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Profound Medical Signs US Distribution Deal with Cook Medical's iMRI Division for TULSA-PRO

🇺🇸 Profound Medical Corp. (PROF) · Tue 03 Nov 2026

Profound Medical has agreed to supply TULSA-PRO to Cook Medical's iMRI Division for US sales through the Copernicus program, while keeping its own direct sales team.

Profound Medical announced on 30 October 2026 a supply and distribution agreement with Cook Medical's iMRI Division covering the US market. Under the deal, Cook will sell the FDA-cleared TULSA-PRO system, which is used for MRI-guided transurethral ultrasound ablation of prostate tissue.

Sales will run through Cook's Copernicus program. Cook will purchase systems from Profound at a set transfer price. The summary of the announcement does not give the price, the contract term or any volume commitments.

Profound will retain its direct sales team in the US. It will also supply disposables and service contracts to Cook's customers, so the company stays involved in the recurring supply and support of installed systems.

Separately, Profound said it is working with the FDA on 510(k) clearance for using TULSA-PRO with Siemens Healthineers' MAGNETOM Free.Max scanner. No timeline for a decision was given in the information available. A 510(k) is the premarket notification route by which the FDA clears many moderate-risk devices by establishing substantial equivalence to a legally marketed device.

What it means for your team

  • Market-access teams should note that TULSA-PRO will be sold through two US channels: Profound's direct sales team and Cook's Copernicus program.
  • Quality and service teams at hospitals and distributors should expect Profound to continue supplying disposables and service contracts to customers acquired through Cook.
  • Regulatory teams can watch the pending 510(k) for use with Siemens Healthineers' MAGNETOM Free.Max, which would affect scanner compatibility if cleared.
  • Financial terms beyond the existence of a set transfer price were not disclosed.

Company's press release (SEC filing): Profound Medical Corp. ↗

Article written by VigiEye from the official source (Profound Medical Corp.). Claims are the company's own. AI-assisted; check the source before acting.

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