Calzada files for US approval for NovoSorb in TNP
Calzada (ASX:CZD) subsidiary PolyNovo has applied for US regulatory approval of its NovoSorb wound dressing in topical negative pressure (TNP) procedures.
The company has submitted a 510(k) application - the path for regulatory approval for medical devices - with the US FDA.
510(k) submissions are required to be accompanied with information on the safety and efficacy of a device. PolyNovo in April completed a clinical trial involving using NovoSorb for TNP in vacuum-assisted closure of pressure sores.
The company said that compared to market leader GranuFoam, NovoSorb was able to reduce dressing fragmentation, reduce the risk of infection, lower the difficulty of dressing removal and cut down on undesirable dressing retention in the wound.
PolyNovo plans to market NovoSorb for TNP under the brand name NovoPore. If the 510(k) application is successful, the company expects to have regulatory clearance to market the product in Q1 2014.
PolyNovo is also using its NovoSorb technology in NovoSorb BTM, a dermal scaffold treatment primarily designed for use in burns and other full-thickness wounds. In July, the company announced the completion of treatment in a trial of NovoSorb BTM in free flap donor site repair surgery.
The company also recently entered a joint venture with a group of US plastic surgery specialists that will explore opportunities for the technology in the facial implant and aesthetic surgery markets.
Calzada (ASX:CZD) shares were trading 5.33% higher at $0.077 as of around 1 pm on Wednesday.
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