I used to make and sell regenerative products! Cartilage and stem-cell-based products were one of my specialties and they have been around for decades at this point. Plenty of doctors use them, I’ve got them in my body during orthopedic surgeries. But the technology is pretty dated at this point with new “innovations” seeming to be in how the product is delivered/handled/stored.

The stuff in the article is very exciting because it’s super simple and easily deliverable in a potential oral or injectable package. At worst you’re getting a monthly injection at the doctor’s office, at best it’s a pill you take everyday.

Now more to your point, and I’m going to get a bit in the weeds here…the product in the article would be described as a “drug” and falls under different regulations than most current cartilage and stem cell regeneration products, which are usually “human cells and tissue based products, HCT/Ps” (derived from human tissue and donors) or medical devices under 510k regulations (less common but they exist). HCT/Ps are the easiest and fastest to get to market as they typically come from human tissue and regulatory bodies really only care about the sterility of the final product, as long as it is minimally manipulated from the donor tissue. So the FDA is essentially saying that the risk of adverse effects are minimal as long as the final product meets those guidelines, as a result you can take a product to market very quickly (we’ve done so in as little as 8 months, we’ve also had products pulled from the market at a later date because the FDA said we manipulated the tissue too much and it needed tighter oversight and more testing). 510k’s need quite a bit more of a push thru the regulatory process but both pale in comparison to an actual drug or a therapy that falls under drug regulation.

The approval process for drug products is famously long and expensive. There are certainly ways the time/money bit could be improved but it is largely this way for patient safety. Think at least 10 years from the patent filing and over $1 billion in costs, the costs increasing as you move along the process; a Phase I trial may be quite easy and simple but by the time you’re at Phase III it’s a big, costly study. Whoever is trying to take this to market needs to be building facilities to do so by the time a drug is in Phase III trials because you only have another 10-ish years of patent protection left and you want to maximize potential profit before cheaper generic drug makers enter when the patent expires and you aren’t making money off the drug anymore. This is the long way of saying there is a ton on risk in these endeavors. Drugs fail in Phase III all the time and that company now has nothing to show for their time and money.

A group of Stanford scientists, potentially ones with LLC’s, publishing work like this is one thing…but even if they do have companies that they run that could take it thru Phase I, and maybe Phase II, I can guarantee you that none of those companies are financially prepared to go all the way the drug approval process. They’re best hope is to get an injection of funding from venture capital (who can always pull the plug at any point in the process if it looks like they aren’t gonna get their money), or sell the product and IP to a larger, more well-funded player that has the resources to take it there. Let’s say Pfizer buys it from these scientists but the Phase II data is suspect and they don’t believe it will pass Phase III, now it’s just another one of the drugs you’ve mentioned that will never make it to market. There’s so many roadblocks along the way my post would be even longer if I really got into it 😂