Profound Medical Corp. filed an 8-K on November 3, 2026, disclosing that its wholly owned subsidiary Profound Medical (U.S.) Inc. entered into a Supply and Distribution Agreement with Cook Medical Holdings LLC, effective October 23, 2026, for distribution of the TULSA-PRO system in the United States and its territories.

Key Highlights

  • Agreement date: The Supply and Distribution Agreement was entered into on October 28, 2026, with an effective date of October 23, 2026.
  • Non-exclusive distributor: Cook Medical Holdings LLC was appointed as a non-exclusive distributor of the TULSA-PRO system, authorized to sell the Products only for use with Cook's intraoperative MRI suite equipment.
  • Five-year initial term: The term begins on the date Profound U.S. provides Cook with written evidence of FDA clearance needed for commercial distribution, with automatic 12-month renewals thereafter.
  • Regulatory deadline: If the Regulatory Approval Date has not occurred by April 30, 2027, Cook may terminate the Agreement without liability.
  • No pre-clearance obligations: Before the Regulatory Approval Date, Cook has no purchase, forecast, payment, or performance obligations, and Profound U.S. may not ship Products.
  • Termination provisions: Either party may terminate without cause on 180 days' written notice; a change of control by Profound U.S. triggers a 90-day termination right, but no earlier than 24 months after the Regulatory Approval Date.
  • Press release: The Company issued a press release announcing the Agreement on October 30, 2026, furnished as Exhibit 99.1.

Profound Medical and Cook Medical: TULSA-PRO Distribution Agreement Terms

According to the filing, Profound Medical (U.S.) Inc., a wholly owned subsidiary of Profound Medical Corp. (NASDAQ:PROF), entered into the Agreement with Cook Medical Holdings LLC on October 28, 2026. Under the arrangement, Cook was appointed as a non-exclusive distributor of the Company's TULSA-PRO system within the United States and its territories. The filing specifies that Cook is authorized to distribute and sell the Products solely for use with Cook's intraoperative MRI suite equipment. Profound U.S. agreed not to appoint any other distributor or reseller to sell the Products for use with Cook Equipment in the Territory without Cook's prior written consent, subject to conditions tied to minimum sales percentages.

The filing states that the five-year initial term of the Agreement does not begin until Profound U.S. delivers written evidence of FDA clearance for commercial distribution of the Products. Prior to that Regulatory Approval Date, Cook bears no purchase, forecast, payment, or performance obligations, and Profound U.S. is not permitted to ship Products. The Agreement also provides that a failure to meet specified minimum sales percentages is not treated as a breach. Profound U.S. retains the roles of manufacturer and regulatory license holder and remains responsible for quality, labeling, installation, service, warranty, complaint handling, and field actions, as the filing describes.

The parties are to coordinate sales and marketing through a joint steering committee and have agreed to co-marketing and training obligations, according to the filing. The Agreement includes customary representations, warranties, indemnification obligations, insurance requirements, confidentiality provisions, and limitations of liability. The filing notes that certain portions of Exhibit 10.1 have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K, and that certain schedules and exhibits were also omitted pursuant to Item 601(a)(5) of Regulation S-K.

What Was Disclosed

Profound Medical Corp. disclosed the entry of its U.S. subsidiary into a Supply and Distribution Agreement with Cook Medical Holdings LLC for the TULSA-PRO system, covering key terms including distributor appointment, a regulatory clearance condition, a five-year initial term, and termination provisions.