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On Monday, a Silicon Valley-based bioelectronic medicine company raised tens of millions of dollars to help the more than 7 million Americans who struggle with essential tremor (ET).
The company, named Cala Health, closed a $50 million funding round co-led by Vertex Growth Fund and Nexus NeuroTech Ventures. All of the company’s existing investors also participated in the round, including GV, Johnson & Johnson, Lux Capital, OSF Ventures and Ascension Ventures.
Cala was founded in 2014 as a Stanford University spinout. Its main goal is to give patients a better option for treating their ET — which is a neurological disorder characterized by involuntary shaking that usually affects the hands, head or voice.
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The condition can have a significant effect on people’s essential abilities, such as writing, eating and speaking, pointed out Cala CEO Deanna Harshbarger.
“As a result, these tremors can impact mental health and discourage people from doing what they love. Clinical studies estimate 50% of ET patients suffer from social phobia, and 80% of ET patients suffer from depression that can severely impact quality of life,” she stated.
The drugs used most often to treat ET include beta-blockers such as propranolol and an epilepsy drug called primidone. While these medications are effective for some patients, they can also induce a range of undesirable side effects such as fatigue, nausea and depression — and some patients might not be able to take these drugs due to contraindications with comorbidity, Harshbarger noted.
There are also surgical options, like deep brain stimulation or ablation — but not all patients are keen on invasive procedures, she added.
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Last year, Cala gave ET patients a new option through the commercial launch of its kIQ system, which the company says is the first noninvasive wearable device cleared by the FDA to temporarily relieve tremors in people with ET and Parkinson’s disease.
“Our goal is to leverage bioelectronic medicine to transform the standard of care for chronic disease and allow patients to live life fully,” Harshbarger declared.
The kIQ system is a wrist-worn device prescribed by physicians to manage a patient’s hand tremors. It senses each patient’s unique tremor signature and individualizes stimulation, Harshbarger said.
The at-home therapy system delivers transcutaneous afferent patterned stimulation (TAPS) therapy, meaning it applies specific patterns of electrical stimulation through the skin to modulate neural activity and promote therapeutic effects. Using TAPS, the device noninvasively counteracts the patient’s tremor through the nerves on the wrist, she explained.
Once a patient completes an at-home therapy session, they can view their body’s responses via Cala’s online patient portal. Nine out of 10 patients experience tremor reduction with a complete 40-minute session, Harshbarger noted.
Medicare, the VA and several commercial health plans pay for the therapy, she said.
She also said that Cala has no direct competitors, given there are no other companies selling FDA-cleared, noninvasive neurostimulation devices for the relief of hand tremor. There are some other companies developing devices to treat ET using noninvasive neurostimulation, including Allevion Therapeutics and Encora Therapeutics, but they haven’t cleared regulatory hurdles yet in the U.S.
Cala is also currently in the process of developing TAPS therapy-based solutions for other indications, such as cardiology and psychiatry, Harshbarger said.