Muscle Atrophy Device Gets CE Mark

CyMedica Orthopedics, Inc., has received a CE mark for its QB1 Muscle Activation System. The system received clearance from the U.S. FDA in April 2015.

“Securing the CE Mark for the QB1 System marks an important milestone for our company, greatly expanding our market opportunity to patients in Europe and paving the way for a global sales and distribution network. We are excited to have the clearance to deliver our revolutionary technology to millions of patients outside of the United States, ” said CyMedica President and CEO Rob Morocco.

The OB1 is designed to help patients suffering from quadriceps muscle atrophy—a weakening of the major leg muscles after anterior cruciate ligament (ACL) and total knee replacement surgery. The company maintains that quad atrophy can significantly slow healing and affect a patient’s activities, leaving them prone to delayed rehabilitation and further injury.

The press release states that the QB1 incorporates this patented technology with a postoperative knee brace to bring rehabilitation therapy into a patient’s home. Company officials state that this enables all knee patients to potentially improve their quad strength markedly faster and more comfortably than with other methods.

CyMedica Orthopedics, Inc. is based in Scottsdale, Arizona. It is a privately held medical device company that develops and commercializes products that target muscle atrophy using the firm’s platform technology. That technology includes “the first closed-loop power control system” to provide patients what the company calls “comfortable yet aggressive treatment.”