For millions of Americans with essential tremor, simple tasks like writing a note, putting on makeup or plugging in an appliance can be difficult.
In recent years, companies like Cala Health and Fasikl have introduced wearable wristwatch-like devices designed to alleviate the shaking and make it easier to carry out daily activities.
Now, Boston-based Encora Therapeutics, a Massachusetts Institute of Technology spinout, is entering the mix, announcing Thursday, Feb. 12, that it’s received FDA clearance to market its Encora X1 neurostimulation device to treat the common movement disorder.
More than 7 million people in the U.S. have essential tremor, a progressive condition which tends to run in families. It most often affects the upper limbs, causing uncontrolled shaking during activity, such as reaching for a glass.
Roughly half of patients don’t improve with medication or have serious side effects, historically leaving invasive brain therapy as the only option, according to the company. Encora earned the FDA’s breakthrough device designation for the wearable in 2021.
Resembling a smartwatch, Encora’s prescription wearable uses proprietary algorithms to analyze a patient’s tremors in real time and delivers targeted stimulation to the wrist that disrupts the tremor signal, the company said in a release.
“Encora X1 offers a non-surgical, drug-free alternative, allowing patients to manage their symptoms on their own terms,” said Alli Davanzo, Encora co-founder and vice president of business operations, in a statement.
The FDA’s decision was backed by data from a randomized sham-controlled trial and a 90-day home-use study, which found patients using the device experienced consistent improvement in tremor severity and functional tasks such as eating, drinking and writing, according to the company.
Encora is now working to secure state-level distribution licenses and finalize its reimbursement framework to ensure the device is accessible and affordable, Chairman and CEO Nadim Yared told Fierce Medtech in a statement.
He said a phased geographic rollout of the device is planned in the coming months. Yared, the former head of neurostimulation device maker CVRx, replaced former Encora CEO and co-founder Daniel Carballo in November.
