DeepQure Submits U.S. FDA IDE Application for Global Pivotal Trial of 'HyperQure' eRDN System

MedTech innovator DeepQure announced on August 5 that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to launch a global Pivotal Study under the Premarket Approval (PMA) pathway. The IDE submission marks a crucial milestone toward the U.S. commercialization of HyperQure™, its novel extravascular renal denervation (eRDN) system.

Unlike the 510(k) clearance process—typically reserved for diagnostic devices or substantially equivalent modifications—the PMA track represents the FDA’s most rigorous regulatory hurdle, mandatory for first-of-its-kind therapeutic technologies. The IDE filing builds on clinical data accumulated from DeepQure’s First-in-Human (FIH) trial in South Korea and its Early Feasibility Study (EFS) in the United States.

Across 16 initial clinical cases conducted in South Korea and the U.S., HyperQure demonstrated an outstanding safety profile, recording zero device-related Serious Adverse Events (SAEs). Furthermore, interim data from the Korean clinical trial revealed a profound mean systolic blood pressure (SBP) reduction of 50 mmHg at 12 months post-procedure. Upon receiving IDE approval, DeepQure plans to initiate a large-scale, multi-center Pivotal Study involving premier academic medical centers across the U.S., Germany, Australia, and South Korea.

The announcement follows DeepQure’s impactful presence at the Society of Robotic Surgery Annual Meeting 2026 (SRS 2026) in Miami, Florida, where its technology garnered significant attention from global surgical and urological experts. As one of the world's foremost robotic surgery congresses, SRS gathers top-tier Key Opinion Leaders (KOLs) alongside global industry giants such as Intuitive Surgical and Medtronic. Throughout the conference, DeepQure’s booth attracted a steady stream of industry executives and clinical authorities, including delegates from Intuitive Surgical.

"It is highly encouraging for a domestic MedTech startup to submit an FDA Pivotal Trial IDE via the demanding PMA pathway," said Chan Ho Park, Chairman of the Board of Directors at DeepQure. "Our participation at SRS 2026 underscored the high level of anticipation that global industry leaders and academics hold for our HyperQure eRDN system."

Park added, "By successfully executing this upcoming Pivotal Trial, we intend to solidify strategic partnerships with major global medical device corporations and maximize corporate value."

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