DeepCure Starts US Clinical Trial for Laparoscopic RDN 'HyperCure'..."IRB Approval from Major US Clinical Institutions"

DeepCure, a company specializing in laparoscopic renal denervation (RDN) devices, is entering clinical trials in the United States for a resistant hypertension treatment device.

On the 9th, DeepCure announced that it had obtained IRB (Institutional Review Board) approval for clinical trials of the laparoscopic RDN medical device 'HyperCure' from the University of California, Irvine (UC Irvine) and the Mayo Clinic.

This clinical trial will be conducted at seven major university hospitals in the United States, including UC Irvine and the Mayo Clinic. IRB approvals are currently underway at other major U.S. university hospitals, including ▲Stanford University ▲Emory University Medical Center ▲University of Arizona ▲University of Florida ▲Henry Ford Health System.

The company has completed registration of the first clinical patient through screening and plans to perform the first laparoscopic RDN surgery in the U.S. on this patient in early January. By the first half of 2025, the company also plans to complete registration of a total of 15 clinical patients.

A company representative stated, "We received FDA (Food and Drug Administration) Investigational Device Exemption (IDE) approval and obtained IRB approvals from major U.S. clinical institutions within three months. Starting with the first patient procedure in January next year, we will officially begin U.S. clinical trials to demonstrate the high safety and efficacy of HyperCure."

Meanwhile, HyperCure is the world's first laparoscopic RDN device for treating resistant hypertension. It is classified as a Class III medical device by the FDA and is conducting the first pre-market approval (PMA) clinical trial in Korea.

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