Cala Health announced today that it received FDA breakthrough device designation for its Cala Trio treatment for action tremors in people with Parkinson’s disease.
Burlingame, Calif.-based Cala Health’s Cala Trio is FDA cleared to relieve hand tremors from essential tremor (ET), but the company is now nearing the initiation of clinical trials to evaluate the therapy in treating action hand tremors in adult patients with Parkinson’s disease.
Cala Trio is a non-invasive targeted therapy which is available in the U.S. by prescription. The company believes its indications can be expanded because many patients with Parkinson’s experience the same action tremor as those with ET, according to a news release.
The company plans to start the next clinical trials for Cala Trio by the end of 2020, with virtual clinical trials allowing participants to volunteer from home, using the therapy as indicated in the study design and partaking in telemedicine visits with a neurologist throughout the study.
“Cala Health is committed to pursuing rigorous scientific and clinical research to demonstrate the mechanism, benefits, useability, and safety of our technologies,” Cala Health founder & chief scientific officer Kate Rosenbluth said in the release. “We are pleased to have the FDA recognize the novelty and potential for our wrist-worn neuromodulation therapy.”