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 their impact on the children’s quality of life. The company is collaborating with researchers to recruit 20 candidates between six 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 (FDA) to obtain clearance for Limbitless to market the prosthetic to the public and work with insurance companies to cover the cost. The nonprofit company has 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. Limbitless Solutions was founded in 2014 and gained national recognition for its personalized designs and mechanics. The company is believed to be the first to combine 3D printing with electromyography — an established technology that records the electrical activity of muscle tissue — to create a prosthetic arm for children. The Limbitless prosthetic arms are not available for sale on the market, which is part of the reason the company is launching a clinical trial to gather evidence about the effect of its product on the lives of children who use it. Meanwhile, what is available on the market can cost tens of thousands of dollars, and insurance companies aren’t keen on covering them, because children grow and will need to replace their prosthetics more frequently than adults. It is estimated a Limbitless prosthetic, including parts and labor, costs less than $5,000. The trial has been fully funded by philanthropists, and there will be no charge to the participants.
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