SAN MATEO, Calif.--(BUSINESS WIRE)--Cala, the bioelectronic medicine leader setting a new standard of care for chronic disease, today announced the commercial launch of its next generation system: the Cala kIQ™ System, the first and only FDA-cleared wearable device that delivers effective therapy for action hand tremor relief in people with essential tremor and Parkinson’s disease.
The Cala kIQ System delivers Cala TAPS (Transcutaneous Afferent Patterned Stimulation) therapy, which is validated by large clinical studies and real-world evidence demonstrating clinically meaningful tremor reduction and improvement in activities of daily living (ADLs).
“At Cala, we’ve always been committed to expanding patient access and accelerating innovation in TAPS therapy for indications beyond essential tremor,” said Renee Ryan, CEO at Cala. “By expanding into Parkinson’s disease, we are now able to bring this powerful treatment to additional patients who suffer from action hand tremors.”
The Cala kIQ System empowers patients and physicians by providing an on-demand, comfortable, at-home therapy for ease of use and management of action hand tremors. This type of tremor occurs when the patient undergoes intentional movement or posture.
Millions of people across the US live with essential tremor or Parkinson’s disease, and diagnoses continue to rise. Treatment options for these conditions have historically been medications or, in more severe cases – surgery. The Cala kIQ System with TAPS therapy offers a non-invasive, non-pharmacologic solution with minimal side effects.
The Cala kIQ System measures each patient's unique tremor physiology and individualizes a stimulation pattern for tremor relief. The system is designed to be easy to use for patients and easy to manage for clinicians. Therapy is on-demand for patients and delivered via a wrist-worn wearable. Designed with patients in mind for comfort and usability, the system also offers online data insights through the MyCala.com patient portal. Patients can see their therapy session results over time and choose to share with their providers to adjust treatment plans.
“Current research shows that tremors can severely impact patients’ mental health and activities of daily living,1 which are essential tasks such as holding a cup, unlocking a door, or dialing a phone,” said Pravin Khemani, M.D., FAAN. “There’s a real need for patient populations who suffer from action hand tremors to have an effective, safe option when it comes to managing their symptoms – which is exactly where TAPS therapy can come in and make a significant difference.”
Cala is committed to providing patients expanded access to Cala TAPS therapy. Cala is a contracted provider with major national and regional health plans for essential tremor including both commercial and Medical Advantage members. The Cala kIQ System is covered by the Veterans Affairs (VA) Health System at no cost to VA beneficiaries. Cala is working to secure additional coverage and reimbursement for the new breakthrough designated Parkinson's disease indication for the Cala kIQ System.
Cala Health is a bioelectronic medicine company transforming the standard of care for chronic disease. The company’s wearable neuromodulation therapies merge innovations in neuroscience and technology to deliver individualized peripheral nerve stimulation, and its direct-to-home digital durable medical equipment (DME) platform is reshaping the delivery of prescription therapies. Cala Health’s products are the only FDA-cleared, clinically validated non-invasive devices for the relief of hand tremors so patients with essential tremor can return to the moments that matter. New therapies are under development in neurology, cardiology, and psychiatry. Founded in 2014, the company is headquartered in the San Francisco Bay Area and backed by leading investors in both healthcare and technology.
The Cala kIQ device is indicated to aid in the temporary relief of hand tremors in the treated hand following stimulation in adults with essential tremor.
Cala kIQ device is indicated to aid in the temporary relief of postural and kinetic hand tremor symptoms that impact some activities of daily living in the treated hand following stimulation in adults with Parkinson’s disease.
Caution: Federal law restricts this device to sale by or on the order of a physician.
Prior to use, refer to the product labeling for complete product instructions for use, contraindications, warnings, and precautions at https://calahealth.com.
©2019-2023 Cala Health, Inc. All Rights Reserved. Cala Health and Cala kIQ are trademarks of Cala Health, Inc.
1 Smeltere L, Kuzņecovs V, Erts R. Depression and social phobia in essential tremor and Parkinson’s disease. Brain and Behavior, 2017.