Israeli startup SoniVie, which has developed a novel system for the treatment of pulmonary arterial hypertension (PAH), announced today that it has successfully completed the first two procedures for its First In Human (FIH) multi-center clinical trial.
Based in Rosh Ha'ayin, SoniVie has developed a dedicated therapeutic catheter (TIVUS - Therapeutic Intra-Vascular Ultrasound) that offers a unique treatment for PAH, a progressive and fatal illness with no cure, to date. Patients with this disease have an average life expectancy of five years. Procedures were performed as part of a clinical study which will include 15 patients in leading centers in Europe (Belgium, UK, Austria) and Israel with a 1 year follow up period. The first procedures were performed by Dr. Pr. Jean-luc Vachiery, at Hôpital Erasme, Brussels Belgium, a large center in Europe for the treatment of pulmonary hypertension.
SoniVie was founded by Israeli medical device investment fund Accelmed, as part of its Targeted Innovation investment model. Following the recommendation of Accelmed cofounder and chairman Mori Arkin, and leading cardiology experts, technology originally developed for renal denervation to control systemic blood pressure for Cardiosonic Inc., was identified and spun out into the field of pulmonary hypertension. Dr. Martin Leon from the Center for Interventional Vascular Therapy Columbia University Medical Center / New York-Presbyterian Hospital, a cardiologist who is considered the world's most influential interventional cardiologist, is Sonievie's medical director. To date, Accelmed has invested $3 million in SoniVie.
Pulmonary hypertension results in stiffening of the lung's small blood vessels. This causes elevated pulmonary-artery pressure leading to deteriorated functioning of the heart, and an average survival rate of five years. In the US alone there are five million patients suffering from PAH while current drug treatments are suited only to a small sub group of several tens of thousands of patients. The market potential is estimated at $6.5 billion.
SoniVie’s TIVUS catheter is inserted into the pulmonary artery, in a catheterization procedure, and selectively damages nerves associated with disease activity without touching the vessel walls or damaging the adjacent tissues. This treatment may significantly slow down the disease progression.
SoniVie CEO Assaf Bernstein said: "We are excited about the completion of the first two therapeutic procedures in patients. The clinical team will monitor the patients in accordance with the clinical protocol and we hope to report clinical improvement in these patients and others over the coming year."
In October 2015 SoniVie won first prize in the innovative companies’ competition at the TCT 2015 - most meaningful interventional cardiology conference held in the US.
Published by Globes [online], Israel business news - www.globes-online.com - on March 8, 2016
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