DeepCure Applies for US FDA IDE for Laparoscopic RDN Medical Device..."Global Clinical Trial Launch"

DeepCure, developing the world's first laparoscopic renal denervation (RDN) medical device 'HyperQure™' for resistant hypertension treatment, is entering global clinical trials.

On the 8th, DeepCure announced that it has submitted an Investigational Device Exemption (IDE) application for HyperQure to the U.S. Food and Drug Administration (FDA). Through this, the company plans to actively pursue not only domestic but also global clinical trials.

The upcoming clinical trial will be conducted as a prospective, multicenter, single-arm, open-label study. At major U.S. university hospitals including △ University of Arizona △ Stanford University △ Emory University Medical Center △ University of Pennsylvania Hospital △ Mayo Clinic △ University of California, Irvine (UC Irvine), the efficacy and safety of HyperQure will be evaluated in 15 patients with resistant hypertension.

HyperQure is a medical device that uses a high-frequency electrode-equipped instrument to laparoscopically block the sympathetic nerves around the renal artery. It approaches from outside the blood vessel, completely blocking the renal nerves without damaging the vascular endothelium, thereby treating resistant hypertension.

Notably, HyperQure is classified as a Class III medical device by the FDA and is subject to Premarket Approval (PMA). PMA is a very stringent medical device marketing process, and until now, no domestic medical device has undergone the PMA procedure. If HyperQure proceeds with the PMA process, it will be the first in Korea.

A DeepCure representative stated, "We confirmed the safety and excellent efficacy of HyperQure through two domestic clinical trials. If this IDE is approved, we will accelerate entry into global clinical trials and commercialize the world's first laparoscopic RDN device."

Meanwhile, the company successfully completed a second clinical surgery using HyperQure earlier this month following one in February, demonstrating its safety and efficacy. Both patients who underwent the laparoscopic RDN surgery immediately experienced blood pressure reduction to normal levels.

This content was produced with the assistance of AI translation services.