Profound Medical Expands U.S. TULSA-PRO Distribution Through Cook Agreement
Key Facts
Profound Medical has signed a supply and distribution agreement with Cook Medical’s iMRI division to expand U.S. sales of its TULSA-PRO system, according to a company statement. Cook will buy the systems from Profound at a predetermined transfer price and distribute them in the U.S. market. The agreement places the system in the Copernicus program alongside the iMRI Suite, allowing Cook to offer hospitals and urologists a comprehensive solution for treating prostate disease. In turn, customers who obtain the system through Cook will buy single-use consumables and service contracts directly from Profound. The company aims to expand commercial access and increase the number of systems and sites using the technology, making the procedure available to more doctors and patients.
The agreement adds a distribution channel to Profound’s existing direct sales, as its sales force will continue selling TULSA-PRO to sites with compatible MRI scanners. Cook’s new channel targets customers investing in iMRI capabilities and bundles the system into an offering that includes setup, training and implementation readiness. Cook describes its Copernicus program as a training and readiness service that prepares institutions to implement iMRI safely and at scale, including implementation support, clinical training and procedural assistance. Chief Executive Aron Minow said the agreement expands commercial access, adding: "Together, we have an opportunity to bring TULSA to more institutions and build procedure volumes as new sites establish and expand their therapy programs." The company presents increases in systems, sites and procedure volumes as goals of the agreement, not results already achieved.
Profound relies on sales of the capital system alongside recurring consumables and service revenue in the U.S. market. In the second quarter of 2026, the company reported total revenue of $2.483 million, including $871,000 from one-time capital equipment sales and $1.612 million in recurring non-capital revenue. Under the agreement’s model, sales of systems distributed through Cook remain directly tied to Profound’s sales, while consumables and service contracts are purchased directly from Profound by customers. The partnership therefore aims to open an additional path to expand the installed base, while keeping revenue tied to system use and service within the direct relationship between Profound and the buyer. The company described growth in recurring revenue as an expected goal of the expansion, not a financial impact already realized.
The partnership joins a broader network of commercial relationships; it complements the existing sales and co-marketing relationship between Profound and Siemens Healthineers to market a solution combining TULSA-PRO with the MAGNETOM Free.Max scanner. Profound said it is working with the U.S. Food and Drug Administration to obtain 510(k) clearance to use the system with that scanner. According to the company, TULSA-PRO is already cleared for use with multiple compatible MRI systems at 1.5T and 3T. The FDA database lists the device in the category of high-intensity ultrasound systems for ablating prostate tissue. The original 510(k) clearance decision dates to August 15, 2019, while the regulatory document classifies the device as Class II.
The agreement comes as Profound announced preliminary, unaudited third-quarter 2026 revenue expectations of $9.8 million to $10 million, compared with revenue of $5.3 million in the third quarter of 2025. The projected range implies year-over-year growth of 85% to 89%, and the company said it exceeds the Bloomberg consensus estimate of $6.78 million by about 45% to 47%. Profound also expects its gross margin to exceed 70% for the quarter. The company had said its installed base of TULSA-PRO systems totaled 84 at the end of the second quarter and estimated its combined qualified sales pipeline for the system and Sonalleve at about $70 million. In the second quarter, it received more than $7 million in new purchase orders, a quarterly record, according to the chief executive; equipment worth about $3.1 million was also shipped in July, and the company expected to recognize the revenue in the third quarter after resolving a logistics issue it said had delayed recognition.
The system’s clinical background includes the randomized CAPTAIN trial, which completed enrollment and treatment during 2025 with 211 participants; 148 were assigned to TULSA treatment and 63 to robotic surgery, with long-term follow-up planned for up to 10 years after treatment. In a separate Phase 2 study for benign prostatic hyperplasia, average International Prostate Symptom Score fell from 17 to 4 after 12 months among 30 participants. Those results concern benign prostatic hyperplasia, while the CAPTAIN trial is comparing TULSA treatment with robotic surgery. Profound is scheduled to report full third-quarter financial results after the market closes on November 5, 2026. The company said it will hold a conference call that day at 4:30 p.m. Eastern time to review results and discuss business developments.