People who suffer from migraine are keeping their fingers crossed in the hope that a new and promising drug family will prove effective and is cleared for marketing. The new drugs aim to lower the number of people suffering from episodic and chronic migraines by 10%-20%. At the same time, intriguing news come from Israel’s field of medical devices: Neurolief has developed a non-invasive brain neuro-modulation interface system. It believes its technology can achieve even better outcomes for patients without the side effects typical of pharmaceutical therapies.
Even before they developed the migraine-treating device, the two entrepreneurs behind Neurolief, Shmuel Shany and Amit Dar were among the founders of NESS, which developed a series of breakthrough devices that provide mild electrical neuromuscular stimulation to help stroke survivors move paralyzed arms and legs. The key investor in NESS, billionaire Alfred Mann, regarded NESS devices as an integral part of his operations and founded an American company called Bioness to market them. In 2007, Bioness acquired NESS for $75 million. NESS has been gradually relocated to the US, although manufacturing continues in Israel via a sub-contractor. The founders have eventually left NESS to start a new company. Bioness has meanwhile became a global leader in neuromuscular stimulation with the products developed by Dar and Shany in Israel selling worldwide for hundreds of millions of dollars. "We take great pride at Bioness’ success but just as much in the hope that the Israeli technology has given thousands of physically challenged people across the globe," says Shany.
Shany and Dar’s Neurolief has meanwhile developed a brain neuro-modulation system for treating migraine which will be later expanded into depression and additional indications. The company seeks to offer significant improvement in a market dominated by large companies offering implant therapies that involve invasive surgery. Implanting a device in the brain to treat headache may sound like using cannons to kill flies, but migraine is a serious condition, which can affect the patients for more days than not every month. During a migraine episode, the patient is practically debilitated and unable to function.
According to Amit Dar, some 50%-60% of the patients with implanted neuro-stimulation device require an additional surgery, either because the electrodes have shifted or due to infection and inflammation around the implant. "Our purpose," adds Shany "is to provide the stimulation in a non-invasive way."
"We compete mainly against the strong pain killers. We have declared it as our purpose to create a product, which is more effective than any drug. We are not targeting the patients whose symptoms are alleviated with Advil but those who require drugs frequently. These drugs have multiple side effects and they do not eliminate the problem. Our device is not meant to be used throughout the day, only during a migraine attack and occasionally for maintenance purposes. However, the patients need to carry the device along with them."
A first, small-scale controlled study of the product was held last year, demonstrating average 80%-reduction in pain symptoms. These are extremely unusual good results for migraine. Half the patients reported migraine pain had disappeared during the trial. An additional study in 56 patients will be concluded this year. If successful, it will allow the Company to file for marketing clearance in Europe. Concurrently, a trial involving 140 patients will be held in the USA and Israel. Its outcomes will be filed to the US FDA to obtain a marketing clearance in the USA.
How does neuro-modulation help treat migraine?
"Migraine is a neural condition triggered by various causes, which may differ from one patient to another. It can be stress, lack of sleep, hard cheese, chocolate, wine or pre-menstruation. However, regardless of the trigger, migraine is characterized by activity in a specific area of the brain stem. Combined stimulation of several nerves leading to this region achieves a dual effect: it normalizes the activity in that given moment, thus preventing the secretion of agents that may trigger pain and excitation of other nerves. In addition, the stimulation modulates the activation threshold of the neural system so that the next time the migraine trigger is present, these nerves will not react in the abnormal way characteristic of migraine."
Dar points out that the patients using the device will experience sensitive scalp during use, followed by desensitization and reduction or disappearance of pain. Unlike drugs, which are prescribed for limited use due to side effects, the use of Neurolief’s device is unlimited and involves no significant side effects.
In addition to migraine, Neurolief also treats depression. A clinical trial on depression has yielded excellent interim results and the Company hopes it will be able to offer a home treatment.
Neurolief raised initial capital from Terralab Ventures Incubator and then closed $5 million Series A financing round from US investors and from Terra Venture Partners, the franchisers of Terralab incubator.
Published by Globes [online], Israel business news - www.globes-online.com - on May 9, 2018
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