Cala Health received FDA clearance for its Trio device to treat the symptoms of essential tremor in 2018. Photo credit: Cala Health
After getting de novo clearance for its device from the Food and Drug Administration in 2018, Cala Health touted data from a post-market analysis that it hopes will prove the device’s benefit to insurers.
The Burlingame, Calif.-based startup has a wearable device to help patients with essential tremor manage their symptoms.
The condition is characterized by involuntary shaking of the hands, and can affect people’s quality of life, including their ability to write, eat, and speak. Beta blockers are sometimes prescribed as a treatment, but not everyone tolerates the side effects well.
Cala’s device works by using mild electrical stimulation to temporarily relieve symptoms. It also uses a built-in accelerometer to track the severity of users’ tremors.
The company recently shared results of a post-market analysis at the International Parkinson and Movement Disorder Society Conference, showing an improvement in tremor strength in people who had used the device at least 10 times.
The analysis was based on a small number of people: 58 VA patients who used the device at home. They used it roughly 5.5 times per week. A smaller segment of patients had used the device 10 or more times. Those 24 people saw a median 51% reduction in tremor power and a 71.7% rate of tremor “relief,” according to the analysis.
Senior Director of Reimbursement Ali Samiian said Cala hopes to share the results with payers as it seeks coverage of the device. In particular, it was important to show that patients are using the device, and that the benefits Cala demonstrated in previous trials translated to the real world.
After getting FDA clearance, Cala started shipping out its first devices in 2019, but most of its patients until this year have paid for it in cash. In April, it was granted a HCPCS code, used to process claims by Medicare and other insurers, Samiian said.
“As of April 1 of this year, we’ve started talking to insurance companies, and submitting individual claims with patients to certain payers,” he said. “It’s a one-by-one discussion we’re having this year.”
Cala is headed up by Renee Ryan, who previously led Johnson & Johnson Innovation medical technology investments. The startup has raised $89 million to date, with backers including GV, Novartis, Baird Capital, and Ryan’s former company.
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