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VidaMed TUNA BPH 510(k) "half way" through FDA review, company estimates.

This article was originally published in The Gray Sheet

Executive Summary

VIDAMED SWITCHES TO DIRECT/DEALER TUNA MARKETING STRATEGY, company President and CEO James Heisch said during an April 23 conference call held to discuss VidaMed's first quarter results. The firm had planned to market the transurethral needle ablation device for treating benign prostatic hyperplasia through an exclusive direct force. "However, with approximately 8,000 to 10,000 urologists in the U.S. who might be TUNA users in the future, we have been challenged on how to call upon them as soon as possible," Heisch said. As a result, the firm has decided to "utilize a combination of a direct sales force and selected medical device dealers."
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