Cala Health today touted data demonstrating that its Cala Trio therapy is safe and effective in improving essential tremor in patients.
Burlingame, Calif.-based Cala Health said in a news release that the data for the wearable technology came from use at home, unsupervised and under real-world conditions, further validating the results reported in the Prospect study nearly one year ago.
Cala Health reported the results at the International Parkinson and Movement Disorder Society’s MDS Virtual Congress 2020, being held from Sept.12 to Sept. 16.
The data covered 44 patients using Cala Trio for symptomatic tremor relief in hand tremors over three months of unsupervised home use. Tremor severity was quantified through tremor power, which was collected through motion sensors and assessed before and after each of the first 40 therapy sessions and every subsequent seventh session.
According to Cala Health, 93% of patients experienced at least a 50% reduction in tremor power following their most severe tremors and 57% of patients experienced the same reduction in tremor power over all sessions.
Among 18 patients who completed a survey after 90 days of use, 61% reported improvement in their ability to eat, drink and write while 56% reported improvement in their quality of life. Three out of 44 patients reported minor adverse events (skin irritation or electrical burns) that resolved with a pause in treatment and with no medical intervention.
“Patients with ET often need to choose between living with tremors that negatively impact their daily lives or risk unwanted side effects from pharmacologic therapy – our mission is to change that equation and improve lives,” Cala Health founder & chief scientific officer Kate Rosenbluth said in the release. “As a bioelectronic alternative, Cala Trio offers a new approach for managing tremors without the systemic side effects of pharmacologic treatments or the brain surgery needed for implanted devices.
“The real-world evidence presented at MDS shows that excellent outcomes can be achieved with Cala Trio and that the device is easy for patients to use in their everyday lives – not just in controlled clinical trials.”