Ceragenix's antimicrobial Cerashield to be reviewed as a device

By Elaine Rigoli

Tampa, Fla., June 14 - Ceragenix Pharmaceuticals, Inc. announced that the FDA's Office of Combination Products said Cerashield's primary mode of action is that of a device and it has been assigned to the FDA's Center for Devices and Radiologic Health for lead review.

The company said the device will be reviewed through the pre-market approval process to confirm reasonable assurance of safety and effectiveness.

Cerashield is intended to be used as an antimicrobial wound dressing to help prevent bacterial colonization and infection at the site of catheter and other indwelling medical device insertions into the body, according to a news release.

Cerashield mimics or exceeds antimicrobial activity of the naturally occurring antimicrobial peptides that form part of the human body's innate immune system, the release said.

In-vitro testing has shown that Cerashield retains its efficacy for at least 21 days and is able to eradicate a daily inoculum of 1 million colony forming units of methicillin resistant staph aureus bacteria within two hours.

Prior to filing of the Cerashield pre-market approval application, Ceragenix said it will request an expedited review by the FDA of the application.

Ceragenix is a biopharmaceutical company located in Denver.

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