why this is so good! They continue to lie about animal trials I would suspect that HTW has in fact done more animal trials than big gut brick device VCR.
For those who care this is the truth from the company:
During the period following the release of the prospectus and in the six weeks since listing on the
Australian Stock Exchange, HeartWare has continued to focus on activities which will lead to the start of
clinical trials of the HVAD.
I am pleased to advise you that we have completed the sequence of preclinical implants prior to the
initiation of the final series of studies to be conducted under the Good Laboratory Practice (GLP)
standard. You may recall that these GLP studies are an important precursor to an application to the US
Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE) to implant the
HVAD in humans. The GLP studies are a formal requirement for the clinical trials, although they are not
intended to provide new information about the performance of the HVAD.
The 90 day GLP studies will begin this month. In addition, we have also recruited an experienced
specialist to manage the HVAD preclinical study program.
It is of note that in the preclinical studies to date, we continue to use no anticoagulation following the
operative period and have found no evidence of thrombus formation in the HVAD. Further, we have seen
very low levels of haemolysis, which indicates that the HVAD causes no significant mechanical damage
to the blood as it passes through the pump. In combination, these observations suggest that the HVAD
will meet its design criteria with respect to haemocompatibility in clinical use.
HeartWare remains confident of success and believes the Ventracor complaint to be defective and
improper, although there can be no guarantee that the case will be dismissed and it may progress to be
heard on its merits. HeartWare, Inc. will continue to defend this action by Ventracor. Shareholders will
be informed of any substantial events related to the litigation between HeartWare and Ventracor.
Importantly for our investors, HeartWare is firmly of the opinion that defence of Ventracor’s action will
not materially impact our cash flow or prevent our ability to carry forward the plans as presented in the
prospectus.
It is not our choice to be involved in the legal action with Ventracor. It is particularly disappointing, given
that the demand for these products will not be satisfied for several years, by which time the clinical
community would already have made their choice as to which device is best suited for their patients.
Shorter operating time, lower levels of haemolysis and reduced use of anticoagulants will be the
determining factors in this choice.
Summary
At HeartWare, we believe our HVAD implantable cardiac assist device has the potential to substantially
reduce the morbidity and mortality associated with heart failure, one of the leading causes of death in the
developed world. The market for these devices is large and growing: approximately 100,000 end-stage
heart failure patients worldwide could benefit from HeartWare’s HVAD.
We will continue to keep you informed of developments.
HTW
heartware limited
