While VCR talks about finishing trials in hope of applying for a licence to sell in Europe and dreams of one day hoping to trial and seek US approval the sector horse has bolted:
OTTAWA, Sept. 16 /PRNewswire-FirstCall/ - (NASDAQ: WHRT, TSX: WHT) World
Heart Corporation ("WorldHeart" or the "Company") has completed the financing
that was initially announced on September 10, 2004.
On September 15, 2004 WorldHeart issued five-year unsecured convertible
debentures and warrants for gross proceeds of US$13,318,750 through a private
placement. ...
"This is an important step for WorldHeart as we begin to accelerate
enrollment under our RELIANT Trial, which we believe will prove to be a
landmark device-to-device study of the use of ventricular assist devices as
destination therapy for late-stage congestive heart failure. In addition to
the primary endpoint of survival, the study will evaluate health status and
cost-effectiveness, which will provide important data for the expanded use of
long-term mechanical circulatory support", commented WorldHeart President and
Chief Executive Officer Jal S. Jassawalla.
"We are also particularly pleased that the majority of the investors in
this financing are existing shareholders of WorldHeart," continued Mr.
Jassawalla.
About Novacor(R) LVAS
---------------------
Novacor LVAS is an implanted electromagnetically driven pump that
provides circulatory support by taking over part or all of the workload of the
left ventricle. There have been no patient deaths attributed to device failure
in more than 1,500 implants. Many recipients have lived with their original
pumps for more than four years - statistics unmatched by any other implanted
electromechanical circulatory support device on the market.
Novacor LVAS is commercially approved as a bridge to transplantation in
the U.S. and Canada. In Europe, the Novacor LVAS has unrestricted approval for
use as a bridge to transplantation, an alternative to transplantation and to
support patients who may have an ability to recover the use of their natural
heart. In Japan, the device is commercially approved for use in cardiac
patients at risk of imminent death from non-reversible left ventricular
failure for which there is no alternative except heart transplantation.
About the RELIANT Trial
-----------------------
The RELIANT Trial will evaluate the Novacor LVAS for Destination Therapy
use by patients suffering from irreversible left ventricular failure who are
not candidates for transplantation. Recipients will be randomized, on a 2:1
basis, to receive the Novacor LVAS or the HeartMate(R) XVE LVAS.
The objective of the Trial is to demonstrate that use of Novacor LVAS is
superior to optimal medical therapy by demonstrating equivalence to HeartMate
XVE LVAS, which has been evaluated and approved for such use. Novacor LVAS has
Category B status under the existing IDE that permits reimbursement by the
Centers for Medicare and Medicaid Services (CMS) for implants within the
Trial.
VCR
ventracor limited
