WorldHeart Will End Its Levacor(R) VAD Program and Will Focus on Developing Its Next-Generation MiFlow(TM) Miniature Ventricu...
30 July 2011 - 2:00AM
World Heart Corporation (WorldHeart)
(Nasdaq:WHRT), which is developing ventricular assist devices
designed for adults, children and infants suffering from heart
failure, announced today 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 BTT clinical study delay associated with
the previously announced device refinements, the Company does not
believe that the Levacor VAD can be competitively commercialized.
Therefore, the Company will focus its resources on the smaller,
next-generation technologies of the PediaFlow and MiFlow VADs, both
currently in development. This decision means that the Company will
not pursue further enrollment in the Levacor bridge-to-transplant
(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, the Company also
announced that it would reduce its workforce by 42%. The Company's
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. The Company 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 it has been developing
the Company's 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.
Mr. 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. Thus we believe the MiFlow VAD represents significant
clinical potential and value to our shareholders."
About World Heart Corporation
Based in Salt Lake City, Utah, WorldHeart is a developer of
mechanical circulatory support systems.
The World Heart Corporation logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7572
Any forward-looking statements in this release are made pursuant
to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995 and include all statements relating to
WorldHeart's Levacor VAD, including those related to the end of its
clinical trial and continued technical support for the device, its
change in strategy to focus on developing its next-generation
miniature MiFlow VAD and PediaFlow VAD, including those related to
the ultimate size of the devices, availability of financial
resources to adequately advance the MiFlow and PediaFlow programs,
and the timing of the clinical trials; WorldHeart's ability to
translate the Levacor VAD positive experience with the von
Willebrand factor deficiency to the MiFlow VAD and PediaFlow VAD;
the market opportunity and acceptance for the devices; the increase
in shareholder value and return; the ability to address a
wider range of patient needs; and the invasiveness of the surgery.
Investors are cautioned that all forward-looking statements involve
risk and uncertainties, including without limitation: risks
involved in the product development and clinical trials of the
MiFlow and PediaFlow VADs, including availability of financial
resources to advance the MiFlow and PediaFlow development and
clinical programs, regulatory approvals and market acceptance
of and demand for WorldHeart's products; and other risks detailed
in WorldHeart's filings with the U.S. Securities and Exchange
Commission, including without limitation its Annual Report on Form
10-K for the year ended December 31, 2010, and its Quarterly Report
on Form 10-Q for March 31, 2011.
www.worldheart.com
CONTACT: Corporate Contact:
Morgan Brown, EVP and CFO
World Heart Corporation
+1-801-303-4361
Media Contact:
Ronald Trahan, APR, President
Ronald Trahan Associates Inc.
+1-508-359-4005,x108
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