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Biotech / Medical : World Heart Corp - WHRT and TSE/WHT -- Ignore unavailable to you. Want to Upgrade?


To: Stang who wrote (282)7/22/1999 5:04:00 PM
From: Crocodile  Respond to of 500
 
World Heart second quarter results


World Heart Corp WHT
Shares issued 14,078,743 Jul 21 close $15.00
Thu 22 Jul 99 News Release
Dr. Tofy Mussivand reports
The second quarter saw significant advances by World Heart Corporation in
bringing Heartsavervad to initial clinical use and in developing the
strength and capabilities of the corporation. With six months remaining in
this millennium, the objective of implanting the first Heartsavervad in a
human during 1999 continued to be achievable. However, on July 16, during
internal performance testing, a reliability issue arose respecting the
battery currently intended for use with the device. Full assessment of this
issue is being undertaken by World Heart and the battery supplier. In light
of the time required to complete this assessment and fully test any changes
in the battery, it is likely that preclinical trials will not be completed
in time for clinical use of Heartsavervad this year.
Operating financial results for the quarter were again better than
forecast, with no revenues reported and expenses below budget by
approximately $396,000. The net loss for the quarter was $2,199,016, or 16
cents per share, compared with $922,671, or nine cents per share for the
second quarter of 1998. As budgeted, research and development expenses for
the quarter, reflecting the costs of prototype production and preclinical
trials, were $1,296,910 compared with $211,664 for the second quarter last
year.
The financial condition of the corporation was strengthened with net
proceeds of $26.5-million from the sale of 1,780,548 shares from treasury
at $16.50 per share. At end of the quarter cash and securities held by the
corporation totalled $36,381,913. Total cash usage for the first six months
of the year was approximately $5.5-million, and is projected to be
approximately $10-million for the second half. The projected cash balance
of approximately $26-million entering 2000 is expected to finance the
corporation well into 2001.
Dr. Tofy Mussivand, president of World Heart, said: "Overall, activities in
the quarter added to our confidence in the success of Heartsavervad.
Although first human use will not likely occur this year, we do not
anticipate delays, which would be material in the timing of completion of
clinical trials or commercial introduction of the product."
The program to complete preparations for clinical trials progressed well
during the quarter. Seven in vivo performance tests of the final
preclinical system were conducted bringing the total of such tests to 12
for more than 70 hours of run time. The decision was made to group
long-term formal trials in the third and fourth quarters, resulting in the
two long-term trials that had been forecast for the quarter not being
performed. The absence of these trials during the second quarter does not
affect the timing of completion of the preclinical trials. These trials
will be completed 90 days following the final in vivo preclinical implant.
To provide added flexibility in managing the timing of these trials,
additional preclinical trial centres were added, bringing the total to
nine. With timely availability of systems during the third quarter, and
subject to the battery review now under way, the preclinical trial program
can be completed in the fourth quarter.
An additional 12 preclinical systems were manufactured bringing total
preclinical systems to 23. These were subjected to a range of in vitro
tests including more than 32 weeks of cumulative run time. Six of these
systems were implanted for in vivo performance tests. A further 20 systems
were in various stages of manufacturing at the end of the quarter. These
systems, together with the systems built during the second quarter, are
expected to be available for use in the preclinical trials program.
The in vivo performance tests provided satisfactory results respecting
evidence of the efficacy of the Heartsavervad system. The system is
designed to support the patient's natural heart by replacing part or all of
the pumping capacity of the left ventricle. In vivo tests indicated blood
flow rates of more than 10.5 litres per minute from the device. This
comfortably exceeds the maximum capacity of eight litres per minute,
currently accepted as a guideline.
A key factor in the success of Heartsavervad is minimization of any
thrombogenic effect of the device, potentially permitting operation with
little or no continuing use of anticoagulant. In vivo tests during the
quarter demonstrated the best results yet achieved in this regard. Earlier
prototypes had performed satisfactorily, however, a number of technical
improvements in the manufactured product appear to have further reduced
risks of thrombosis.
Operation of transcutaneous energy and information transfer (TEIT) system
was tested in the in vivo performance tests. Initial tests in this series
indicated a need for increased strength of the communication signal between
the internal electronics of the device and the external controller.
Technical adjustments were made followed by a series of in vivo tests,
which produced satisfactory results from the TEIT. The corporation believes
that this is the only VAD, which is powered, monitored and controlled
remotely without perforation in the skin and tissue. During the quarter the
corporation agreed to supply, subject to the appropriate propriety rights
and confidentiality agreement, a TEIT system to Baylor College of Medicine
for use in the college's research and development activities.
The second quarter test program identified eight items affecting
operational reliability or convenience of implantation requiring further
improvement. Action on each of these items was in process at the end of the
second quarter. Technical adjustments are being made to existing devices
and those in process.
Preparation of preclinical and clinical protocols proceeded according to
plan. Manufacturing staff increased by eight people, engineering by three
and regulatory affairs by one person.
WARNING: The company relies upon litigation protection for
"forward-looking" statements.
(c) Copyright 1999 Canjex Publishing Ltd. canada-stockwatch.com