Lim­bit­less in­tro­duces new gen­er­a­tion of arms for kids

Orlando Sentinel - - FRONT PAGE - By Naseem S. Miller Staff Writer

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 ef­fect on the chil­dren’s qual­ity of life.

The com­pany is col­lab­o­rat­ing with re­searchers at Ore­gon Health & Science Uni­ver­sity to re­cruit 20 can­di­dates be­tween 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 ob­tain clear­ance for Lim­bit­less to 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 when he was 6.

There are cur­rently no com­pa­ra­ble al­ter­na­tives 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 elec­tromyo­g­ra­phy — 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.”

On Wed­nes­day, Lim­bit­less also un­veiled 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 does not know if he will be se­lected for the study, said he would choose an arm with the war­rior theme.

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 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 School of Vis­ual Arts and De­sign.

The Lim­bit­less clin­i­cal trial is ex­pected to start around the time school be­gins 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 ses­sions 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.

STAFF FILE PHOTO

Alex Pring was 6 when UCF engi­neer­ing stu­dents used a 3D printer to build him a pros­thetic arm. Their work evolved into Lim­bit­less So­lu­tions, which is start­ing a clin­i­cal trial to ex­pand its pros­thet­ics of­fer­ings.

JOE BURBANK/STAFF FILE PHOTO

Wy­att Falardeau, 12, and his mother, Cyn­thia, show off a Blue Man Group sleeve on his Lim­bit­less arm in 2015.

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