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WorldHeart starts VAD trial

This article was originally published in The Gray Sheet

Executive Summary

Human implantation of the firm's rotary ventricular assist device (VAD) occurred March 8 in Greece, kicking off a feasibility trial for the device. WorldHeart will seek a bridge-to-transplant indication initially, but eventually aspires to sell the device as a destination therapy. The firm received approval from the Greek Ministry of Health to begin the trial in February (1"The Gray Sheet" Feb. 20, 2006, In Brief)...

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WorldHeart raises $14 mil., cuts costs: Private placement of common stock valued at $14.1 mil. will help fund operations into the second quarter of 2008, including initiation of U.S. trials of the firm's "fourth generation" Levacor rotary ventricular assist device, WorldHeart says. The study is slated to begin in the "latter part of 2007." In March, the firm commenced a European feasibility trial of the continuous-flow pump, touted by WorldHeart as "the only bearingless, fully magnetically levitated implantable centrifugal rotary pump in trials" (1"The Gray Sheet" March 20, 2006, In Brief). In conjunction with the private placement, announced Nov. 14, the firm unveiled a cost containment plan that will include a 50% workforce reduction totaling 50-55 employees. WorldHeart is experiencing waning demand for its first-generation Novacor pulsatile left ventricular assist system, used as a bridge-to-transplant in heart failure patients. Third quarter corporate sales of $1.4 mil. were down 35% from a year ago. A net loss of $7.6 mil. in Q3 compares to a loss of $28.1 mil. a year ago. The firm had $1.5 mil. in cash on hand as of Sept. 30...

WorldHeart to begin rotary VAD trial

WorldHeart announced Feb. 15 that it has received approval from the Greek Ministry of Health to begin clinical trials of its second-generation rotary ventricular assist device. WorldHeart acquired the continuous flow pump technology in February 2005 with the purchase of Medquest. The firm says that the VAD initially will be indicated as a bridge to transplant but will eventually be expanded for use as a destination therapy. Thoratec's HeartMate is the only device with FDA approval for permanent support of heart failure patients who are ineligible for transplant...

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