Ann: Orthocell Webinar Presentation, page-4

  1. 311 Posts.
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    My notes from the webinar:

    • No US Tarrif impact expected.
    - we have deep defence ties
    - AU has Trade Deficit with USA.

    • Effect of DOGE on FDA efficiency and approvals:
    - No imopact as most the staff has been retained by FDA
    - Regular and Positive interactions with FDA
    - Our Lead Reviewer remains teh same at FDA
    - US approval ETA for Remplir remians on track for Mar/Apr 2025

    • 3 Consecutive qurters if record revenue
    - 9% CAGR of quarterly revenue since launch of Remplir

    • Crendentialed board with ties and experience in US market

    • Tendon product SmartGraft scaffold) expected to launch in AU in CY25

    • REMPLIR
    - 127% revenue growth in AU from FY 23($457k) to FY24($1.04M)
    - US TAM: USD$1.6B
    - 700,000 nerve repair surgerical procedure done in US annualy. Most are suturing and 55% of them are unsuccessful.

    • Expected REMPLIR Approvalsapplications already submitted)
    - US: Q1 25
    - Thailand: Q3 25
    - Canada: Q4 25

    https://hotcopper.com.au/data/attachments/6838/6838150-c741b96dfc228bfbff37be7ef4ef56d0.jpg
    *Total TAM (markets planned to enter): U$3.5B
    Aim to achieve at least 20% i.e. U$700k or AUD$1B

    **No questions taken.
 
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