Rapid Non-Invasive Treatment for Stroke

Dr. Mark Borsody, Founder and Chief Medical Officer at Nervive Inc, spoke about stroke healthcare, at www.bio2devicegroup.org event.

Stroke has been a #1 cause of severe disability, #2 cause of death in the world (responsible for more than 5 million deaths, each year), and it is 4^th leading cause of death in the US.  About 800,000 people in the US have stroke, each year.  One American dies from stroke, about every 4 minutes.  In fact, stroke is responsible for putting the biggest healthcare burden, worldwide and the burden is likely to increase in the foreseeable future, said Dr. Borsody.  Stroke results from “plumbing problem”, in the brain.  Ischemic stroke is caused by blockage of a blood vessel due to reasons like thrombosis or arterial embolism.  Hemorrhagic stroke is caused by bleeding of blood vessels of the brain, either directly into the brain or into the surrounding brain tissue.

While treatment options for hemorrhagic stroke are limited, current treatment options for ischemic stroke include intravenous “clot busting” through tissue plasminogen activator (tPA) or through endovascular catheter devices for blood clot retrieval.  Worldwide, an estimated 180,000 tPA treatments are done every year and 22,000 clot retrieval treatments are done.

Microphotograph of HE stained section of human brain tissue upon acute ischemic stroke. Orgininal magnification 400x (Photo credit: Wikipedia)

Honing in on the major problem, Dr. Borsody discussed why do so few patients with stroke receive timely treatment.  Timely intervention is the key for treatment of stroke.  Like all cells in the body, neurons and other brain cells require oxygen and glucose delivered through the blood in order to function and survive.  A few minutes of oxygen deprivation can kill millions of neurons.  Additionally, stroke can provoke inflammation, swelling (edema), and other processes that can continue the damage for hours or days after the initial attack.  However, often treatment of stroke within 60 minutes is very rare due to the time required for patient transportation and in-hospital evaluation.  Effective treatment for stroke can be simple, but it needs to be immediate.  So how come there aren’t many innovations to bring the treatment to the patient, even to buy them some time?

Nervive’s Vital Flow Stimulator is a simple device that is aimed at targeting the facial nerve behind the middle ear.  The objective is to control the cerebral arteries through the facial nerve, which regulates the function of the arteries.  It is comprised of 3-4 cm coil placed over the ear.  Magnetic fields readily penetrate any tissue and creates electrical currents in neural tissues, leading to axonal and soma depolarization.  Early indications are that it is effective in treating ischemic stroke and it is safe in ischemic and hemorrhagic stroke.  This device is moreover, simple enough to use without any special training.  Vital Flow complements other therapies and bring exponential benefits of rapid treatments.  The device will be inexpensive, portable, and extremely easy to transport in the ambulance.  The treatment can be administered within a few minutes.  Animal studies show increased blood flow after facial nerve stimulation and improvement in several measures after stroke.

Ending his talk, Dr. Borsody said, Nervive has a strong IP position, the technology is targeting a market with huge potential, and it is substantiated by preclinical and clinical science.  They are starting fund raising for series A round.  To emerge from the dark ages of stroke healthcare, we need some disruptive, out of box (out of hospital) thinking, said Dr Borsody.
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