By David Holley
The premise of Aperion Biologics’ business is a bit of a no-brainer: Provide the market with a product used to repair anterior cruciate ligaments of the knee, because there is demand and not necessarily enough supply.
The way the San Antonio, TX-based company does that is a bit more complicated. Aperion uses a patented process to make pig tissue such as tendons, which are readily available, usable for human ACL reconstruction. Normally, the human body rejects animal tissue that doctors try to use surgically.
The cells of most mammals , including pigs, contain a carbohydrate called alpha-gal that human bodies lack, according to Aperion. When animal tissue is placed in the human body, the immune system responds and tries to attack that carbohydrate, rejecting the tissue. Aperion solves the problem by treating the pig tissue with an enzyme (called alpha galactosidase) that makes it compatible with the human body, while still keeping the tissue intact, the company says. The company also uses a process to help “humanize” and sterilize the implants, the company says.
Last year, Aperion received regulatory approval in Europe to sell the treated tissues for use in ACL surgeries—which it is starting to do—and now the company has plans to seek approval in the U.S. with a pivotal trial it hopes to start in 2016. But first, Aperion is looking for funding and is using a lesser-known option of approaching the public markets.