American bioelectronic medicine company Cala Health has received breakthrough device designation from the Food and Drug Administration (FDA) for its therapy for treating action tremors in the hands of adults with Parkinson’s disease (PD).
Called Cala Trio, the therapy has been previously cleared by FDA to relieve hand tremors due to essential tremor (ET). The company now plans to evaluate the therapy in the treatment of action hand tremors in patients with Parkinson’s disease.
Action tremors are caused by the voluntary movement of a muscle and the majority of tremors are considered to be action tremors.
Patients with both ET and PD suffer from tremors during muscle contractions. It includes tremors that occur when patients are using their hands to perform activities.
Cala Health noted that it pursued FDA breakthrough device designation for Cala Trio because many patients with Parkinson’s disease face the same action tremor as patients with essential tremor.
Cala Health founder and chief scientific officer Kate Rosenbluth said: “Cala Health is committed to pursuing rigorous scientific and clinical research to demonstrate the mechanism, benefits, useability, and safety of our technologies.
“We are pleased to have the FDA recognise the novelty and potential for our wrist-worn neuromodulation therapy.”
A non-invasive targeted therapy, Cala Trio is currently available in the US by prescription.
The company plans to start the trials of Cala Trio in patients with Parkinson’s disease-related action hand tremors by the end of the year.
The study is being planned as a virtual clinical trial that will enable participants to volunteer from home with telemedicine visits from a neurologist throughout the study.