Financial Data and Key Metrics Changes - The company reported global revenues of $16.1 million for Q3 2025, marking the second consecutive quarter of record overall quarterly revenue [2] - HIFU revenue reached $7.7 million, a 57% increase compared to Q3 2024 [2] - Total revenue for Q3 2025 was EUR 13.9 million, a 6% increase from EUR 13.1 million in Q3 2024 [11] - Gross profit for Q3 2025 was EUR 6 million, with a gross margin of 43%, up from 39.4% in the same period last year [12][14] - Net loss for Q3 2025 was EUR 5 million, an improvement from a net loss of EUR 6.4 million in Q3 2024 [15] Business Line Data and Key Metrics Changes - HIFU business grew 49% year-over-year, driven by six capital sales in Q3 2025 compared to three in the prior year [11][12] - Focal One placements increased by 167% year-over-year, with eight placements in Q3 2025 [3] - Focal One procedures in the US grew more than 15% year-over-year, indicating a return to double-digit growth [3][4] Market Data and Key Metrics Changes - The company is seeing meaningful progress in reimbursement coverage, particularly among Medicare Advantage providers [4] - The latest hospital and physician payment rules from CMS reinforce the use case of HIFU, providing a clear reimbursement pathway [5] Company Strategy and Development Direction - The company aims to make Focal One the standard of care for localized prostate cancer, focusing on expanding clinical adoption and market access [2][18] - Plans to expand into new clinical indications, including benign prostatic hyperplasia (BPH) and endometriosis, are underway [6][8] - The company maintains financial guidance for 2025, expecting core HIFU business revenue growth of 26%-34% [18] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of the HIFU business, supported by strong clinical evidence and expanding market access [18] - The company is focused on accelerating adoption and utilization across its Focal One install base while maintaining a disciplined investment approach [18] Other Important Information - The company received the first tranche of EUR 11 million from the European Investment Bank, aimed at supporting strategic investments in HIFU [16][22] - The company is monitoring the impact of US tariff policies, estimating a full-year impact of EUR 900,000 [17] Q&A Session Summary Question: Details on the EIB deal and its use - Management indicated that proceeds from the EIB deal will be used for product development, clinical development, and commercial growth, primarily focused on the HIFU core business [22] Question: Coverage of US Focal One procedures and expected growth - Management noted that the procedure mix includes Medicare patients, Medicare Advantage plan patients, and commercial patients, with positive trends in Medicare Advantage coverage expected to drive volume growth [23] Question: Expectations for Q4 given typical seasonal softness - Management reiterated guidance for 2025, confident that Q4 numbers will align with year-end targets of $58 million to $62 million [24]

Pharmaceutical Sector - Pfizer and Astellas Pharma announced significant final overall survival results from the Phase 3 EMBARK study for XTANDI (enzalutamide) in combination with leuprolide, showing a 40% reduction in the risk of death compared to leuprolide alone in men with non-metastatic hormone-sensitive prostate cancer [2][3] - The study reported an unprecedented 8-year overall survival rate of 78.9% for patients receiving XTANDI plus leuprolide, compared to 69.5% for those on leuprolide alone [3] Geopolitical Tensions - The European Union is intensifying efforts to counter Russia's "shadow fleet," which consists of aging oil tankers used to bypass Western sanctions, with discussions on new legislation to enable boarding and potential seizure of these vessels in the Baltic Sea [4][5] - The "shadow fleet" is estimated to account for up to 17% of the global oil tanker fleet and transports over 80% of Russia's crude oil, providing significant financial support to Moscow [5] Semiconductor Sector - Dutch Economy Minister Vincent Karremans plans to engage with Chinese officials regarding the Nexperia dispute, following the Dutch government's intervention due to governance issues by Nexperia's former CEO [6][7] - The intervention has led to China imposing an export ban on Nexperia chips, raising concerns about potential global automotive chip shortages [8]

Core Insights - Knight Therapeutics Inc. has relaunched ORGOVYX (relugolix) in Canada, marking a significant step in its oncology portfolio [1][4] - ORGOVYX is the first oral GnRH receptor antagonist approved in Canada for advanced prostate cancer treatment, with a market valued at over $200 million and a five-year CAGR of 8% [3][5] Company Overview - Knight Therapeutics Inc. is a specialty pharmaceutical company focused on acquiring and commercializing pharmaceutical products in Canada and Latin America [7] - The company has entered into exclusive license and supply agreements with Sumitomo Pharma America Inc. for multiple products, including ORGOVYX [2] Product Details - ORGOVYX (relugolix) is designed to provide a convenient oral alternative for rapidly suppressing testosterone production in prostate cancer patients [4] - Sales of ORGOVYX in Canada were approximately $1.2 million in 2024 [5] Market Context - Prostate cancer is the most prevalent malignancy among Canadian men, with an estimated 24,700 diagnoses and approximately 4,700 deaths in 2023 [6] - The treatment landscape for prostate cancer includes both GnRH agonists and antagonists, with ORGOVYX positioned to compete effectively in this market [3]

MINNEAPOLIS--(BUSINESS WIRE)--Agiliti, a leading manufacturer and provider of medical device solutions to the U.S. healthcare industry, has expanded its oncology offerings to physicians and hospitals, providing greater value and access to focal therapy services for diagnosing and treating prostate cancer. "There are approximately 313,000 new prostate cancer cases every year in the U.S., and innovative technologies like HIFU and other focal therapies are an important component of modern care,†e. ...

Core Message - The Depend campaign emphasizes the significance of early detection and emotional support for prostate cancer, with advocates encouraging open dialogue and screenings [1][2]. Group 1: Campaign and Advocacy - The Stand Strong for Men's Health™ campaign, launched in 2020, has donated over $1 million to the Prostate Cancer Foundation (PCF) to support critical research [2][6]. - Depend will donate up to $300,000 from select product sales to PCF during Prostate Cancer Awareness Month and Men's Health Awareness Month [2][7]. Group 2: Personal Stories and Impact - Griffey Jr. shares a personal connection to prostate cancer, highlighting that one in eight men will be diagnosed, and emphasizes the importance of early detection through simple blood tests [2][3]. - Smith stresses the need for open conversations about prostate cancer, particularly for Black men who face a 70% higher diagnosis rate [2][3]. Group 3: Research and Technological Advances - Research funded by PCF has led to advancements in prostate cancer evaluation and treatment, including the PSMA-PET scan, which improves early detection [3][6]. Group 4: Company Background - Kimberly-Clark, the parent company of Depend, operates in over 175 countries and is recognized for its sustainable practices and innovative products [5]. - The Prostate Cancer Foundation is a leading organization in funding prostate cancer research, having raised nearly one billion dollars since its inception [6].

Group 1 - The webinar series is hosted by Radiopharm, featuring discussions on advancements in prostate cancer treatment [1][2] - Dr. Oliver Sartor provided an overview of the prostate cancer treatment landscape, highlighting unmet medical needs and emerging therapies, including the combination of radium-223 with enzalutamide and targeted approaches like PSMA radiotherapeutics [2] - Pluvicto has significantly changed the prostate cancer treatment landscape, demonstrating efficacy in patients before and after chemotherapy, as evidenced by the PSMA 4 and VISION trials, and recently in hormone-sensitive prostate cancer through the PSMAddition trial [3] Group 2 - Despite advancements with PSMA-targeting treatments like Pluvicto, there remains a substantial medical need for new therapies as all patients receiving these treatments will eventually relapse [4]

Company Overview - Teleflex Incorporated (TFX) has launched the Barrigel rectal spacer in Japan, following regulatory approval and insurance coverage acceptance, marking a significant step in its global expansion strategy [1][8] - The Barrigel rectal spacer is the first hyaluronic rectal spacer designed to protect the rectum during radiation therapy for prostate cancer, made from Non-Animal Stabilized Hyaluronic Acid [4][5] Financial Performance - Following the Barrigel launch announcement, Teleflex's shares increased by 3.7%, closing at $124.30 [2][8] - Teleflex has a market capitalization of $5.55 billion and an earnings yield of 11.3%, which is favorable compared to the industry's -5.2% [3] Product Efficacy - A clinical study in the U.S. showed that 98% of men treated with the Barrigel rectal spacer achieved at least a 25% reduction in radiation exposure to the rectum, with an average reduction of 85% in rectal V54 Gy radiation [6] Industry Prospects - Japan's prostate cancer diagnostics market generated revenues of $345.5 million in 2023 and is projected to reach $438.0 million by 2030, with a CAGR of 3.4% from 2024 to 2030 [9] - Prostate cancer was the most common cancer among men in Japan in 2022, accounting for 18% of all cancer diagnoses [9] Recent Developments - Teleflex completed the acquisition of the majority of BIOTRONIK SE & Co. KG's Vascular Intervention business for €760 million, enhancing its interventional access product line and global presence [10]

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]

Company Overview - Proactive is a financial news publisher that provides fast, accessible, informative, and actionable business and finance news content to a global investment audience [2] - The company has a team of experienced news journalists who produce independent content across various financial markets [2] Market Focus - Proactive specializes in medium and small-cap markets while also covering blue-chip companies, commodities, and broader investment stories [3] - The content includes insights across sectors such as biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto, and emerging digital and EV technologies [3] Technology Adoption - Proactive is recognized for its forward-looking approach and enthusiastic adoption of technology to enhance workflows [4] - The company utilizes automation and software tools, including generative AI, while ensuring that all content is edited and authored by humans [5]

Core Insights - CEO.CA is a leading investor social network focused on junior resource and venture stocks, providing exclusive updates to CEOs of junior mining explorers [1][6] - The platform has gained popularity since its founding in 2012, attracting millions of global investors to discuss stocks, commodities, and emerging companies [2][6] - The "Inside the Boardroom" series offers insights from industry leaders, enhancing understanding of their vision and strategies [3][4] Company Highlights - Dr. John Yu, CEO of Kairos Pharma, discussed the company's prostate cancer trial, which reported zero grade 3 or 4 toxicities, a significant improvement compared to over 50% with standard treatments [4] - The upcoming efficacy data in September and plans for expansion into lung cancer and other tumor types were also highlighted [4][8] - CEO.CA serves as a platform for showcasing companies and connecting with investors, emphasizing its role in the investment community [5][6]