rah surgeons receive approval to use btm, page-8

http://www.proactiveinvestors.com.au/companies/news/52487/calzadas-wound-support-device-approved-for-use-by-australian-plastic-surgeons-52487.html

Calzada www.calzada.com.au/

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


Calzada's wound support device approved for use by Australian plastic surgeons Tuesday, February 04, 2014 by Proactive Investors

Calzada's wound support device has been requested and granted for use by Australian plastic surgeons.


Calzada Limited (ASX:CZD) should trade higher today after three plastic surgeons were granted authorisation to prescribe the NovoSorb Polymer Biodegradable Temporising Matrix wound implant in deep surgical wounds.

Calzada's wholly owned subsidiary PolyNovo Biomaterials produces the device, which 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.

The authorization is given under an early access scheme which allows Australian surgeons to apply to use products prior to full marketing approval.

It will allow the surgeons to refine the use of Novosorb under controlled but real conditions, collect more data and derive more valuable clinical experience with the product.

The authorisation is valid until 28 January 2015 and other surgeons may also apply to be authorised Novosorb prescribers.

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

Additionally, PolyNovo expects to submit a 510(k) regulatory submission with the US FDA for NovoSorb
in surgical wound applications during the first quarter this year.

Other jurisdiction regulatory pathways are also currently being investigated.

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

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