The medical device company MYOLYN has submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for its functional electrical stimulation (FES) stationary bikes — MyoCycle Home and the MyoCycle Pro — to stimulate muscles during exercise.
The bikes can be used by people experiencing muscle weakness or who have lower body paralysis as a result from certain conditions such as cerebral palsy.
The clearance submission marks a major landmark for MYOLYN, a start-up company from the University of Florida, which flourished with help from the university’s Institute for the Commercialization of Public Research and local angel investors.
An FES bike is essentially a stationary exercise bike that helps activate the muscles of individuals who are paralyzed or who experience muscle weakness. The electrical stimulation is applied through electrode pads that are placed on the skin over target muscle groups. The electrical current stimulates the peripheral nerves in the muscle, causing the muscle to contract, using the body’s own energy to perform functional movement.
“FES is a very promising technology that can help many people with paralysis or muscle weakness,” Alan Hamlet, PhD, MYOLYN co-founder and CEO, said in a press release. “MYOLYN is innovating FES solutions to make this technology more widely available. The MyoCycle is an affordable, easy-to-use FES bike that enables therapeutic, load-bearing exercise despite even complete paralysis.”
The MyoCycle bikes can benefit those with cerebral palsy, spinal cord injury, and other conditions that cause muscle weakness, atrophy, and spasms. The bikes can prevent muscle atrophy, relax muscle spasms, increase blood circulation, maintain or increase range of motion, and can be used for muscle re-education following disease or injury.
The MyoCycle Home is one of the most affordable and easy-to-use FES bike. It can be used in the home so patients can take control of their health and perform the therapeutic exercise they need.
The MyoCycle Pro is designed to meet the varying and stressful demands of the busiest physical therapy clinics. It combines FES and isokinetic cycling to give physical therapy patients improved health and meet progressive functional therapeutic outcomes.
“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, the company’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.”