Shanghai Bio-heart Biological Technology Co., Ltd. announced that the RCT of the Company's Iberis ® 2nd Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System in patients with Essential Hypertension ("Iberis-HTN") has achieved its primary clinical endpoint according to the Statistical Report that the Company has just received. The Company will continue its efforts to obtain the clinical research report as soon as possible for the submission of product registration application. The board of directors of the Company (the "Board") announced that the RCT of the Company's Iberis ® 2nd Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System in patients with Essential Hypertension ("Iberis-HTN") has achieved its primary clinical endpoint according to the Statistical Report that the Company has just received.

The Company will continue its efforts to obtain the clinical research report as soon as possible for the submission of product registration application. Iberis-HTN is a prospective, multicenter, blinded, randomized controlled trial to evaluate the safety and efficacy of the Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System for the treatment of essential hypertension, with the control group in the trial receiving a sham procedure (Renal arteriography). The trial aims to evaluate the safety and efficacy of the Company's Iberis ® 2nd Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System for the Treatment of Essential Hypertension.

A total of 217 subjects were enrolled in the trial. The results from the trial showed that the primary clinical endpoint of change in mean systolic blood pressure from baseline during 24-hour ambulatory blood pressure at 6 months after the procedures in the test group achieved the primary clinical endpoint of efficacy and was significantly superior to that in the sham control group. In this study, the safety of patients receiving RDN procedures using the Iberis ® 2nd was similar to that of patients receiving sham procedures, with no increased risk of adverse events, and there were no serious adverse events related to the device trialed.

RDN is one of the few device therapies with proven clinical efficacy to treat uncontrolled hypertension and resistant hypertension and is considered by many industry experts as having the potential to transform the treatment paradigm of hypertension. According to Frost and Sullivan (Beijing) Inc., Shanghai Branch Co. ("Frost & Sullivan"), Iberis ® 2nd is expected to be the first approved multi-electrode RDN product in China.