VentrAssist LVAD
Sydney, Mar 29, 2007 AEST (ABN Newswire) - Ventracor Limited (ASX: VCR)(ADR: VTCRY) has made great progress in the last few months, and we are poised for major expansion as the year develops.
Key milestones achieved include:
- CE Mark approval to market in Europe - December 2006
- FDA grants conditional approval for Destination Therapy (DT) Clinical Trial protocol - December 2006
- Feasibility Study - 10 patient enrolment achieved - January 2007
- FDA agreement to extension of Feasibility Trial
- FDA agrees to US Bridge to Transplant (BTT) Pivotal Trial protocol, unconditional approval granted - January 2007
- Australian Government approval of Commercial Ready Grant - January 2007
US Progress
Our business in the United States is growing rapidly. Our facilities in San Francisco are fully operational, and we have a top team of dedicated professionals in clinical, regulatory, field support and logistics. The VentrAssist will be the subject of the featured presentation at the key US scientific meeting of the International Society for Heart and Lung Transplantation (www.ishlt.org) in San Francisco on 26 April 2007.
We expect that the FDA will soon approve enrolment in the BTT Pivotal Trial, after reviewing the results of the Feasibility Trial we submitted to the FDA on 3 March 2007.
The FDA has conditionally approved an innovative design for the US DT trial that we believe has the potential to reduce the time from first implant to FDA approval by up to 18 months compared to earlier DT trial designs.
We plan to conduct the DT and BTT Trial in the same centres. We have selected the first 20 clinical trial centres from the many that expressed interest, and we anticipate that enrolment in both trials will start soon. All devices implanted in the US under both the DT and BTT protocols are invoiced under normal commercial terms, so we anticipate that our revenues will grow in the US as the clinical trials accelerate.
European Progress
Following CE Mark approval in late December 2006, we have expanded our European Team, which will soon total 10 people. We use a direct sales force in the major markets of Germany, France and UK, and distributors for Italy and Scandinavia, and we will soon be opening a European logistics centre in the Netherlands.
We have set up and trained over a dozen European centres, and half of these have already conducted their first implant of the VentrAssist. Over 10 patients have been implanted under the BRACE protocol, and now CE Mark approval has been achieved, more of these will be billed and contribute to revenue. In parallel we are working to engage new centres outside the BRACE study. BRACE stands for Better Results and Cost Effectiveness.
The VentrAssist is also attracting more attention in the public press. For example, the VentrAssist was the main topic on the national Norwegian TV news on Saturday 17 March. Doctors from Rikshospitalet in Oslo were interviewed, and the destination therapy patient and family were interviewed and talked about his new life. To view the program, please go to http://www1.nrk.no/nett-tv/indeks/90651.
Australia/Pacific Progress
There are presently five active centres in Australia and New Zealand, and we intend to expand that number. The Company has applied to the Therapeutic Goods Administration (TGA) in Canberra for approval of the VentrAssist, and we anticipate that this approval will soon be forthcoming.
Operations
Our manufacturing facility is fully operational with all key processes in house and under control. Ventracor has never had to decline an implant due to an inability to supply product. As the number of implants and centres grows, we will ramp up our manufacturing to meet those expanded needs. Our Quality Assurance systems are in place and working well.
We have a pipeline of exciting future products in development, and anticipate releasing the first of those new products this year. However, it is our policy to not provide details of our future products before they are released.
General
We are pleased and proud that the VentrAssist is an Australian success story that has improved the lives of almost 100 patients world-wide. The VentrAssist is still the only centrifugal LVAD and the only third generation LVAD in clinical trials in the USA. There is more world-wide clinical experience with the VentrAssist than all centrifugal LVADs from all competitors, combined.
It is clear that Ventracor is now considered a serious player in the LVAD business with a very strong competitive position. We focus our energies on being successful in our own right, and strengthening our leadership position.
I am excited and confident about the future of our company. Although there will be many challenges on the way to our commercial success, our momentum will continue with our fine team of people in Australia and world-wide who will rise to those challenges.
Please refer to the "Facts and Figures" for more detail.
Yours Sincerely,
Peter Crosby
Managing Director and Chief Executive Officer
"Clinical Trial Facts and Figures"
US Clinical Trials
Ventracor is conducting two major clinical trials in the United States.
- Bridge to Transplant (BTT) Pivotal Trial - A clinical trial to test the safety and efficacy of the VentrAssist in patients in end stage heart failure who are on the heart transplant list.
- Destination Therapy (DT) Trial - a clinical trial to test the safety and efficacy of the VentrAssist in patients in end stage heart failure who are not candidates for a heart transplant.
In addition, a Feasibility Trial of a small number of patients was conducted for the FDA to reach a level of confidence so that a larger clinical trial could commence.
Feasibility Trial
Enrolment in the target 10 patients was reached in January 2007. Clinical data from these patients and others was collected, and a submission was sent to the FDA on 3 March. We anticipate the FDA will soon approve start of enrolment of patients in the Pivotal BTT Trial. To maintain momentum, we requested the FDA to extend enrolment under the Feasibility Trial to up to 30 patients total in up to 10 centres. The Feasibility Trial and the Pivotal Trial have the same protocol, data from suitable patients enrolled in the Feasibility Trial will be consolidated with data from patients enrolled in the Pivotal Trial, to possibly allow an earlier FDA submission for approval to market. Once implants start in the Pivotal Trial, no further patients will be recruited in the Feasibility Trial.
Bridge To Transplant (BTT) Trial
The FDA has granted unconditional approval for the US BTT Trial Protocol (IDE approval). The trial will be conducted on approximately 140 patients in up to 40 centres. Success is defined as when 75 percent of the patients either have a heart transplant or are still listed for heart transplant at 180 days after implant of the VentrAssist.
The clinical trial protocol is presently being reviewed for approval at the Institutional Review Boards (Ethics Committees) at more than 15 US clinical trial centres, and it is anticipated that enrolment of patients in these hospitals will begin promptly.
Destination Therapy (DT) Trial
The US Destination Therapy trial is an innovative design that the Company believes has the potential to reduce the elapsed time from first implant to FDA approval by up to 18 months compared to earlier DT trial designs. A patent application has been filed on the trial design.
It is a prospective, randomised, controlled trial with two modules, and the primary outcome for both modules is stroke free survival. Module A is for up to 180 patients in end stage heart failure. After enrolment, patients will be randomly assigned 2:1 to either implant of a VentrAssist within 48 hours, or continuation of optimal heart failure therapy (eg: medical management or device therapy such as a biventricular pacemaker). This design does not require implantation of an alternative market approved LVAD in patients in the control arm, but allows it if deemed clinically necessary six weeks or later after enrolment.
Module B is for patients in end stage heart failure who are judged by the clinician to require an LVAD within 48 hours. It consists of up to 45 patients, with 2:1 randomisation of the VentrAssist to an LVAD approved by the FDA for DT. Module B may be extended if 45 patients are enrolled before Module A enrolment is complete. A PMA application for Destination Therapy can be submitted on the results of Module A alone. The end point of the trial is reached when there is a statistically significant improvement in survival for patients with the VentrAssist compared to optimal heart failure therapy.
The DT Trial is approved for up to 40 centres, and the Company plans to conduct the DT and BTT Trial in the same centres. The FDA granted Conditional Approval for this trial (IDE approval), which means enrolment could begin immediately, provided the Company addresses the questions asked by the FDA. We will submit the protocol to the IRBs once we have responded to the FDA's requests. We are confident there will be no substantial changes to the protocol, and expect that enrolment will begin shortly.
Europe and the BRACE Study
Business success in Europe depends on having a significant number of LVAD implanting centres using the VentrAssist as their LVAD of choice. The clinician's choice of which LVAD to implant depends on many factors, the most important of which is excellent clinical data from many patients published in peer reviewed journals. A key element of our strategy for driving market and sales growth in Europe is the BRACE Study.
The purpose of the BRACE study is to:
- Develop a body of excellent clinical data which will lead to publications in major medical journals by key opinion leaders.
- Explore ideas for improved patient selection and patient management in the context of a clinical study with ethics committee approval.
- Rapidly engage LVAD implanting centres with the VentrAssist LVAD program.
The BRACE Clinical Study Steering Committee is established, and the physicians are working well together. We are already using information gathered from the BRACE study to refine our future product pipeline.
Ventracor will be exhibiting this year at the 21st Annual Meeting of the European Association of Cardio-Thoracic Surgeons (EACTS - www.eacts.org) in Geneva on 15-19 September 2007.
Note:
This material is provided for background purposes only. It is not an offer to buy or sell shares in Ventracor Limited. The information is provided in a summary form and is accurate at January 2007. Ventracor, the circle device, VentrAssist and Ventraview are registered trademarks of Ventracor Limited. The VentrAssist LVAD incorporates technology covered by US patents 6,609,883, 6,250,880, 6,227, 797 and 6,638,011. Caution: Investigational device. This device is limited by law to investigational use only. US Federal Law restricts this device to sale by or on the order of a physician.
Contact
Ventracor
126 Greville Street
Chatswood NSW 2067
Sydney Australia
T: +61 2 9406 3100
F: +61 2 9406 3101
E: info@ventracor.com
W: www.ventracor.com
USA
Ventracor Inc.
101 Lincoln Centre Drive
Suite 420
Foster City CA 94404
T: +1 866 882 5089 (US Toll Free)
+1 650 356 5900 (Outside US)
F: +1 650 356 5901
Europe
Ventracor (UK) Limited
10 Wellington Street
Cambridge CB1 1HW, UK
T: +33 6 9927 0706
F: +33 4 2623 6711
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