DeepCure Achieves Milestone in U.S. Clinical Trial
DeepCure announced on the 20th the successful completion of the first patient surgery for HyperCure, the world's first laparoscopic renal nerve block (RDN) device, in a U.S. clinical trial. This groundbreaking surgery took place on the 17th at the University of California, Irvine, under the supervision of Professor Pengbo Jiang. Notably, this procedure marked the first use of a single-hole robot (da Vinci SP) in both domestic and international clinical trials for HyperCure.
About HyperCure
HyperCure is designed as a treatment device for resistant hypertension, utilizing radio frequency electrodes to block sympathetic nerves through a laparoscopic approach. This innovative method allows for the complete blockage of the renal nerve without causing damage to the patient's vascular endothelium. Clinical trials are currently being conducted in both Korea and the United States, with the goal of securing approval for the world's first laparoscopic RDN device.
Clinical Trial Progress
In addition to the University of California, Irvine, the U.S. clinical trials are being conducted at seven major university hospitals across the country. DeepCure plans to finalize the approval of the IRB (Medical Research Ethics Review Committee) for these clinical trials and complete the enrollment of 15 clinical patients within the first half of the year. Following this, the company aims to apply for a U.S. licensed clinical study (Pivotal Study) by the end of the year to further corroborate the safety and effectiveness of HyperCure.
Future Outlook
A DeepCure official expressed optimism about the trial's progress, stating, "The successful completion of the first patient surgery in the U.S. clinical trial, particularly with the application of a single-hole robot, is expected to accelerate the clinical progress and utilization of HyperCure." HyperCure is classified as a U.S. Food and Drug Administration (FDA) Medical Device Class III and is undergoing its first clinical trial for pre-marketing approval (PMA) in Korea. The approval of the PMA procedure, which involves rigorous screening and evaluation, is anticipated to establish high entry barriers, including securing exclusive rights to clinical data for six years.
This development represents a significant step forward in the treatment of resistant hypertension, offering hope for patients and advancing the field of medical device innovation.
