Liveyon is back (again) with unproven exosome product

Remember our old friends Liveyon? Their leader John Kosolcharoen?

Liveyon’s continuing metamorphosis

This biologics supply firm has gone through several stages of corporate metamorphosis as a supplier of biologics including at first a purported living umbilical cord stem cell product.

That stem cell thrust ultimately landed a dozen or more people in the hospital as some of the product was somehow contaminated with bacteria along the way before injection in patients. There was a recall, an FDA warning letter, lawsuits, and a voluntary suspension of sales by the company. They started selling another in-house produced product.

In addition, they were the subject of the podcast Bad Batch that shone a bright light on the company.

New exosome product Luma has Liveyon style

Now it seems to me that they are marketing an exosome cosmetic product called Luma.

Does this mean they’ve gotten to the pretty butterfly stage of corporate life? Not exactly.

If you go to their exosome website here, you can see all the typical Liveyon style of partially-nude young women splashed all over the place interspersed with marketing for the new Luma exosome product.

I’ve included here one screenshot of the type of marketing on their website that has come to be associated with the firm at right. The actual website has some more risqué images.

What is this product?

On the new website they are “introducing” their new “Luma Restore Exosome” line. The key difference here from their past products is that this is apparently a cosmetic product rather than something intended for injection IV.

I think. I hope so at least.

They also say the product is acellular, so I guess they are forging ahead without a stem cell focus, at least with Luma? They’ve thrown the buzz phrase “nanoparticles” in there too.

Who are the intended customers here? Doctors and more specifically dermatologists? The public?

Liveyon video ads

Also, in the commercial video on the Liveyon Luma website they mention “stem cell enhanced skin treatments”, which potentially brings stem cell drug products into the mix too. I don’t know what this all means from a regulatory perspective.

Some of you might recall that Liveyon was tied to an odd sci-fi-like advertisement-short film called Awakening a few months back. The new Liveyon Luma website makes it 100% clear now, if there was any longer any doubt, that they are all tied together because the website includes another video commercial harkening back for me to the Awakening ad. The same producer, James Buzzacco, did both commercials too.

Note that the new Liveyon Luma video may be “not safe for work” entirely so be a little careful.

In or out of the domain of the FDA?

Since Liveyon is just pitching an exosome cosmetic product does that mean they are OK FDA-wise?

Not necessarily.

Since exosomes are drug products, it’s not clear to me at least that you can market them as a cosmetic without approval. Maybe, maybe not.

FDA, what do you think of all of this?

The Big picture

In a way to me as a stem cell biologist this stem cell “exosome cosmetics” fluff stuff is not so different than iffy stem cell supplements out there and a host of stem cell creams (cremes?) that have been on the market for a long time.

Underscienced and overpriced.

It’s also notable that the FDA, even if not their CBER branch, has taken enforcement action on stem cell cosmetics in the past and could do so again.