Profound(PROF)2025-03-07 22:05Regulatory 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 7.199 million in 2023, representing a growth of approximately 48.5%[453]. - Recurring non-capital revenue increased to 6.806 million in 2023, a growth of about 21.0%[459]. - Capital equipment revenue surged to 393,000 in 2023, marking a significant increase of approximately 520.1%[459]. - Gross profit for 2024 was 4.312 million in 2023, reflecting a gross margin improvement[459]. - Total operating expenses rose to 32.963 million in 2023, an increase of about 21.6%[459]. - The net loss attributed to shareholders for the year was 28.323 million in 2023[459]. - Cash reserves as of December 31, 2024, were 26.213 million in 2023[458]. - Total assets increased to 43.956 million in 2023, representing a growth of approximately 59.8%[458]. - Total liabilities decreased to 12.732 million in 2023, a reduction of about 22.5%[458]. - The company’s total shareholders' equity increased to 31,224,000 in 2023, representing an increase of 93.5%[461]. - The company reported a cumulative translation adjustment loss of 644,000 in 2023[461]. - The company issued 8,425,039 shares in private placement and public offerings, raising 23,453,000 in 2024, compared to 2,581,000 in 2024 from 656,000 in 2024 from 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].