From the investor presentation on 1/9/2016 page 9
Bringing NovoSorb BTM to market
o Regulatory paths through clinical trials
1. Achieve 510(k) approval for use in Surgical Wounds anticipated January 2016
2. Establish Clinical trials for FDA PMA approval in Burns, February 2016 ; • Contingent on BARDA funding.
3. CE Mark trials commenced in Australia & France o CE Mark anticipated Mid-2017
4. Prioritising jurisdictions where access can be achieved with existing data.
o Commercial execution
o We will initiate direct sales to establish market penetration where we have regulatory approval
o Establish commercial partnerships or licence agreements with KPIs around sales performance and revenue generation
We anticipate commercial sales in US Market Early 2016 once 510(k) approved
I think the distribution deal will be sooner rather then later.
Waiting for licencing agreement to be announced, page-23
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