FDA Breakthrough Device Designation for Cala Trio™ Therapy to Treat Action Tremors in Parkinson’s Disease

The U.S. FDA has granted Breakthrough Device Designation to Cala Trio™ for the treatment of action tremors in the hands of adults with Parkinson’s disease.

Background

Cala Health, Inc., is a bioelectronic medicine company developing wearable therapies for chronic disease.

Cala Trio is the first non-invasive targeted therapy that reduces hand tremors for adults living with Essential Tremor (ET). Prescription therapy is a simple, wrist-worn device that is calibrated to treat a patient’s unique tremor symptoms. When activated, Cala Trio gently stimulates the nerves in the wrist to disrupt the tremulous activity in the brain, without the need for invasive brain surgery or medication.

Cala Trio is currently FDA-cleared to relieve hand tremors from ET. The Company expects to initiate the next clinical trials evaluating the therapy in the treatment of action hand tremors in patients with Parkinson’s disease by the end of 2020.

Breakthrough Device Designation is granted to specific medical devices that have the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization.

Cala Health sought Breakthrough Device Designation for Cala Trio because many patients with Parkinson’s disease experience the same action tremor as patients with essential tremor.

The Company expects to initiate the next clinical trials of Cala Trio virtually in patients with Parkinson’s disease in 2020.

Clinician comments

“While hand tremor in patients living with Parkinson’s disease typically occurs when the arm is at rest while sitting or walking, it is also estimated that more than half of patients also experience action tremor, which occurs when the arm is being used to perform an activity or task,” said Stuart Isaacson, MD, Director of the Parkinson’s Disease and Movement Disorders Center of Boca Raton in Florida. “Furthermore, published data suggest that levodopa, the primary treatment for motor symptoms of Parkinson’s disease, is not usually effective in treating this type of tremor, which can negatively affect performing daily tasks like eating and writing. For this reason, treatment for action tremor in patients with Parkinson’s disease remains a significant unmet medical need that impacts their daily activities and overall quality of life.”

Company comments

“Cala Health is committed to pursuing rigorous scientific and clinical research to demonstrate the mechanism, benefits, useability, and safety of our technologies,” said Kate Rosenbluth, Ph.D., Founder and Chief Scientific Officer of Cala Health. “We are pleased to have the FDA recognize the novelty and potential for our wrist-worn neuromodulation therapy.”

Source: Business Wire


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