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Profound Medical Corp. plans to share the first clinical outcomes from its Level 1 post‑market CAPTAIN trial, which compares the TULSA Procedure™ to robotic radical prostatectomy in men with localized prostate cancer.
Results will be presented at the EAU 2026 Congress in London on March 13, 2026, followed by an investor webinar that day at 11:30 a.m. EDT featuring trial investigator Dr. Laurence Klotz and company management. Profound also plans one‑on‑one investor meetings at the 38th Annual Roth Conference from March 22‑24, 2026.
Profound Medical Corp. files its annual report describing a commercial-stage medical device business focused on AI-powered, MRI-guided, incision-free tissue ablation. Its main products are the TULSA-PRO system for prostate tissue ablation and the Sonalleve system for uterine fibroids, bone metastasis pain, osteoid osteoma and desmoid tumors.
TULSA-PRO has FDA clearance and CE Mark, with multiple clinical trials showing durable prostate cancer control and favorable urinary and sexual function outcomes. Sonalleve is CE Marked and cleared in several countries for non-invasive MR-guided focused ultrasound applications. For 2025, about 76% of revenue came from the United States, 5% from the EU and 19% from Asia. As of March 5, 2026, 36,293,640 common shares were outstanding, and non‑affiliate market value at the prior second fiscal quarter was $152,237,865. The company pursues a capital-plus-recurring revenue model, global regulatory expansion, and maintains a broad patent portfolio covering MRI-guided ultrasound ablation.
Profound Medical Corp. reported strong revenue growth but wider losses for 2025. Fourth quarter 2025 revenue reached $6.0 million, up 43% year-over-year, with $2.3 million from recurring non-capital sales and $3.7 million from capital equipment. Q4 gross margin was 67%, down from 71%, mainly due to product mix and introductory pricing in new international markets. Operating expenses were $11.4 million, leading to a Q4 net loss of $8.2 million, or $0.27 per share.
For full year 2025, revenue rose to $16.1 million from $10.7 million, and gross margin improved to 71% from 66%, driven by higher selling prices and more capital system sales. Operating expenses increased to $52.6 million, reflecting higher headcount, CAPTAIN trial costs, and commercial expansion, and net loss widened to $42.6 million, or $1.41 per share. Cash was $59.7 million as of December 31, 2025, supported by a $36.0 million registered direct offering and a $6.45 million private placement.
The TULSA-PRO installed base reached 78 systems, with a qualified pipeline of 110 potential new systems and an internal expectation of about 120 installs by the end of 2026. The company highlighted CMS reimbursement for the TULSA Procedure, new distribution agreements in Canada, Saudi Arabia, Australia and New Zealand, and upcoming Level 1 CAPTAIN trial outcome data. Profound also announced that Frank Baylis joined the Board, replacing Kris Shah.
Profound Medical Corp. filed a current report to let investors know when it will share its next results. The company plans to release its fourth quarter and full year 2025 financial results after market close on Thursday, March 5, 2026, and will host a conference call at 4:30 p.m. Eastern Time that day to review the numbers and discuss business developments.
Profound is a commercial-stage medical device company focused on interventional MRI procedures, including its TULSA-PRO® system for prostate disease and Sonalleve® platform for non-invasive treatment of uterine fibroids, certain bone and soft-tissue conditions, and other potential oncology and hyperthermia applications.
Profound Medical Corp. filed a current report describing a press release announcing that INOVAIT honored the company with its 2025–2026 Mount Logan Award, recognizing the TULSA Procedure for prostate disease. The award highlights Profound’s performance as an industry member in image‑guided therapy and AI.
The press release notes milestones such as treating the 4,000th TULSA Procedure patient, securing new U.S. Medicare reimbursement codes, and expanding global access through strategic partnerships. Profound is commercializing its MRI‑guided TULSA-PRO system for prostate disease and the Sonalleve platform for several other indications, backed by multiple regulatory approvals.
Profound Medical Corp. furnished an update under Regulation FD noting clinical use of its Sonalleve technology. On February 5, 2026, the Company announced that the PRO FAMILIA Specialist Hospital in Rzeszów, Poland has completed its 500th Sonalleve® Procedure, marking a notable usage milestone at that site.
Profound Medical Corp. furnished a current report to let investors know it has issued a press release announcing upcoming investor events. The company attached this press release as Exhibit 99.1 so readers can access the full details of those events.
The company specifically states that the information about these investor events, including the exhibit, is being provided under Regulation FD and is considered "furnished" rather than "filed" under U.S. securities laws. This means it is not subject to certain liability provisions and is not automatically incorporated into other SEC filings.
Profound Medical Corp. reported that Mount Sinai Hospital has treated its first prostate cancer patient using the company’s TULSA-PRO® system. This update was shared through a press release dated January 15, 2026, which is included as an exhibit to the report. The disclosure is made under Regulation FD, meaning the company is sharing this operational milestone to keep all investors informed at the same time.
Profound Medical Corp. filed a current report to share an operational update on its TULSA-PRO® technology platform. The company announced in a press release that its installed base of TULSA-PRO® systems stood at 78 systems as of December 31, 2025. This figure reflects the number of systems placed at customer sites by the end of the year.
The press release containing this information is furnished as an exhibit and is not deemed filed for liability purposes under U.S. securities laws or incorporated by reference into other SEC filings.
Profound Medical Corp. filed a preliminary Form S-3 shelf registration to offer, from time to time after effectiveness, up to $150,000,000 of securities. The shelf covers common shares, warrants, debt securities, subscription receipts, and units, with specific terms and pricing to be set in future prospectus supplements.
Sales may occur through underwriters, dealers, agents, directly to investors, or via methods such as at-the-market or equity line transactions, as described in the plan of distribution. Net proceeds will be used for working capital, capital expenditures, and general corporate purposes, and may include investments or acquisitions noted in future supplements.
The company’s common shares trade on Nasdaq as “PROF” and on the TSX as “PRN”; on November 12, 2025, closing prices were $6.47 (Nasdaq) and C$9.05 (TSX). Shares outstanding were 30,193,592 as of the date of this prospectus.