Sonivie Ltd. has won breakthrough device designation from the U.S. FDA for the Therapeutic Intra-Vascular Ultrasound (TIVUS) system for renal artery denervation (RDN) to treat resistant hypertension. At the same time, the company revealed that it has bought the remaining intellectual property and other assets related to the use of the TIVUS System from Cardiosonic Inc.

DUBLIN – Shares in Pluristem Therapeutics Inc. were down 40% by midday Dec. 9 on news that it was terminating a pivotal phase III trial of its allogeneic, placenta-derived cell therapy, PLX-PAD, in critical limb ischemia (CLI), following a futility analysis, which concluded that the study would be unlikely to meet its primary endpoint.