Core Insights - Profound Medical Corp. is set to announce its second quarter 2024 financial results on August 8, 2024, after market close [4] - The company is actively commercializing innovative medical technologies, including Sonalleve® and TULSA-PRO®, aimed at non-invasive treatment of various medical conditions [3][6] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing and marketing customizable, incision-free therapies for the ablation of diseased tissue [4][7] - The company has received CE marking, Health Canada approval, and FDA clearance for its technologies, indicating compliance with regulatory standards [6] Product Developments - Sonalleve® is a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases, with potential applications in non-invasive ablation of abdominal cancers [3] - TULSA-PRO® combines real-time MRI and ultrasound technology for customizable prostate ablation, with applications in various stages of prostate cancer and benign prostatic hyperplasia [6]

Profound management will host a conference call at 4:30 p.m. ET to review the financial results and discuss business developments in the period. Date: Thursday, August 8, 2024 Live Call Registration: https://register.vevent.com/register/BIbfa8c9bee6c6463c8ca3a1937fbfd804 About Profound Medical Corp. Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide custo ...

Earlier this month, the company announced that the United States Centers for Medicare and Medicaid Services issued its proposed rules establishing, for the first time, a Category 1 CPT code for its lead-marketed product Tulsa-Pro system, approved for the ablation of prostate tissue effective Jan 1, 2025. This might have driven the share price rally. While earnings and revenue growth expectations are important in evaluating the potential strength in a stock, empirical research shows a strong correlation betw ...

According to the proposed rule, TULSA will have 3 physician codes to cover how therapy is delivered depending on if there are one or two physicians involved in the procedure: 5x006 TULSA Device Management and 5x007 TULSA Treatment, when two physicians are involved in the procedure, and 5x008 TULSA Complete Procedure, when performed by a single physician. TULSA will have a 0-day global period, indicating that the payment associated with the codes will only cover the work performed on the day TULSA is perform ...

Core Insights - Profound Medical has received FDA clearance for its Contouring Assistant AI module, which enhances automated treatment planning for prostate cancer using the TULSA-PRO system, indicating significant advancements in prostate cancer treatment through AI integration [1][6] - The TULSA procedure offers a minimally invasive treatment option for prostate cancer, utilizing real-time MR guidance and precise sound absorption technology to target diseased tissue while preserving urinary continence and sexual function [2][6] - The Contouring Assistant employs a deep learning convolutional neural network for precise prostate segmentation, improving treatment plan accuracy and efficiency, as demonstrated in clinical studies [4][5] Price Performance - Profound Medical's shares have increased by 0.6% year to date, contrasting with a 7% decline in the industry and a 10.3% rise in the S&P 500 Index [3] AI Technology for Prostate Segmentation - The Contouring Assistant has shown non-inferiority in segmentation accuracy compared to expert radiologists, with urologists reporting a 32% improvement in contouring speed, suggesting significant time savings in clinical practice [5][6] Future Developments - Profound Medical is expanding its AI portfolio beyond the Contouring Assistant, with plans for additional modules under the TULSA-AI brand, including a forthcoming TULSA BPH module aimed at benign prostatic hyperplasia [8] - A non-exclusive collaboration with Siemens Healthineers was announced to integrate the TULSA-PRO system with the Siemens Magnetom Free.Max scanner, providing a comprehensive therapeutic solution for prostate cancer [9]

– Prostate segmentation using a deep learning convolutional neural network – First, a Reference Standard was created by combining contours from three expert prostate radiologists: Edward Steiner, MD (WellSpan York Hospital); Steven Raman, MD (UCLA Health); and Robert Princenthal, MD (Rolling Oaks Radiology/RadNet). Then, Contouring Assistant was validated in two clinical studies: – Urologists testing this TULSA-AI module improved their segmentation accuracy and were 32% faster in their contours – TORONTO, M ...

Thank you, everyone, for your participation in today's conference call. This does now conclude the program. You may now disconnect. Yes. I think that is certainly the principle that we're using. And I think as you heard from Mathieu comments, also, we think that TULSA a very efficient procedure, and that efficiency will continue to grow. And so we think that on use per unit time basis, we will continue to show productivity and that could over time be a reason to maintain our prices and maybe improve upon th ...

Financial Data and Key Metrics Changes - Total operating expenses in Q4 2023 were $9.8 million, a 5% increase from $9.4 million in Q4 2022 [51] - R&D expenditures increased by 28% year-over-year to $4 million, G&A expenses rose by 41% to $3 million, and selling and distribution expenses surged by 74% to $3 million [52] - Revenue for Q4 2023 was $2 million, a 60% increase from $1.3 million in the same period in 2022 [54] - The net loss for Q4 2023 was $8.9 million or $0.42 per share, compared to a net loss of $9.5 million or $0.46 per share in Q4 2022 [55] - Cash as of December 31, 2023, was $26.2 million, which increased to $45.4 million by January 31, 2024, after recent financings [56] Business Line Data and Key Metrics Changes - The company reported that TULSA is increasingly being used for a variety of prostate disease patients, with 67% treated for primary prostate cancer, 23% for hybrid patients, 7% for salvage treatments, and 3% for BPH only [32] - The installed base of TULSA-PRO systems reached 50, with expectations to grow to 75 by the end of 2024 [17][18] Market Data and Key Metrics Changes - TULSA usage is currently primarily cash pay, with a transition to a payer pay model expected to start in 2025 [18] - The American Medical Association established three new CPT Category 1 codes for TULSA in mid-2023, which is expected to facilitate reimbursement [18][37] Company Strategy and Development Direction - The company aims to position TULSA as one of the three mainstream treatments for prostate cancer, alongside radical prostatectomy and radiation therapy [15] - A collaboration with Siemens Healthineers aims to create a total diagnostic and interventional MR solution to streamline workflow and optimize costs [22][41] - The company is focused on building a high-quality installed base and executing a U.S. reimbursement strategy for TULSA [18][37] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the increasing adoption of TULSA, despite the current reliance on cash pay patients [61] - The company is confident in the upcoming reimbursement decisions from CMS, which are expected to positively impact utilization rates [89][102] - Management noted that the number of patients educated about TULSA is significant, indicating strong interest despite current treatment costs [25] Other Important Information - The CAPTAIN post-market study is ongoing, comparing TULSA to radical prostatectomy, with recruitment rates increasing [44] - The TULSA AI brand is being aggressively built, with the first AI module already in use for about 50% of patients treated [38] Q&A Session Summary Question: Can you talk about your pipeline and how it’s looking? - Management acknowledged the positive trajectory of the pipeline and the successful installations at various sites [10][12] Question: What is the status of the reimbursement strategy? - Management confirmed ongoing communication with CMS and expressed confidence in securing appropriate reimbursement amounts [89][102] Question: What are the expectations for revenue in 2024? - Management indicated a potential revenue range around $12 million, driven by an increasing installed base and service utilization [75] Question: Are hospitals concerned about transitioning to the payer model? - Management noted that hospitals might slow down in the second half of the year as they await clarity on reimbursement codes [90] Question: What is the expected impact of the Siemens collaboration? - Management highlighted that the collaboration could streamline the sales cycle and enhance the economic model for ASCs and hospitals [96][99] Question: How many systems are expected to be sold under the revised capital sales model? - Management estimated that at least half of the new systems could come from existing contracts, with the remainder from the pipeline [140][141]

Summary Fourth Quarter 2023 Results For the quarter ended December 31, 2023, the Company recorded revenue of approximately $2.0 million, with the full amount coming from recurring revenue, which consists of the sale of TULSA-PRO consumables, lease of medical devices, procedures and services associated with extended warranties. Fourth quarter 2023 revenue increased 60% from approximately $1.3 million in the same three-month period a year ago. Q4-2023 recurring revenue growth of 60% over Q4-2022. TULSA-PRO sy ...

Stephen Kilmer For the benefit of those, who are new to the Profound story, I would also like to take a moment to summarize our business. Profound develops and markets customizable incision-free therapies for the ablation of diseased tissue. We are currently commercializing TULSA-PRO, a technology that combines real-time MRI roboticallydriven transurethral ultrasound and closed-loop temperature feedback control. The technology is designed to provide customizable and predictable radiation-free ablation of a ...