Osprey Medical dives on failed trial despite FDA wins

Australian investors, reacting today to news that Osprey Medical (ASX:OSP) failed to meet a key endpoint in a clinical trial, took OSP shares down by some -55% today. The plunge came despite news that the FDA approved expanded claims for Osprey’s Avert device, which is designed to reduce and monitor the amount of contrast agent injected during angiographic heart and peripheral vascular imaging procedures. Avert won 510(k) clearance from the FDA in August 2014 under a”controlled infusion of dye” indication and soon began a clinical trial aimed at expanding the indication to include “reduction of contrast-induced nephropathy” in angiography or stenting patients. But the trial failed to show a significant difference in contrast-induced nephropathy between the cohort treated with Avert and the control group, the Melbourne-based company said today. That prompted a massive selloff that sent OSP shares down -55.2% to a close of just A30¢ apiece today on the Australian stock exchange. The company vowed to expand a pilot sales program it started in Texas by hiring another 5 direct sales reps before the end of the year and said it’s fielded interest from “2 leading medical device companies” for worldwide sales & marketing rights for its its line of dye-saving devices. “The company will access this inbound interest prior to scaling up its sales force to 20 reps in 2016,” Osprey Medical said. “We are thrilled to ha...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Clinical Trials Food & Drug Administration (FDA) Imaging Regulatory/Compliance Wall Street Beat Osprey Medical Source Type: news