Sydney, Nov 22, 2007 AEST (ABN Newswire) - The Annual General Meeting of Ventracor Limited was held in Brisbane on 24 October and was well attended. We were very grateful and pleased to see the continuing interest and support by our shareholders. All resolutions put to the meeting were passed.
The presentation by our Chairman, John Massey, and the slides of my presentation to the AGM, can be found on our website http://www.ventracor.com
in the section labelled 'News Room'. This newsletter contains some of the points of interest from the meeting.
Growing positive clinical results
The clinical results achieved with the VentrAssist have been very pleasing. With the longest duration implant now in excess of three years, our confidence in the long-term performance of the VentrAssist is growing.
We monitor clinical performance in many ways. The most commonly accepted scientific method is called a Cumulative Survival Curve, as shown above. This plots the number of people still alive after implant of the VentrAssist.
The current data show that about 83% of patients implanted with a VentrAssist are still alive at six months, and over 75% are still alive at one year.
For comparison, this type of patient would expect a 50% chance of dying within one year without the VentrAssist.
Many physicians are now saying that data like this shows that LVAD implantation can be expected to provide the same survival benefit as a heart transplant. Clinical results of the VentrAssist are being published and presented in the scientific journals more and more. The clinical results of the CE Mark Trial were published in the prestigious European Journal of Cardio-Thoracic Surgery in October, and several presentations have been accepted for the International Society of Heart & Lung Transplantation in Boston in April 2008.
US clinical trial progress
There are 10 clinical trial sites in the United States that have performed at least one implant of the VentrAssist. With surgical training scheduled for more sites in the coming weeks, we are confident that there will be over 20 sites ready to implant by the end of this calendar year. Of course, the time of first implant for each site depends on patient needs.
There has been good progress in our US Bridge to Transplant (BTT) Pivotal Trial, and we anticipate US Food and Drug Administration (FDA) approval in 2010. At the time of writing, there have been 18 patients enrolled in the BTT Trial out of an expected enrolment of about 140 patients.
The FDA has given unconditional approval for the Bridge to Transplant (BTT) Trial, and conditional approval for the Destination Therapy (DT) Trial. The process of getting a clinical trial site up and running includes negotiation of several contracts, and approval of the clinical protocol and patient informed consent by the Institutional Review Board (IRB), or Ethics Committee, for each trial.
This paperwork burden is substantially complete, and we are seeing growing momentum in enrolment as more sites come online.
Ventracor is one of two companies leading the growth of the US Destination Therapy market, and we are narrowing the gap on the leader. We hope for FDA approval of the VentrAssist for the DT indication in 2012. At the time of writing, eight patients have been enrolled in the DT Trial out of an expected 225 patients total.
New product innovation
We have a future product pipeline building on the VentrAssist technology platform. The VentrAssist is still the only third-generation LVAD, and the only centrifugal LVAD in clinical trials in the US. There have been more implants of the VentrAssist than all other centrifugal pumps from all other competitors combined, and the gap between us and those that follow us is expanding.
Our Chairman stated at the AGM that 'we consider that the VentrAssist has an optimum combination of design parameters, including size, to be the basis for Ventracor's future commercial success.'
We have announced three major future releases in our product pipeline. The first, called LVA4, has a replaceable wire from the battery pack and controller to a connector that sits just outside the skin. This connector is attached to a wire which passes through the skin to the implanted pump. Previously, the cable was permanently connected to the pump so inadvertent damage to the cable might necessitate replacement of the pump or repair of the cable. We projected that the first implants of LVA4 would be by the end of 2007 but are very pleased to report the first three patients have been implanted under the Special Access Scheme (SAS) in Australia.
We anticipate that we will soon receive regulatory approval to sell the LVA4 in Europe and Australia and to introduce the LVA4 into both of our clinical trials in the US.
There has been good progress on the next version of external controller and battery pack, which is designed to be smaller, lighter, and provide longer battery life, and we hope will be appreciated by patients as improving overall quality of life. The goal of a fully implantable system with rechargeable implantable battery and implanted controller is in sight, with excellent progress on the technology building blocks. We have also been active in protecting our intellectual property and our portfolio continues to grow.
Financial performance
Our revenues are growing as the number of implants of the VentrAssist increases worldwide. We expect the revenue growth to be trending steadily upwards, although there will be some variability month to month as clinical trials gain momentum. We carefully control our expenditure and monitor our cash position.
Outlook
There is growing validation of the market for LVADs, and a key event is coming up on 30 November with the FDA Panel meeting for the HeartMate II for Bridge to Transplant (BTT) which, we anticipate, will lead to market approval in 2008 and rapid growth of the market. US investment analysts see Ventracor as poised to benefit from this market expansion. We project that by the end of June 2008, we will be able to report between 300 and 400 cumulative implants of the VentrAssist worldwide. This means between 170 and 270 devices implanted in FY2008. Note that devices implanted in the US as part of the clinical trials are sold at full value.
Continuing Communication
We are committed to providing regular and informative communications to our shareholders. As an ASX listed company, we take seriously our obligations for continuous disclosure. We also recognise there are times when shareholders would like to learn of progress at Ventracor in a less formal manner. Therefore, we will continue to provide updates like this, from time to time.
We are proud of our achievements at Ventracor and are always pleased when shareholders take time to visit and see our worldclass manufacturing facility. Please contact our investor relations department on +61-2-9406-3100 or email info@ventracor.com to register your interest.
Peter CrosbyChief Executive Officer and Managing Director
Contact
T: +61 2 9406 3100
F: +61 2 9406 3101
E: info@ventracor.com
W: www.ventracor.com
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