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Ventracor. CEO on Start of US Trial & Market Update

 

26/07/05

 

corporatefile.com.au

 

Ventracor Limited recently announced its first US implant. You indicated youÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re one of only two publicly listed companies in the world with a third generation Left Ventricular Assist System (LVAS) and that your device will be the first third generation centrifugal pump to be trialled in the US . What is the significance of this milestone in terms of your commercialisation strategy?

 

CEO Colin Sutton PhD

 

Our first US implant marks the start of our US feasibility study involving 10 Bridge-to-Transplant (BTT) patients. It represents a major step towards commercialising our implantable heart assist system. While we conduct this feasibility study, we expect the implant procedure and the devices to be eligible for reimbursement, and thereby receive our first revenues.

 

corporatefile.com.au

 

How is your US expansion programme progressing?

 

CEO Colin Sutton PhD

 

Our US-based chief operating officer Peter Crosby is recruiting a team of people to assist us in our feasibility study which will involve up to five hospitals and 10 patients. Peter is an experienced senior manager with more than 25 yearsÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ experience in implantable medical devices. Our principal investigator for the US feasibility study, Dr. Eric Rose, and the chairman of the trial steering committee, Professor Robert Kormos, are both leaders in the field. WeÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re working with the best available people.

 

corporatefile.com.au

 

In your last Open Briefing on 21 June 2005, Peter Crosby talked of advancing from your BTT feasibility study in the US to a pivotal trial by the end of the first quarter or start of the second quarter of calendar year 2006. Are you still on track to meet this timetable?

 

CEO Colin Sutton PhD

 

WeÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re on track to meet that timetable. We anticipate the 10 implants required will be completed before the end of this calendar year. Once the patients meet the end point of the trial and weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ve collected the clinical data, weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ll be in a position to submit the results to the FDA.

 

corporatefile.com.au

 

If your European trial is already well underway, with approval and marketing anticipated in 2006, why are you also aggressively targeting the US?

 

CEO Colin Sutton PhD

 

We remain committed to completing the product approval process in Europe. However, the US is the largest market for medical devices worldwide. Our companyÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s future ultimately lies in that market. While we focus on advancing into the European market, weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re also pursuing registration and approval in the US as soon as possible.

 

corporatefile.com.au

 

In recent investor presentations in Australia, youÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ve described your path to market as a ÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Â¦ÃƒƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…âہ“race against timeÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚ÂÂ. What growth potential do you see for VentrAssist TM in Bridge-to-Transplant and Destination Therapy (DT)? What factors are driving you to pursue both these segments of the market?

 

CEO Colin Sutton PhD

 

 

 

We see ourselves as being in a fast-moving technological race against our competitors. As part of the approval process, weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re pursuing two areas: Bridge-to- Transplant for people who need circulatory support until they receive a heart transplant, and Destination Therapy or Alternative-to-Transplant for patients who donÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢t qualify for a transplant because of age or medical conditions but need circulatory support.

 

We think the current market is held back by the inadequacy of current devices. Today, market estimates suggest there are at least 27,000 patients each year in the US who would be candidates for an implantable device like ours for Destination Therapy. In contrast, the BTT opportunity comprises only around 3,500 patients worldwide per year. However, itÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s important to understand that weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re pursuing approval for Bridge-to-Transplant because the current US regulatory environment mandates BTT approval before DT approval. The statistical end point to measure success for a BTT trial is only a few months or until the patient receives a heart. This is much shorter than the measurement of success for Destination Therapy which can be longer.

 

corporatefile.com.au

 

What are the main risks associated with your trials and how will you address them?

 

CEO Colin Sutton PhD

 

WeÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ve made a considerable investment in the establishment of robust risk management systems and operational protocols to greatly reduce our business and clinical risks.

 

With each implant, our clinical risks are reduced and we learn a substantial amount about the clinical management of our patients. This very importantly sets us apart from companies who are yet to gain a body of clinical experience. Having completed nearly 30 implants, we believe many of the clinical risks are now much better understood and have been substantially reduced, clearly defined or eliminated.

 

Trial costs are being addressed. Last year, the US agency that determines which devices are reimbursable in the US classified the implantation of an LVAS like ours as reimbursable in trials at the same rate as a fully approved device.

 

With each implant, weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re learning more and becoming increasingly confident that our product is performing in accordance with its design specifications, and weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ve articulated the key competitive advantages that make our device well-suited to our target markets.

 

The potential risk of slow recruitment is also being addressed. IÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢d like to point out that patient selection is carefully defined in the protocol; the priority is to ensure a positive outcome for every patient whilst, at the same time, to collect useful data for the purposes of our regulatory submissions.

 

Recruitment and management of our clinical trials in the US is being guided by our experienced partners at the International Center for Health Outcomes and Innovation Research (InCHOIR), based at Columbia University in New York.

 

corporatefile.com.au

 

In addition to your BTT trial, are you on track to lodge an Investigational Device Exemption (IDE) application for a DT pivotal trial in the US by year end?

 

CEO Colin Sutton PhD

 

As Peter Crosby stated in our last Open Briefing, the objective is to reach a DT approval as quickly as possible. WeÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re focused on meeting that objective but there are certain undefined elements associated with the trial protocol, and it may be in our best interests to delay filing a submission until weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ve reached agreement with the regulatory agencies on the protocol in order to reach the end point in the shortest possible time. WeÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ll work on this with our partners at Columbia University.

 

corporatefile.com.au

 

You indicated that youÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ve started to ramp-up your manufacturing capability. What cost savings are you targeting by bringing in-house your critical manufacturing processes?

 

CEO Colin Sutton PhD

 

WeÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ve recently commissioned our own in-house steriliser. For example we have reduced the cost of each sterilising run from $6,000 to $600 by moving the process in-house.

 

corporatefile.com.au

 

WhatÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s your monthly cash burn? HowÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s your cash burn likely to be affected by the ramp-up of your manufacturing capabilities and your progress in the US and Europe?

 

CEO Colin Sutton PhD

 

Our current cash burn is about $2.4 million per month, of which about $1.8 million is spent on facilities and staff, while the remaining $600,000 is spent on capital equipment, raw materials and pump assembly. We have a substantial stock of materials, work-in-progress and finished goods which have been written off and factored into our cash burn figure.

 

corporatefile.com.au

 

As you continue to advance your European trial simultaneously in both Bridge-to- Transplant and Destination Therapy for CE Mark approval to sell VentrAssist TM , how will you overcome the challenges of a highly fragmented European market?

 

CEO Colin Sutton PhD

 

This CE Mark trial is essentially a one-approval process. Obtaining CE Mark approval will give us European-wide product registration and allow us to sell our device for both clinical indications of Bridge-to-Transplant and Destination Therapy across Europe. We expect to receive European-wide approval next calendar year.

 

WeÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢re now in the process of negotiating with clinical support staff who are able to visit, service and support hospitals in Germany, France and Scandinavia.

 

corporatefile.com.au

 

Which segments of the market (BTT or DT) and which European countries will you most likely be able to initially access and what time frame are you targeting?

 

CEO Colin Sutton PhD

 

A VentrAssist TM has already been implanted in the UK. Once weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ve received CE Mark approval at the end of 2006, weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ll target other major markets in Europe; Germany and France are the largest markets in Europe and are high on our list.

 

corporatefile.com.au

 

What initiatives are in place to expand your European implant programme?

 

CEO Colin Sutton PhD

 

We are in negotiation with other implant centres which should increase our recruitment rate and, at this stage, we are on track to complete CE Mark recruitment by year-end.

corporatefile.com.au

 

What measures are you taking to build on your competitive strengths and what are you doing to enhance the functionality of your device?

 

CEO Colin Sutton PhD

 

Our device has the inherent ability to respond to physiological demand without external adjustment. However, we believe more sophisticated physiological responsiveness will be an increasingly significant requirement for LVASs. We have an advanced research programme in place targeted at developing and building even more advanced physiological responsiveness into our device. Our research strategies are aimed at developing functions which would better assist cardiologists in post-implant patient management.

 

corporatefile.com.au

 

When do you expect to receive clarity on the outcome of your US patent infringement claim? Is the litigation in any way affecting your ability to progress your strategic and clinical development objectives?

 

CEO Colin Sutton PhD

 

The litigation is in no way impeding our progress or ability to meet any of our objectives. The case is before the Florida court, with documents being lodged virtually every week. At this stage, we cannot predict when it will be resolved.

 

corporatefile.com.au

 

What will be your main priorities in the coming 12 months? Will a capital raising be necessary to help advance your trials?

 

CEO Colin Sutton PhD

 

At 30 June 2005 , we had $33 million cash. Given our current monthly cash burn of $2.4 million, we will need to raise additional capital within the next 12 months and itÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢s likely that weÃÆâ€â„¢ÃƒÆ’ƒâہ¡ÃƒÆ’‚¢ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡Ãƒâہ¡ÃƒÆ’‚¬ÃƒÆ’¢Ã¢Ã¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¾Ãƒâہ¡ÃƒÆ’‚¢ll start the process in the next quarter.

 

corporatefile.com.au

 

Thank you Colin.

 

 

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In reply to: joyful on Wednesday 27/07/05 07:12am

Yes joyful, its about a week old.

 

Thoratec Reports Quarterly VAD Product Sales Increase of 23 Percent as Total Company Sales Increase 17 Percent

 

 

 

Company Announces 49 Patients Have Been Implanted in Heartmate II Pivotal

Phase II Clinical Trial

PLEASANTON, Calif., July 26 /PRNewswire-FirstCall/ -- Thoratec Corporation (Nasdaq: THOR), a world leader in products to treat cardiovascular disease, said today that sales for the second quarter of 2005 increased 17 percent over the second quarter of 2004.

 

For the quarter ended July 2, 2005, product sales were $47.6 million versus $40.6 million in the same quarter a year ago. The company said the increase was driven by a 23 percent growth in sales of its VADs (Ventricular Assist Devices) versus the same period a year ago. Sales at the company's International Technidyne Corporation (ITC) division increased seven percent versus the second quarter last year.

 

The company also announced that it has now implanted 49 patients in its pivotal Phase II trial for the HeartMate® II, the company's next generation assist device. This compares with seven patients enrolled in the trial as of late April. Thoratec received FDA approval to initiate the study in February 2005.

 

Thoratec reported GAAP net income of $2.4 million, or $0.05 per diluted share, in the second quarter of 2005, versus GAAP net income of $207,000, or $0.00 per share, in the second quarter of 2004.

 

Non-GAAP net income for the second quarter of 2005 was $4.3 million, or $0.09 per diluted share, compared to non-GAAP net income of $2.1 million, or $0.04 per diluted share, in the second quarter of 2004. The company also reports non-GAAP net income, which the company previously referred to as taxed cash earnings, a measure of our financial performance that excludes from GAAP income (loss) before taxes, as applicable, amortization of intangibles, in- process R&D, impairment of intangibles, certain litigation, restructuring and other unusual or non-recurring costs and takes into account the tax effect of these adjustments.

 

"Thoratec had an excellent quarter as it increased sales of existing products and achieved great progress with our clinical trial activities. Growth in our Cardiovascular Division was driven by the increasing adoption of cardiac assist devices among clinicians, growing volume from our Thoratec® IVAD (Implantable VAD) and sales of the HeartMate II for clinical trial use," said D. Keith Grossman, president and chief executive officer of Thoratec. "Our ability to produce a gross margin of more than 61 percent in the quarter reflects the leverage we are able to realize as VAD sales increase," he added.

 

"We are also continuing to see the lessening of a clear delineation between the voluntary reporting of bridge-to-transplantation (BTT) and Destination Therapy (DT) patients that we have discussed in the past. This is a result of the growing acceptance of long-term VAD use by clinicians as they become more comfortable listing higher risk patients for transplantation with the option of permanent or sustained support if the patient does not improve to an ideal transplant status," he continued.

 

Thoratec said it received voluntary notifications of at least 42 DT implants during the quarter versus 34 in the second quarter a year ago. The company's HeartMate LVAS (Left Ventricular Assist System) is the first, and to date, only FDA-approved device for DT, or the long-term support of patients not eligible for transplantation.

 

Thoratec also announced that 49 patients have now been implanted in the Phase II pivotal clinical trial for its HeartMate II, including 27 in the BTT arm and 22 in the DT arm. This is an increase of 42 patients since the first quarter of 2005. These enrollment results have taken place in only the first 19 centers, although at present there are 25 centers that have the proper approvals and are beginning to screen patients. Overall, 86 patients have now been implanted with the HeartMate II worldwide. The company said that its filing for approval to CE Mark the device, which would allow its commercial launch in Europe, is on track and could be approved by the end of 2005.

 

The HeartMate II is designed to provide long-term cardiac support. Thoratec completed a very successful Phase I trial for the device in August 2004 that involved 25 patients. The initial patient in the Phase I trial has now been supported for more than 20 months and is among six patients that have been supported by the device for a year or longer.

 

"The rapid pace of enrollment in the current HeartMate II trial, along with the compelling results of our Phase I trial and the growing adoption of our devices, reflect increasing awareness among clinicians about the benefits of supporting late-stage heart failure patients with cardiac assist devices," said Jeffrey Nelson, president of the company's cardiovascular division. "Our performance this quarter speaks to our industry-leading technology, the company's deep experience in generating market adoption of approved products and our expertise in facilitating these clinical trials," he added.

 

For the first six months of fiscal 2005, Thoratec reported revenues of $98.1 million, an 18 percent increase over revenues of $83.4 million in the first six months of 2004. The six month results reflect a 23 percent increase in VAD product sales, and a 10 percent increase in sales at the company's ITC division over the prior year. Net income for the first six months of 2005 was $5.6 million, or $0.11 per diluted share, versus net income of $1.5 million, or $0.03 per diluted share, in 2004. Non-GAAP net income for the first six months of 2005 was $9.4 million, or $0.19 per diluted share, compared with non-GAAP net income of $5.3 million, or $0.09 per diluted share, in the same period a year ago.

 

The following statements are based on current expectations. These statements are forward-looking and actual results may differ materially. For a more detailed discussion of forward-looking statements, please see additional information below.

 

The company is updating prior guidance for fiscal 2005. Thoratec now expects revenues for the full year to be in the range of $193-$197 million. This compares with previous guidance for revenues of approximately $190 million in 2005. Net income per share on a GAAP basis is expected to be approximately $0.19-$0.20, based on a total diluted share count of 50-51 million shares. This compares with prior guidance for net income per share on a GAAP basis of $0.15-$0.16 per share, based on a total diluted share count of approximately 49-50 million shares. The company indicated that GAAP net income could be impacted by further litigation-related expenses that are not easily predicted at this point in time. Non-GAAP net income per share for fiscal 2005 is expected to be approximately $0.35-$0.36. This compares with prior guidance of non-GAAP net income per share of $0.34-$0.35.

 

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I wish VCR was as quick as Thoratec....

 

'Thoratec also announced that 49 patients have now been implanted in the Phase II pivotal clinical trial for its HeartMate II, including 27 in the BTT arm and 22 in the DT arm. This is an increase of 42 patients since the first quarter of 2005. These enrollment results have taken place in only the first 19 centers, although at present there are 25 centers that have the proper approvals and are beginning to screen patients. Overall, 86 patients have now been implanted with the HeartMate II worldwide. The company said that its filing for approval to CE Mark the device, which would allow its commercial launch in Europe, is on track and could be approved by the end of 2005'.

 

 

VCR need to hurry up as much as possible...........

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QUOTE (dory @ Wednesday 27/07/05 12:14pm)

I actually bought at $1.425 Dory, come on get it right! http://www.sharescene.com/html/emoticons/biggrin.gif Yes looking a wee bit better this am http://www.sharescene.com/html/emoticons/rolleyes.gif

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