In October 2025, Profound unveiled new, real-world data from the internationally recognized Busch Center. The data — marking the center’s milestone of 500 completed TULSA Procedures™ — demonstrated the procedure’s versatility and success in treating a broad spectrum of prostate diseases, severities, and aggressions.
As user interest in Profound’s technologies continues to build, the Company is deploying its own direct sales team in North America, while partnering with select strategic distribution partners to support the business potential and the customer base in other parts of the world. In November 2025, Profound: Regained exclusive distribution rights for TULSA-PRO in Canada;Entered into an exclusive distribution and supply agreement for its TULSA-PRO and Sonalleve® technologies in Saudi Arabia with Al Faisaliah Medical Systems Co. (FMS), a subsidiary of one of the Kingdom’s most prominent business conglomerates, Al Faisaliah Group (AFG); andEntered into a strategic distribution agreement with Getz Healthcare to introduce TULSA-PRO in Australia and New Zealand.
Also in November, Profound announced that the Hong Center Scottsdale, led by Dr. Y. Mark Hong of Integrative Urology in Phoenix, Arizona, achieved a world-first milestone: 200 TULSA Procedures performed independently by a urologist, without radiologist involvement.
In November/December 2025, Profound launched its TULSA-AI® Volume Reduction module for optimizing the treatment of patients with BPH at the Radiological Society of North America meeting in Chicago, IL. The use of AI to streamline the workflow and reduce procedure times is a significant advancement that makes using TULSA-PRO for treating enlarged prostate just as efficient as other modern procedures, but with the advanced benefits of precision and customization to any prostate shape or size. The Company believes the reduced procedure times for BPH will increase adoption of the TULSA Procedure and triple Profound’s total available market in prostate disease to about 600,000 patients annually.
In December 2025, Pejman Ghanouni, MD, PhD, Associate Professor in the Department of Radiology, Division of Body MRI at Stanford University School of Medicine, received the Cum Laude award for his presentation titled “CAPTAIN Randomized Controlled Trial of MRI-Guided Transurethral Ultrasound Ablation (TULSA) Versus Robotic Radical Prostatectomy” at the 2025 Radiological Society of North America (“RSNA”) Annual Meeting.
Also in December, the Company significantly strengthened its balance sheet via the closing of a $36.0 million registered direct offering in the United States and an upsized $6.45 million private placement in Canada. Both the registered direct offering and private placement were structured as straightforward equity investments with no warrant coverage and were led by healthcare-dedicated investors alongside existing shareholders.
In January 2026, Profound announced two U.S. commercial milestones. The Johns Hopkins Hospital (Baltimore, MD) treated its first non-clinical-trial prostate cancer patient using the Company’s TULSA-PRO system, marking the official launch of Profound’s technology at one of the world’s most influential centers for prostate cancer innovation and coinciding with the opening of Johns Hopkins Medicine’s new iMRI suite. Soon thereafter, the world-renowned Mount Sinai Hospital (New York, NY) successfully treated its first prostate cancer patient with the TULSA-PRO system, becoming the first health system in the New York metropolitan area to offer the TULSA Procedure.
In February 2026, PRO FAMILIA Specialist Hospital in Rzeszów, Poland completed its 500th Sonalleve® Procedure.
Also in February, the Company received the 2025/2026 Mount Logan Award from INOVAIT, the Canadian national network for commercializing breakthroughs in image-guided therapy (IGT) and AI. The award recognizes Profound’s achievement of significant milestones, including treating the 4,000th TULSA Procedure patient, securing reimbursement for the TULSA Procedure by the U.S. Centers for Medicare & Medicaid Services (CMS) at Urology APC Level 7, and establishing strategic partnerships to expand patient access to TULSA-PRO globally.
Today, Profound is pleased to announce that Laurence Klotz, M.D., FRCSC, an esteemed urologist and professor of surgery at the University of Toronto and the Sunnybrook Chair of Prostate Cancer Research, will present the first clinical outcomes from the Level 1 post-market CAPTAIN trial comparing the safety and efficacy of the TULSA Procedure with robotic radical prostatectomy in men with localized prostate cancer next week at the 41st Annual European Association of Urology (EAU) Congress in London, UK. EAU26 is a premier academic urology meeting, and the Company is pleased that the data have been selected for inclusion in the meeting’s Late-Breaking and High-Impact session on Friday, March 13th.
Original source: ca