Things that stood out to me about today's presentation @ the Piper Sandler Conference:
• Customer complaints for Recell are incredibly low.
• They have two indications (soft tissue repair & vitiligo) that are going in for a PMA supplement next month.
• Japan received their first stocking order for Recell in September and has already treated dozens of patients in that first month.
• Since Japan's healthcare industry is about a 1/3 the size of the U.S., it could be a 10 million dollar business in 3-4 years.
• Avita sees a big international potential of Recell being used in 20 countries, if not more. Plans in how to go about getting that done will happen in 2023.
• Their priority in 2023 is the launch for their soft tissue indication. Plans to file in December of this year. Expect approval in June 2023.
• The clinical outcome for their soft tissue repair study "was just exceptional". "We had a P-value of 025 that we had to meet or beat, and we beat it. And by beating it, that is really a healing definition."
• "Economically, the soft tissue repair market is 3-4 times bigger than the burn market. It sits in level 1 & 2 trauma centers. The synergy is rather interesting. Half of the burn centers are level 1 or 2 trauma centers. We will instantly get access to that broader indication on the day of approval and we have reimbursement. Secondly, in the level 1 and 2 trauma centers sits 25% of the burn market we don't call on." Their sales team will hit the ground running in those level 1 & 2 trauma centers that they didn't previously have access to.
• Avita will be doubling the size of their sales reps. Announcing those details in February.
• Vitiligo - They expect approval in June 2023. Estimated that it will get to market by January 2025.
• "What is most interesting to us is our most recent market research: 438,000 patient sought treatment for their vitiligo last year which is an enormous market because really none of those treatments are very effective. It happened in our trial that it was against a control and at 6 months where we had a responder group of about 80%, the control actually had a 0% responder to the standard of care today at 6 months. So, that is such a divergent outcome, we know that if we get it right, we will have a big winner...Well, ultimately this is a couple billion dollar market. You take those 438 (thousand) and you multiply them by $6,000, you get 2.5 billion."
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