Medinol Ltd. develops and markets stents and delivery systems for use in the field of interventional cardiology. Its products include NIRxcell, a stent that supplies additional flexibility and enhanced conformability to the vessel’s shape while maintaining its scaffolding capabilities; and X-SUIT-NIR, a self-expanding biliary stent that enables trackability and minimized tissue trauma upon insertion. Medinol Ltd. was founded in 1992 and is based in Tel Aviv, Israel.
Bldg. #7, Entrance A
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Founded in 1992
ARIAD and Medinol Announce Initiation of Two Registration Trials of the Nirsupreme(TM) Ridaforolimus-Eluting Stent for Use in Coronary Artery Disease
Jan 14 14
ARIAD Pharmaceuticals Inc. announced the initiation of two registration trials of Medinol's NIRsupreme(TM) Ridaforolimus-Eluting Coronary Stent System incorporating ARIAD's mTOR inhibitor, ridaforolimus. The two NIRsupreme clinical trials are randomized, single-blind, global studies taking place in the United States, Europe, Israel and Canada and will enroll approximately 2,200 patients with coronary artery disease. ARIAD licensed ridaforolimus to Medinol for use in drug-eluting stents in 2005. Drug-eluting stents (DES) are now implanted in over 500,000 patients yearly in the United States. The commencement of patient enrollment in Medinol's clinical trials, along with the submission of an investigational device exemption with the U.S. Food and Drug Administration, triggers milestone payments to ARIAD of $3.75 million, with the potential for additional regulatory, clinical and sales milestones, as well as royalties on product sales. The BIONICS trial aims to show that the NIRsupreme stent is comparable (non-inferior) to a comparator drug-eluting stent with the primary endpoint of coronary target lesion failure (a composite of cardiac death, target vessel myocardial infarction or ischemia-driven target lesion revascularization) at 12 months. This trial is expected to enroll approximately 1,900 patients. The NIREUS trial aims to demonstrate angiographic non-inferiority of the NIRsupreme stent to a comparator stent and has a primary endpoint of late loss in lumen diameter within the stent determined by coronary angiography at six months. This trial is expected to enroll approximately 300 patients. ARIAD entered into a non-exclusive agreement with Medinol to develop and commercialize stents and other medical devices to deliver ridaforolimus to prevent reblockage of injured vessels following stent-assisted angioplasty. ARIAD is eligible to receive additional regulatory, clinical and commercial milestones of up to $34.75 million, if two products are developed, plus royalties on worldwide product sales. ARIAD is responsible for supplying ridaforolimus to Medinol, and Medinol is responsible for the development and commercialization of the medical devices delivering ridaforolimus. These rights are separate from those licensed to Merck for use of ridaforolimus in oncology.