Press Release

For Immediate Release
August 12, 2020
Contact: Tony Simon (tony@cognivive.com)

Cognivive announces world’s first prescription interactive rehabilitation device under new FDA regulation

A virtual reality device designed by Cognivive Inc. to help stroke patients recover mobility is the first product under the U.S. Food and Drug Administration (FDA)’s new prescription use only “interactive rehabilitation exercise device” classification.

The new classification, announced by the FDA in July, was made possible by the 21st Century Cures Act, which aims to accelerate development of innovative medical devices and get them to patients sooner.

CogniviveVR, which can be used at home, helps patients recover control over their arms and hands by delivering personalized treatments delivered in the form of highly motivational games. FDA registration positions Cognivive to market the device to clinicians, clinics, hospitals and health systems as a prescription digital medicine for post-stroke neuro-motor rehabilitation.

“Stroke presents a massive problem in that 85 percent of patients have difficulties using their upper extremities, and 65 percent of them have not really recovered five years after the stroke,” said Dr. Tony Simon, a neuroscientist and co-founder and CEO of Cognivive. “The effects on quality of life are huge. Getting patients to do physical therapy at home, which can be boring, unmotivating and frustrating, has been the holy grail. We have developed an effective – and engaging – solution.”

The COVID-19 crisis, which has kept many patients home without in-person access to post-stroke physical therapy, presents a timely opportunity for digital health technologies that can be used remotely and prescribed via telemedicine, Simon added.

“Since Cognivive’s treatments are designed to be used at home by patients under the guidance of their treating clinician, but without the need for direct supervision, they are exactly what neurorehabilitation providers need to speed and enhance recovery treatment remotely.”

CogniviveVR transports post-stroke patients to a virtual resort world where they can immerse themselves in a fantastical vacation environment while exercising their brains and bodies. Patients wear an off-the-shelf, lightweight headset loaded with Cognivive software. They use hand-held controllers, allowing them to respond to stimuli as if in the real world, whether hitting a ball, firing a cannon or swinging a paddle.

“With stroke, you have to retrain the brain to regain control of the body,” said Simon. “We recreate the conditions where we make the movements possible then leverage the neuroplasticity of the brain to create new connections in neural circuits.”

Unlike most other virtual reality stroke recovery solutions, Cognivive’s system constantly measures the user’s movements and uses proprietary algorithms to automatically adjust its challenge to the patient’s current abilities, making treatment highly personalized and more motivating.

Dr. Bruce Dobkin, director of the NeuroRehabilitation Program at the Geffen School of Medicine at University of California, Los Angeles, has tested the CogniviveVR software, and calls it a “potentially formidable patient care option.”

“Dr. Simon has an unusually well-conceived understanding of the requirements for a novel VR intervention to enhance a disabled person’s cognitive-motor systems toward better recovery after stroke or any other neurological disease that induces loss of sensation, strength and functional use of an arm/hand,” he said in a statement.

Incorporated in January 2017 with the backing of the University of California Davis Venture Catalyst program, Cognivive was the recipient of two UC Davis STAIR grants and a Phase 1 Small Business Innovation Research Grant from the National Institutes of Health. The company has raised over $750,000 in angel investments and plans its first equity round in early 2021. Additional funding will allow Cognivive to expand the therapeutic capabilities of treatments and to carry out clinical trials.

In addition to Simon, company principals include Ted Aronson, a game developer who is co-founder and Chief Creative Officer; Dr. Joseph Salisbury, a neuroscientist and software engineer who is Head of Digital Therapeutics; and Dr. Anastasia Peck, a physical therapist who serves as clinical lead.

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