fda 510k received, page-28

http://www.proactiveinvestors.com.au/companies/news/53452/calzada-clinches-510k-fda-clearance-for-wound-dressing-technology-53452.html

Calzada www.calzada.com.au/

Calzada (ASX: CZD) has 100% ownership of PolyNovo Biomaterials Pty Ltd and Metabolic Pharmaceuticals Pty Ltd.


Calzada clinches 510k FDA clearance for wound dressing technology
Thursday, March 06, 2014 by Proactive Investors

Calzada has clinched 510k FDA clearance for its wound dressing technology.

Calzada has clinched 510k FDA clearance for its wound dressing technology.

Calzada Limited (ASX:CZD) should trade higher again today after its subsidiary PolyNovo Biomaterials was granted a 510k clearance from the U.S. Food and Drug Administration for its Topical Negative Pressure (TNP) foam wound dressing, NovoPore.

NovoPore dressing is intended for the treatment of chronic wounds such as pressure sores.

It is designed to remove wound exudate and regenerate the dermal tissue by applying vacuum through a dressing placed in the wound cavity.

The global TNP dressing market is estimated to be worth around US$400 million.

Existing TNP dressings have raised concerns from the FDA in respect to complications associated with infection as a result of foam fragments remaining in the wound and bleeding upon removal of the dressing.

Importantly, NovoPore demonstrated in its clinical trial completed last year that it had the potential to address these concerns.

PolyNovo's commercialisation strategy includes forming an alliance with a global partner to market and distribute NovoPore in the US, whilst retaining manufacturing and supply rights.

In addition to the US 510k, PolyNovo is currently finalising its NovoPore CE mark application, which would give approval to market NovoPore in Europe.

Recently, Australian three plastic surgeons were granted authorisation to use the NovoSorb Polymer wound implant, a separate product, in deep surgical wounds.

This device is implanted to act as a dermal scaffold, allowing tissue regeneration and subsequent skin grafting.

The authorization from the Australian Government Therapeutic Goods Administration follows a specific request from the surgeons, who had experience with the device in the successfully completed human clinical trial completed in October 2013.

That surgeons involved in the initial trials are keen implement the wound support device 'in the field' is a ringing endorsement of its efficacy and useability.

Calzada also wholly owns Metabolic Pharmaceuticals, which controls a peptide with potential applications in the treatment of obesity, bone, cartilage and muscle diseases.

Calzada shares have doubled in the last month after hitting an intraday high of $0.14 today.