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Biotech / Medical : Conceptus (CPTS) -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (70)8/10/2005 3:24:02 PM
From: tuck  Respond to of 96
 
>>SAN CARLOS, Calif.--(BUSINESS WIRE)--July 18, 2005--Conceptus, Inc. (Nasdaq:CPTS - News), developer of the Essure® non-incisional permanent birth control procedure, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to extend effectiveness data on the Essure product labeling.

The PMA supplement filed in late January supports an extension of the effectiveness rate of Essure to 99.80% after four years and 99.74% after five years of follow-up, from the previously approved 99.80% at three years. The five-year effectiveness was demonstrated in a portion of the women undergoing clinical studies and follow-up of the remaining clinical trial patients is ongoing. The PMA supplement was supported by Phase II and Pivotal clinical trial data demonstrating zero pregnancies in more than 29,000 women-months of reliance on Essure. There continue to be no pregnancies to date among patients who had been enrolled in the Essure phase II and pivotal trials.

"Essure has reached an important long-term milestone with an exceptionally high effectiveness rating that has remained consistent over time," commented Mark Sieczkarek, President and Chief Executive Officer of Conceptus. "Essure has now established a long-term efficacy very critical to physicians, payers and patients. For women looking for permanent birth control, we believe that Essure is the best choice from every perspective, including cost, convenience, risk and effectiveness." <<

snip

CPTS popped hard on this news, and has priced a private financing today. The stock is reacting very well considering the discount given to investors and directors -- almost a fireworks candidate.

Cheers, Tuck