SoniVie gets IDE approval from US FDA for REDUCED1 Pilot study to treat hypertension with renal artery denervation TIVUS technology

SoniVie, a medical device company, announced that on 5th May, 2022 the US Food and Drug Administration granted IDE approval for its "REDUCED1" Pilot study to treat resistant hypertension patients with renal artery denervation using TIVUS, its innovative ultra-sound ablation system. Resistant hypertension is defined as blood pressure higher than 140/90 mmHg despite use of three antihypertensive medications of different classes at the best tolerated doses, one of which must be a diuretic. Millions of people world-wide suffer from resistant hypertension which substantially increases the risk of heart attack, stroke and kidney failure. "We are very pleased that FDA has approved the REDUCED1 (Renal Denervation using Ultrasonic Catheter EmitteD energy) study. Sites initiation has started, and many clinical teams have responded very favourably about participating to the study. There is a significant number of patients that may benefit from our technology and we are genuinely happy for this important step towards the introduction of TIVUS in the US. There is a lack of effective therapeutic solutions for patients suffering from resistant hypertension, and physicians are looking forward to a safe, effective and easy to use device treatment," says Christian Spaulding, CMO, SoniVie Ltd. "This is a significant US Regulatory milestone for SoniVie, starting the feasibility study using the Ultra-Sound ablation platform in the US for the renal denervation indication. This is a major step and priority in the company's history," says Tomaso Zambelli, CEO, SoniVie LTD. The REDUCED1 study will further expand the Company's clinical experience based on two clinical trials in Renal Denervation performed using the earlier generation of the TIVUS. Renal denervation with TIVUS is a minimally invasive procedure that uses high-frequency non-focused ultra-sound energy to ablate nerves in the renal artery. This causes a reduction in the nerve activity, which may decrease blood pressure. This procedure is designed for patients who suffer from resistant hypertension. SoniVie is a medical device company developing the TIVUS, the only ultra-sound denervation platform with active development programs in three therapeutic areas: pulmonary artery denervation for pulmonary hypertension, renal artery denervation for resistant hypertension, and lung denervation for chronic obstructive pulmonary disease with chronic bronchitis.

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