tissue for the repair of damaged cartilage. Organovo of San Diego uses a 3-D bioprinter to assemble cultured cells into structures such as bio-engineered blood vessels.
For her PhD project, Kaufmann made prototype grafts out of a biodegradable polymer called polycaprolactone. The idea was to create a matrix where a patient’s own cells could attach and organize themselves into tissue layers something like those in the aortic wall. Using a manufacturing process tailored for the purpose, she spun the polymer material into fibers, varying the shape of the fibers within the graft.
The fibers on the inner surface of the graft are curvilinear, to attract the endothelial cells that could make up a smooth inner blood vessel wall where clots can’t stick. In the outer part of the gradient, the polymer fibers are straighter and more spread out, to accommodate smooth muscle cells that could add structural strength to the new tissue.
The polymer fibers themselves are absorbed by the body within about a year, Kaufmann says. Ideally, a durable and flexible structure of natural cells will be left behind, and this could conform to the changes in the aorta’s shape over time. Blood vessels become more “tortuous,’’ or curving, as people age, Kaufmann says. Most aortic aneurysms are found in older people, and the currently used grafts of straight, inert webbing can lose their fit inside the aorta as years pass.
With the potential for leaks, as well as the loss of “fit,” doctors must monitor patients with grafts for the rest of their lives—a costly consequence of the surgery, Kaufmann says.
In tests of her prototype in pigs, both endothilial and smooth muscle cells colonized the graft. For Kaufmann, this was enough encouragement to form Cardiovate with her faculty advisors, Mauli Agrawal, dean of the UT San Antonio College of Engineering, and Steven Bailey, head of cardiology in the School of Medicine of The University of Texas Health Science Center at San Antonio. The three are co-inventors of the graft technology, and now make up Cardiovate’s board of directors.
Kaufmann is just one of the students being propelled into the startup world by University of Texas initiatives. Daniel Mendez was a UT San Antonio senior in 2010 when he and two other undergraduates won the top prize in the university’s Center for Innovation and Technology Entrepreneurship competition. Their experimental device was a soft, gel-filled helmet designed to protect the skulls of hospitalized infants from being deformed as they rested on their beds. The prize was about $35,000 worth of professional services that supported patent filings and the formation of the company Invictus Medical in San Antonio.
“It really helped kick-start us into being a real company,” says Mendez, who was 24 when he founded the startup.
Invictus’ infant cranial support device is now in the final stages of product development, and the company’s goal is to commercialize it in 2014. Invictus will initially focus on premature babies being treated in neonatal intensive care units. The company estimates the number of such babies in the U.S. at about 500,000 a year.
Mendez, Invictus’ chief technology officer, has been joined by a CEO, CFO, COO, and vice president of sales, who each have more than 25 years’ experience in the medical device field. Invictus has raised 80 percent of its target amount in an ongoing seed funding round.
Meanwhile, Cardiovate has also been busy over its first year. Kaufmann has been rebuilding the aneurysm graft manufacturing equipment, producing prototypes, lining up parts suppliers, and perfecting the company business plan. Cardiovate is in fundraising talks with angel investors and foundations, with a target of about $700,000 to start a long-term study of the experimental graft in animals.
If Kaufmann’s aortic graft eventually succeeds in clinical trials, it would compete in a cardiovascular stent and graft market now estimated at $507 million. According to Cardiovate’s market research, approximately 1.2 million people in the US have developed an abdominal aortic aneurysm, and surgeons perform about 65,000 repairs a year.
Kaufmann sees her company as a plausible competitor to medical device giant Medtronic and other companies selling grafts to treat abdominal aortic aneurysms, including Irvine, CA-based Endologix (NASDAQ: [[ticker:ELGX]]) and Cook Medical of Bloomington, IN. But Kaufmann also sees such established device companies as potential buyers for Cardiovate if and when the startup successfully completes the first clinical trial for its graft.
For now, Kaufmann is buckling down to the long-term effort that will be required to get to that point. Her speedy launch from grad student to company executive may have prepared her for an equally fast pace of progress at Cardiovate.
“It’s been a little slower than I thought,” she says.
