Here's a summary of key points I took from the conference call September 24, 2018
FDA approval for treatment of both 2nd and 3rd 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 2nd and in combination for 3rd >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;
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&
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.