Group 1 - Shares of Profound Medical (PROF) have increased by 2.8% over the past four weeks, closing at $7.83, with a mean price target of $15.67 indicating a potential upside of 100.1% [1] - The average price targets range from a low of $12 to a high of $18, with a standard deviation of $3.21, suggesting a potential increase of 53.3% to 129.9% from the current price [2] - Analysts show strong agreement in revising EPS estimates higher, which correlates with potential stock price movements [9][10] Group 2 - The Zacks Consensus Estimate for the current year has increased by 9.5%, indicating positive sentiment among analysts [10] - PROF holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11] - While consensus price targets may not be reliable for predicting exact gains, they can provide guidance on price movement direction [12]

Group 1 - Profound Medical Corp. intends to offer and sell common shares in an underwritten public offering, with a 30-day option for underwriters to purchase an additional 15% of the shares sold [1][3] - The net proceeds from the offering are expected to fund the commercialization and development of the TULSA-PRO® and Sonalleve® systems, as well as for working capital and general corporate purposes [2] - The offering is expected to close on or about December 10, 2024, subject to customary closing conditions and necessary approvals [4] Group 2 - A preliminary prospectus supplement has been filed, and a subsequent prospectus supplement will be filed in accordance with securities regulations in Canada and the United States [5][6] - The common shares are being offered under the prospectus supplement, which will be accessible on SEDAR+ and EDGAR [6] - Profound Medical Corp. is a commercial-stage medical device company that develops incision-free therapies for the ablation of diseased tissue, including the TULSA-PRO® and Sonalleve® systems [9]

Core Insights - Profound Medical Corp. has introduced its third TULSA-AI® software module, UA Alignment Assistant, aimed at enhancing the TULSA procedure for prostate treatment [1][5] - The TULSA procedure is positioned as a potential mainstream treatment for various prostate conditions, including prostate cancer and benign prostatic hyperplasia (BPH) [2][9] - The upcoming presentations at RSNA 2024 and SUO 2024 will showcase the efficacy and advancements of the TULSA procedure [5][7] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on customizable, incision-free therapies for diseased tissue ablation [8] - The company is commercializing the TULSA-PRO® system, which integrates real-time MRI guidance and ultrasound technology for precise treatment [9][10] TULSA Procedure Details - The TULSA procedure utilizes real-time MR guidance to precisely target prostate tissue, heating it to 55-57°C without incisions or radiation [2][9] - It is designed to preserve urinary continence and sexual function, with a single-session treatment that typically requires no hospital stay [2][9] UA Alignment Assistant Software - The UA Alignment Assistant streamlines the alignment of the ultrasound applicator during the TULSA procedure, improving workflow consistency and reducing manual steps [4][5] - This software enhancement is expected to simplify the procedure for users, thereby increasing efficiency and confidence in clinical outcomes [3][5] Upcoming Presentations - The RSNA 2024 will feature multiple presentations on the TULSA procedure, including studies on its efficacy and patient outcomes [5][7] - Notable presentations will come from institutions such as the Busch Center, UT Southwestern Medical Center, and the Mayo Clinic [5][7]

Financial Data and Key Metrics Changes - For Q3 2024, the company recorded revenue of $2.83 million, a 64% increase from $1.73 million in Q3 2023, with $2.65 million from recurring revenue and $179,000 from one-time capital equipment sales [7] - Gross margin in Q3 2024 was 64%, up from 61% in Q3 2023, with expectations to maintain or improve this margin throughout 2024 [8] - Total operating expenses for Q3 2024 were $10.8 million, a 42% increase from $7.6 million in Q3 2023, with R&D expenses up 22%, G&A expenses up 84%, and sales and distribution expenses up 34% [9] - The net loss for Q3 2024 was $9.4 million, or $0.38 per share, compared to a net loss of $5.6 million, or $0.26 per share, in Q3 2023 [10] Business Line Data and Key Metrics Changes - The TULSA procedure is gaining traction, with 64% of treatments for primary prostate cancer, 28% for hybrid patients with both cancer and BPH, and 6% for salvage treatments [18] - The commercial use of the TULSA procedure continues to grow, with 82% of treated patients classified as intermediate risk and 11% as high risk [18] Market Data and Key Metrics Changes - The company anticipates revenue for the full year 2024 to be in the range of $11 million to $12 million, based on current business planning [8] - The Medicare national average facility payment for the TULSA procedure will be $12,992, which is 25% higher than that for robotic radical prostatectomy [20] Company Strategy and Development Direction - The company is transitioning from a recurring revenue model to a more traditional medical device business model, which includes upfront capital sales and service agreements [31] - The introduction of TULSA AI modules is expected to enhance treatment efficiency and confidence among urologists, with plans to launch a BPH TULSA AI module in the second half of 2025 [28] - The CAPTAIN study is ongoing, with expectations for data to support further reimbursement acceptance by private insurance companies [29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong pipeline and the positive reception of the TULSA procedure following the PRO-TALK Live event [26][38] - The upgraded reimbursement codes are expected to drive adoption and utilization of the TULSA procedure, with management optimistic about achieving growth in 2025 [41][42] Other Important Information - The company held a successful PRO-TALK Live event, which attracted 70 physicians and highlighted the capabilities of the TULSA procedure [11] - The company is actively recruiting to expand its sales team, aiming to grow from 13-15 salespeople to about 40 [53] Q&A Session Summary Question: Update on the goal of reaching 75 installs by year-end - Management reaffirmed strong pipeline and revenue guidance, but achieving 75 installs by year-end may be optimistic due to the transition period [35][36] Question: Response from attendees of the PRO-TALK Live event - Attendees had a strong positive reaction, with many ready to discuss financial justification and moving forward with installations [38] Question: Implications of higher reimbursement on physician uptake and revenue growth - Management believes the upgraded reimbursement will positively impact physician uptake and revenue growth, aligning well with clinical data and existing user satisfaction [40][41] Question: Dynamics behind sales and install pipeline - There was a notable wait-and-see approach from prospects regarding the final reimbursement rule, but now there is increased urgency to close deals [46][49] Question: Sales team hiring plans - The company plans to add at least five more salespeople this year, aiming for a total of about 40 to support growth [53] Question: Interest in traditional model versus pay-per-use model - The shift to a traditional model is driven by increased predictability in patient treatment volumes, making it easier for practices to justify capital expenditures [56][59] Question: Plans for commercial insurance reimbursement - The company is prioritizing getting added to commercial insurance plans, leveraging clinical data from the CAPTAIN trial to support these efforts [63][66]

TORONTO, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) ("Profound" or the "Company"), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, will announce its third quarter 2024 financial results after market close on Thursday, November 7, 2024. 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. ...

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]