Profound Medical (NASDAQ: PROF; TSX: PRN) has announced that it has entered into a supply and distribution agreement with the iMRI Division of closely held Cook Medical to expand U.S. sales of its TULSA-PRO system.
Headquartered in Bloomington, Indiana, Cook is one of the largest privately held medical device manufacturers in the world, and a dominant force in the urology and prostate spaces.
The agreement establishes an additional new capital equipment sales channel for Profound by bringing its TULSA-PRO system into Cook’s Copernicus program alongside the iMRI Suite, enabling Cook to offer a turnkey prostate disease treatment solution to urologists and hospitals. The collaboration is intended to increase TULSA-PRO system placements, expand the base of systems generating recurring revenue, and broaden physician and patient access to the TULSA Procedure.
Under the agreement, Cook will purchase TULSA-PRO systems from Profound at a predetermined transfer price for distribution in the U.S. Customers purchasing systems through Cook will obtain single-use disposables and service contracts directly from Profound.
In a statement, Arun Menawat, CEO and chairman of Profound, commented, “This agreement broadens our commercial reach by making TULSA-PRO part of a comprehensive offering for hospitals investing in MRI-guided intervention. Cook’s expertise in minimally invasive procedures, its large presence in urology, and its investment in iMRI complement our direct sales capabilities. Together, we have an opportunity to bring TULSA to more institutions and build procedure volumes as new sites establish and expand their treatment programs.”
The iMRI Suite, unveiled recently by Cook and Siemens Healthineers (XETRA: SHL), is a fully integrated procedural environment that enables real-time MRI-guided interventions without ionizing radiation. It is built for intervention from the ground up. Cook’s Copernicus program connects the iMRI Suite with designed-for-MRI devices, clinical training, implementation support, and partner therapies, giving hospitals a single pathway from planning an iMRI program to treating patients.
Profound’s existing capital sales team will continue to sell TULSA-PRO directly to sites with compatible MRI systems. Together, these channels allow the company to serve customers using existing MRI infrastructure and those investing in new iMRI capabilities.
Pete Polverini, VP, Interventional MRI Division at Cook, remarked, “Cook Medical has spent decades helping physicians perform minimally invasive procedures, and our iMRI Division is carrying that work into MRI-guided intervention. Through our Copernicus program we help hospitals plan, build, and sustain iMRI programs, and TULSA-PRO gives those hospitals an FDA-cleared, incision-free prostate therapy to offer patients who want to return to their daily lives sooner. Together with Profound, we aim to bring the TULSA Procedure to more urologists and more hospitals and, over time, to additional sites of care.”
Uniquely, the TULSA Procedure has approved CMS reimbursement in all major treatment settings, including hospitals, ASCs and private physician offices.
Building a Broader iMRI Ecosystem
Profound’s TULSA-PRO system combines real-time MRI guidance, artificial intelligence, and supervised robotic autonomy for incisionless prostate disease treatment. Physicians use the TULSA Procedure to see, ablate, and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care—from whole-gland to subtotal, hemi, multifocal, and focal treatment. This approach enables individualized care using prostate tissue ablation, while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.
The Cook agreement complements Profound’s existing co-sales and co-marketing agreement with Siemens Healthineers to commercialize a total MRI-guided prostate therapy solution combining TULSA-PRO with Siemens Healthineers’ 0.55T MAGNETOM Free.Max magnetic resonance scanner.
Together, these commercial relationships broaden Profound’s access to customers across existing MRI installations and new interventional suites, strengthening the foundation for sustained adoption of the TULSA Procedure.
Editor’s Note: Profound noted that it is working with the FDA to obtain 510(k) clearance for the use of TULSA-PRO with the MAGNETOM Free.Max MR scanner. TULSA-PRO is already FDA-cleared for use with multiple compatible 1.5T and 3T MRI systems, and has been CE marked for use with MAGNETOM Free.Max in Europe.
