Profound Medical Corp. SEC filings document regulatory disclosures for a commercial-stage medical device company focused on interventional MRI procedures. Recent Form 8-K reports cover results of operations and financial condition, Regulation FD disclosures, furnished press releases, revenue guidance and business updates tied to TULSA-PRO®, the TULSA Procedure™ and Sonalleve®.
The filing record also includes clinical and commercial disclosure categories, such as CAPTAIN trial updates, scientific-meeting presentations and TULSA Procedure adoption milestones. Governance filings record director changes and board appointments, while exchange-act cover disclosures identify the company’s common shares registered on Nasdaq under the PROF symbol.
Profound Medical Corp. reports new quality-of-life data from the Level 1 post‑market CAPTAIN randomized controlled trial comparing its MRI‑guided TULSA Procedure with robotic radical prostatectomy in men with organ‑confined, intermediate‑risk Gleason Score 7 prostate cancer.
At 1 month, there was no median change in penile length after whole‑gland TULSA, versus a 0.65 cm median reduction after robotic radical prostatectomy, with a 0.42 cm between‑arm difference from a mixed‑effects model (p<0.001). CAPTAIN enrolled 211 patients at 20 U.S. sites, two in Canada and one in Europe, aiming to show non‑inferior cancer control for TULSA with superior quality‑of‑life outcomes, including preservation of erectile function and urinary continence.
Profound Medical Corp. plans to release its second quarter 2026 financial results after market close on Thursday, August 6, 2026, followed by a conference call at 4:30 p.m. Eastern Time to review the results and discuss business developments. The call will be broadcast live and archived in the Investors section of the company’s website.
Profound Medical is a commercial-stage medical device company focused on interventional MRI (iMRI) procedures. Its flagship TULSA-PRO platform enables MRI-guided, incision-free prostate ablation, while its Sonalleve system provides non-surgical MRI-guided therapy for certain bone, tumor, and gynecologic conditions.
Profound Medical Corp. announced that its MRI-guided, AI-powered, robotically driven and incisionless TULSA Procedure will be featured in multiple physician-led presentations at the Society of Robotic Surgery Annual Meeting in Fort Lauderdale, FL, scheduled for July 23-26, 2026.
Clinical talks will cover real-world outcomes, randomized trial primary safety data, single-center efficacy and safety, salvage treatment after prior therapies, and program adoption, with leading presenters from UT Southwestern and other centers. Profound will also be one of only eight companies spotlighted in the Society of Incisionless Surgery plenary session on imaging, AI and robotic autonomy.
Before the clinical program, management plans to participate in an SRS Investor Session on July 22, 2026, discussing innovative robotic technologies and TULSA-PRO. Profound describes itself as a commercial-stage medical device company focused on MRI-guided, incision-free therapies including TULSA-PRO and Sonalleve, which have clearances or approvals in multiple global markets.
Profound Medical Corp. reported the results of its 2026 annual and special shareholder meeting. Shareholders elected eight directors, including two new nominees, to serve until the next annual meeting. Support for individual directors ranged from about 79% to 91% of votes cast.
Shareholders approved the appointment of PricewaterhouseCoopers LLP as auditors, with 25,193,910 votes for and 99.497% support. They also approved an ordinary resolution confirming all unallocated restricted share units and deferred share units under the long-term incentive plan, with 9,046,376 votes for and 63.922% support versus 36.078% against. The circular notes 36,337,637 common shares outstanding as of April 2, 2026, and describes the company’s equity-based compensation, governance structure, and executive/director pay philosophy.
Profound Medical Corp. furnished a current report describing plans to spotlight its MRI-guided TULSA Procedure™ at the American Urological Association’s 2026 Annual Meeting in Washington, DC. Four oral presentations on MRI-guided transurethral ultrasound ablation for localized prostate cancer will be delivered by clinicians from Mayo Clinic, Turku University Hospital and Sapporo Hokuyu Hospital.
The company will also demonstrate TULSA-PRO® and a Siemens Free.Max MR system at Booth #413 and has launched an initiative to explore integrating PSMA PET molecular imaging with TULSA-PRO treatment planning. This effort aims to support intent-to-treat decisions and patient monitoring across focal, subtotal and whole-gland prostate ablation strategies.
Profound Medical Corp. registers for resale up to 921,428 common shares previously issued in a private placement closed on December 30, 2025. The shares were issued at $7.00 per share for aggregate gross proceeds of $6.45 million. The company will not receive proceeds from resales.
The prospectus states the selling shareholders may sell shares at fixed or market prices, through underwriters, broker-dealers or agents, and by other customary methods. The registration permits resale on Nasdaq ("PROF") and the Toronto Stock Exchange ("PRN").
Profound Medical Corp. reported strong top-line growth but continued losses for the quarter ended March 31, 2026. Revenue rose to $5,337 from $2,621 a year earlier, driven by higher capital equipment sales and recurring device revenue, while gross margin held near 72%.
Operating expenses fell to $11,853 from $13,019, narrowing the net loss to $7,053 from $10,724, or $0.19 per share versus $0.36. Cash declined to $50,295 from $59,723 at December 31, 2025, mainly from operating use of cash, and management believes current cash and product sales can fund operations for at least 12 months.
Profound Medical Corp. reported strong first quarter 2026 results, with revenue of about $5.3 million, up 104% from the same period in 2025. Capital equipment sales were approximately $2.9 million and recurring non-capital revenue, including one-time use devices and services, was about $2.5 million. Gross margin improved slightly to 72%.
Operating expenses fell 9% to roughly $11.8 million, helping narrow the net loss to about $7.0 million, or $0.19 per share, a 34% improvement year over year. Cash was approximately $50.3 million as of March 31, 2026. Management issued full-year 2026 guidance for $25 million in revenue, implying 56% annual growth, and expects gross margin of at least 70%. The TULSA-PRO installed base reached 80 systems, and Humana became the first U.S. national payor to cover the TULSA Procedure, adding about 8.5 million covered lives.
Profound Medical Corp. announced it will release its first quarter 2026 financial results after market close on Thursday, May 7, 2026, and host a conference call at 4:30 p.m. Eastern Time that day to review the results and discuss business developments.
The company is a commercial-stage medical device business focused on AI-powered, MRI-guided, incision-free therapies. Its flagship TULSA-PRO platform supports MRI-guided prostate therapy, while Sonalleve provides non-surgical, MRI-guided treatments for bone metastases, certain tumors, and gynecologic conditions.