First prize ($10,000): Nanografts
University of California, Berkeley

With over 500,000 performed each year, coronary artery bypass surgery is the default procedure for people with severe heart disease. But the surgery, in which doctors remove a healthy blood vessel from the patient’s arm or leg and use it to build a detour around a blocked artery in the heart, isn’t without its drawbacks: 50% of vein grafts fail in 5-10 years, the surgery to harvest the vein is expensive and invasive, and some patients have veins that simply aren’t strong enough to act as a coronary bypass graft.

Synthetic grafts have long held promise as a way to improve on the vein graft, but have yet to be widely implemented. The biggest reason? They’re too big. The smallest currently possible diameter for a successful synthetic graft is around 5mm—too large to replace most coronary arteries, which range from 2-6mm. Additionally, many of today’s synthetic grafts are made from foreign materials that can be rejected by the body’s immune system, rendering them ineffective.

It all adds up to a problem; or, looked at another way, an opportunity for innovation.

Craig Hashi is the innovator. The Berkeley bioengineering Ph.D. student, leader of the Nanografts team that grabbed first place in the 2006 BMEidea competition, has come up with a novel approach to synthetic grafts. He creates sheets made from polymer nanofibers, then seeds the sheets with the patient’s own bone marrow stem cells. The stem cells allow the sheets to mimic the native blood vessel tissue, reducing the risk of being rejected, and the nanofibers allow the building of grafts as small as .7mm in diameter. After letting the cells grow for a couple of days, the sheets are rolled into a tube, similar to the shape of an artery. Once implanted, the nanofiber tube degrades, leaving a fully functioning blood vessel.1

Sound clean and simple? Not so much. Although Nanografts has certainly made progress since winning BMEidea funding, continuing their lab research and talking with venture capitalists, the biggest challenge remains the technology itself. This is radical stuff—giving the body the capability to grow wholly new veins—and will take time to develop. Says Hashi, “Right now, the biggest challenge we face is getting the technology to work—understanding what’s really going on with it. I’ve been finishing up a paper on the project, but we want to make sure we’re confident about the technology before we present something to the research community—we want to be able to show exactly how these stem cells work and what they do.”

Beyond the technical challenges, there are problems with using stem cells themselves. Due to the surgery timeline (the patient may not be able to wait several days for stem cells to grow), potential cost factors, and strict FDA regulations, the team believes moving away from a stem cell-based approach for the moment gives them the best shot at commercialization. “We understand that in order to commercialize this in the near future we’ll have to steer away from cell-based therapy,” says Hashi. “Adding stem cells is an extra step that slows down the implantation process, to say nothing of regulatory issues. But if you have a synthetic graft that’s readily available off-the-shelf, the surgeon can use it right away and implant it directly.”

Although the science is still in the early stages, Hashi has a plan for how to commercialize Nanografts. “Ideally, we’ll start with some small seed rounds, about 150-200k,” he says. “We’ll work six to nine months with that, and then hopefully talk to some more VCs, get a term sheet, and get in contact with people that can provide us with more corporate experience, more managerial direction. From there we take it to market.”

Participating in the BMEidea competition has given Hashi a way to connect with those VCs. “Getting national exposure as a result of winning the competition has gotten us a lot of attention that we wouldn’t have received otherwise,” says Hashi. “It really gives me credibility when I walk into a VC’s office. I can say, ‘I just won BMEidea, a national biomedical design competition. My team went through a rigorous competitive process and we were fortunate to win first place.’ It gives me not only confidence and credibility but a great way to begin the conversation.”