Limbitless Solutions, a University of Central Florida-based company that makes 3D-printed bionic arms for children, is launching the first clinical trial of its kind to study the effectiveness of its prosthetics and the impact on the children's quality of life.
The company is collaborating with researchers at Oregon Health Sciences University to recruit 20 candidates between ages 6 and 17 years old for the yearlong study.
The ultimate goal is to gather data from 100 users and present it to the Food and Drug Administration to get clearance, so that Limbitless can market the prosthetic to the public and work with insurance companies to cover the cost.
The nonprofit company on Wednesday also unveiled the fourth generation of its bionic arm, which enables users to move each finger separately, has full rotation and features interchangeable sleeves so that children can further personalize their prosthetic limbs.
"The full rotation is something that we've really been waiting for for a while, because the ability to turn your hand and put your hand flat on the desk or turn it upward and hold a tray in school, that's a big deal," said Alyson Pring, whose son Alex was the first to wear a Limbitless arm four years ago at age 6.
There are currently no comparable alternatives available on the market for kids who are missing part of their arm.
"Hopefully this is the first step in the future for the next generation of prosthetics," said Dr. Albert Chi, associate professor of surgery in the OHSU School of Medicine and lead clinical investigator of the Limbitless study. "I truly believe that we are right now witnessing the evolution of a new technology and a new device that can truly impact so many."
Limbitless Solutions was founded in 2014 and quickly gained national recognition for its personalized designs and mechanics.
The company is the first to combine 3D printing with electromygraphy - an established technology that records the electrical activity of muscle tissue - to create a prosthetic arm for kids.
Small pads extend from the 3D-printed prosthetics and attach to the children's arms, sending the muscles' electrical signals to a computer chip in the arm, which translates those signals into movement.
"The future is already here," said Dr. Deborah German, dean of UCF College of Medicine, during Wednesday's news conference. "Everyone in this room has witnessed the future today. Advances in material science, medicine and engineering have allowed us to enter this new age and we're applying our knowledge using technology to improve the quality of life."
Limbitless also unveiled on Wednesday four themes for the decorative sleeves of the arms: warrior, shadow, serenity and ethereal. The new magnetic sleeves can snap on and off the body of the prosthetic and help children express themselves more than they can now.
"Anecdotally we've seen that the designs have a huge impact on kids' psychosocial develpment," said Limbitless CEO and co-founder Albert Manero. "It makes it easier for them to go to school and makes them more confident and that confidence can translate to all sorts of areas from their academics to just their normal day-to-day life."
Alex Pring, who still doesn't know if he'll be selected for the study, said he would choose an arm with the warrior theme.
The Limbitless prosthetic arms aren't available for sale on the market, which is part of the reason the company is launching a clinical trial to gather evidence about the impact of its product on the lives of children who use it.
Meanwhile, what's available on the market can cost tens of thousands of dollars and insurance companies aren't keen on covering them, because kids grow and will need to replace their prosthetics more frequently than adults.
"Kids have the highest degree of challenge with accessibility to prosthetics right now," said Manero.
Using 3D printing to make the prosthetics significantly reduces the cost, said Manero. He estimated that a Limbitless prosthetic, including parts and labor, costs less than $5,000.
Also unique to Limbitless are games that are designed to teach children how to use their arms while having fun.
"One of the greatest things about Limbitless is that each one of us can't do it all by ourselves. It takes a village," said Matt Dombrowski, Assistant Professor of Digital Media at UCF College of Visual Arts and Design.
The Limbitless clinical trial is expected to start around the time the schools begin in the fall.
In the meantime, Manero and Chi will lead recruitment efforts and eventually a computer program will use a selection matrix to choose the 20 participants.
Children will learn how to use the arm during the pilot study and receive four occupational therapy session during the year.
"We're so excited because this represents a major leap forward of our goal of being able to have every kid in the United States who wants a bionic arm to be able to have one," Manero said.
The trial has been fully funded by philanthropists, and there will be no charge to the participants.
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