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Ann: Paradigm AGM Presentation, page-58

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    I found your comments quite interesting, particular around the hurdles with price tag of $2-3k being too prohibitive and the willingness of PBS/Insurers to reimburse.

    May I suggest you look into what's actually happening now and is predicted to play out in the OA space, particularly for Knee OA. Hyaluronic acid (HA) is increasingly now being used and is expected to become a main go to treatment pre TKR. It's a viscosupplementation agent injected directly into joint to help lubricant for the knee and replace the diseased synovial fluid.

    There a dozens now available with Euflexxa being considered one of the better ones. It's retailing at around US$5,000 per series (3 shots) and lasts 2-6 months. Whilst ~50% of people are getting good to great results one aspect I noted with HA is that ~40% of patients that have negative result (increased pain). Despite all this most US insurers are fully reimbursing it.

    The cost of OA to the health budget of our target markets are multiples of the cost of iPPS. The direct and downstream costs to society are immense and this is well documented and understood by the relevant authorities. You can simply google the "Burden of OA disease" and you'll find dozen or recent publications for Oz, US, UK etc to support this proposition.

    IPPS:
    • Does not need to be injected directly into joint versus HA treatments which are problematic and require a specialist often using an ultrasound to assure placement of injection (i.e. could never be self- administered)
    • Duration is likely to be at least as good as any leading HA
    • OA-008 may show its at a minimum slowing the progress of the disease if not altering its course via additional protection.
    • Very limited recorded adverse events for IPPS (no one I understand has reported an increase in pain unlike HA)

    Our clinical trials have been designed based on some of the key variable noted above.
 
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