Some have dubbed Abilitech’s device “a wheelchair for the arms.” Its machined aluminum exoskeletal arm and breathable cloth vest use a spring counterbalance system and a “living hinge” that spreads the load, making it — and the arm — feel weightless.
Nancy Crotti, Managing Editor
Rob Wudlick brushed his teeth on his own recently for the first time in 8 years.
The 35-year-old industrial engineer is a quadriplegic as a result of an accident. He’s been working for three years as a consultant to Abilitech Medical (St. Paul, Minn.), a startup whose Abilitech Assist device enables wearers to use their arms to feed themselves, brush their teeth, comb their hair, turn on a light switch, open doors — activities for which they’ve needed help from caregivers.
Before founding Abilitech in 2016, CEO Angie Conley was working for a nonprofit called Magic Arms, which was trying to develop a 3D-printed device powered by rubber bands for children with a congenital joint contracture called arthrogryposis. When she joined Magic Arms, the device was in the prototype phase, fundraising for further development was difficult and the nonprofit had not fit any patients.
“I was a senior product manager at Medtronic and I’ve worked on six different cardiovascular products,” Conley said. “I had the skill set to develop a solution but no budget and no staff — only a few volunteers with extremely limited capacity. We even struggled to pay for things like QuickBooks. It was a bake-sale approach every time I fit a patient.”
Conley raised enough money over 18 months to fit 12 children. “I saw patients moving their arms for the first time ever and their parents just wept in disbelief,” she said. “It was an incredibly moving experience.”
Meanwhile, her inbox was filled with people asking Magic Arms to help their adult loved ones who lived with multiple sclerosis, amyotrophic lateral sclerosis (ALS) or spinal cord injuries, but the nonprofit was focused on children with pediatric orphan conditions. When Magic Arms tried its system on a 90-lb doctor who had a neurologic condition, the device broke.
From nonprofit to business
When it became clear that the Magic Arms device was not scalable and needed to be redesigned, Conley decided to develop new technology powered by springs and motors and to focus on a market that included adults.
Aaron Fletcher, managing director of Fort Worth, Texas–based venture capital firm Bios Partners, was her first investor. His daughter, Maddy, now 10, was born with arthrogryposis. Although the condition affects Maddy’s legs rather than her arms, Fletcher was inspired by the need to help children affected with rare diseases.
Bios Partners normally invests in biotechnology companies, but Fletcher saw an opportunity for a business that could do a lot of good if it could develop a smaller, more durable device that would be scalable for people of different sizes and eligible for insurance reimbursement. Bios Partners invested $2.3 million and subsequently participated in a follow-on raise.
“Angie has been with us since the beginning, and it has really been just all the credit to her continual hard work on trying to get this developed,” Fletcher said.
Last year was an important year for Abilitech. The company won the top two awards for startups in Minnesota: the MN Cup entrepreneurship competition and the Minnesota High Tech Association’s Tekne award for medtech. It also participated in the Texas Medical Center accelerator program in Houston, which provides free office space, business advisors and clinical study opportunities.
‘Wheelchair for the arms’
Some have referred to the Abilitech Assist as “a wheelchair for the arms.” It consists of an exoskeletal arm with a machined aluminum shell and a breathable cloth vest made by Core Products International (Chetek, Wis.). It has a spring counterbalance system and a “living hinge” that articulates across the back and wraps around the chest to spread the load of the device and the arm so that they feel weightless. The vest’s plastic-and-aluminum structure is padded with formable foam for comfort and has a lumbar sacral orthotic to secure it to the hips.
“It is not robotically powered,” said Mark Oreschnick, Abilitech’s VP of R&D. “It just takes gravity out of the equation… We’re actually supporting their arm and the weight of the device for them – it’s like power steering for the arms.”
The other challenge was making the arm portion as light as possible (up to 3.5 lb) but still strong enough to meet testing regulations. Abilitech was advised to use carbon fiber, but Oreschnick said it is not strong enough to withstand the 150 lb of force created by arm extension. The company went with 70-75 grade aluminum, the type used in the interior of an airplane.
“It has a very good strength-to-weight ratio,” he said. “This is not as good as steel, but it is a close competitor. Going up a little bit in thickness, you can outperform steel and still be lighter.”
The company worked with spring manufacturers R&L (Lake Geneva, Wis.) and Century Spring (Commerce, Calif.) to provide the correct lift and pretension the springs for each wearer, Oreschnick explained. Caztek Engineering (St. Paul) is the main design firm for the Abilitech Assist, with Primordial Soup, also in St. Paul, doing the machining. Abilitech is using Linak (Nordborg, Denmark) linear actuators and Carl Stahl Sava Industries’ (Riverdale, N.J.) custom cables. Nortech Systems (Maple Grove, Minn.) is doing the manufacturing.
Abilitech has also worked with the rehabilitation services department at Gillette Children’s and Regions Hospital in St. Paul for 3 years for input on design and functionality. Rehabilitation services director Marny Farrell said she appreciates being able to help the company problem-solve.
“I think it’s the big litmus test to be involved with practitioners to see how it will work,” said Farrell, who witnessed one patient fed himself for the first time since his injury. “It’s just amazing when it’s the right piece. It can change their quality of life.”
Rob Wudlick, the engineer who’s been working with Abilitech, said the device allows him to move his hand to his face and helps him with range-of-motion. The vest also provides him with core stability to support arm function, with the latest iteration enabling him to independently feed himself and brush his teeth. “Having the ability to do it on your own, it’s really nice,” Wudlick said.
No more bake sales
Conley has raised $11 million over the past three years to fund the device’s development, and to support device testing, FDA registration, clinical studies and commercialization into 2021. Abilitech plans to enroll 75 muscular dystrophy patients in a clinical trial at the University of Minnesota and Gillette Children’s Hospital. The endpoints will measure how the device helps users complete activities of daily living such as eating, drinking and toothbrushing; quality-of-life improvements; and economic benefits.
Abilitech Assist is designed for people over 5 feet tall and is Class I, FDA 510(k)-exempt. The company plans to launch the right-arm version in June 2020 and follow with the left within a few months. There’s strong interest in using it for rehabilitation, and future clinical studies will be planned for stroke and spinal cord injury rehabilitation, according to Conley. A National Institutes of Health grant is funding the adaptation for use with children, fulfilling Conley’s mission at Magic Arms. She expects to conduct a pediatric clinical trial in the first quarter of 2021.
“It’s motivating for our team to have a mission to restore independence for these people,” Conley said. “We will have a physical, social and economic impact that will make a profound difference in patients’ lives and in the lives of their families.”