San Mateo, California-based Cala develops multiple devices for treating essential tremor, including the Cala Trio and the kIQ. The company launched the kIQ wrist-worn device last year. They deliver transcutaneous afferent patterned stimulation (TAPS) therapy for treating tremor.
One randomized, pragmatic CVS Health trial found that adding Cala TAPS therapy to standard of care improved outcomes over standard of care alone. The study recruited patients from the database of health insurer AETNA. The company says it marks the largest prospective device study run in essential tremor to date, with 310 subjects.
According to a news release, the study found significant improvements in tremor power and Bain & Findley Activities of Daily Living (BF-ADL) upper limb scores over one month of TAPS. It demonstrated TAPS as a safe and effective treatment option for patients with ET.
Other data from Cala
Cala also reported real-world evidence demonstrating consistent relief over multiple years of use for TAPS therapy. It looked at usage data and effectiveness data from 1,223 and 808 subjects, respectively. Data showed effective tremor reduction at a 64% average. It also showed consistent usage with no significant habituation over long-term use (up to 3.4 years).
A secondary analysis looked at TAPS response in patients with high unmet need and those who benefitted from TAPS during their first month of use. It found a significant improvement over the sham in the high unmet need subgroup. The analysis also saw significant improvements over multiple months in the high unmet need group.
“We are excited about the growing body of evidence demonstrating that TAPS improves patient outcomes in real-world settings,” said Kate Rosenbluth, co-president and chief scientific officer, Cala Health. “With these latest publications, TAPS has now been assessed in nearly 2,000 ET patients and with use extending beyond 3 years. TAPS addresses the large treatment gap between medications and surgery for ET patients struggling with activities of daily living such as eating, drinking writing and self-care.”
