An implant launched in the ’80s gave hope to thousands of people suffering with disorders of the temporomandibular joint, commonly known as the TMJ.
Many who received the treatment to solve issues with the tissues involved with the working of the jaw, however, ended up with shattered pieces of Teflon in their brains.
Cartilage Inc., a biomedical startup from the University of California, Irvine, is developing a product that seeks to avoid such a “catastrophic” outcome for people afflicted with TMJ disorders, co-founder Kyriacos A. Athanasiou told the Business Journal.
Athanasiou, a professor of biomedical engineering at UCI, leads the research team developing the startup’s engineered neocartilage implant, Hyaleon.
Cartilage officials hope that the implant will restore TMJ function by regenerating missing tissue and repairing defects in the jaw joint. Due to Hyaleon’s bioloic composition, the implant does not pose the risk of leaving foreign matter in patients’ brains in the event that it breaks.
UCI and Cartilage’s research team last month received a $6 million grant from the California Institute for Regenerative Medicine to complete their animal studies on the product.
The grant also requires the team to develop a manufacturing and distributing process for Hyaleon, which will allow them to submit an Investigational New Drug Application to the Food and Drug Administration.
Biomedically Engineered
About 1 in 4 adults live with a TMJ disorder. Symptoms include jaw pain, difficulty chewing and speaking, earaches and locking of the joint. Most people who live with TMJ pathologies are premenopausal women, Athanasiou said, which presents a “gender paradox” that researchers have yet to solve.
Current treatments for TMJ disorders and injuries, such as injections and total joint replacement, are not as effective or long lasting as patients would like, according to Athanasiou.
Cartilage intends Hyaleon to be a longer-lasting, biological alternative to standard TMJ implants, which are made of plastic and metal.
Mini Pig Subjects
Athanasiou’s team is currently testing Hyaleon on mini pigs, which have similar TMJ functions to humans.
“The ways mini pigs and humans eat are identical,” he said. Additionally, “the makeup of tissues in the TMJ is very similar between the two species.”
Hyaleon so far has demonstrated higher durability and resilience than controls in the mini pig studies, according to university officials.
Once the animal trials prove successful, Cartilage can move on to performing clinical trials on humans.
Melt-and-meld
Cartilage’s other product is the Melt-and-meld, which repairs early signs of cartilage injury and enhances integration between engineered and native cartilage, according to the company’s site.
Like Hyaleon, Melt-and-meld has yet to be FDA-approved. It’s currently being used in animal and in vitro research. Hyaleon is expected to hit the market within five years, officials said.
Cartilage, founded in 2019, is led by Athanasiou’s wife, Kiley Athanasiou, who earned an MBA from the Thunderbird School of Global Management at Arizona State University.
To date, the company has raised over $6.5 million from grants.
