I think we can all agree on here the market is pretty ignorant...

I think we can all agree on here the market is pretty ignorant of OCC, with the BioHorizons Striate deal alas doing little to fundamentally move the stock significantly.

Another pivotal moment in OCC's potential future has also been evolving since late August particularly, when a Federal District Court Judge ruled against the FDA after a four year lawsuit in late August on stem cells:

https://www.latimes.com/business/story/2022-08-31/federal-judge-tosses-lawsuit-targeting-stem-cell-clinic

The story is in the detail. For 'off the shelf' stem cell treatments, the goal post have not been drastically moved. For autologous stem cell treatments it has. The ruling included:

"The court rejected this argument on Tuesday, ruling that the surgical procedure does not create a new prescription drug. The court wrote: "The adipose tissue Defendants remove from patients clearly consists of human cells. And whatever is injected back into patients as part of Defendants' SVF Surgical Procedure and Expanded MSC Surgical Procedure certainly contains such cells.""

https://www.prnewswire.com/news-releases/federal-judge-enters-judgment-in-favor-of-cell-surgical-network-ending-lawsuit-brought-by-the-fda-301616731.html

Essentially the ruling being that because the procedure used the patients own adipose (fat) cells, it falls under a surgical procedure rather than a drug. The devil is in the detail. If that treatment involves adding non-autologous cells, it would arguably fall outside the definition of this ruling and under the FDA's remit. But OCC's ATI procedure, merely amplifying the patients own tenocyte stem cells, DOES fall under this Federal Court ruling.

I cannot stress this enough. Some industry insiders are getting a bit carried away in the US, declaring FDA's regulation of stem cells defunct. That's rubbish. Importantly the ruling was on a procedure that involved "the patients own cells" i.e. autologous per OCC's ATI treatment, in the particularly case ruling, mesenchymal stem cells harvested from the patients fat cells (specifically, stromal vascular fraction (SVF) per their procedure, derived from adipose tissue that contained heterogeneous cell populations such as mesenchymal progenitor/stem cells, etc):

https://stemcellrevolution.com/about-us/our-mission/

The FDA is now getting pushed from many quarters to at least update its IND pathways in light of this ruling:

https://www.prnewswire.com/news-releases/perinatal-stem-cell-society-calls-emergency-session-to-garner-industry-support-for-fda-301659391.html

The FDA will no doubt appeal the ruling, but right now Surgeons can theoretically legally offer stem cell treatments using a patients own (autologous) cells under the umbrella of surgical procedures - obviously an off the shelf or donor cellular product would still technically fall under the FDA's remit, but amplifying the patients own cells, as ATI does, would not. OCC could offer ATI right now without its flagged plans for a stage III trial, until this ruling overturned at least, if it is overturned. I don't think it actually will be regards autologous cells, just the area clarified. Again, for 'off the shelf' or donor stem cell products I do not think much has changed. For autologous procedures it has.

(to be balanced, unfortunately this likely means some more bad press on stem cells going forward as some cowboys in medicine use patients own stem cells for an assortment of magical cures)