Profound Med Corp Stock Price, News & Analysis

Profound Medical (NASDAQ:PROF) will launch the TULSA-AI Volume Reduction module for benign prostatic hyperplasia (BPH) at RSNA, Nov 30–Dec 4, 2025, and present new TULSA-PRO clinical data at RSNA and SUO (Dec 2–5, 2025).

The AI-powered module is described as optimizing BPH treatment workflow, reducing procedure times, and enabling multiple same-day cases with existing hardware and reimbursement codes. Company cites pilot trial success, CAPTAIN perioperative data comparing TULSA favorably to robotic prostatectomy on blood loss, length of stay, post-op pain and recovery, and projects a total available prostate-disease market of ~600,000 patients annually.

Profound Medical (NASDAQ:PROF) announced that The Hong Center Scottsdale, led by Dr. Y. Mark Hong, reached a world-first milestone of 200 independent TULSA Procedures performed by a urologist without radiologist involvement on Nov 18, 2025. The milestone highlights a urology-led, MRI-guided, incision-free workflow using the TULSA-PRO system, which offers real-time MRI thermography, autonomous temperature control, and robotically controlled directional ultrasound to ablate prostate tissue while protecting nearby structures.

The announcement notes consistent high-volume experience across whole-gland, focal, BPH and salvage cases, with no procedural blood loss or hospitalization reported and an emphasis on preserved urinary and sexual function.

Profound Medical (NASDAQ:PROF) reported record Q3 2025 revenue of $5.3M, up 87% YoY, driven by $4.1M recurring non-capital revenue and $1.2M capital equipment sales. Gross margin expanded 1,119 bps to 74.3% on manufacturing efficiency. Installed base reached 70 systems with a qualified pipeline of 93 new systems; the company expects at least 75 installs by year-end. Q3 net loss improved to $8.0M ($0.26/share) from $9.4M a year ago. Cash was approximately $24.8M as of September 30, 2025. The company announced new distribution agreements and clinical program milestones to support adoption.

Profound Medical (NASDAQ:PROF) announced an exclusive distribution and supply agreement with Getz Healthcare to commercialize the TULSA-PRO system in Australia and New Zealand, dated November 12, 2025. TULSA-PRO is an AI-powered, MRI-guided, robotically controlled system for prostate ablation that enables real-time MRI thermography and autonomous temperature control.

The partnership aims to expand access to incision-free prostate therapy in Australasia while Profound continues direct sales in North America and seeks further APAC distribution opportunities with Getz Healthcare.

Profound Medical (NASDAQ:PROF) announced an exclusive distribution and supply agreement with Al Faisaliah Medical Systems for its incision-free, MRI-guided TULSA-PRO and Sonalleve technologies in Saudi Arabia on Nov 11, 2025. All required import and sales regulatory approvals for Saudi Arabia are in place. TULSA-PRO has an installed base of 67 systems (Oct 2025) and >4,000 men treated; Sonalleve has 10 devices operational globally and >4,000 women treated for uterine conditions. The deal targets the Kingdom’s large healthcare market and leverages FMS’s regional distribution capabilities.

Profound Medical (NASDAQ:PROF) regained exclusive Canadian distribution rights for the TULSA-PRO system from Knight effective Nov 10, 2025, in exchange for a one-time payment of CDN$90,000 (US$64,000) and a 5% royalty on Canadian Net Sales for 15 years. Currently only Sunnybrook Health Sciences Centre in Toronto offers the TULSA Procedure and has performed >100 procedures. Profound plans to deploy its North American direct sales team, pursue additional Canadian sites through a concierge model, and use upcoming CAPTAIN trial results (readouts starting 2026) to support provincial coverage applications.

Profound Medical (NASDAQ:PROF) announced real-world data from the Busch Center marking its 500th TULSA Procedure on Oct 16, 2025. The center reported a mix of indications: ~50% primary prostate cancer, ~33% BPH, and remaining salvage cases.

Key outcomes include whole-gland ablations covering >90% of prostate in >75% of cases, treatment volumes up to 250 cc, >15% high-risk cancers treated, and a retrospective PSA fall from 6.7 to 0.9 ng/mL with 93% no residual disease. Reported functional outcomes: 100% pad-free continence and 82% preserved erectile function in the analyzed cohort.

Profound Medical (NASDAQ:PROF) will present an update at the Stifel 2025 Healthcare Conference on Tuesday, November 11, 2025 at 1:20 p.m. ET in New York City. Management's presentation will be broadcast live and later archived on the company's investor website under News & Events.

The company describes itself as a commercial-stage medical device maker of customizable, AI-powered, incision-free therapies for tissue ablation.

Profound Medical (NASDAQ:PROF) announced preliminary unaudited Q3 2025 revenue of $5.2M–$5.3M, representing 84%–87% YoY growth versus $2.8M in Q3 2024. Gross margin is expected to be ~72%, up from 64% a year ago. The company reported its TULSA-PRO installed base at 67, up from 60, and said it still expects to reach at least 75 systems by year-end.

These figures are preliminary and unaudited; full Q3 2025 results will be released after market close on November 13, 2025, followed by a conference call at 4:30 p.m. ET.