A urethane liner inside a carbon fiber prosthetic socket can make it difficult for body heat to escape, causing sweat to build up in the socket, resulting in friction blisters and skin breakdowns in amputees. Disabled army veteran Gary Walters proposed that his team of four mechanical engineering students tackle this problem and develop a solution for their senior capstone project at the University of Texas at San Antonio.

Walters, a transtibial amputee, was mowing his lawn in August 2012, when the idea came to him.

The Aquilonix Prosthetic Cooling System won the UTSA Center for Innovation and Technology Entrepreneurship award. Image: Tim Luukkonen, UTSA

“I had been trying to think of ideas all summer for my senior capstone course and our team project, and I was mowing the lawn one day and thought ‘why don’t I cool this prosthesis,’” Walters said.

His idea evolved into the Aquilonix Prosthetic Cooling System, named after Aquilon, the Roman god of the north wind. The system includes two small thermoelectric devices. When electricity is applied to the devices through a control box and a battery mounted on the prosthesis, one side gets cold and the other side gets very warm, which is then cooled by a little fan.

“We stuck with a keep it simple type of concept that is unobtrusive to the user and easy for the prosthetists to install,” said Walters, who is also the operations manager of Leto Solutions, the company that will market the device.

The Aquilonix project

At the University of Texas at San Antonio (UTSA), senior engineering students must write an engineering proposal as if they are going to present it to a client, Walters told O&P Business News. This includes identifying a problem, setting up functional requirements, coming up with three or four alternative designs and selecting one based on a criteria list. The design is then finished in the next semester when the team builds a prototype and enters into a testing phase to prove that the product works.

Walters and his team members chose to enter the Student Technology Venture Competition presented by the UTSA Center for Innovation and Technology Entrepreneurship (CITE), where they were teamed up with a group of business students to make a comprehensive business plan.

“Our goal was to mirror the hard work that the engineers had put into the product throughout the entire previous semester,” Justin Stultz, entrepreneur graduate and regional sales manager of Leto Solutions, said. “Everybody in the class had an opportunity to pair up with a group of engineers. There were a lot of good products out there, but my team and I thought the Aquilonix System was one product that didn’t just help as a luxury item. I saw it as a necessity and as something that could help people.”

Jake Montez, engineering team leader for Leto Solutions, exhibits the Aquilonix System.

Throughout the 4-month process, the team sent surveys to potential end users, spoke to prosthetists and developed a market analysis that determined there are about 800,000 transtibial amputees who could benefit from the Aquilonix System. The team then constructed a presentation, which was delivered to the 10 judges in a room filled with their families, peers and members of the San Antonio business community. Not only did the team win the CITE competition, but the Aquilonix System also won the top mechanical engineering project for the semester, which was awarded by a separate set of judges.

“I think one of the big problems for all amputees is discomfort. The sweating can cause ulcers and they can’t wear their prosthesis because they might get an infection. But what really hits home is for a type 2 diabetic where if they get a sore it may not heal, it may go gangrenous, they could lose more of their limb or possibly die. Stopping those ulcers and friction blisters before they start is what really sets the Aquilonix System apart,” Walters said. “The current standard of care is to put deodorant on your limb or wear an absorbent sock, but many patients can’t wear those all day. Instead of treating the symptoms, we’re stopping the problem before it starts.”

Leto Solutions

Whether the team won or lost the CITE competition, they knew they wanted to bring the Aquilonix System to market, so they began researching and gathering information they would need to make their dream a reality.

“Since this was a medical product, we had a number of unique circumstances that had to be addressed,” Becky Ariana, chief executive officer of Leto Solutions and Walters and Stultz’s mentor in the CITE competition, said. “For example, we had to develop a solid plan for how we were going to get regulatory approval clearance from the FDA to market in the United States; develop a plan to collect the clinical data we need to substantiate that our product is better than the standard of care; and then address the economic issue of reimbursement for the use of this system and develop a plan to ensure that we would get Medicare coverage for it.”

Besides gathering medical information, the team also has filed articles of incorporation and made tweaks in the business plan to put together the new business entity Leto Solutions.

“What compelled me to go forward with Leto Solutions, aside from working so closely with Gary and realizing there was a need for the system, was everybody we talked to along the way, who we got guidance and information and help from, was really excited to help us out with this,” Stultz said. “It is something I think you could talk to anyone about for 5 or 10 minutes and they would become passionate about it.”

Next step

The next step for Leto Solutions is to secure their first round of funding to build beta test units to validate the design of the system and obtain FDA clearance. The second round of funding will be used to conduct a 2-arm clinical study that will compare the Aquilonix System to the current standard of care.

When the Aquilonix System is approved for marketing, it will first help benefit patients at the Center for the Intrepid in San Antonio, Balboa Naval Medical Center in San Diego and Walter Reed National Military Medical Center in Baltimore, followed by the Department of Veterans Affairs and, finally, it will be distributed to patients throughout the United States. Plans include making the device available in select international markets.

“This has been an amazing experience,” Walters said. “Watching a product go from just an idea I had while cutting the grass to a full working prototype and then watching the individuals on the business side develop it into an actual business has just been amazing.” — by Casey Murphy