Pinned straw:
Very impressed with the planning and prep, deployment and execution of the RECELL GO. FDA approval was received on Thu 30 May 24, so 1st use was the day after.
The Joseph M. Still Burn Center at Doctors Hospital of Augusta is the first U.S. burn center to treat a patient using its RECELL GO™ System
- RECELL GO introduces enhanced features that streamline the preparation of Spray-On Skin™Cells.
- This next-generation device significantly reduces the training burden on medical staff, improves workflow efficiency in the operating room, and controls the RECELL Enzyme™ incubation time to ensure optimal cell yield and viability.
- These advancements simplify the user interface, enabling medical teams to provide quality care readily and consistently to their patients.
@jcmleng The announcement had the opposite effect on me. I saw it as a bit of an act of desperation to create positive newsflow. That is because it is not common practice to announce first patient treat after receiving a PMA, as far as I am aware, let alone a PMA Extension, as in this case.
Secondly, a signfiicant number of these devices will have been pre-loaded into the market, For example, with clinical investigators who have received an FDA IDE (Investigational Device Exemption) to allow them to undertake clinical studies which $AVH would almost certainly have under way. Those centres involved in the treatments that contributed to the PMA submission, would commonly continue to use the device after completion of the formal registration study, to build data for follow-on indications. In the case of ReCEll GO I would definitely expect that becase the GO PMA was an extension of the original ReCell PMA, as I understand it.
Third, because many clinicans are already using ReCell, there's also a lower barrier to adoption of ReCell GO. For surgeons already using ReCell there are several benefits of using ReCell GO including: improved and streamlined process; reduced training burden; and enhanced user interface.
Don't get me wrong - I am not doing a downer on $AVH. I think the ReCell, ReCell GO and Vitiligo approvals altogether are a strong platform and I am watching it closely. It is also a complementary treatment to both biologic and synthetic dermal repair treatments.
I used to own $AVH, and got out some time ago because I was worried about the cost management - they seemed to go very hard on building out sales and marketing ahead of sales. But will all these approvals now in place, perhaps now we see the top line take off. If that happens, then a SP at sub $3.00 may well in time prove to have been a great entry point.
So, its very much on my watchlist and I have been considering a buy. With forecast revenue growth over the next two years of 40-50% p.a., there is every chance that they can significantly outstrip cost growth.
Analyst consensus is SP of US$20.60 vs US$9.51SP with a huge range of $9.00-$40.00 (n=9; tradingview). So against those analyst views, I guess management might feel the business is very undervalued and be keen to get eveything little bit of news out there. Who knows, maybe they are right.