Cala Launches Next Generation Wearable Tremor Therapy Nationwide

SAN MATEO, California—Bioelectric device maker Cala announced nationwide availability of the Cala kIQ Plus System, the latest advancement of its wearable neurostimulation device for action hand tremor in essential tremor (ET) and Parkinson’s disease (PD).

Recently cleared by the Food and Drug Administration, Cala kIQ Plus says it is the first and only wearable to offer multiple stimulation waveform modes, which users can choose and change at any time, and adaptive calibration to personalize therapy. A study of the three waveform modes presented earlier this year at the annual American Academy of Neurology Conference, demonstrated that patients using their preferred waveforms, traditional transcutaneous afferent patterned simulation (TAPS) or one of the new waveforms, obtained significantly greater improvement on the Bain and Findley Activities of Daily Living scale. All TAPS therapy modes delivered robust, meaningful and statistically significant tremor relief, with a majority of patients (ranging from 76%-89%) achieving greater than or equal to a one-point reduction in the gold standard clinician rated TETRAS performance score.

“Cala kIQ Plus device is a groundbreaking advancement in wearable neuromodulation to treat action hand tremor in essential tremor and Parkinson’s disease. The system’s unique multiple therapy modes and adaptive calibration optimizes outcomes and personalizes therapy for patients. It is the result of collaboration amongst our Cala patients and physicians, backed by science,” said Cala CEO Deanna Harshbarger.

Key features of the Cala kIQ Plus System include:

1. Multiple therapy modes: The device now offers three stimulation modes. Users are in control to select or switch modes at any time to optimize what works best for them. In a clinical study, allowing patients to choose their preferred waveform significantly increased overall treatment efficacy compared to using a traditional waveform alone.
2. Adaptive calibration: The Cala kIQ Plus device personalizes therapy by calibrating before each session, capturing and adjusting to the patient’s unique tremor fluctuations throughout the day. 
3. Intuitive experience: The Cala kIQ Plus System comes fully assembled with on-device guidance simplifying onboarding. Comfortable to wear all day, patients can use therapy as often as desired throughout the day.

The Cala kIQ Plus System is now available nationwide with a prescription from a healthcare provider, typically a neurologist or movement disorder specialist. The Cala system is available by the Veterans Affairs (VA) Health System at no cost to eligible VA beneficiaries and has Medicare coverage for those who meet local coverage criteria. The company said it is advocating on behalf of patients with ET and PD to secure additional coverage and reimbursement in Medicare Advantage and commercial payor plans.