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PolyNovo Biomaterials submits FDA 510(k) application for wound dressing device

PolyNovo Biomaterials, a wholly-owned subsidiary of Calzanda, has filed 510(k) application with the US Food and Drug Administration (FDA) for an approval to market its NovoSorb wound dressing in topical negative pressure (TNP) wound dressings.

The company has recently completed pilot clinical study of NovoSorb (to be called NovoPore) and showed significant safety and efficacy advantages over the existing GranuFoan TNP treatment device.

The NovoPore device showed reduced dressing fragmentation, reduced risk of infection, reduced the difficulty of dressing removal, and reduced undesirable dressing retention in the wound when compared with GranuFoan device.

Earlier, the FDA had cited some problems with existing TNP treatment devices.

The company is expected to have regulatory approval to market the NovoPore device in the first quarter of 2014 if the 510(k) submission is successful.

Currently, PolyNovo Biomaterials is in on-going discussion with potential distribution and marketing partners for the TNP treatment device and TNP dressings market is a significant commercial opportunity for the company.