FDA has awarded breakthrough device designations to two futuristic devices, granting the regulatory privileges to Blackrock Neurotech's brain-computer interface (BCI) and an exo-suit from ReWalk Robotics' intended to help stroke patients walk.
Blackrock landed the breakthrough status for MoveAgain, a BCI system designed to enable immobile patients to control a mouse cursor, keyboard, mobile device, wheelchair or prosthetic device using their brains. The device features an array that is implanted in the patient's brain to decode intended movement neuronal activity. The decoded signals are sent to an external device such as a wheelchair to enable the immobile patient to control their external environment.
Buoyed by the breakthrough designation, Blackrock is aiming to commercialize the device next year. The target reflects Blackrock's belief it has enough safety and efficacy data to support applications. Blackrock plans to seek authorization of the first system while working to further miniaturize the technology to enable a wireless version and "future smart systems."
The breakthrough ReWalk device represents a different way to overcome physical problems. FDA awarded the status to ReBoot, an exo-suit intended to help stroke patients walk. The device, a sister product to the ReStore system FDA cleared for use in 2019, is targeted at the home-use market.
By working with muscles in the affected leg, ReBoot could help survivors of stroke and other neurological injuries to re-educate their muscles, improve walking speed and fall less. ReWalk is now finalizing the design of the device before moving into the clinical studies needed to support a filing for clearance from FDA.
The recent batch of breakthrough designations also features awards for treatments of Alzheimer's disease, concussion and chronic cluster headache.
FDA granted breakthrough status to a Renew Bioscience device that is designed to treat mild Alzheimer's symptoms by improving blood flow, thereby countering the role poor vascular health plays in the disease. The device consists of inflatable cuffs wrapped around the calves, thighs and hips. The cuffs will then synchronize to inflate and deflate between heartbeats, compressing vessels in the legs to get blood back to the heart.
TecTraum secured breakthrough designation for the concussion treatment device pro2cool. The device is designed to reduce symptom severity by cooling the head and neck areas, which is intended to lower the temperature of blood before it enters the brain. The approach reflects evidence that cold therapy interrupts the inflammatory response and thereby reduces the damage the body causes in response to concussion injuries. TecTraum is aiming to complete enrollment in a pivotal clinical trial by the end of the year.
The other recent neurological treatment designation went to Man & Science, which picked up FDA breakthrough status for a neuromodulation treatment of chronic cluster headache. The designation covers a minimally invasive occipital nerve field stimulation system.
FDA also recently awarded breakthrough designations to Theradaptive and Datar Cancer Genetics. The Theradaptive designation covers a spinal fusion implant that is designed to improve on the safety and consistency of existing treatments. Theradaptive says its implants enable precise regeneration of tissues, in the case of the breakthrough device to treat degenerative disc disease, spondylolisthesis or retrolisthesis.
Datar received its breakthrough status for a breast cancer blood test, called TriNetra. The test looks for circulating tumor cells to detect early-stage breast cancer in women aged 40 years and up. Datar, which has already received a CE mark, aims to establish multiple test centers in the U.S. and overseas by 2024.
