Core Insights - The CAPTAIN trial is the first randomized controlled trial comparing MRI-guided transurethral ultrasound ablation (TULSA) to robotic radical prostatectomy (RP), successfully recruiting to target [1][4] - Dr. Pejman Ghanouni received the Cum Laude award for his presentation on the CAPTAIN trial at the RSNA Annual Meeting, highlighting the significance of the study [1][2] - The TULSA Procedure offers a quicker recovery time compared to robotic RP, with patients feeling better the day after the procedure, while robotic RP patients take nearly three weeks [3] Company Overview - Profound Medical Corp. specializes in AI-powered, MRI-guided, incision-free therapies for tissue ablation, with a focus on the TULSA Procedure [1][5] - The TULSA-PRO system is the only AI-powered, MRI-guided robotic system for prostate therapy, allowing real-time monitoring and personalized treatment [3][6] - Profound is also commercializing Sonalleve, a therapeutic platform for various conditions, including uterine fibroids and bone metastases [7] CAPTAIN Trial Details - The CAPTAIN trial is a multi-center study comparing the safety and efficacy of TULSA with RP in men with organ-confined, intermediate-risk prostate cancer [4] - As of January 2025, 210 patients were randomized, with 69% receiving TULSA and 31% receiving RP, ensuring balanced baseline characteristics [4] - The trial commenced in 2022 across 20 sites in the U.S., two in Canada, and one in Europe, with the last patient treatment occurring in August 2025 [4]

The Swoop® Portable MR Imaging System is Driving the Future of Brain Health Corporate Investor Deck – December 2025 The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo is a trademark of Hyperfine, Inc. PROPERTY OF HYPERFINE. ©2025. All rights reserved. Forward-Looking Statements This presentation includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Actual re ...

Hyperfine Overview - Hyperfine's Swoop system is the first FDA-cleared, AI-powered portable MR brain imaging system, targeting a market opportunity exceeding $6 billion[4, 74] - The company's growth strategy is supported by the launch of the next-generation Swoop system and Optive AI software, which enhances image quality for ultra-low field MRI[4] - Hyperfine has secured approximately 200 patents related to its proprietary technology[9] Market and Expansion - The company is targeting expansion across multiple sites of care, including inpatient, outpatient, and community settings, with a total addressable market (TAM) potentially exceeding $16 billion[8] - Hyperfine has an installed base of over 190 Swoop systems globally[52] - The company estimates a potential US Swoop system revenue of $100 million for every 1.5% market penetration[54] Financial Performance - Q3 2025 revenue reached $3.4 million, representing a 27% sequential increase[58] - The effective average selling price (ASP) for the Swoop system in Q3 2025 was approximately $360,000[58] - Cash burn decreased to $5.9 million in Q3 2025, a 27% reduction compared to the previous quarter[59]