A University of Central Florida based nonprofit that makes 3D-printed prosthetics for children is launching the first U.S. clinical trial for their bionic arms.
At a press conference on Wednesday, Limbitless Solutions announced a partnership with Oregon Health & Sciences University for the trials.
“Where this goes from here is going to be huge,” lead clinical investigator Dr. Albert Chi said. “It’s my personal aspiration to provide advanced prosthetics to all those in need. Making it affordable and accessible is the goal, and I really do believe 3D printing technology is the solution.”
The clinical trial will recruit 20 children, primarily from the Southeast and the Pacific Northwest, who will be fitted with prosthetic arms custom-designed by Limbitless Solutions.
“We hope our work will ultimately allow us to provide prosthetic arms to children at little or no cost,” the CEO of Limbitless Solutions, Albert Manero, said. “There is a real psychological-social aspect of having an arm they can customize and which reflects their personality. It allows kids to be kids and understand their opportunities are limitless.”
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According to a release by Limbitless Solutions, the bionic 3D-printed arms are operated by using a pair of lead wires placed on the skin to activate the device when children flex their muscles.
The devices can be produced at a hardware cost of less than $1,000 each in the lab located at UCF, the release said.
Children participating in the year long trial will be taught to use the arms with occupational therapy support. The trial will test the functionality of the arms in children 6 to 17, gauge the effect on their quality of life and determine how the arms are used in specialized tasks.
The Food & Drug Administration uses clinical trials to help determine if a product reaches certain criteria for market clearance, which would enable it to be covered by insurance.
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Partners participating in the trial said they hope it’s the first of several that would establish a nonprofit model for 3D-printed prosthetics for children in need.
“It’s been a long journey, and we are so excited to see the trial start because we believe it will make a difference in children’s lives,” Manero said.
The clinical trial is open to children across the United States, but close proximity to the trial sites in Orlando and Portland, Oregon, is needed.
For information about how to participate, visit 3DHope.com.