Sydney, April 3, 2008 AEST (ABN Newswire) - Ventracor Limited (ASX: VCR)(PNK: VTCRY) CEO, Peter Crosby Letter to Shareholders.
Dear Shareholder,
The first three months of 2008 have seen Ventracor make great progress, with record sales, clinical trial achievements and rapid business growth. Most importantly the clinical experience and confidence among surgeons, cardiologists and their patients with our VentrAssist Left Ventricular Assist Device (LVAD) continues to grow, and that is helping to drive adoption of our technology in more hospitals world wide.
We continue to see excellent long-term survival of patients with the VentrAssist LVAD, and many physicians have said the results are similar to the performance of the early era of heart transplants. The Numbers As of 31 March 2008:
- 22 implants worldwide for March 2008 - a record sales month
- 230 cumulative implants of the VentrAssist LVAD in 34 hospitals worldwide
- 47 implants in the US Bridge to Transplant clinical trial (34% complete)
- 20 patients enrolled in the US Destination Therapy clinical trial
- 17 hospitals in the US have performed at least one implant of the VentrAssist LVAD, out of a total of 21 centres trained and ready to go
- The longest duration patient has had approximately 3.5 years of support from the VentrAssist
US Clinical Trials Speed Ahead
Our US clinical trials continue to gain momentum, with enrolments accelerating as more new hospitals complete training and recruit their first patients. Additional hospitals will be added in the coming months. Details of the clinical trials and participating hospitals can be found at the website sponsored by the US Government, http://www.clinicaltrials.gov. Please be aware there is a time lag of a few weeks from what is happening in the field and what is found on the website.
This website will show you that we have partnered with many of the leading cardiac surgery and heart transplant hospitals in America.
Bridge to Transplant Trial
The Bridge To Transplant (BTT) Trial is designed to show the safety and efficacy of the VentrAssist LVAD in a population of patients who are on the heart transplant list but whose own heart may deteriorate before a donor heart becomes available. In this trial, the job of the VentrAssist LVAD is to provide ongoing circulatory support to keep patients alive until heart transplant. There will be 140 patients implanted in up to 40 hospitals in the BTT Trial.
As of 31 March 2008, 47 patients have been enrolled (34% complete) and we believe we are on track to complete enrolment in the fourth quarter of calendar year 2008 which is consistent with the timetable announced in early 2006.
There will be up to six months follow up of each patient, and we estimate that we will submit our clinical results by the fourth quarter of calendar 2009. Based on the history of FDA approval timing, we expect FDA pre-market approval (PMA) in the fourth quarter of calendar year 2010. Depending on the results of the clinical trial, it may be possible to complete the trial earlier than this estimated timing.
Innovative DT Trial (EVERLAST Trial)
The Destination Therapy (DT) clinical trial has an innovative design which was developed in a collaborative process of consultation with our physician advisors and the FDA, and is the subject of a patent application filed by Ventracor. We have named the trial EVERLAST (Early VERsus Late ventricular ASsist devices or medical Treatment). The EVERLAST Trial has two modules.
Module A tests the idea that implantation of the VentrAssist LVAD earlier in heart failure patients will yield superior results than continuing with drugs and waiting until the patient has deteriorated and an LVAD is needed urgently. This module will require 180 patients, of whom 120 will receive the VentrAssist LVAD, and the end point is stroke free survival with 2 year follow up.
Module B tests the idea that the performance of the VentrAssist LVAD is no worse than the performance of the Heartmate XVE in patients who need an LVAD urgently. Patients will continue to be enrolled in Module B as long as Module A is enrolling.
We received unconditional FDA approval for the DT Trial in early March, which removes an impediment to patient enrolment in some sites. It also eases some of the challenges in obtaining reimbursement for the procedure for some patients. We expect that the enrolment rate will accelerate due to unconditional approval, combined with growing VentrAssist experience physicians are gaining in the BTT trial, and the increase in the number of hospitals enrolling.
We are very pleased that Professor Mariell Jessup of the Hospital of the University of Pennsylvania in Philadelphia, has recently agreed to become the Cardiology Principal Investigator of the EVERLAST trial and believe that her appointment will contribute to its overall success. She joins Professor Lyle Joyce of the University of Minnesota in Minneapolis who is the Surgical Principal Investigator.
Excellent Clinical Results Continue
The results of the US Feasibility trial will be presented at the International Society of Heart and Lung Transplantation in Boston in early April 2008. The success rate in the 28 patients was approximately 85%, consistent with the results of the earlier CE Mark Bridge Trial. Additional scientific presentations will be made this year at the American Society of Artificial Internal Organs (ASAIO) in June, at the Heart Failure Society of America (HFSA) in September, and the European Association of Cardiothoracic Surgery in September.
European Business
In Europe, we are focussed on the major markets of Germany, Scandinavia and the UK, where there is good reimbursement and an established market. We are working towards reimbursement in France, Netherlands and Belgium. Active in all key markets, our sales team is taking share from our competitors while also growing the market with new LVAD centres.
There were 23 VentrAssist implants in Europe in the 2007 financial year, and there are 37 patients implanted so far this financial year to the end of March.
Asia/Pacific Business
Our business in Asia/Pacific continues to grow at a steady rate. We were pleased that, in March, Ash Attia started as VP Asia/Pacific Business Development. Ash has more than 20 years' experience in the medical device industry, including growing the Asia Pacific business of Biotronik (a heart pacemaker company).
The first two implants of the VentrAssist LVAD in India occurred at the Narayana Hrudayalaya Institute of Cardiac Science in Bangalore in March.
Our Strong Product Pipeline
A new version of the VentrAssist LVAD, referred to as the LVA4, has been introduced in all our markets and will replace the previous version over time. It uses the proven VentrAssist blood pump with a thinner percutaneous lead (the wire from the pump that goes through the skin) which is designed to lower the risk of infection. It also features a detachable external lead to the controller, which will allow replacement with little fuss in the event of accidental damage or wear from long term use.
We have learned from surgeons with extensive LVAD experience that even the smallest LVAD will not fit in all patients and there is a need to accommodate a range of sizes and positions of the heart. We have introduced a new more flexible outflow cannula (the tube that directs blood from the pump to the aorta) and an updated range of inflow cannulae (the tube that connects the heart to the VentrAssist pump), with more choice available in the coming months. We believe the size and flexibility of placement of the VentrAssist LVAD meets the widest range of surgical needs.
We are making good progress on the improved and enhanced external controller and battery pack, and are on track for first human use in early 2009.
Acceleration of the Development of the Fully Implantable Device
We believe that the availability of a fully implantable LVAD will accelerate the growth of the DT market to its full potential. Our fully implantable system is built on the VentrAssist technology platform, with an implantable controller and rechargeable battery connected to a Transcutaneous Energy Transfer System (TETS). Use of the TETS will eliminate the wire that goes through the skin, removing the associated infection risk, enhancing long term reliability, and improving the patient's quality of life. We have been investing in research for a fully implantable system for the last few years, and have knowledge, intellectual property and technology we intend to rapidly develop into a product ready for human use.
We have hired an R&D team based in New Jersey USA, with expertise in a fully implantable LVAD. This team is being integrated with our Sydney based R&D team as part of our evolution into a global medical device company. Animal studies of prototype parts of the fully implantable system will commence in the next month.
Looking Ahead
We will continue to keep shareholders updated with progress towards our goal of a profitable, sustainable, scalable global based medical device company. As our US clinical trials move towards regulatory approval, our competitive position becomes stronger, and we remain the only LVAD company with a global presence and operations in Australia. There continues to be more clinical experience with the VentrAssist LVAD than all other next generation centrifugal pumps combined, and the VentrAssist LVAD is the only centrifugal pump in both BTT and DT Trials in the US.
I would like to thank our exiting Chairman, Mr. John Massey, for his outstanding contribution to the Company over nearly a decade of service and wish him well for his future. We welcome our newly appointed Chairman, Mr. John Ward, a Ventracor director since August 2001, and look forward to working with him as we build on our past successes to create an even stronger future for Ventracor.
Yours Sincerely,
Peter Crosby
Chief Executive Officer and Managing Director
Contact
Angela Edwards
Investor Relations
Tel: +61(2)94063100
Web: www.ventracor.com
| ||
|
