Core Insights - The CAPTAIN trial is the first Level 1 study comparing the TULSA procedure with radical prostatectomy (RP) in men with intermediate-risk prostate cancer, showing TULSA's advantages in safety and patient experience [1][4][7] - Initial perioperative data indicates TULSA has no blood loss, shorter hospital stays, and reduced post-procedure pain compared to RP, leading to quicker recovery [1][5][6] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, incision-free therapies for tissue ablation [1][8] - The TULSA-PRO system combines real-time MRI, AI-enhanced planning, and ultrasound technology for precise treatment of prostate conditions [9] Clinical Trial Details - The CAPTAIN trial recruited 201 patients across 20 sites in the U.S., Canada, and Europe, with 69% receiving TULSA and 31% RP [3][7] - The primary endpoints include preservation of erectile potency and urinary continence at one year, and freedom from additional treatment or cancer-related death by three years [7] Key Findings - TULSA showed a median blood loss of 0 mL compared to 100 mL for RP, and a median length of stay of 0.29 days versus 1.24 days for RP [5] - Patient-reported outcomes indicated significantly lower pain levels and better quality of life for TULSA patients compared to those undergoing RP [5][6] Market Implications - The positive outcomes from the CAPTAIN trial are expected to drive patient demand and influence insurance coverage policies, as Level 1 trials are considered the gold standard in evidence-based research [6]

Summary of ProFound Medical (PROF) Update / Briefing April 29, 2025 Company Overview - ProFound Medical focuses on TULSA (Transurethral Ultrasound Ablation) technology for prostate cancer and benign prostatic hyperplasia (BPH) treatment [1][2] Key Industry Insights - TULSA is positioned as a mainstream treatment option for personalized prostate ablation, both malignant and benign [1] - The company has successfully enrolled in the CAPTAIN level one randomized control trial for prostate cancer, demonstrating strong clinical outcomes [1][4] Core Points and Arguments Prostate Cancer Treatment - The CAPTAIN trial has shown that TULSA PRO eliminates blood loss and overnight hospital stays, with TULSA patients averaging 0.29 days in the hospital compared to 1.24 days for robotic prostatectomy patients [10][11] - TULSA PRO patients reported statistically significant less pain and better overall health compared to those undergoing robotic prostatectomy [12][13] - The trial included 201 patients, with 194 treated or scheduled for treatment, indicating strong recruitment and interest in TULSA technology [5][6] BPH Treatment - ProFound Medical is introducing a new TULSA AI volume reduction module aimed at making TULSA a mainstream option for BPH patients [2][48] - The company estimates a total addressable market (TAM) of $5 billion for prostate cancer and BPH treatments, with a significant portion expected to be recurring revenue [48] Technological Advancements - The introduction of AI modules aims to improve clinical outcomes, reduce treatment time, and enhance workflow efficiency [50] - Features like the thermal boost module and contouring assistant are designed to ensure comprehensive treatment coverage and improve procedural efficiency [52][54] Patient Experience and Satisfaction - High patient satisfaction is indicated by an 88.5% recommendation rate for TULSA among patients, alongside a low regret score of 5.2 [15] - The TULSA procedure is noted for its precision, allowing for targeted treatment while minimizing damage to surrounding tissues, thus preserving erectile function and urinary control [80][81] Additional Important Insights - The CAPTAIN trial is the first of its kind to successfully randomize patients between TULSA and robotic prostatectomy, addressing previous challenges in trial design [5][8] - The company emphasizes the importance of patient demand in driving the adoption of surgical robots and TULSA technology [2][3] - ProFound Medical's focus on real-world outcomes and longitudinal tracking of patient data positions it favorably within the competitive landscape of prostate cancer treatments [44][65] Conclusion - ProFound Medical is at a pivotal point in establishing TULSA as a leading treatment option for both prostate cancer and BPH, supported by strong clinical data, technological advancements, and a focus on patient satisfaction and outcomes [1][4][48]

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices by Profound Medical Corp and its officers or directors [1] Group 1: Financial Disclosure - On March 7, 2025, Profound disclosed an error that overstated revenue by $472,000 in Q1 2024, leading to the conclusion that its quarterly reports for the first three quarters of 2024 should no longer be relied upon [3] - Profound intends to file restated interim financial statements as soon as practicable following the identification of the error [3] Group 2: Market Reaction - Following the news of the revenue overstatement, Profound's stock price fell by $0.43 per share, or 5.9%, closing at $6.86 per share on March 7, 2025 [4]

Core Viewpoint - Profound Medical Corp. is set to announce its first quarter 2025 financial results on May 8, 2025, and will host a conference call to discuss these results and business developments [1][2]. 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 [3]. Product Offerings - The company is commercializing TULSA-PRO®, a technology that integrates real-time MRI, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control, aimed at treating various prostate conditions [4]. - TULSA-PRO® is designed to be a mainstream treatment for prostate cancer and benign prostatic hyperplasia (BPH), offering a "one-and-done" procedure that is incision- and radiation-free, with quick recovery times [4]. - Profound is also marketing Sonalleve®, a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases, with potential applications in non-invasive ablation of abdominal cancers [5].

Core Viewpoint - The Schall Law Firm is investigating Profound Medical Corp. for potential violations of securities laws related to misleading statements and undisclosed information affecting investors [1][2]. Group 1: Investigation Details - The investigation centers on whether Profound Medical Corp. issued false or misleading statements and failed to disclose critical information to investors [2]. - On March 7, 2025, Profound disclosed an error that overstated revenue by $472,000 in Q1 2024, leading to the conclusion that its quarterly reports for the first three quarters of 2024 are no longer reliable [2]. - Following this announcement, shares of Profound fell by 5.9% on the same day [2]. Group 2: Legal Representation - The Schall Law Firm is representing investors globally and specializes in securities class action lawsuits and shareholder rights litigation [3]. - Shareholders who suffered losses are encouraged to contact the firm for a free discussion of their rights [3].

Group 1 - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of investors of Profound Medical Corp. regarding potential securities fraud by certain officers and/or directors of the company [1] - Profound Medical Corp. disclosed an error in an SEC filing on March 7, 2025, which overstated revenue by $472,000 in Q1 2024, leading to the conclusion that its quarterly reports for the first three quarters of 2024 are no longer reliable [2] - Following the announcement of the revenue overstatement, shares of Profound Medical Corp. fell by 5.9% on the same day [2]

Group 1 - Wolf Haldenstein Adler Freeman & Herz LLP is investigating claims on behalf of investors of Profound Medical Corp. regarding potential securities fraud by certain officers and/or directors of the company [1] - Profound Medical Corp. disclosed an error in an SEC filing on March 7, 2025, which overstated revenue by $472,000 in Q1 2024, leading to the conclusion that its quarterly reports for the first three quarters of 2024 are no longer reliable [2] - Following the announcement of the revenue overstatement, shares of Profound Medical Corp. fell by 5.9% on the same day [2] Group 2 - Wolf Haldenstein has a strong reputation in prosecuting securities class actions and derivative litigation across various courts in the United States, with multiple offices and a recognized expertise in shareholder litigation [3]

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 [3][4] - The company is known for its TULSA-PRO® technology, which combines real-time MRI, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control for treating prostate diseases [4] Upcoming Investor Event - Profound will host a hybrid investor event on April 28, 2025, during the American Urological Association's Annual Meeting in Las Vegas, NV [1] - The event will feature presentations from the management team and leading physicians discussing TULSA-PRO®, peri-operative results from the Level 1 CAPTAIN post-market study, the upcoming TULSA-AI® module for BPH, and the TULSA+ program [2] TULSA-PRO® Technology - TULSA-PRO® is designed to treat a wide range of prostate diseases, including low-, intermediate-, and high-risk prostate cancer, as well as benign prostatic hyperplasia (BPH) [4] - The procedure is incision- and radiation-free, performed in a single session, and aims to preserve urinary continence and sexual function while effectively targeting prostate tissue [4] Sonalleve® Technology - Profound is also commercializing Sonalleve®, a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases [5] - The technology has received CE marking and FDA approval under a Humanitarian Device Exemption for specific treatments, with ongoing exploration for additional markets [5]

Core Viewpoint - Profound Medical Corp. is under investigation for potential securities fraud following the disclosure of a revenue overstatement of $472,000 in Q1 2024, leading to a significant drop in stock price [2][3]. Group 1: Company Financials - Profound Medical Corp. identified an error that overstated revenue by $472,000 in the first quarter of 2024 [2]. - The company announced that its quarterly reports for the first three quarters of 2024 should no longer be relied upon and intends to file restated interim financial statements [2]. Group 2: Stock Market Reaction - Following the news of the revenue overstatement, Profound's stock price fell by $0.43 per share, or 5.9%, closing at $6.86 per share on March 7, 2025 [3]. Group 3: Legal Investigation - Pomerantz LLP is investigating claims on behalf of investors regarding potential securities fraud or unlawful business practices by Profound and its officers and/or directors [1].

Regulatory Approvals and Compliance - The TULSA-PRO system received FDA clearance in August 2019 for thermal ablation of prostate tissue, based on the TACT pivotal study[17]. - The Sonalleve system is CE Marked in the EU for multiple applications, including the treatment of uterine fibroids and osteoid osteoma[19]. - The TULSA-PRO system received 510(k) clearance for commercial sale as a class II device in the United States on August 15, 2019, and has also received regulatory approvals in multiple countries including Canada and China[99]. - TULSA-PRO received approval as a class III device from Health Canada on November 20, 2019, which is crucial for the company's global expansion strategy[137]. - The EU's new Medical Devices Regulation (EU) 2017/745 requires compliance for devices to be marketed in the EU, with transitional provisions valid until December 31, 2028 for certain devices[119]. - Medical devices must meet General Safety and Performance Requirements (GSPRs) under the new EU MDR, requiring a conformity assessment procedure[124]. - The Notified Body issues a certificate of conformity valid for up to five years, allowing manufacturers to affix the CE Mark to their devices[122]. - Manufacturers must report any device-related death or serious injury to the FDA within 10 days of the event[110]. - The FDA can require recalls of medical devices if there is a reasonable probability that the device would cause serious adverse health consequences or death[111]. - Any modification to a marketed device that significantly affects safety or effectiveness requires a new 510(k) submission or PMA[112]. - The FDA conducts routine inspections to ensure compliance with clinical trial and regulatory requirements, with enforcement actions including civil penalties and product seizures[113]. - Clinical studies are required to support PMA applications and must comply with FDA's good clinical practice regulations[114]. - A pivotal clinical trial sponsor must develop a diversity action plan for enrollment, which must be submitted to the FDA if an IDE application is required[117]. - The UK Conformity Assessed (UKCA) marking will be mandatory for medical devices placed on the UK market after June 30, 2028[130]. - The TCA provides for cooperation in product safety and compliance between the UK and EU, impacting regulatory requirements for the company's product candidates[133]. - The Medical Device License is a pre-market requirement for Class II, III, and IV medical devices in Canada, ensuring compliance with the Canada MDR[135]. Financial Performance - Total revenue for the year ended December 31, 2024, was $10.68 million, an increase from $7.199 million in 2023, representing a growth of approximately 48.5%[453]. - Recurring non-capital revenue increased to $8.24 million in 2024 from $6.806 million in 2023, a growth of about 21.0%[459]. - Capital equipment revenue surged to $2.44 million in 2024, compared to $393,000 in 2023, marking a significant increase of approximately 520.1%[459]. - Gross profit for 2024 was $7.037 million, up from $4.312 million in 2023, reflecting a gross margin improvement[459]. - Total operating expenses rose to $40.099 million in 2024 from $32.963 million in 2023, an increase of about 21.6%[459]. - The net loss attributed to shareholders for the year was $27.816 million, slightly down from $28.323 million in 2023[459]. - Cash reserves as of December 31, 2024, were $54.912 million, a significant increase from $26.213 million in 2023[458]. - Total assets increased to $70.234 million in 2024 from $43.956 million in 2023, representing a growth of approximately 59.8%[458]. - Total liabilities decreased to $9.812 million in 2024 from $12.732 million in 2023, a reduction of about 22.5%[458]. - The company’s total shareholders' equity increased to $60,422,000 by December 31, 2024, up from $31,224,000 in 2023, representing an increase of 93.5%[461]. - The company reported a cumulative translation adjustment loss of $2,823,000 in 2024, compared to a gain of $644,000 in 2023[461]. - The company issued 8,425,039 shares in private placement and public offerings, raising $57,211,000 in 2024[463]. - Cash flows from operating activities resulted in a net cash used of $23,453,000 in 2024, compared to $22,609,000 in 2023, indicating a 3.7% increase in cash outflow[463]. - Share-based compensation decreased to $2,581,000 in 2024 from $3,417,000 in 2023, reflecting a reduction of 24.5%[463]. - The company’s inventory increased to $656,000 in 2024 from $353,000 in 2023, representing an increase of 86.1%[463]. Product Development and Market Strategy - The company continues to pursue additional regulatory approvals internationally and invest in research and development to support customer coverage and reimbursement[20]. - The business model in the U.S. is based on recurring revenues from one-time-use devices and comprehensive clinical training services[21]. - The company may consider strategic acquisitions to expand the applications of its platform technology and commercial footprint[20]. - The TULSA-PRO system was launched in the United States in January 2020, evolving to a recurring revenue model that includes durable hardware usage and one-time-use devices[64]. - The company has established direct sales and marketing teams for TULSA-PRO systems and Sonalleve systems, focusing on increasing utilization and generating recurring revenues[69]. - A co-development agreement with GE Healthcare allows the TULSA-PRO system to interface with GE's MRI scanners, expanding its market potential[71]. - The company collaborates with strategic partners like Philips and Siemens for lead generation and distribution of durable equipment[70]. - The company aims to expand its regulatory indications in Asia and other regions where profitable business opportunities exist[99]. Clinical Outcomes and Efficacy - The TACT trial demonstrated a 96% reduction in prostate-specific antigen (PSA) levels to a median nadir of 0.34 ng/ml at 12 months[35]. - Median decrease in perfused prostate volume was 91%, from a median of 37 cc at baseline to 2.8 cc at 12 months[35]. - At 12 months, 96% of men returned to baseline urinary continence, and 75% of potent men maintained or returned to erections sufficient for penetration[37]. - Five-year median PSA remained stable at 0.55 ng/ml, with 100% cancer-specific survival and 97% overall survival reported[40]. - Significant improvement in IPSS from 16.1 to 6.3 (58% reduction) at 12 months in a subgroup of patients with concurrent LUTS and prostate cancer[41]. - In a prospective study, average IPSS decreased from 17.5 to 4.0, and Qmax increased from 12.4 ml/s to 21.8 ml/s at 12 months[42]. - In the sTULSA study, median PSA decreased from 3.3 ng/ml at baseline to 0.05 ng/ml at three months, with 89% of subjects cancer-free in the treated zone at 12 months[44]. - In the pTULSA study, 50% of subjects were catheter-free one week post-treatment, and 100% were free of gross hematuria at last follow-up[45]. - CAPTAIN trial aims to compare TULSA procedure with radical prostatectomy in 201 subjects, focusing on safety and efficacy[47]. - MR-HIFU therapy for bone metastases showed a significant pain reduction of 64.3% compared to 20.0% in the sham group at three months[57]. - Sonalleve MR-HIFU provides a non-invasive alternative for treating osteoid osteoma, avoiding ionizing radiation associated with traditional methods[60]. - The Sonalleve MR-HIFU device has shown a high clinical success rate in treating desmoid tumors, with complete tumor eradication in some cases and low adverse events[62]. Market Presence and Revenue Generation - For the year ended December 31, 2024, approximately 78% of revenues were generated in the United States, 8% in the EU, and 14% in Asia, compared to 71%, 26%, and 3% respectively for the year ended December 31, 2023[65]. - The company expects revenue fluctuations on a quarter-over-quarter basis due to a limited European commercial effort, maintaining a primary focus on the U.S. market[65]. - The final rule for TULSA procedure establishes a Medicare National Average payment of $12,992.42 for hospitals and $10,728.00 for Ambulatory Surgical Centers (ASCs), representing increases of approximately 41% and 49% respectively over previous payments[147]. - TULSA will have three Category 1 CPT codes effective January 1, 2025, allowing for flexible billing based on the number of physicians involved in the procedure[146]. - The total Facility Relative Value Units (RVU) for CPT 55882 TULSA Complete Procedure is set at 17.91 when performed by one physician[148]. - The TULSA procedure will have a 0-day Global Period, meaning all post-operative visits are billed separately, unlike other comparable treatments which have a 90-day Global Period[150]. - Sonalleve system has been registered in several Middle East, North African, and Southeast Asian countries, expanding its market presence[142]. - The company plans to pursue coverage and reimbursement for its products in key markets where marketing authorization is obtained, which is vital for revenue generation[144]. Intellectual Property and Technology - The company has a broad intellectual property portfolio comprising approximately 40 patent families, with around 165 granted or allowed patents and 25 patent applications in various stages of review globally[93]. - The company is committed to protecting its intellectual property through confidentiality agreements and formal assignments for inventions[97]. - The company has invested in maintaining and expanding its intellectual property portfolio acquired from Philips in 2017, enhancing its market position[95]. - The company has an exclusive worldwide and royalty-free license agreement with Sunnybrook for certain technologies related to MRI-guided transurethral ultrasound therapy[98]. Employee and Operational Insights - The company had 142 full-time employees as of December 31, 2024, with a good standing relationship with its workforce[156]. - The company operates in a single segment focused on medical technology for magnetic resonance guided ablation procedures[473].