SoniVie is a medical device company developing a system for the treatment of pulmonary hypertension (PAH). The companys therapeutic intravascular ultrasound (TIVUS) is a dedicated therapeutic catheter that offers a treatment for PAH. The 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 the disease progression. In March 2016, SoniVie successfully completed the first two procedures in its phase 1 multicenter clinical trial. The TIVUS system is currently approved for sale in markets regulated by the CE mark. In September 2019, the TIVUS system received a breakthrough device designation by the FDA for use in the treatment of pulmonary arterial hypertension, and in December 2020, the system received a breakthrough device designation for use in renal artery denervation for the treatment of resistant hypertension.