New Skin

New Skin

North Phoenix firm Axolotl Biologix is bio-engineering “replacement skin” and soon replacement blood vessels and heart patches. Is your body due for a high-tech upgrade?

 

By Jimmy Magahern

At first glance, it might look like a miniature sandwich bag for a Barbie doll tea party, or maybe one of those clear breath-freshening strips that dissolve on the tongue.

But in fact, the small, fibrous patch developed by the North Phoenix-based biotechnology company Axolotl Biologix is actually a novel biopolymer material that can aid in the repair of damaged muscles, tendons and ligaments and may some day replace damaged skin without scarring and even patch congenital heart defects.

Axolotl calls the miracle material AxoBioMembrane, defined as a “dehydrated allograft membrane” patch derived from the amniotic fluid present in placentas following childbirth. It’s not exactly stem cells, although the fluid originates in the stem cells remaining in the afterbirth.

“It’s basically a sheet of tissue derived from the amniotic membrane that’s a part of the placenta, which most hospitals throw away after a cesarean section delivery,” explains Rob Kellar, Axolotl’s chief science officer. “And so after a baby is born, the tissue that is typically discarded is donated to us and we screen it, dissect out the cells and use what’s left over for our regenerative membrane.”

In addition to the patches, Axolotl also uses the tissue to produce a liquid formula in both a frozen and ambient temperature form. All three products are manufactured in the company’s two-story office building located in the industrial park just northwest of the Phoenix Deer Valley Airport runway and sold to physicians throughout the country, who in turn use the materials for a wide variety of purposes – from wound healing to orthopedic reconstruction, treatment of diabetic ulcers and burns and even cosmetic use, reducing the formation and incidence of wrinkles.

“The way that we market it is very generically, because that’s what the FDA’s rules dictate,” says Kellar, referring to the Food and Drug Administration’s regulation for cellular and tissue-based products, which states the products can only be marketed as an investigational new drug. “That being said, we’re getting a lot of great reports back from doctors who use the product and they’re finding that it promotes repair and restoration of function in all sorts of different tissue sites throughout the body.”

Phil Larson, Axolotl’s president, goes a little further. “We have physicians that use our products who have saved limbs,” he says, noting that the company was recently awarded a $224,500 grant from the National Institutes of Health for research into their products’ effectiveness in healing chronic wounds in patients suffering from diabetic foot ulcers. “When you consider that many diabetic patients who end up losing a limb due to a diabetic ulcer often die within two to five years, you’re not only saving a limb,” says Larson. “You’re saving a life.”

Incorporated in February 2016, Axolotl Biologix is already a major player in the global soft tissue repair market, a products segment that is forecasted to grow to $6.67 billion by 2025, according to Research and Markets, a Dublin-based business intelligence firm. “We’re already selling to doctors at 354 medical facilities nationwide,” says Larson, who encourages interested patients to ask their own physicians if they can treat them with Axolotl’s therapies.

However, it remains a field fueled by both hope and hype. In California, where voters approved a $3 billion bond measure in 2004 to fund stem cell research, clinicians have yet to develop a federally approved treatment using the technology. Meanwhile, several hundred clinics have sprung up nationally catering to patients desperate for the extraordinary potential promised by the treatments, many of which have been halted by the FDA or derided by mainstream scientists.

Larson and Kellar believe Axolotl (named for a Mexican salamander capable of regenerating virtually any damaged part of its body) is built for the long haul.

“A lot of the amniotic companies that are out there will likely fall by the wayside because they don’t go through the right regulatory pathways or they don’t have any future growth plan,” Larson says. Axolotl does: Keller says his team is already working on bio-engineered “replacement skin” that will be able to replace damaged skin without any scarring (“It’s made up of the same components that our native skin is made of”), and even bio-engineered replacement blood vessels. Plus, the company is banking on its patented tropoelastin, a precursor to elastin developed with Northern Arizona University microbiology professor Burt Ensley, to treat the growing population of older adults eager to restore lost elasticity in aging skin.

“When you put this young fluid into an older patient, that patient’s cells now are responding to younger growth factors,” Keller says. “So you kind of resurrect those cells to do what they used to know how to do. Can we reverse aging with this? Probably not. But we can promote healing later into adult life.”

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