Finally a Good Amniotic Tissue Company? My Review of Axolotl

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Axolotl Bio

Credit: Shutterstock

You might say to yourself, that since Chris Centeno only ever posts negative stuff about the birth tissues injury, he obviously has an axe to grind. However, so far, I have yet to meet many honest players. This week I investigated Axolotl and I have to say I was overall pleasantly surprised. So now, here’s something completely different. Let’s dig in.

What Is Axolotl?

Axolotl is an amniotic tissue manufacturer based in Arizona. This is a company I first heard about from a sales rep a few years back. He swore to me that they were one of the good ones, but somehow I could never connect with anybody at the company. This week, however, a sales rep sent a message on Linkedin to a colleague claiming that this fluid could also be billed to Medicare.

This was the message: ”

“HI Dr. ,

My name is Sarah XXXXX. Thank you for taking the time to read this message. My group has picked up an exciting product that has been showing incredible results, I would love the opportunity to tell you a little more about it.

It is an injection in the amniotic family. The medicare billable is 8, 000 per 2 ml. With an average rebate to the practice between 2200-2400. We have seen tremendous patient results. I would love the opportunity to send you an email with more detail, followed by a ten minute phone call to answer more in depth questions or concerns you might have.

Thank you for your time and consideration.

Sarah”

Hence, it was time to perform a deep dive.

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The Website

Talk about current regulatory compliance! There is NOTHING on this website other than contact information:

axolotl biologics

Hence, there wasn’t much to find out there.

Trying to Get These Guys On the Phone

I tried to call Axolotl early this week. I called about 10 times over two days and got no answer on any line. However, someone did call me back about 24 hours after I left a message. I have since learned that the company has about 6 employees, so they are a bit overwhelmed, which is to be expected when you look at what they have planned.

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Rob Kellar, Ph.D.

While I had expected to find that Axolotl, like most amniotic vendors was a sales and marketing company with almost zero research horsepower, when I found Rob Kellar’s CV and reviewed it, I was frankly impressed. The few birth tissue companies that list a Ph.D. are usually people without any actual scientific knowledge in the area of cell biology or tissue scaffolds. However, after digging into Rob’s publications, he’s the real deal. Hence, I wanted to learn more. Could this company be the rare pearl in the oyster sitting in a putrid sea of stem cell scams?

While Rob looks part-time at the company and many other people on his science team are also part-time (on loan from the University of Northern Arizona), at least this company has a team. In that way, they’re similar to Regenexx who also has a real science team (ours is full time). Meaning, they have the horsepower to perform real lab research.

An FDA IND and Rogue Sales Rep?

Rob informed me that they had applied for an FDA IND to use their amniotic product to treat ankle arthritis. He put me in touch with CEO Josh Sandburg who called me back and informed me that before May, 31st (the end of the FDA enforcement discretion period) they had sold their entire stock of product. When I informed him about the sales rep claiming that physicians could bill Medicare for orthopedic injections of Axolotl, he wanted no part of it. He stated that the rep likely bought the product and was acting on their own and that they would shut this down immediately.

It’s Not All Roses

Just to make sure I wasn’t snowed by the people I spoke to, I did some digging on the Internet Archive to see if there was a record of Axolotl making past claims that were not regulatory compliant. That’s when, much to my dismay, I found this:

axolotl cryo

Arggghhh! The company made a claim of mesenchymal stromal cells (the same thing as mesenchymal stem cells=MSCs) in July of 2019! While this is carefully worded, IMHO any reasonable person would believe that this product contains MSCs. In 2019, the research was clear, these products do not contain live and functional MSCs. So that’s a bummer.

It also turns out that Axolotl applied for Q-codes for their amniotic fluid product in 2019, which was the industry trend at the time. By itself, that’s not an issue. Where it becomes an issue is the placement of language in the Q-code summary that is not permitted by the FDA. That last part is what allowed countless companies to get Medicare to pay amniotic fluid claims when that shouldn’t be reimbursable for orthopedic or pain injections. This is what Axolotl placed in their product summary:

“According to the applicant, Axolotl Ambient and Axololt Cryo are intended for homologous use and to support the repair of soft tissue injury. The products are applied to the wound surface and/or injected into the wound margins.”

That’s not nearly as bad as most companies, that had the temerity to place language describing specific orthopedic uses. However, right now the company is getting hurt by the rouge sales rep because it used the phrase “repair of soft-tissue injury“. While that’s in the context of wound care here, my guess is that the sales reps who bought their product in bulk has found some scammy billing outfit to try to get Medicare claims through using just that one phrase.

The upshot? When I started this deep dive, I expected to find yet another birth tissue vendor pushing the envelope at every turn and encouraging doctors to defraud Medicare. However, if Josh follows up and puts a stop to this rogue sales rep, I remain pleasantly surprised. That isn’t to say that this company hasn’t dabbled in making claims that can’t be scientifically supported. However, sitting here in the latter half of 2021, this one is about as good as it gets right now. Hence, this is a company that’s trying to do it right.

__________________________________________

After the blog was posted, I got this text from Josh Sandburg: “Hi Dr. Centeno, I hope you are gearing up for a great weekend. I just wanted to let you know that I spoke to the distributor that purchased the product and informed him of our discussion. They have terminated the agreement with that rep so we should have some closure. This is a game of whack a mole so I appreciate the heads up and wanted to let you know that we have responded quickly to eliminate this issue. If you happen to hear anything going forward, please let me know and we will deal with it directly and quickly. Enjoy a great long weekend!”

Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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