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TWST: We would like to begin with a brief historical sketch of CryoCor
and a picture of the things you are doing at the present time.
Dr. Brennan: The company is a spinout of CryoGen. CryoGen was originally
chartered with using cryotechnology to treat atrial arrhythmias. Shortly
after its formation, the company approached women's healthcare issues
because of the perceived ease of obtaining FDA approval for that
particular indication. For about four years, they proceeded down that
path, and then began to strengthen their program in cardiology. In late
1999 and 2000, CryoGen spun out CryoCor with funding from MPM Capital
and that was the genesis of the cardiac ablation concept. We believe
cryoablation is well suited to the complex arrhythmias of atrial
fibrillation and atrial flutter, where the safety profile of a device
treatment is very important. We have conducted a pivotal trial for
atrial flutter and are nearing completion of a pivotal trial for atrial
fibrillation. The third area of focus for the company is our R&D effort.
We are continuing the development of a next generation catheter which we
call 'Quantum,' which is able to create long curvilinear lesions in the
left atrium for treatment of atrial fibrillation. I should note that our
PMA for the first indication, atrial flutter, was recently stated as
non-approvable by FDA; however we have evaluated our data set from our
pivotal trial and anticipate filing an amendment with the FDA to obtain
approval for that indication. TWST: What were the reasons for the non-approval?
Dr. Brennan: The FDA had no issues with our chronic safety data. Their
concern was the chronic efficacy data. To address this question, we
have had the data set independently reviewed by a panel of
electrophysiologists to assist us in an independent evaluation of
chronic efficacy.
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