MYOLYN has asked the U.S. Food and Drug Administration (FDA) for a patent for the functional electrical stimulation (FES) bikes it makes for people with neurological and muscle conditions such as Parkinson’s disease (PD).
The MyoCyle Home is MYOLYN’s most affordable, easy-to-use bike. It is designed to help patients take control of their health by getting the therapy they need at home.
The MyoCycle Pro is for clinic use. It combines FES and constant-speed cycling into a single system designed to maximize therapy.
This 510(k) patent-application is a milestone for MYOLYN, a startup founded at the University of Florida in 2013. It marks the completion of the company’s development of its flagship medical device.
“FES is a very promising technology that can help many people with paralysis or muscle weakness,” Alan Hamlet, PhD, MYOLYN co-founder and chief executive officer, said in a press release.
“MYOLYN is innovating FES solutions to make this technology more widely available,” he added. “The MyoCycle is an affordable, easy-to-use FES bike that enables therapeutic, load-bearing exercise despite even complete paralysis.”
Paralyzed people are able to use an FES bike because it activates their muscles for them. The bikes are designed to relax muscle spasms, prevent muscle atrophy, increase blood circulation, maintain or increase motion, and re-educate muscles after disease or injury.
The devices can also be used by those who have had a stroke or who have multiple sclerosis, cerebral palsy, or a spinal cord injury. And they can be used by people who need orthopedic rehab after an injury.
The FES technology can be customized for each patient, eliminating the need for a specialist to make expensive preparations.
“The patent-pending algorithms we use automatically select the optimal stimulation parameters for the patient, making the MyoCycle not only effective, but extremely easy and intuitive to use,” said Matthew Bellman, PhD, MYOLYN’s chief technology officer.
“Our goal was to make this technology practical for use in the home for the first time, so we designed the MyoCycle from the ground up to be affordable and as easy-to-use as a regular exercise bike,” Bellman said.
MYOLYN makes rehabilitation-technology and electrical-stimulation devices. The University of Florida is patenting the core technology. MYOLYN has the rights to the technology in its products, however.