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Israeli Innovators at the Forefront of Brain Health Solutions

World Brain Day 2023 was celebrated on July 22 as an initiative of the World Federation of Neurology (WFN), using the slogan “Brain Health and Disability: Leave No One Behind.” Recognizing the importance of the day, we decided to give a platform to a number of trends and pioneering companies in the field and tell about their contribution to the latest developments intended to save lives and improve the quality of life.

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Innovative Doppler-Based Technology: A TCD Robot for Scanning Blood Vessels Through Natural “Windows” In Our Skull

Intracerebral Doppler technology (Transcranial Doppler – TCD) enables a non-invasive examination of intracranial blood vessels through the echoes of ultrasound waves that penetrate the skull and deliver information on the speed and direction of blood flow in the blood vessels in the brain.

Intracerebral Doppler products are often used as diagnostic tools and for intracerebral monitoring of patients, for monitoring the condition of patients at risk of embolism in cases of narrowing of blood vessels or after replacing a heart valve, and in cases of aneurysm eruption in the brain.

Israeli company VIASONIX, which has been operating since 2009, has developed a Doppler device that enables mapping of the blood vessels in the brain through the skull, with data on the speed and direction of blood flow in them. The company’s device is characterized by comfort and simplicity of handling.

Intracerebral Doppler technology, which is performed using ultrasound transducers that are applied to the head, has been studied since the 1980s. Since then, there have been many developments in the field which have enabled the development of different and diverse clinical tools. The tools that exist today require the examiner to have in-depth knowledge of the anatomy of the intracranial blood vessels as well as expertise in directing the ultrasound waves to locate the blood vessels that require monitoring. Such skills can be acquired through a very long training process and gaining experience, so few medical teams currently have the required skill for effectively monitoring blood vessels of the brain utilizing the Intracerebral Doppler technology available nowadays.

VIASONIX developed a TCD monitoring system that can perform a scan of the blood vessels in the brain without the need for the user to acquire profound skills over a long period of time. The system includes robotic TCD probes that are placed and attached to the patient’s head using a harness that allows easy and comfortable manual positioning of the TCD probes over the acoustic windows (bone windows) in the skull. As soon as the robotic probe locates the blood vessel to be monitored, it focuses on it to obtain continuous and reliable flow data. The scanning process of both sides of the brain is obtained within about 10 seconds by VIASONIX’s TCD monitoring system.

Dr. Dan Manor, Co-founder and CEO of the company, points out that for patients hospitalized in intensive care and for whom there is a risk of embolisms from blood clots from different parts of the body, it is particularly important to carry out continuous monitoring, which is usually not possible with the existing systems that require the expertise and in-depth involvement of a specialist doctor. VIASONIX ‘s robotic probes enable automatic ambulatory two-sided monitoring of the blood vessels in the brain when the device is worn on patient’s head, allowing the patient to carry out regular daily activities, without being confined to the hospitalization bed. The robotic probes assist the medical team in identifying in real-time embolisms risks and significant changes in blood flow speeds in the brain that can cause strokes and other life-threatening conditions.

The technology developed by VIASONIX is in patent registration process. The robotic probes and the harness that carries them are currently sold in most countries of the world and are used in most of the major hospitals in Israel, including Ichilov, Hadassah Ein Kerem, and Soroka.

Photo: Gabriel Manor.

Neuroplasticity and Rehabilitation Technologies: Rehabilitation Robotics System That Enhances Errors Occurring During Motor Activities Practice, Resulting in Adaptive Corrective Response

Neuroplasticity, which concerns the brain’s ability to undergo adaptive changes and adjustments, is currently receiving significant attention. Rehabilitation approaches, such as cognitive training and physical therapy, leverage the traits of neuroplasticity to accelerate recovery and improve function in people with brain injuries or disabilities.

Most of the millions of neurological injury victims in the world each year are expected to undergo prolonged, limited, and excruciating rehabilitation. Even the most effective technologies that combine virtual reality, robotics, and automation when applied to traditional treatment methods do not offer a new treatment modality but are mainly an improvement of the existing one. The patent-protected rehabilitation technologies of the Israeli company BioXtreme enable new treatment methods and have aroused great interest in the field of neurotherapy.

Nini Blumen, co-founder and CTO of the company, explains that, unlike treatment methods that allow free active movement or correct the motoric errors of the patients (for example, tremors, weakness, lack of range or precision, stiffness, and low tone), the treatment methods developed by BioXtreme are based on unique techniques that enhance the patients’ errors during motor activity practice. BioXtreme systems detect and measure the patient’s errors and apply a corresponding force that amplifies the patient’s errors to cause an adaptive, biological, opposite, and corrective response from the patient. Clinical trials prove that the improvements achieved with this approach take half the time required to achieve the same improvements using traditional (e.g., error correction based) techniques, and with much better results of improvement at the end of the rehabilitation.

The company sells its products in the USA and Europe and is about to complete a fundraising round of $5 million, which is necessary for the next stage of development and sales.

Assistive Technologies: Bridging the Communication Gap Between Patients and Their Caregivers

Rapid progress in assistive technologies, such as wearable devices and systems that aim to protect the patient’s mental health and cognitive state, have changed the lives of people with temporary or permanent disabilities. These technologies enable improved communication, mobility and independence, preservation of brain health, and a better quality of life.

EyeControl is one of the pioneering companies in the field and develops innovative solutions to bridge the communication gap between patients, their medical teams and loved ones in hospital and home environments. The company’s patented technology enables comprehensive communication controlled by patient eye movements.

Or Retzkin, EyeControl’s Co-founder and CEO, explains that a unique head unit developed by the company, which includes an eye-tracking camera and audio component, facilitates detection of the ICU patient’s waking state and enables bi-directional interaction between the patient, family, and care staff via a web-based nurse station dashboard.

The patient receives audio feedback, heard exclusively by them, through a bone conduction pad placed near their temple; they respond through specific eye movements that are tracked by the camera and translated into communication. For example, the audio system can offer a multiple choice question, and the patient can select their response by blinking when they hear the suitable answer; cognitive individuals can also initiate communication with the device. This way, independence and privacy are granted to the patient, and the device adapts communication to their abilities.

EyeControl-Home is already included in the Israeli Health Basket; EyeControl-Med is implemented in Clalit hospitals and other medical facilities in Israel and around the world.

In recent years, the company has been promoting commercial activity and groundbreaking research, whereby the product accompanies ICU patients from sedation/unconsciousness to various stages of awakening/consciousness. It’s unique personal and adaptive communication functions are being investigated for their efficacy in reducing the phenomenon of ICU Delirium — a cognitive decline typical of the intensive care environment — especially among the respiratory population, but not only.

The company’s research earned it the prestigious BIRD grant in May 2023, which is supporting a multicenter clinical trial that includes activity at the Harvard-affiliated Beth Israel Deaconess Medical Center in Boston, led by a world-leading field team.

Photo: Yeruslav Luski.

Technologies Addressing Mental Health: Non-Invasive Neurostimulation to Effectively Treat Depression

Neuromodulation techniques such as transcranial magnetic stimulation (TMS) and deep brain stimulation (DBS) are at the forefront of research to treat various neurological conditions. These interventions aim to regulate brain activity and relieve symptoms in conditions such as depression, Parkinson’s disease, and epilepsy. Such treatments are very helpful for people that conventional drug treatment no longer affects them, or who suffer from the side effects of such drugs.

TMS treatment applies a magnetic field to an area of the brain that changes the pattern of brain activity and produces a response that reduces symptoms in these situations. At the same time, conventional TMS only treats targeted points close to the surface and located in the center of the treatment area. How is it possible, then, to reach the deeper places in the brain?

The Israeli company BrainsWay, a dual-listed public company that is traded on Nasdaq and the Tel Aviv Stock Exchange, is a world leader in advanced non-invasive neurostimulation treatments for mental health disorders. The company developed the Deep Transcranial Magnetic Stimulation (Deep TMS™) technology for the treatment of, among other things, major depressive disorder (including reducing anxiety symptoms, commonly known as anxious depression), obsessive-compulsive disorder (OCD), and smoking addiction. The technology is protected by a long series of patents worldwide.

Physicist Dr. Yiftach Roth, one of the founders of the company, and the Chief Scientific Officer, together with Prof. Abraham Zangen, Professor of Neuroscience at Ben Gurion University, developed the technology with the awareness that many brain centers related to depression and addiction are located in the deep areas of the brain — areas that standard TMS does not reach. BrainsWay’s Deep TMS™ technology is unique, not only in the depth of penetration of the brain but also in its width. In this context, it should be emphasized that brain disorders such as depression are not related to a single point in the brain, but to a network of brain centers. Therefore, a wider influence of the technology is beneficial for a larger cross-section of patients.

Following a controlled multicenter study by BrainsWay, the company received FDA approval in 2013 to treat depression. To date, over 200,000 patients have been treated with the company’s devices. From studies among depressed patients who did not respond to medication and psychotherapy, it appears that the response to treatment is very distinct and results in an improvement of 50% or more in symptoms among 70-80% of patients and remission of symptoms in 60% of patients.

The treatment is done using a magnetic coil helmet placed on the patient’s head. The therapist activates the magnetic field for about 20 minutes, during a series of daily treatments over 4 to 6 weeks. For each type of treatment, there is a dedicated helmet with a coil adapted to stimulate the respective area of the brain.

In 2018, another FDA approval was received by the company for the treatment of OCD through the company’s systems, and in 2021 approval was received for the treatment of smoking addiction.

The device primarily targets the US market, where it benefits from medical insurance coverage. In Israel, the treatment is accessible through specialized hospitals and is also available for private purchase.

Minimally Invasive Medical Devices: Wrapping and Removing Entire Blood Clots

Stroke is one of the leading causes of death and a leading cause of permanent disability. The devices on the market for the treatment of stroke are guided by a catheter that is typically inserted through the inguinal artery, and guided through the arteries to the brain. The device includes a kind of spring element that expands inside the blood clot for opening the blockage. In this process, parts of the blood clot are sometimes detached and propagate with the blood flow toward the brain and can also cause great damage.

Inretio, an Israeli start-up company, is in the advanced stages of developing an innovative device for the treatment of strokes, with the goal of saving lives and reducing the disability caused by strokes. The company’s patent protected device, named PREVA, , utilizes tiny expandable net baskets made of nitinol threads having a thickness of 40 microns, which wraps the blood clot and removes it completely from the vasculature.

PREVA is the first device in the world that can wrap and pull an entire blood clot while protecting the brain and body from clot fragments. The device has been proven effective in all the early stages of the trial, and a clinical trial on humans is expected to begin in January 2024 in collaboration with one of the leading hospitals in Israel.

The company is seated in Sapirim Industrial Park, in the north of the Negev, and most of the company’s employees come from areas bordering the Gaza Strip.

The development of breakthrough medical technologies is characterized by long-term and high costs. To ensure exclusivity while the technology is developed, patent protection is required. A proper umbrella of patents will make it difficult for a competitor to use the technology developed, and to copy the key products, without requiring huge investments in research and development of the original developer. The companies mentioned in this article and others owe their success to an extent to a patent portfolio that was built, among other things, with the purpose of getting wide and enforceable patent protection, with a deep understanding of the business needs and the market.

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