DeepCure, HyperCure Successfully Complete Surgery on Fourth Clinical Patient "Fully Prepared for Global Clinical Trials"

DeepCure announced on the 8th that it has successfully completed the fourth clinical patient surgery using the laparoscopic renal denervation (RDN) medical device 'HyperQure™,' led by Professor Janghee Han from the Department of Urology and Professor Hyungkwan Kim from the Department of Cardiology at Seoul National University Hospital.

A company representative stated, “With the successful completion of four clinical surgeries so far, the safety and efficacy of HyperQure are being demonstrated. In this latest clinical case, although the patient was taking six antihypertensive medications before surgery without blood pressure control, after surgery, the patient was discharged maintaining normal blood pressure without any antihypertensive medication, confirming the high effectiveness of HyperQure.”

HyperQure is a medical device that treats hypertension by blocking the sympathetic nerves around the renal artery using a laparoscopic method with a device equipped with a radiofrequency electrode. Since January, domestic clinical trials of HyperQure have been underway targeting patients with hypertension.

Along with the successful progress of domestic clinical trials, preparations are being accelerated for global clinical trials scheduled for the second half of this year. Following the approval of HyperQure’s Investigational Device Exemption (IDE) by the U.S. Food and Drug Administration (FDA) in June, a workshop for U.S. principal investigators (PIs) was also successfully completed.

This PI workshop, the second event following last year’s, was held over two days starting on the 28th of last month (local time). Clinical surgeons (urology) and hypertension specialists (nephrology or cardiology) from the University of California, Irvine campus, Stanford University, Emory University, and Mayo Clinic, who are participating in the clinical trials, attended. The researchers engaged in in-depth discussions on clinical design and conducted cadaver surgery training using HyperQure.

The representative added, “As the first domestic medical device to conduct the FDA’s most stringent premarket approval (PMA) clinical trial, more thorough preparation is required. We will do our best to actively cooperate with the PIs to successfully carry out the U.S. clinical trials.”

Meanwhile, DeepCure is a medical device specialist company that developed the world’s first laparoscopic RDN medical device, HyperQure. HyperQure is classified as a Class III medical device by the FDA and plans to proceed with approval under the PMA process for the first time in Korea.

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