Woundchek Partners with SerenaGroup to Complete U.S. Clinical Trails
Woundchek Laboratories is partnering with the SerenaGroup, a Cambridge, Mass.-based network of 20 wound care centers, to complete two clinical trials in 2014 aimed at gaining FDA clearance for the company’s two products.
U.S. studies of Woundchek’s Protease Status and Bacterial Status diagnostic tests are set to begin this month, Jack Wilkens, president and CEO, told Device Daily Bulletin.
According to the North Yorkshire, England wound care products maker, Protease Status is the world’s first point-of-care test to detect elevated protease activity in chronic wounds. Wounds with EPA have a 90 percent chance of healing improperly without protease modulating intervention and also carry a higher likelihood of graft failure than wounds with low protease activity, the company said.
The other product, Bacterial Status, assesses bacterial protease activity in chronic wounds, indicating if a wound requires intervention for bacterial infection.
Global costs of ineffective wound treatment run from $20 billion to $25 billion annually, Wilkens said, adding that the planned trials bring Woundchek closer to introducing wound diagnostics in the U.S. market.
Protease Status is currently available in Europe, the Middle East and South Africa. Bacterial Status is still in development. — Kellen Owings
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