Walters says that the heat builds up even when he’s sitting still indoors. He would constantly ask his doctors and prosthetic manufacturers: “Why hasn’t anyone come up with a fix for this?” This past winter, his bubbling frustration dovetailed along with an assignment in his engineering design course at the University of Texas at San Antonio. The result is what he calls the Aquilonix Prosthetic Cooling System, a ceramic plate that uses battery-powered thermoelectric components to pull the heat from inside the socket of the prosthesis and eject it outside the limb. The device is embedded into the socket and has an on/off switch.
In January, Walters, along with three other engineering students and four business students, formed a company, Leto Solutions. And last month they won first place in the $100,000 Student Technology Venture Competition sponsored by the university’s Center for Innovation and Technology Entrepreneurship. The prize was a combination of cash and in-kind services such as legal services and free office space. “We are excited that our first prototype worked exactly as expected,” says Becky Arianas, a longtime pharmaceutical and medical device consultant in San Antonio who served as the students’ industry mentor. She’s now signed on as CEO and is leading the company’s efforts to transform a university project into a commercial product, including replacing its provisional patent with a general one, securing FDA approval, and fundraising.
“We have been meeting with potential investors, and we have a couple who are very interested,” she says. They are speaking to angel investors to raise an initial round of $750,000, she says. The money will go toward making some refinements to the device and building additional units for more testing. At the same time, the company will be pursuing grants from the National Institutes of Health and the Veterans Administration.
The current prototype was built for about $200, and Walters is working on aesthetic improvements “to make it prettier” and less industrial-looking, he says.
Leto Solutions will be working with Coastal Life Technologies, a certified medical-device manufacturer in San Antonio, which would also warehouse and ship the devices according to customer demand. “We want to do a beta test with eight to 10 participants in September, and assuming those results are positive, we will be immediately going into full-scale manufacturing and commercialization,” Ariana says. “By early winter, we want to be making the product available.”
They plan to sell the device to prosthetics manufacturers for about $650 each.
It’s very early days for the company, of course, but there could be some demand for the device. Leto Solutions’ market study shows that, in the United States, there are approximately 800,000 lower-leg amputees—people who have had amputations through the tibia bone. Sockets of prosthetic devices must be replaced every two to three years, Walters says, with about 300,000 new sockets being made each year.
So far, Walters himself has served as chief guinea pig for the startup. He wore the device in his prosthetic leg every day for three weeks, turning it on and off to see how quickly it would cool in daily use. “When I’m about to go cut the grass, I’ll turn it on five minutes ahead of time,” he says. He also tested it by running 10-minute increments on a treadmill at high speed. “When I took my leg off, my lower limb was dry as a bone,” he says. “The rest of me was soaking wet, but the limb stayed dry.”
Walters, who is 38, was injured in 2005, a year after the National Guardsman was deployed to Iraq. He then spent two and a half years in rehabilitation at the Center for the Intrepid at Brooks Army Medical Center in San Antonio, a hospital specifically built to treat soldiers wounded in the wars in Iraq and Afghanistan.
“My personal experience as a patient is that the military is always looking for new and innovative products,” he says. “Amputees I know personally are constantly asking me when it will be available for purchase so they can get one themselves.”
REFERENCE: Angela Shah; Xconomists; 10 June 2013