Repairing beating human hearts with living patches is the aim of Avery Therapeutics, a startup company founded on technology developed by University of Arizona researchers.
The company recently licensed a new heart-graft technology from the UA and is working to get it into human clinical trials to treat heart failure within a few years.
Avery was co-founded in 2014 by cardiologist Dr. Steve Goldman of the UA’s Sarver Heart Center and Jordan Lancaster, who earned his UA doctorate in physiology while working in Goldman’s lab.
Avery’s biologically active heart graft, dubbed MyCardia, combines commercially available living cells called fibroblasts, heart-muscle cells derived from stem cells and a biologically absorbable “scaffold.”
The resulting graft can be sewn onto a live heart where it can build up new muscle cells to improve heart function as it grows with the patient’s own tissue.
“You can basically think of it as a living Band-Aid,” said Lancaster, who is chief science officer of Avery.
Goldman and Lancaster began research in the area in 2009 at the Southern Arizona VA Health Care System, where Goldman was chief of cardiology, for a San Francisco-based company developing a heart graft using fibroblasts on a scaffold material to treat angina, or heart-related chest pain.
That project ended when studies showed little improvement with the graft, Lancaster said.
But Goldman and Lancaster extended the research at the UA, tapping Nobel Prize-winning technology developed by Japanese scientists using so-called “induced pluripotent stem cells” — which have the ability to turn into any kind of cell — to create a new kind of living heart patch.
The Avery research team already has published scientific studies showing improvement in heart function in rats treated with the heart patch.
Immersed in a nutritive medium, the company’s prototype patches contract in rhythm, on their own.
“They’re waving or winking at you, every time you see them in the lab,” Lancaster said.
Though much work remains to be done even to get to human clinical trials, Avery is proceeding apace to commercialize the technology with the help of Tech Launch Arizona, the UA’s technology-commercialization arm.
Jen Koevary, who earned her doctorate in biomedical engineering from the UA, joined Avery as chief operating officer after helping the company as a business-development officer for TLA.
Avery also is being advised by Bruce Burgess, a TLA mentor-in-residence with more than 30 years of entrepreneurial experience in medical devices, diagnostics and drug delivery.
Though an approved product is still years away, the company has published numerous scientific papers, raised hundreds of thousands of dollars in research grants and won one patent, with more in the pipeline.
In August, Avery was awarded a Phase 1 Small Business Innovation Research grant of nearly $500,000 by the National Institutes of Health’s National Heart, Lung and Blood Institute to develop manufacturing, cryopreservation, storage and reconstitution methods for the MyCardia patch.
Lancaster noted that Phase I SBIR contracts are generally up to $150,000, so the much larger NIH grant was significant.
The company also has won a $750,000 grant through the UA from the Arizona Biomedical Research Commission, and $60,000 in cash and prizes at Tucson’s Get Started business-pitch competition in October.
The company has delivered its pitch internationally, at the Falling Walls Venture conference in Berlin in November.
Last week, Avery presented at the TechCode event space in Mountain View, California, where Silicon Valley investors learned about the company along with four other UA spinoffs.
Koevary said the company will keep pitching its technology and writing grants to raise money for further studies, likely including a bid for a larger Phase II SBIR grant.
Avery plans to present its technology at the 2017 BIO International Convention — one of the biggest biotech events in the world — in San Diego in June.
Scientifically, the next step is to test the patch in large-animal studies using pigs, which provide a close match to humans, she said.
“There’s a lot that still needs to be done,” Koevary said, noting that induced pluripotent stem cells have been tested in just one clinical trial, a Japanese effort focused on treating the eye.
“We have to do a lot of work on the manufacturing side, in proving we can manufacture a quality product every time,” she said.
After the animal studies the company also will have to submit a rigorous lab-practices study, which the company hopes will pave the way to start human clinical trials by 2020, Koevary said.
Koevary said the company will likely need upward of $10 million to take the heart patch to human clinical trials.
Avery is working on a private investment round among friends and family, she said, adding that the company also is establishing relationships with investor groups and looking at partnerships with established biomedical companies.
Researchers worldwide are working on regenerative tissue therapies, including a University of Minnesota group that recently published a paper on a heart graft made by 3-D printing heart-muscle stem cells and growing them in the lab.
But Lancaster said Avery — named for his daughter’s middle name — has a big advantage with Goldman and his lab, which he said offers a rare combination of clinical expertise in cell culturing, bioengineering and animal modeling.
“Being able to cover that spectrum has really allowed us to move faster than others,” Lancaster said. “I think we’ve got a very good head start on a lot of people.”