The US Food and Drug Administration (FDA) has cleared Encora Therapeutics’ neurostimulation wearable for essential tremor (ET) management.
The Massachusetts-based company’s Encora X1 is a wrist-worn device that uses closed-loop technology powered by artificial intelligence (AI) to sense tremor rhythm and deliver personalised stimulation in real-time to the nerves in a patient’s wrist to disrupt tremor signals. The system provides stability and improved motor control during daily activities.
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FDA approval for Encore X1 was based on data from a randomised, sham-controlled trial (NCT06343285) and a 90-day home-use study (NCT07078422). The combined study results demonstrated the device’s ability to deliver consistent improvement in patients’ tremor severity and functional tasks such as drinking and writing, Encora stated.
Alli Davanzo, co-founder and vice president of business operations at Encora, commented: “Encora X1 offers a non-surgical, drug-free alternative, allowing patients to manage their symptoms on their own terms.”
“Encora X1 offers a non-surgical, drug-free alternative, allowing patients to manage their symptoms on their own terms.”
While Encora did not disclose an anticipated market release date for Encora X1, once available, the device will be available to patients via a prescription-only model.
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By GlobalDataAround seven million individuals are living with ET in the US. The neurological disorder is characterised by rhythmic shaking, most commonly seen in upper limbs, that individuals cannot control. Often confused with Parkinson’s Disease, ET is a distinct condition. While the cause of ET is unknown, some theories posit that it is caused by the cerebellum, the brain region responsible for muscle control, and other parts of an individual’s brain not communicating correctly. ET is often inherited and most commonly presents in individuals aged 40 and above.
Several devices for treating essential tremor have been cleared by FDA. These include Fasikl’s Felix NeuroAI, a comparable device to Encora’s, and Insightec’s Exablate Neuro platform that uses focused ultrasound waves to precisely target and ablate tissue deep within the brain.
Analysis by GlobalData indicates that the global neuromodulation device market reached approximately $6bn in 2023 and is expected to nearly double by 2033, approaching $11bn.
