czd summary & milestones still to come...

Hi all,

I have made a quick summary of Calzada’s (mainly PolyNovo) achievements and milestones yet to come. Please note, while I have tried to be as factual as possible it is always important to do your own research.

Achievements to date:

1. Successful clinical trial of NovoSorb Topical Negative Pressure (TNP) foam dressing.

2. FDA approval (510k) received to market TNP for sale in the US with results from the clinical trial showing advantages over the incumbent GranuFoam which currently holds market share of ~75% to 80% of the $400 million market.

3. Successful clinical trial of NovoSorb Biodegradable Temporising Matrix (BTM) for the treatment of free flap donor sites (deep full thickness surgical wounds).

4. Three Surgeons have request and received TGA approval to continue to use NovoSorb BTM in free flab donor sites based on trial results.

5. Recruitment commenced for the BTM 3rd degree burn human trail where BTM will be used to treat 5 patients with 3rd degree burns.

6. Continued communication with BRADA in relation to receiving a grant to progress BTM technology in burns.

7. Continued strengthening of PolyNovo’s patent portfolio to protect the company’s intellectual property.

Milestones still to come...

1. Submit CE mark application for regulatory approval of TNP foam dressing in Europe (PolyNovo currently finalising application).

2. Finalise partnership agreement to market and distribute NovoPore (TNP) in the US.

3. Submit 510(k) application with the US FDA for NovoSorb BTM for the treatment of surgical wounds (expected Q1 2014, pathway to approval should be faster now NovoSorb TNP has been approved).

4. Complete 3rd degree BTM human trail and submit 510(k) application with the US FDA for treatment of burns (pending trial results).

5. Continue to explore new device opportunities for NovoSorb in wound management, hernia repair (massive market!), etc.

6. Continue Composite Cultured Skin (CCS) studies where partnered with BTM in the treatment of full thickness wounds could effectively abolish the need for a skin grafts (Study completed in April 2012 yielded very positive results).

7. BRADA grant outcome (hopefully positive).

Financials:
1) Cash at hand = 5.32 Million (31/12/13)
2) Burn rate = ~2.2 Million pa (incl R&D tax incentives)
3) Revenue = 161k (31/12/13)

See half year results for full details, with TNP approval in the US it can be expected that revenue will increase once partnership agreements have been finalised and the product is marketed and distributed. Metabolic will also contribute to overall revenue with the licencing of AD9604 for the sale and manufacture with Australia’s largest compounding chemist Australian Custom Pharmaceuticals.