DeepCure's Laparoscopic RDN Device 'HyperCure' Clinical Trial Progresses Smoothly... "Third Patient Surgery Successful"

DeepCure's laparoscopic renal denervation (RDN) medical device 'HyperQure™', the world's first of its kind, is progressing smoothly in domestic clinical trials.

DeepCure announced on the 28th that it successfully completed surgery on the third clinical trial patient using HyperQure. This clinical trial was conducted by the team of Professors Han Woong-kyu and Kim Joong-sun at Yonsei University Medical Center Severance Hospital.

The patient participating in this trial suffered from resistant hypertension, experiencing difficulty controlling blood pressure despite taking three or more antihypertensive medications. Immediately after the laparoscopic RDN surgery using HyperQure, the patient's blood pressure was regulated within the normal range, and the patient was discharged on the second day after surgery, the 27th.

DeepCure explained that since the first hypertensive patient in February, all three clinical trials have been successfully completed. Domestic clinical trials for HyperQure are currently underway at seven institutions: Seoul National University Hospital, Severance Hospital, Hwasun Chonnam National University Hospital, Hanyang University Hospital, Seoul St. Mary's Hospital, Asan Medical Center, and Bundang Seoul National University Hospital.

HyperQure is the world's first laparoscopic RDN medical device that treats hypertension by blocking the sympathetic nerves around the renal artery using a device equipped with a radiofrequency electrode. It perfectly blocks the renal nerves without damaging the vascular endothelium, enabling treatment of resistant hypertension patients whose blood pressure cannot be controlled with medication.

A DeepCure representative stated, “The success of the three surgeries has accelerated the progress of clinical trials. We will strive to complete the registration of domestic clinical trial patients within this year to provide new treatment opportunities for patients with resistant hypertension.”

They added, “Along with the smooth progress of domestic clinical trials, we are making thorough preparations for the approved U.S. clinical trials to obtain approval as the world's first laparoscopic RDN device.”

Meanwhile, on June 6, DeepCure received approval for the Investigational Device Exemption (IDE) for HyperQure from the U.S. Food and Drug Administration (FDA). HyperQure is known to be the only domestic medical device currently pursuing U.S. clinical trials through the premarket approval (PMA) process. Receiving IDE approval alone is considered recognition of substantial scientific evidence and completeness of non-clinical experimental data. If final approval of the medical device is obtained through the PMA process, exclusive rights to clinical data for six years will be granted, establishing a high entry barrier.