Neurolutions Receives U.S. Food and Drug Administration De Novo Market Authorization for IpsiHand

IpsiHand robotic hand-piece uniquely leverages brain-computer interface technology for chronic stroke rehabilitation

Neurolutions, Inc., a medical device company developing and commercializing a first-of-its-kind device leveraging brain-computer interface (BCI) technology for upper extremity chronic stroke rehabilitation, announced today that the U.S. Food and Drug Administration (FDA) granted De Novo market authorization for its groundbreaking IpsiHand Upper Extremity Rehabilitation System. The IpsiHand System has been cleared for use in chronic stroke patients to facilitate muscle re-education through its novel BCI platform. In addition to the De Novo Authorization, the IpsiHand device notably received Breakthrough Device designation from the FDA as well. The Breakthrough designation is a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The Breakthrough designation may also streamline the process required for Medicare reimbursement.

The Neurolutions IpsiHand System is designed for home or clinic use as part of prescribed rehabilitation therapy. IpsiHand includes a wearable robotic hand-piece that is worn over the patient’s hand and wrist, a tablet computer, and an EEG-based biometric headset. The system translates brain signals from the uninjured, or ipsilateral, hemisphere of the brain, into movement of the robotic hand-piece. As a result, when the patient thinks about opening their hand, the device physically opens the patient’s impaired hand. This ability to physically open and close the patient’s hand based on the patient’s thoughts facilitates muscle reeducation, improving upper extremity rehabilitation. Developed by a team of innovators in Silicon Valley and neuroscientists from Washington University in St. Louis. the neuro-prosthetic and robotic capabilities of the IpsiHand System have been shown in clinical trials to provide both statistically and clinically significant outcomes for chronic stroke patients.

“Progress in improving rehabilitation outcomes for stroke patients has historically been challenging, but the market authorization of the IpsiHand System promises to usher in a bright future for our stroke patients and allows us to support their recovery throughout the rehabilitation process,” said Eric Leuthardt, MD, Chief Scientific Officer of Neurolutions and Chief of Division of Neurotechnology and Professor of Neurosurgery and Neuroscience at Washington University.

IpsiHand is indicated for use in patients 18 and older undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion. All participants in an unblinded 40-patient study over 12-weeks demonstrated motor function improvement with the device over the trial. Adverse events reported included minor fatigue and discomfort and temporary skin redness.

About Neurolutions, Inc. Neurolutions, Inc. is a medical device company developing a revolutionary platform of devices, focused on improving function for patients disabled as a result of neurological injury. The company’s first product, the IpsiHand System, is a Brain-Computer Interface (BCI) device developed for chronic stroke patients with impaired upper extremity. More information is available at neurolutions.com.