a urologist without radiologist involvement, establishing a new model for MRI-guided prostate therapy [1][2][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 [5][6] - The company is commercializing the TULSA-PRO® system, which combines real-time MRI, AI-enhanced planning, and robotically-driven ultrasound for precise prostate treatment [6][7] TULSA Procedure Details - The TULSA Procedure is a clinically proven treatment for prostate disease that utilizes robotically controlled ultrasound to ablate prostate tissue while preserving surrounding structures [2][6] - This procedure is performed in a single session, takes a few hours, and does not require hospitalization, with most patients reporting quick recovery [6][7] - The TULSA Procedure is designed to treat a wide range of prostate conditions, including low-, intermediate-, and high-risk prostate cancer, benign prostatic hyperplasia (BPH), and salvage therapy for radio-recurrent localized prostate cancer [6][8] Clinical Impact - Dr. Y. Mark Hong's independent execution of the TULSA Procedure demonstrates that urologists can safely perform the entire procedure, achieving excellent outcomes without the need for radiologist collaboration [2][3] - The procedure has shown to result in high cure rates, rapid recovery, and preservation of urinary and sexual function, with no procedural blood loss [3][4] Future Outlook - Dr. Hong believes that the TULSA Procedure represents the future of prostate disease treatment and may eventually replace radical prostatectomy as the first-line option for prostate cancer [4]

Core Insights - Profound Medical reported a quarterly loss of $0.26 per share, better than the Zacks Consensus Estimate of a loss of $0.38, marking an earnings surprise of +31.58% [1] - The company generated revenues of $5.29 million for the quarter ended September 2025, exceeding the Zacks Consensus Estimate by 0.74% and showing a significant increase from $2.83 million a year ago [2] - Profound Medical shares have declined approximately 13.9% year-to-date, contrasting with the S&P 500's gain of 16.5% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.34 on revenues of $8 million, while for the current fiscal year, it is -$1.58 on revenues of $15.6 million [7] - The estimate revisions trend for Profound Medical was mixed prior to the earnings release, resulting in a Zacks Rank 3 (Hold), indicating expected performance in line with the market [6] Industry Context - The Medical - Drugs industry, to which Profound Medical belongs, is currently ranked in the top 34% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8]

Financial Data and Key Metrics Changes - For Q3 2025, the company recorded revenue of $5.3 million, an increase of 87% from $2.8 million in Q3 2024 [4] - Gross margin improved to 74.3% in Q3 2025 from 63.1% in Q3 2024 [5] - The net loss for Q3 2025 was $8 million, or $0.26 per share, down from a net loss of $9.4 million, or $0.38 per share, in the same period last year [5] Business Line Data and Key Metrics Changes - Recurring revenue accounted for $4.1 million, while one-time sales of capital equipment contributed $1.2 million to total revenue [4] - The pilot launch of the new TULSA AI Volume Reduction Software has led to an increase in BPH procedures from Q2 to Q3 and into the first half of Q4 [11] Market Data and Key Metrics Changes - The company has established 70 TULSA-PRO sites, with a growing sales pipeline of 93 new systems in the final stages of the sales process [15] - The TULSA-PRO platform is seeing broader adoption across both academic and community hospitals due to increased awareness of its clinical benefits [15] Company Strategy and Development Direction - The company aims to achieve profitable growth by focusing on existing MR installations and targeting an install base of 200 TULSA-PRO sites [19][21] - Strategic partnerships are being built globally, including distribution agreements in Saudi Arabia and Australia [17] - The introduction of the TULSA AI Volume Reduction Software is expected to significantly enhance the efficiency of BPH treatments, potentially adding 400,000 patients to the annual total addressable market [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to sustain growth, driven by the expanding interest in image-guided interventions and the flexibility of the TULSA system [16] - The company anticipates securing national or regional coverage decisions from commercial payers starting mid-next year, supported by ample clinical data [22] Other Important Information - The Kapton trial has been fully recruited, marking a significant milestone for the company, with data readouts expected to demonstrate TULSA's superiority over robotic surgery [13] - The company plans to file an S3 registration statement to keep financing options open as it moves forward with financial growth [6] Q&A Session Summary Question: Utilization trends in Q3 and Q4 - Management confirmed that the utilization trend has continued into Q4, driven by Medicare reimbursement and individual wins with private insurance [30][31] Question: Commercial payer rates compared to Medicare - Medicare rates are around $13,000, while commercial payer rates range from $25,000 to $65,000 per patient, indicating a significant contribution margin [35][36] Question: Expectations for fourth quarter revenue growth - Management remains comfortable with the 70% growth target for the year, supported by a strong pipeline and recent site closures [45] Question: Closing rates in the sales pipeline - The closing rate for the final stages of the pipeline is expected to be around 50%+, with potential increases as the sales team gains more experience [48] Question: Upcoming data reveals and their impact - The most impactful data reveals will likely be related to clinical efficacy and reimbursement coverage, which are crucial for driving adoption [54][56] Question: Renewed focus on Sonalleve technology - The renewed focus on Sonalleve is driven by recent market interest and the potential for MR-based treatments for various diseases, including uterine conditions and cancers [59][60]

Revenue Growth - Revenue for the nine months ended September 30, 2025, was $10,121, a 56% increase from $6,504 in 2024[69] - For the three months ended September 30, 2025, revenue reached $5,289, representing an 87% increase from $2,832 in 2024[69] Profit and Loss - Gross profit for the nine months ended September 30, 2025, was $7,402, an 82% increase from $4,075 in 2024, with a gross margin of 73%[70] - The net loss attributed to shareholders for the nine months ended September 30, 2025, was $34,395, a 50% increase from $22,869 in 2024[70] - For the nine months ended September 30, 2025, the net loss was $34,395 and net cash used in operating activities was $31,641[90] Operating Expenses - Operating expenses for the nine months ended September 30, 2025, totaled $41,287, a 43% increase from $28,792 in 2024[70] - Research and development expenses for the nine months ended September 30, 2025, increased by $4,008, or 33%, to $16,324 compared to $12,316 in 2024[80] - Selling, general and administrative expenses for the nine months ended September 30, 2025, were $24,963, a 52% increase from $16,476 in 2024[70] - SG&A expenses for the three months ended September 30, 2025 increased by $806, or 12%, to $7,426 compared to $6,620 for the same period in 2024[83] - SG&A expenses for the nine months ended September 30, 2025 increased by $8,487, or 52%, to $24,963 compared to $16,476 for the same period in 2024[84] Cash Flow and Financing - As of September 30, 2025, cash was $24,826 compared to $54,912 as of December 31, 2024[88] - Net finance income decreased by $194 to $910 during the nine months ended September 30, 2025, compared to $1,104 during the same period in 2024[87] - The company projects to be in violation of a financial covenant under the CIBC Credit Agreement by June 30, 2026[98] - The company intends to seek additional financing from investors or other sources of capital to fund operations over the next year[91] Regulatory Approvals - The TULSA-PRO system is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA, indicating regulatory compliance for commercialization[66] - Sonalleve has received approval from the China National Medical Products Administration for the treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption[67] Revenue Model - The company employs a hybrid recurring revenue model in the U.S. for TULSA-PRO, combining one-time payments with ongoing service charges[71] Use of Proceeds - Total spending of proceeds from the 2024 Public Offering as of September 30, 2025 was $36,132, with $25,214 allocated for TULSA-PRO commercialization[94]

Core Insights - Profound Medical Corp. reported a record revenue growth of 87% year-over-year, reaching $5.3 million in Q3 2025, driven by increased demand for its TULSA-PRO technology [2][4] - The gross margin improved significantly by 1,119 basis points to 74.3% in Q3 2025, attributed to enhanced manufacturing efficiency [2][5] - The company is expanding its sales pipeline and installed base for TULSA-PRO, with expectations to reach at least 75 installations by year-end [2][3] Business Highlights - Revenue for Q3 2025 was $5.3 million, with $4.1 million from recurring non-capital revenue and $1.2 million from one-time capital equipment sales, marking an 87% increase from $2.8 million in Q3 2024 [4] - The TULSA-PRO installed base increased to 70 systems, with a growing sales pipeline of 93 new systems in various stages of the sales process [2][3] - The TULSA Procedure was utilized for a diverse range of prostate disease patients, with 79% treated for prostate cancer only [2] Financial Performance - Operating expenses for Q3 2025 totaled approximately $12.8 million, up from $10.8 million in the prior year, primarily due to increased headcount and sales force [6] - The net loss for Q3 2025 was approximately $8.0 million, or $0.26 per share, showing a 15% improvement from a net loss of $9.4 million, or $0.38 per share, in Q3 2024 [7] - As of September 30, 2025, the company had cash reserves of approximately $24.8 million [8] Strategic Developments - In September 2025, Profound launched the TULSA-PROgram in collaboration with Texas Prostate and Dallas Medical Center to enhance access to advanced prostate treatments [2] - The company regained exclusive distribution rights for TULSA-PRO in Canada and entered into a distribution agreement for its technologies in Saudi Arabia [2][3] - A strategic distribution agreement was also established with Getz Healthcare to introduce TULSA-PRO in Australia and New Zealand [3]

Core Insights - Profound Medical Corp has entered into an exclusive distribution and supply agreement for its TULSA-PRO system with Getz Healthcare in Australia and New Zealand, marking a significant step in advancing precision prostate care in these regions [1][3] 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 [6][8] - The TULSA-PRO system is the only AI-powered, MR-guided robotic system for prostate therapy, allowing real-time MRI thermography and autonomous temperature control [2][7] Product Details - The TULSA Procedure is a significant advancement in prostate care, utilizing robotically controlled, directional ultrasound to precisely ablate prostate tissue while protecting surrounding structures [2][7] - The procedure is incision- and radiation-free, performed in a single session, and has shown to preserve patients' urinary continence and sexual function [7][8] - TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA [8] Market Context - Prostate cancer is the most commonly diagnosed cancer in men in Australasia, highlighting the importance of the TULSA-PRO system in addressing this health issue [3] - The partnership with Getz Healthcare aims to expand the reach of TULSA-PRO and explore additional key markets across the Asia Pacific region [3][5] Strategic Initiatives - Profound Medical is deploying its own direct sales team in North America while partnering with strategic distribution partners globally to support business potential [3]

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.

Core Insights - Profound Medical Corp. has regained exclusive distribution rights for the TULSA-PRO system in Canada from Knight Therapeutics Inc. for a one-time payment of CDN$90,000 (US$64,000) and a 5% royalty on Canadian net sales for 15 years [3][4][5] 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 [6][8] - The TULSA Procedure™ is designed to ablate prostate tissue in men suffering from prostate cancer and benign prostatic hyperplasia (BPH) [2][7] Technology and Procedure - The TULSA Procedure utilizes real-time MRI guidance and robotically guided ultrasound to precisely ablate targeted prostate tissue without harming surrounding structures [4][7] - The TULSA-PRO system is the only AI-powered, MRI-guided robotic system for prostate treatment, allowing for unmatched precision in therapy [4][7] - The procedure is incision-free, radiation-free, and typically performed in a single session, with most patients reporting quick recovery [7][8] Market Potential - Currently, there is only one Canadian site offering the TULSA Procedure, but there are plans to expand this through additional sites using a concierge service model [4][5] - The company aims to leverage results from the Level I prostate cancer CAPTAIN trial to support applications for health insurance coverage in Canada, which could significantly increase the market opportunity for the TULSA Procedure [4][5] Strategic Initiatives - Profound is deploying its own direct sales team in North America while partnering with strategic distribution partners to enhance business potential globally [5]