Encora Therapeutics Gains FDA Clearance for Essential Tremor Device

Encora Therapeutics has secured U.S. Food and Drug Administration (FDA) clearance for its Encora X1 neurostimulation wearable, positioning the company to enter the growing market for non-invasive essential tremor (ET) treatments.

The Massachusetts-based company designed the Encora X1 as a wrist-worn device that uses artificial intelligence-driven, closed-loop technology to sense a patient’s tremor rhythm in real time. The system then delivers personalized neurostimulation to nerves in the wrist, aiming to interrupt tremor signals and improve motor control during daily activities. As a result, patients may experience greater stability while performing tasks such as drinking, writing, and other fine motor movements.

Clinical Data Supports Clearance

The FDA based its clearance on results from a randomized, sham-controlled clinical trial (NCT06343285) as well as a 90-day home-use study (NCT07078422). Together, the studies demonstrated consistent improvements in tremor severity and functional performance among participants using the device.

By combining controlled clinical data with real-world home-use results, Encora strengthened the case for both safety and effectiveness. The company stated that patients showed measurable gains in completing everyday tasks, reinforcing the device’s practical value outside of a clinical setting.

A Non-Surgical, Drug-Free Alternative

Encora is positioning the X1 as a non-invasive alternative to both pharmacological therapies and surgical interventions.

“Encora X1 offers a non-surgical, drug-free alternative, allowing patients to manage their symptoms on their own terms,” said Alli Davanzo, co-founder and vice president of business operations at Encora.

Unlike invasive procedures such as focused ultrasound ablation or implanted deep brain stimulation systems, the X1 allows patients to manage symptoms through an external wearable. Consequently, the device may appeal to individuals who are either ineligible for surgery or prefer to avoid procedural risks.

Prescription-Only Rollout

Although Encora has not disclosed a specific commercial launch date, the company confirmed that the device will be available in the United States through a prescription-only model once it reaches the market. This approach aligns with other neuromodulation devices that require physician oversight to ensure appropriate patient selection and usage.

Large Addressable Market

Essential tremor affects approximately seven million people in the United States. The neurological disorder causes rhythmic, involuntary shaking—most commonly in the upper limbs—and frequently gets mistaken for Parkinson’s disease, despite being a distinct condition.

While researchers have yet to determine the exact cause of ET, many theories point to dysfunction in the cerebellum and disrupted communication between brain regions responsible for motor control. The condition often runs in families and typically presents in individuals aged 40 and older.

Encora enters a competitive but expanding field. The FDA has already cleared several ET-focused devices, including Fasikl’s Felix NeuroAI—another wearable neuromodulation system—and Insightec’s Exablate Neuro platform, which uses focused ultrasound to ablate targeted brain tissue.

Meanwhile, market fundamentals remain favorable. According to GlobalData, the global neuromodulation device market reached approximately $6 billion in 2023 and is projected to approach $11 billion by 2033. As demand grows for less invasive, technology-driven therapies, Encora’s AI-enabled wearable could capture a meaningful share of this expanding segment.

With FDA clearance secured, Encora now shifts its focus toward commercialization and physician adoption, as it looks to establish a foothold in the evolving neuromodulation landscape.

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