WorldHeart Ends Levacor VAD Development to Focus on Miniature VAD


August 2, 2011

August 2, 2011 – WorldHeart, which is developing ventricular assist devices designed for adults, children and infants suffering from heart failure, announced that it will cease its efforts to commercialize the Levacor ventricular assist device (VAD) technology and will focus its resources on developing and commercializing its smaller, next-generation MiFlow VAD.

With the lengthening bridge to transplant (BTT) clinical study delay associated with the previously announced device refinements, WorldHeart does not believe that the Levacor VAD can be competitively commercialized. Therefore, WorldHeart will focus its resources on the smaller, next-generation technologies of the PediaFlow and MiFlow VADs, both in development. This decision means that the company will not pursue further enrollment in the Levacor BTT clinical study. However, the company will continue to provide technical support to existing Levacor VAD recipients and clinical centers. In conjunction with this decision, WorldHeart also announced that it would reduce its workforce by 42 percent. It expects its existing capital resources to be sufficient to allow it to adequately advance the MiFlow program through mid-2012.

The MiFlow VAD is a miniature device slightly larger than the size of an AA-battery and is being designed to provide up to 6 liters of flow per minute. WorldHeart believes that the small size of the MiFlow VAD will reduce the invasiveness of traditional VAD surgery and speed patient recovery. The small size is the result of using the company's proprietary MagLev technology, which includes recent breakthroughs in miniaturization as WorldHeart has been developing its pediatric VAD, the PediaFlow. The PediaFlow VAD has been in development since 2005 and has been supported by two grants from the National Institutes of Health.

"We are very encouraged by the preliminary preclinical findings on the PediaFlow VAD. We believe that the MiFlow VAD and PediaFlow VAD are likely to have similar blood handling characteristics to the Levacor VAD with respect to the reduction or elimination of acquired von Willebrand deficiency, which is believed to be a significant contributor to bleeding complications and hemorrhagic stroke," said Alex Martin, president and CEO.

Martin further noted, "The MiFlow VAD represents a major step in size reduction. We believe it will ultimately support a larger patient population than the late-stage heart failure population alone.  We are currently working on a MiFlow VAD prototype and expect to begin conducting animal studies with the MiFlow VAD by mid-2012 and human clinical trials in Europe by 2013."

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