By ANDREW MOORE
Reporter with Silicon Hills News
“If you get a good blister you might be out of your leg for a day or two. If that doesn’t heal and becomes a real sore, you might be out of your leg for a week or two,” said Walters.
It’s a common problem for amputees but also an unsolved one, and the only solution Gary’s Prosthetist could suggest was to “put deodorant on the limb” to try and keep it dry.
As a University of Texas at San Antonio undergraduate engineering student, Walters later pitched this problem in his capstone design class. Fellow engineers Austin Darius, Jake Montez, and David Schultz tackled the problem head on. Their solution – now named the Aquilonix prosthetic cooling system – is a prosthetic component that keeps an amputee’s limb dry even while active. The device is now the central product of new San Antonio medical startup Leto Solutions.
The team, Leto Solutions, went on to win UTSA’s $100,000 Student Technology Venture Competition. The biannual competition is held by the Center for Innovation and Technology Entrepreneurship – or CITE. In the CITE program that precedes the competition, business students and engineering students come together to market a product – in this case the Aquilonix system — and form a viable business model as company.
For the competition, Walter’s engineering team was joined by business majors Nam Do, Eric Michael Garza, Enrique Medrano and Justin Stultz. In the program, the students did market research, created a business plan, and presented the product to a board of judges. Becky S. Ariana, who specializes in bringing medical technology from the conceptual prototype stage to the market, mentored the group.
Now hired as the startup’s CEO, Ariana says that Leto Solutions is not just a business venture; it’s a personal mission for everyone involved.
“This product spoke to all of us because it’s a necessity for amputees,” said Ariana. “Almost everyone on the team had contact with someone in their life who was also an amputee.”
UTSA graduate Justin Stultz, who led the Leto Solutions business team, has both a cousin and a neighbor who use prosthetics and suffer from heat buildup — giving Stultz firsthand experience of the struggles they face.
“Once they have this freedom and then due to a secondary infection caused by heat and sweat buildup they have to go without the prosthetic for three and four days…it just puts a complication in their life that doesn’t need to be there,” said Stultz. “It’s 2013 and we have the technology to do this. It’s just a matter of getting it done.”
The buildup of heat and sweat can cause more than just discomfort and pain for amputees, however. Diabetic amputees can contract gangrene leading to additional limb loss and even death.
When heat and sweat buildup inside a prosthetic joint, it causes skin breakdown, friction blisters, and open sores. For diabetic patients who have trouble healing, these sores can become infected by bacteria and then develop gangrene. As the flesh starts to decay, it must be further amputated. If the gangrene gets into the blood stream, the diabetic may become septic and possibly die.
The Aquilonix prosthetic cooling system helps prevent these problems by keeping the limb from sweating in the first place, which means the user will no longer slide around and become blistered. The system uses special thermoelectric disks that, when subjected to electricity, actually pull heat from one side of the disk material to the other and away from the limb. A second component then dissipates the heat with a small fan. The system can be turned on and off at will from a control switch on the prosthetic and runs on a rechargeable lithium polymer battery. The battery life is only two to three hours, but it can be easily charged at home in a similar manner to a mobile phone. Incorporating the system to an existing prosthetic only adds 2 pounds. According to Walters, the system is complex enough to self-regulate the heat removal – meaning users will never have to worry about over-cooling their limb. While Leto Solutions is still perfecting their system, any additional changes will be mostly of an aesthetic nature.
In the product’s first official test, where Walters actually wore the prototype on a treadmill for a ten minute walk, the limb stayed completely dry the entire time – even while Walters was drenched in sweat.
“We were actually surprised it worked as well as it did,” said Walters.
For Walters in particular, the prosthetic cooling system presents not only an exciting business venture, but increased personal freedom in many daily activities – from working in the yard to going to the park with his daughter.
“After about an hour we’ve got to go home because I’m sweaty and the limb is starting to slip and slide around,” said Walters. “With the system on, I’ll be able to go play with her as long as I want.”
As a new medical startup, Leto Solutions is still taking its first steps to becoming a company. The startup is currently filing its articles of incorporation and the provisional patents on its new technology. It will soon file the cooling system with the Food and Drug Administration as a Class 1 Exempt Medical Device. According to CEO Ariana, the company will need to go through three rounds of funding and should be profitable by their third year of operation.
Five of the eight students are moving forward with the company. Walters will be the startup’s new operations manager, Stultz with be the regional sales manager, and engineering graduate David Shultz will be the engineering and science manager. The other two members of the engineering team will be unpaid consultants until the startup can afford to bring them on. As the winners of the CITE competition, Leto Solutions will have additional resources available such as legal services from Cox Smith, free office space for a year at the San Antonio Technology Center, and funding from additional sponsors.
The business plan for Leto Solutions will be to sell the Aquilonix cooling system to Prosthetists, who build prosthetics out of multiple components based on each patient’s needs. According to the startup’s market research, there are approximately 800,000 below knee amputees in U.S. and around 300,000 prostheses sockets made per year – virtually all of which can incorporate the cooling system. Leto Solutions will be contracting with Coastal Life Technologies, a local company, for the manufacturing and packaging of their system. The predicted price point for the Aquilonix system is $650.
Leto solutions plans to begin their beta testing as soon as possible and will also apply for insurance and Medicare reimbursement so patients will not have to pay out of pocket. The startup plans to partner with the Center for the Intrepid in San Antonio for their initial testing and will partner with other Veterans Affairs medical centers across the country to do a 2-arm comparative clinical study.
According to Walters, the whole situation for Leto Solutions was extremely fortunate – from their access to San Antonio Veterans Affairs offices to their mentor who has done this kind of work before.
“Our entire situation was so fortuitous,” said Walters. “We end up with a mentor who – this is what she’s done for the last 40 years. We’re in San Antonio which is a heavy biomedical and highly innovative city and we are doing an innovative and biomedical product. So everything dovetailed perfectly.”