Welcome to our dedicated page for Profound Med SEC filings (Ticker: PROF), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Profound Medical Corp. (PROF) SEC filings page provides access to the company’s U.S. regulatory disclosures, including current reports on Form 8-K and other documents filed under Commission File Number 001-39032. Profound is a commercial-stage medical device company incorporated in Ontario, Canada that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue.
Through its SEC filings, Profound reports material events related to its business and finances. Recent Form 8-K filings have covered topics such as preliminary unaudited financial results, business updates, and exclusive distribution and supply agreements for its TULSA-PRO® and Sonalleve® technologies in markets including Canada, Saudi Arabia, Australia and New Zealand. Other 8-Ks have furnished press releases announcing milestones like growth in the installed base of TULSA-PRO systems and developments in the company’s sales pipeline.
Investors can use these filings to track how Profound describes its revenue mix between recurring non-capital sources, such as TULSA-PRO consumables and equipment leases, and capital equipment sales, as well as to follow its equity financings, including registered direct offerings and private placements of common shares. Over time, annual reports on Form 10-K, quarterly reports on Form 10-Q, and additional 8-Ks provide a structured record of the company’s financial condition, risk factors, and key operational metrics.
On Stock Titan, each new PROF filing is captured from EDGAR and paired with AI-powered summaries that highlight the main points, helping readers quickly understand the significance of lengthy documents. Users can review core filings such as 10-Ks and 10-Qs, along with current reports and any insider-related disclosures, to build a detailed view of Profound Medical’s regulatory and financial history.
Profound Medical Corp. furnished information that its incision-free, MRI-guided TULSA Procedure™ for prostate disease will be featured in multiple physician presentations at the 2026 Society of Interventional Radiology Annual Scientific Meeting in Toronto from April 11-15, 2026.
The TULSA Procedure, performed with the company’s TULSA-PRO® system, uses robotically controlled ultrasound inside the urethra and real-time MRI thermography to ablate prostate tissue at 55-57°C while protecting surrounding structures. Presentations will cover clinical use in prostate cancer and benign prostatic hyperplasia, outcomes data, automated prostate segmentation, and initial perioperative results from the Level 1 post-market CAPTAIN trial.
Profound Medical Corp. filed an 8-K to share a press release celebrating a clinical milestone for its TULSA Procedure™, an MRI-guided, incision-free prostate therapy. Texas Prostate, led by Dr. James Cochran, has now completed its 100th TULSA Procedure in Dallas Medical Center’s MRI suite.
Dr. Cochran notes that switching from focal HIFU to TULSA expanded the range of prostate diseases and sizes he can treat while improving safety. After moving from a private-pay to a Medicare-based model through collaboration with Dallas Medical Center, TULSA volumes at Texas Prostate increased by 500% and continue to grow with referrals from across Texas and nearby states.
Profound Medical Corp. filed a report highlighting new clinical data from its Level 1 CAPTAIN randomized trial comparing the MRI-guided, incision-free TULSA Procedure™ with robotic radical prostatectomy for intermediate‑risk localized prostate cancer.
The trial treated 211 patients and met its prespecified primary safety endpoint. At 6 months, 50% of men treated with TULSA preserved both erectile function and urinary continence, compared with 24% after surgery. TULSA also showed higher pad‑free continence (84% vs. 49%), similar erectile function preservation (56% vs. 47%), less blood loss, shorter hospital stays, fewer serious complications, and faster return to work. Secondary oncologic outcomes for the TULSA arm, including histology and 12‑month biopsy/MRI data, are pending and expected later in the year.
Profound Medical Corp. reported a board change. On March 5, 2026, director Kris Shah resigned from the Board, effective immediately, and the company states his resignation was not due to any disagreement. The Board simultaneously appointed Frank Baylis to fill the resulting vacancy.
Mr. Baylis will serve as a director until the company’s 2026 annual meeting of stockholders and until a successor is elected and qualified, or earlier departure. He has no disclosed arrangements, family relationships, or related-party transactions with the company. As a non-employee director, he will receive a pro-rated annual cash retainer of $50,000 and be eligible for an annual equity award, and he signed the company’s standard indemnification agreement.
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.