Cala Health has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation (BDD) for its Cala Trio therapy to treat action tremors in adults with Parkinson’s disease (PD).
Cala Trio is an FDA approved non-invasive targeted therapy, intended to reduce hand tremors in adults with essential tremor (ET), and is commercialised in the US as a prescription therapy.
The prescription therapy is delivered through a simple, wrist-worn device, which treats the unique tremor symptoms in patients.
By gently stimulating the nerves in wrist, the device disrupts the tremulous activity in the brain, without requiring invasive brain surgery or medication.
Boca Raton Parkinson’s Disease and Movement Disorders Centre director Stuart Isaacson said: “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.
“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.”
Cala Health will conduct clinical trials of Cala Trio in treating action tremors
Cala Health said that it seeks BDD for Cala Trio based on the observation that many of the patients with Parkinson’s disease experience the similar action tremor as patients with ET.
ET is a chronic condition characterised by involuntary and rhythmic shaking, which worsens over time.
The disease can affect any part of the body, where trembling in the hands is predominant, and makes everyday activities including eating, writing, or getting dressed, difficult for patients.
Action tremor occurs due to voluntary movement of a muscle, and most types of tremor are considered action tremor. There are many sub-classifications of action tremor, and most of which overlap.
The California-based bioelectronic medicine firm intends to begin the clinical trials of Cala Trio in the treatment of action hand tremors in Parkinson’s disease patients, by the end of 2020.
Cala Health founder and chief scientific officer Kate Rosenbluth said: “Cala Health is committed to pursuing rigorous scientific and clinical research to demonstrate the mechanism, benefits, useability, and safety of our technologies.
“We are pleased to have the FDA recognize the novelty and potential for our wrist-worn neuromodulation therapy.”
