Essentially no risk of a competitor emerging.
This questioned was posed to Jim Corbett in 3 out of the last 4 conference calls and he answered it comprehensively so best go and listen to the calls (recorded on AVH website). After hearing this in my mind a competitor has essentially no chance of materialising.
Essentially:
1. Even if secrets of the proprietary enzyme solution and process of creating a similar product were reverse engineered and help by a would-be-competitior, this is a medical device and NOT a drug. Much higher barriers to entering market than a drug that goes "off label". For a competitor to get FDA approval for a medical device would need to submit own PMA, which takes several years ie >4years from beginning, with associated trials, costs etc which as we have seen with ReCell can not be underestimated in the length, cost and difficulty of achieving this.
2. Then even there was a successful competitor product getting a PMA FDA approval, there are several layers of IP that are a hurdle. Many patents and patent pending, I don't pretend to know the exact number as to me this is a non risk. Yes some patents will expire, but one of the other advantages of ReCell GO is that Avita Medical have a bunch of new patents and patents pending connected to ReCell GO which start again on the more advanced, more convenient device.
So a large moat to a competitor entering
For all intents and purposes, Avita Medical has a monopoly on autologous spray on skin cells.
But don't take my advice go and listen to the calls he addresses this exact question.
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