CryoCath Technologies Inc., the world leader in cryotherapy products to treat cardiovascular disease, announced that the U.S. Food and Drug Administration (FDA) has accepted and closed the first of five modules of the Company's Pre-market Approval (PMA) filing plan for the Freezor Cardiac Cryoablation System.
The first module contained pre-clinical data that demonstrated the safety and efficacy of the system in the animal model.
"This is another step toward our goal of receiving approval to market the Freezor Cardiac CryoAblation System commercially in the U.S.," said Steven G. Arless, president & CEO of CryoCath. "Having already filed the next three modules, we are well positioned to receive PMA approval by the third quarter of 2003. The final module will be based on clinical data that will be finalized and ready for filing by September 2002."
The three modules currently under review (two through four) by the FDA provide information on biocompatibility, bench testing data and manufacturing respectively. The FDA is able to consider all three modules concurrently. There is no fixed timetable for a decision.
The fifth and final module will be based on data from CryoCath's FROSTY
Pivotal Study of 165 supraventricular tachyarrhythmia (SVT) patients using the Company's minimally invasive, catheter-based 7F Freezor Cardiac CryoAblation System. Patient enrollment in the study is now completed, and was conducted at 14 leading centres across North America.
"The achievement of this milestone towards our objective of commercializing Freezor comes on the eve of the U.S. commercial launch of SurgiFrost, co-developed with our strategic partner Endocare," said Arless. "By the end of 2003, we expect to have a strong foothold in the world's largest cardiac market and be well on our way to establishing significant product revenue in the U.S. to augment our growing sales in Europe and rest of world."