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].

Revenue Performance - For Q4 2024, Profound recorded revenue of approximately $4.2 million, a 108% increase from $2.0 million in Q4 2023[4] - Full year 2024 revenue was approximately $10.7 million, compared to $7.2 million in 2023, with recurring revenue of $8.2 million[8] - Revenue for Q4 2024 reached $4.177 million, a 108.8% increase from $2.009 million in Q4 2023[26] - Recurring non-capital revenue increased to $2.679 million, up 33.3% from $2.009 million year-over-year[26] - Capital equipment revenue surged to $1.498 million, compared to $0 in Q4 2023, marking a significant growth[26] Operating Expenses - Total operating expenses for Q4 2024 were $11.3 million, up from $9.8 million in the prior year, primarily due to increased headcount and R&D investments[5] - Total operating expenses rose to $40.099 million in 2024, up 21.7% from $32.963 million in 2023[27] - Research and development expenses for Q4 2024 were $4.649 million, up 17.0% from $3.978 million in Q4 2023[27] Net Loss - The net loss for Q4 2024 was approximately $4.9 million, or $0.20 per share, a 45% improvement from a net loss of $8.9 million, or $0.42 per share, in Q4 2023[6] - For the full year 2024, Profound's net loss was approximately $27.8 million, or $1.12 per share, compared to a net loss of $28.3 million, or $1.34 per share, in 2023[10] - Net loss for the year was $27.816 million, slightly down from $28.323 million in 2023[28] - Basic and diluted net loss per share improved to $0.20 in Q4 2024 from $0.42 in Q4 2023[27] Cash Position - As of December 31, 2024, Profound had cash of approximately $54.9 million, an increase from $26.2 million in 2023[11] - Cash and cash equivalents at the end of 2024 increased to $54.912 million, compared to $26.213 million at the end of 2023[29] - Issuance of common shares generated $62.106 million in financing activities, significantly higher than $0 in 2023[29] Collaborations and Innovations - The company announced a non-exclusive collaboration with Siemens Healthineers to expand access to the TULSA procedure[7] - Profound launched the TULSA-AI module 'UA Alignment Assistant' in November 2024, simplifying the TULSA procedure[7] - The CAPTAIN clinical trial has completed patient enrollment, with data expected to be released at the AUA 2025 annual meeting[7] Credit Agreement - The amended credit agreement with CIBC allows for a revolving line of credit of up to $15 million, contingent on achieving certain revenue thresholds[17]

Financial Data and Key Metrics Changes - For Q4 2024, the company recorded revenue of $4.2 million, a 108% increase from $2 million in Q4 2023 [9] - Gross margin in Q4 2024 was 71%, compared to 52% in Q4 2023 [9] - Total operating expenses in Q4 2024 were $11.3 million, up from $9.8 million in Q4 2023 [10] - The net loss for Q4 2024 was $4.9 million, or $0.20 per share, a 45% improvement from a net loss of $8.9 million, or $0.42 per share, in Q4 2023 [10][11] - As of December 31, 2024, the company had cash of $54.9 million [11] Business Line Data and Key Metrics Changes - Recurring revenue for Q4 2024 was $2.7 million, while one-time capital equipment sales contributed $1.5 million [9] - The company transitioned from a placement model to a capital model, which is expected to enhance revenue streams [25][56] Market Data and Key Metrics Changes - The company is focusing on the top 50 cancer centers and regional hospitals for TULSA-PRO adoption [28] - The introduction of the BPH TULSA AI module is expected to triple the total addressable market from 200,000 cancer patients to 600,000 prostate disease patients annually [40] Company Strategy and Development Direction - The company aims to enhance awareness and adoption of TULSA-PRO through increased patient education and a robust sales team [37][42] - Plans to introduce TULSA Plus, a combined solution with Siemens interventional MRI, are set for the second half of 2025 [41] - The company anticipates high double-digit growth in 2025, with potential for triple-digit growth in 2026 and beyond [42] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the clinical value and economic model of TULSA, noting a positive response from hospitals regarding profitability [46][51] - The CAPTAIN trial is expected to provide significant data to support reimbursement and acceptance of TULSA as a treatment modality [38][71] Other Important Information - The company had 17 presentations featuring TULSA-PRO at major society meetings in Q4 2024 [12] - The CAPTAIN trial has randomized 201 patients as of January 2025, with 174 treated or scheduled for treatment [20] Q&A Session Summary Question: What gives confidence for robust growth acceleration in the post-Medicare reimbursement environment? - Management highlighted the clinical value of the product and the economic models showing profitability for hospitals, contributing to confidence in growth rates [46][51] Question: Update on the target of reaching 75 sites and the capital vs. recurring revenue model? - Management indicated that while the target of 75 sites may not be reached, the transition to a capital plus recurring model is yielding positive results [52][53] Question: Timing and regulatory clearances for the BPH product launch? - The BPH module is on track for a mid-year launch, with demo plans at AUA [63] Question: Uptake among Medicare payers and actual payments? - Management noted that actual payments from Medicare take time, but early data suggests positive trends in recurring revenue and satisfaction among users [66][68] Question: Strategy for pursuing specific insurance companies for reimbursement? - A specialized team is being developed to prioritize insurance companies based on payment history and regional install bases [71][72]