FDA clears neuromodulation devices from Epineuron, Aneuvo and Encora
The FDA cleared neuromodulation devices from Epineuron, Aneuvo and Encora Therapeutics. The products address peripheral nerve surgery, spinal cord injury neurorehabilitation and essential tremor.
Epineuron, Aneuvo and Encora Therapeutics announced that the U.S. Food and Drug Administration granted clearance for three neuromodulation devices. The clearances cover an intraoperative electrical nerve stimulation device, a non-invasive transcutaneous spinal cord stimulation system for neurorehabilitation, and a prescription wearable device to aid in the relief of hand tremors in adults with essential tremor.
Mississauga, Ontario-based Epineuron designed its handheld, intraoperative Evala electrical nerve stimulation device to provide surgeons with a rapid and accurate solution for nerve identification and functional evaluation of different nerve sizes, both large and small. Epineuron said FDA clearance marks a significant expansion of its portfolio. It also expands the commercial footprint of its proprietary bioelectronic platform for peripheral nerve care.
Los Angeles-based Aneuvo designed ExaStim to deliver non-invasive, personalized transcutaneous SCS therapy. It supports functional neurorehabilitation for patients paralysis due to spinal cord injury. ExaStim’s approval covers both clinic and home use. It’s indicated to improve hand sensation and strength in individuals aged 18 to 17 years old with chronic, non-progressive neurological deficits resulting from incomplete spinal cord injury, when used in conjunction with functional task practice. The company says its portable neurostimulation system delivers electrical pulses to stimulate nerves along the spinal cord and dorsal roots, while software on a mobile digital device manages system control during the therapy. Aneuvo said FDA clearance enables U.S. market introduction while it expands global access, and said the technology already carries CE mark in Europe.
Encora Therapeutics said the FDA granted 510(k) clearance for the Encora X1. The clearance authorizes the commercial marketing of the Encora X1 as a prescription wearable device to aid in the relief of hand tremors in the treated limb during stimulation in adults with essential tremor. This clearance is supported by data from two clinical studies: a randomized, sham-controlled trial and a 90-day home-use study. Together, these studies demonstrated consistent improvements in tremor severity and functional tasks, showcasing the device's ability to aid in daily activities such as eating, drinking, and writing.
The Encora X1 is a noninvasive, wrist-worn neurostimulation device, roughly the size of a smart watch, designed to sense tremor rhythm and deliver a customized stimulation that disrupts the tremor signal, providing patients with stability and improved motor control during daily activities. The company said device-related adverse events in clinical trials were non-serious and self-resolving, and reported side effects included numbness, skin irritation, muscle weakness, discomfort or pain, buzzing or tingling sensation, and possible temporary worsening of tremor.
Epineuron said Evala complements PeriPulse, its device that sends electrical impulses directly to the damaged nerve during or shortly after surgery. The company was one of 50 startups named in MedTech Innovator’s 2022 cohort. Aneuvo said it has faced scrutiny from competition, but the Unified Patent Court recently upheld the denial of a request for preliminary injunctive relief.