Limbitless Solutions — a Florida company that makes bionic arms for children using Stratasys 3-D printers — is launching the first clinical trial of its kind to study the effectiveness of its prosthetics.
The company, an offshoot from University of Central Florida research, 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 costs.
The fourth generation of the nonprofit company's bionic arm 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 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 at the Oregon university and lead clinical investigator of the Limbitless study.
Limbitless Solutions was founded in 2014 and quickly gained national recognition for its personalized designs and mechanics. The company is the first to combine 3-D printing with electromyography — an established technology that records the electrical activity of muscle tissue — to create a prosthetic arm for kids. Stratasys is based both in Israel and Eden Prairie.
"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," said Dr. Deborah German, dean of UCF College of Medicine.
