First PAH Patients Treated with TIVUS Catheter System in Initial Clinical Trial

SoniVie recently announced that it has completed the first two procedures in an initial clinical trial evaluating TIVUS system (Therapeutic Intra-Vascular Ultrasound) for the treatment of pulmonary arterial hypertension (PAH).

TIVUS is a therapeutic catheter inserted into the pulmonary artery to selectively damage nerves associated with PAH disease activity, without touching vessel walls or injuring nearby tissues. Its goal is to slow disease progression.

The two procedures were executed as part of a multicenter, non-randomized, open-label trial to assess the safety, performance, and initial effectiveness of the TIVUS system when used for pulmonary artery denervation through subjective and objective changes in clinical parameters and hemodynamic evaluation. The procedures were performed at the Hôpital Erasme in Brussels, Belgium, by Dr. Pr. Jean-luc Vachiery.

The study (clinical trial NCT02516722) will be conducted in up to five centers and recruit a total of 15 people diagnosed with PAH, functional class III, whose disease is stable and are on a regular drug regimen of two PAH-specific medications.

“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,” Assaf Bernstein, CEO of SoniVie, said in a press release.

Pulmonary hypertension is an increase of blood pressure in the pulmonary artery, pulmonary vein, or pulmonary capillaries, together known as the lung vasculature. The condition can lead to shortness of breath, dizziness, fainting, and leg swelling, among other symptoms. Pulmonary hypertension can be a severe disease, with a marked decrease in exercise tolerance. Elevated pulmonary-artery pressure leads to a deterioration in the heart’s functioning.

SoniVie, based in Israel, was established by Accelmed as part of its Targeted Innovation investment plan, using technology originally developed for renal denervation to control systemic blood pressure. Accelmed has invested $3 million to date in SoniVie, a startup. Cardiologist Dr. Martin Leon from the Center for Interventional Vascular Therapy at Columbia University Medical Center/New York-Presbyterian Hospital is the new company’s medical director.