Enlightenment, page-47

Here's a summary of key points I took from the conference call:

• FDA approval for treatment of both 2^nd and 3^rd degree burns.
• USA is largest healthcare and burns treatment market globally
• First PMA granted by FDA for burns in over 2 decades
• No requirement for further trials – but Avita plans trials anyway
• 7000 patients treated to date.
• Quote from an investment group to avita team: “our team is astounded at the level of data you have compared to others in the burn and wound healing space”
• Significant portion of $50 million still to be received from BARDA – funding trials with objective for future procurement; timing to be announced.
• 500,000 burn treatments annually USA
• $5billion a year spent treating burns
• Next largest burns market, Germany, only 16% of USA
• Economic modelling – using in 2^nd and in combination for 3^rd >44% reduction in costs for large burns. $13 million saving for a 200 bed burns centre using recell.
  Avita estimates initial target of USD $200 million market.
• Other markets than burns to follow
• Prep for launch:
  • recruitment of sales and marketing leaders with experience in burns;
  • promotional materials
  • sales team recruitment to be completed
  • formally launch Q4 2018
  • details of launch to be released to market over next 60 days
• planned costing per device of $$5,000 to $10,000
• 1 kit per 10% total body surface area
• Clarification of what a “pre-market approval” means – it is a full market approval; this is the type of approval needed when no other device exists on the market that can be compared to
• Avita not aware of Renovacare being very active in R&D: only spending about $300,000/year. No real clinical trials in place. [Implication seems to be Renovacare is not seen as being serious about actually getting a product to market]
• In the US health system, treatment of burns is paid to hospitals per square cm burns. No specific reimbursement is made for the device costs – so so systems need to be established for reimbursement.
• Ongoing investigation of ways to improve the usability of the product (e.g., to require less clinician time to apply treatment)
• Cash burn over next 12 months will depend on how aggressively marketing proceeds. Expect to have a better estimate of this over next 60 days
• Level of US burn specialist awareness of recell characterised as “High” … “A very big buzz going on in the United States about the availability of ReCell”. First major development in burns care in past 2 decades.
• Answering why up-take in areas with existing approval (e.g., Australia, with TGA approval) has been low, answered that this is the first time there has been a body of randomised controlled trials that would be acceptable to physicians to change standards of care. Previously only had case studies; these trials confirm at least equivalent outcomes while cutting treatment costs.