Venaxis files for CE Mark approval for European commercialization

By: Steve Wednesday December 26, 2012 0 comments Tags: appendicitis, APPY 1, Castle Rock, CE Mark, Don Hurd, Venaxis

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CASTLE ROCK - Venaxis Inc. (Nasdaq: APPY) has filed for CE Mark approval in Europe for APPY 1, its blood-based appendicitis test, the company announced.

Venaxis said it expects to obtain CE Mark approval under the European Economic Area by the end of 2012. Initial commercialization in Europe is planned to commence in the first quarter 2013 in the UK, Italy, France, Germany and Benelux countries.

As part of its technical submission for CE marking, Venaxis successfully produced multiple commercial-scale manufacturing lots of APPY 1. The product lots will support the initial European launch and a planned U.S. pivotal trial, the company said.

"This is a landmark accomplishment for Venaxis," said Don Hurd, chief commercial officer. "With the completion of this important regulatory step, we are focusing on market development.

"Our goal in Europe is to be positioned for a successful launch as a soon as possible after obtaining the CE Mark, and I'm proud to say we're well on our way to meeting that goal."

The company said it has begun the process of developing relationships with five to eight hospitals in each of the targeted European territories.

In addition to developing its European market, Venaxis said it is actively focused on training hospital sites for its pivotal clinical study of APPY 1 in the U.S. in 2013.

Ultimately, the study will enroll about 2,000 net evaluable patients in 28 hospital emergency departments across the U.S., the company said.

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