Biotech Values

[DewDiligence]

Re: CABG

This excerpt from today’s PR doesn’t sound too good:

http://biz.yahoo.com/prnews/050804/cgth051.html?.v=20

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The Company also announced that the grafts implanted in the first two Australian patients have become occluded and are no longer functional. The patients are in good health without symptoms and the surgical team has indicated their intent to continue with the human clinical trials once device and clinical trial modifications are complete.

We have analyzed the clinical results to date with our surgeon collaborators and have identified improvements related to manufacturing, our procedure and the post operation anti-coagulation regimen that will be implemented in our ongoing clinical trials which we estimate will begin in September or October as our devices become available.

First, we have developed a new proprietary coating process to spray our heparin coating on the vessel connector. The spray heparin allows for a more uniform and consistent application of the coating, which has demonstrated superior in vitro bench testing results and in vivo preclinical (animal) results.

Second, we have reviewed our animal work and feel that a simple improvement in the surgical procedure is necessary and will be incorporated into our human cases.

Lastly, at the suggestion of our clinical study surgeons, we have implemented a change in the anti-coagulation regimen to include chronic administration of Warfarin. The anti-coagulation change was made based on the review of our first cases, discussions with our clinical investigators and our scientific advisory board. Warfarin is a commonly used anti-coagulant in cardiac surgery.
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Aslan, et al: comments?