The U.S. Federal Circuit’s denial Feb. 11 of an en banc rehearing in a case that could undermine label carveouts and slow the launch of generics is the topic of hallway chatter at this week’s annual conference of the Association for Accessible Medicines.
Abbott Laboratories reported the commencement of a pivotal clinical trial for its Aveir pacemaker in a two-device configuration to provide dual-chamber pacing without the need for leads to deliver the charge. This configuration required the development of i2i technology to ensure that the two Aveirs communicated in a manner that ensures consistent pacing, but the 500-enrollee study has a long road ahead of it before the company can finalize the application with the FDA.
Cincor Pharma Inc.’s IPO at the start of the year underlined hopes for a new way to attack treatment-resistant hypertension and related diseases, as the Boston-based firm touted what one analyst called it ‘pipeline in a pill,” CIN-107, which selectively targets aldosterone synthase to lower aldosterone levels, in turn knocking down blood pressure.
A bioelectronic device developed by U.K. startup Ceryx Medical Ltd. has shown potential to restore cardiac performance in preclinical studies. The Cardiff, Wales-based company published data showing its Cysoni technology increased cardiac output by 20% compared to current pacemakers.
Bioventrix Inc. acquired Materacor Inc., the developer of a heart failure therapy that uses an injectable alginate-based hydrogel and a minimally invasive endocardial delivery system to restructure the left ventricle and reverse or stop the progression of ischemic or non-ischemic congestive heart failure with reduced ejection faction (HFrEF). The terms of the transaction were not disclosed.
Johnson & Johnson business Cerenovus Inc. is launching a balloon guide catheter for the U.S. and Canada stroke market. The Irvine, Calif.-based company’s Emboguard device is designed to remove blood clots by controlling blood flow during mechanical thrombectomy procedures. It is the latest addition to the Cerenovus stroke portfolio, which includes the Embotrap III revascularization device, the Prowler EX microcatheter, the Cerenovus large bore catheter and Cerebase guide sheath.
PARIS – An interdisciplinary academic research consortium in Italy has devised and tested nanowires that restore physiological cell-to-cell conductance. This research team, led by the Experimental and Applied Medical Technology Lab (Tecmed Lab) at the Department of Medicine and Surgery at the University of Parma, Italy, has just published the results of multiple local in situ injections of nanowires into left ventricular infarct regions in Nature Communications.