Cardima receives Shonin approval from the Japanese MHLW to market PATHFINDER catheters

Jan 4 2010

Cardima, Inc. (OTC/BB: CADM), a medical device company focused on the diagnosis and treatment of atrial fibrillation (AF), has received Shonin approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) to re-enter the Japanese market with its family of guidewire-based, multi-electrode PATHFINDER^® diagnostic mapping catheters. Cardima’s PATHFINDER catheters, which are designed for accessing and mapping the vasculature of the heart wall to facilitate treatment of arrhythmias, will be imported into Japan through an exclusive distribution agreement with medical device distributor Robert Reid Inc., an import license holder, and marketed through Japan Lifeline Co. Ltd., an exclusive distributor of Robert Reid Inc.

“We increased our PATHFINDER inventory in anticipation of this approval and have already begun shipping products to Japan. PATHFINDER sales in Japan have the potential to provide Cardima with large revenue generation opportunities.”

“We are delighted to resume sales of our PATHFINDER catheters in Japan through Japan Lifeline, a well-established cardiac device distributor with an extensive marketing network within the electrophysiology and interventional cardiology communities. We thank Robert Reid for partnering with us and managing the Shonin process,” said Robert Cheney, Cardima’s CEO. “We increased our PATHFINDER inventory in anticipation of this approval and have already begun shipping products to Japan. PATHFINDER sales in Japan have the potential to provide Cardima with large revenue generation opportunities.”

Mr. Hideo Shitoto, President of Robert Reid Inc., stated, “The PATHFINDER’s low profile, small size, flexibility and multi-electrode design allow for entry into the most difficult and remote regions of the coronary vasculature. We believe these competitive features will be well received by the Japanese medical community. We look forward to reintroducing this product line in Japan and we hope to expand our relationship with Cardima to include additional products in the future.”

The PATHFINDER catheter is also approved for marketing in the U.S., Europe, Canada and Thailand.