Profound Medical Corp. (PROF)

NASDAQ · Instruments & Medical Devices · Surgical & Medical Instruments & Apparatus

Price
$6.10
Day
+4.10%

Close 2026-09-21.

The company

Products TULSA-PRO Clinical Studies In March 2014, we completed enrollment and treatment of 30 patients in the TULSA multi-jurisdictional safety and precision study. Based on the trial results, in April 2016, Profound received a CE Certificate of Conformity for the TULSA-PRO system from its Notified Body in the EU. In the fourth quarter of 2016, Profound initiated a pilot commercial launch of TULSA-PRO in key European markets where the CE Mark is accepted. We received FDA clearance for the TULSA-PRO system in August 2019 for transurethral ultrasound ablation of prostate tissue, based on results from the Company’s TACT Pivotal Clinical Trial. The TACT Pivotal Clinical Trial is a prospective, open-label, single-arm pivotal clinical study, which initially included 115 treatment-naïve localized prostate cancer patients across 13 research sites in the United States, Canada and Europe, enrolled patients between August 2016 and February 2018. Subsequent to FDA clearance in 2019, the TACT trial re-opened enrollment of an additional 35 patients across 3 research sites in the United States (2 sites from the initial TACT recruitment period and 1 new additional site) to increase the proportion of men in the study who are American and with intermediate-risk prostate cancer.

From Item 1: Products · TULSA-PRO · Clinical Studies.

By product & service

Institutional holders

Largest positions reported on Form 13F for the quarter ended 2026-06-30, by value.

Insider trades

Open-market buys and sales filed on Form 4, newest first. Grants, option exercises and tax withholding are left out.

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