South Korea’s DeepQure Advances Global Clinical Trials for Innovative RDN Technology

DeepQure Inc., a pioneering medical device company, is advancing global clinical trials for its novel extravascular renal denervation (RDN) technology, HyperQure™, aimed at treating resistant hypertension.

Following FDA Investigational Device Exemption (IDE) approval, DeepQure initiated an Early Feasibility Study (EFS) in the United States, enrolling 15 patients across major university hospitals, including Stanford University, Mayo Clinic, Emory University, University of Arizona, and University of California, Irvine. The HyperQure™ system employs a laparoscopic approach to deliver radiofrequency energy directly to the sympathetic nerves surrounding the renal artery, potentially enhancing procedural effectiveness and reducing recurrence rates.

Initial results from the ongoing First-in-Human HyperQure™ trial in Korea demonstrate significant blood pressure reduction in patients with resistant hypertension, with no adverse events reported during or after treatment.

"We are thrilled that the FDA has approved our IDE study plan. This is a significant US regulatory milestone for DeepQure Inc., starting the feasibility study using the extravascular ablation platform in the US for the Renal Denervation indication. We will accelerate our global clinical trials with this IDE approval," said Chang Wook Jeong, co-founder and Chief Medical Officer of DeepQure Inc.