DeepCure, World's First Laparoscopic RDN Device Clinical Trial Progresses... 'First Clinical Patient Surgery Completed'

DeepCure, developing the world's first laparoscopic renal denervation (RDN) medical device 'HyperQure™' for the treatment of resistant hypertension, announced on the 5th that it has completed surgery on the first clinical patient.

The surgery was performed by Professor Shin Jin-ho of the Cardiology Department and Professor Jo Jung-gi's team from the Urology Department at Hanyang University Hospital. This is the first case of laparoscopic RDN surgery using HyperQure, which is expected to bring revolutionary changes in the field of hypertension treatment.

Professor Jo Jung-gi, who performed the surgery, stated, "Despite using eight antihypertensive drugs during the second screening, the patient's blood pressure was high at 175/128 mmHg, but it was controlled to 120/70 mmHg after the day of surgery," adding, "There were no side effects, so expectations for laparoscopic RDN technology are very high."

HyperQure is a resistant hypertension treatment device that uses a laparoscopic method to apply a radio frequency (RF) electrode device in contact with the renal artery to block the sympathetic nerves. It can treat resistant hypertension by perfectly blocking the renal nerves without damaging the patient's vascular endothelium.

Resistant hypertension is a condition where blood pressure is not controlled despite taking three or more antihypertensive drugs, accounting for about 10% of hypertension patients. Global medical device companies such as Medtronic are competing to develop catheter-based RDN technology. However, the catheter method has limitations such as the risk of vascular endothelium damage and incomplete nerve blockade due to its approach from inside the blood vessels.

Dr. David E. Kandzari, Chief Scientific Officer of the Piedmont Heart Institute in the United States and a member of DeepCure's Scientific Advisory Board (SAB), said, "The results of this surgery are very impressive," and added, "I hope clinical trials will proceed in the U.S. as soon as possible."

A DeepCure official said, "We have successfully completed laparoscopic RDN surgery on the first clinical patient," and added, "Starting with this domestic clinical trial, we will make every effort to prepare for the global clinical trials scheduled for the second half of this year to develop the world's first laparoscopic RDN device."

DeepCure is currently conducting domestic clinical trials of HyperQure with major university hospitals in Korea and is preparing for global clinical trials aiming for approval of the clinical trial plan by the U.S. Food and Drug Administration (FDA) in the first half of this year.