FDAnews Device Daily Bulletin

FDA TO REVIEW CERAGENIX'S CERASHIELD AS A DEVICE; COMPANY TO SEEK EXPEDITED REVIEW

June 15, 2006
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The FDA's Office of Combination Products has determined that Ceragenix Pharmaceuticals' Cerashield functions mostly as a device and will be reviewed as such by the FDA's Center for Devices and Radiological Health (CDRH) for lead review, the company announced. The device will be reviewed through the pre-market approval (PMA) process to confirm reasonable assurance of safety and effectiveness.

Cerashield is an antimicrobial wound dressing to help prevent bacterial colonization and infection at the site of a catheter or other device. It is an absorbent foam dressing that contains a novel antimicrobial agent, known as either CSA or Ceragenin. Ceragenins are synthesized aminosterol compounds that mimic or exceed the antimicrobial activity of the naturally occurring antimicrobial peptides that form part of the human body's immune system.

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, according to the company.

Before filing its Cerashield pre-market approval application (PMA), Ceragenix will request an expedited review by the FDA of the application, Ceragenix said in a statement.