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Calzada targets US$400 million per annum market with first wound treatment trial

Calzada’s (ASX: CZD) wholly owned subsidiary PolyNovo Biomaterials has begun patient recruitment for the first human clinical trial of its NovoSorb polymer being developed for burns and wound treatment, tissue repair, orthopaedic procedures and cardiovascular stents.

The topical negative pressure (TNP) consumables market is now worth in excess of US$400 million per annum and is expected to grow significantly as the therapy is gaining increasing general acceptance among medical practitioners.

This first in human trial follows proof of concept studies where NovoSorb, in a Biodegradable Temporising Matrix application, was shown to have excellent biocompatibility and efficacy.

The method of wound treatment to be investigated in this trial is vacuum assisted closure of pressure sores using Novosorb dressings for topical negative pressure.

A total of 20 patients will be randomised to complete the single centre, open label trial. Ten will be treated with the NovoSorb TNP dressing and 10 with the control dressing, Granufoam, for an eight week period.

Patient testing is expected to begin by the end of February with results available by the September quarter of 2012.

Providing the NovoSorb dressing performs well compared to Granufoam, PolyNovo should be in a position to apply for regulatory approval in several jurisdictions including Europe and the U.S.

The company expects the approval process to be relatively rapid due to the nature and classification of the dressing.


TNP Technique

A dressing is fitted to the contours of a wound and sealed with a transparent film. A drainage tube is connected to the dressing through an opening of the transparent film.

The drainage tube is also connected to a vacuum source, turning an open wound into a controlled, closed wound while removing excess fluid from the wound bed to enhance circulation and remove wound fluids.

Advantages of the TNP technique include less time in hospital because patients can continue treatment at home, better healing that can reduce demand on other medical modalities and reduced direct nursing costs because TNP dressings are generally changed every 48 hours, compared to at least once a day for traditional dressings.