Intravascular lithotripsy generally scores well for removal of calcification, but the U.K. National Institute for Health and Care Excellence (NICE) is offering only limited endorsement of this procedure for peripheral artery disease (PAD). NICE said one of the problems with the evidence is that this procedure is often conducted in conjunction with other procedures, and thus the agency will have to see more definitive evidence before an unequivocal endorsement is justified.
DUBLIN – Sanifit Therapeutics SA has found a taker for its phase III calcification inhibitor for kidney dialysis patients, SNF-472, in the shape of Vifor Pharma AG, which is acquiring the Spanish company outright for €205 million (US$231 million) up front, up to €170 million in potential clinical development, regulatory and market access milestones, as well as undisclosed commercial milestones.
PARIS – Cardiawave SAS has been granted authorization by the French National Agency for Medicines and Health Products Safety to extend its clinical trial in France and treat patients with calcific aortic stenosis (AS).
Shockwave Medical Inc., which is focused on intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, saw its stock value rise Friday (NASDAQ:SWAV), eventually closing at $78.22, up $3.47, or 4.64%, following the presentation of positive results from the Disrupt CAD III trial.
Pi-Cardia Ltd. has raised a $27 million round of financing led by Sofinnova Partners. The Rehovot, Israel-based company will use the round to back parallel U.S. feasibility and European pivotal trials of its catheter-based, nonimplant heart valve calcification treatment.
Spain's Sanifit Laboratoris SL, a company developing treatments for calcification disorders, has dosed the first patient in a phase III trial of its lead asset, SNF-472, for the treatment of the rare and sometimes deadly disease calciphylaxis, a calcium accumulation disorder.