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June 30, 2017

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HERITAGE FLORIDA JEWISH NEWS, JUNE 30, 2017 PAGE 3R By ISRAEL21c Staff Multiple sclerosis, one of the most devastating neu= rodegenerative diseases, af- fects some 2.5 million people worldwide and has no known cure. Researchers have long speculated that MS is trig- gered by the body's own im- mune system Unleashing an uncontrolled attack on myelin sheaths that protect nerve cells (neurons). A study published by Israeli scientists in the Journal of the American Chemical Society (JACS) pinpoints a structural instability in the myelin mem- branes, the "insulating tape" surrounding neurons. This vulnerability seems to be what gives the immune system access to otherwise protected regions. "We found that small modi- fications in the myelin sheaths create structural instabilities that may help the immune system to enter and attack neurons," said principal in- vestigator Prof. Roy Beck of Tel Aviv University's School of Physics and Astronomy and Sagol School of Neuro- sciences. "Current therapeutic ap- proaches have focused on the autoimmune response without identifying a clear mechanism. Our research suggests a new avenue for multiple sclerosis therapies and diagnostics," Beck said. Breaking down the insu- lation Axons, which carry elec- trical impulses in neurons. are surrounded by protective myelin sheaths. In MS, an autoimmune "error" mistak- enly identifies these sheaths as hostile foreign entities and breaks them down. The research, conducted by Rona Shaharabani, a doctoral student in Prof. Beck's lab, pinpoints the precise altera- tions to the myelin sheaths that result in structural insta- bilities, creating "easy access" for autoimmune attacks. "After years of research, we were amazed to discover that a possible trigger for the outbreak of the disease could be found in the membrane's physical structure," said Beck. Cylindrical instead of flat He explained that the lipid- and-protein building blocks of the myelin sheaths give the membrane a shape that is critical to their functioning. "Ifthebasicbuildingblocks are straight, the membrane will be flat, which is the pre- ferred structure for a neuron's 'insulating tape,'" said Beck. "However, if they exhibit a more cone-like shape, the membrane will tend to form closed round cylinders. These produce spontaneous holes in the surface of the sheath, ren- dering itvulnerable to attack." For the purpose of the research, the scientists har- nessed X-ray light to examine hundreds of membrane model systems that mimicked those of healthy and diseased ani- mal models. In collaboration with Prof. Ruth Arnon of the Weizmann Institute of Science in Re- hovot, co-developer of the leading MS drug Copaxone, and Prof. Yeshayahu Talmon of the Technion-Israel Insti- tute of Technology in Haifa, the team also used electron microscopy to determine the different nanoscopic struc- tures of both natural myelin sheaths and model system membranes. "The next step is to find a way to reverse the disease progression and find new techniques for early detec- tion," said Beck. By Abigail Klein Leichman Bob Stern's father suffered a stroke at age 40. "When you have a stroke, your life and those around you are af- fected forever," he says from experience. Stern's response was to build one of the largest stroke treatment companies in the world, Micrus Endovascular (MEND), acquired by Johnson & Johnson in 2010 for half a billion dollars. Two months later, he heard from renowned Israeli serial entrepreneur/in- ventor Yossi Gross of Rainbow Medical. Gross invited Stern to Her- zliya to examine his implant- able invention for treating drug-resistant hypertension (high blood pressure). Hyper- tension is the leading cause of cardiovascular events includ- ing stroke, which occurs when the blood supply to the brain is interrupted or reduced. Approximately 75 million Americans have hyperten- sion, and more than five million of them are resistant to drug therapy. Worldwide, it's estimated that one billion people have elevated blood pressure not adequately con- trolled by medication. Stern accepted Gross's invitation and later accepted an invitation to be president and CEO of Vascular Dynam- ics, the company Rainbow founded around this mini- mally invasive solution, called MobiusHD. MobiusHD was awarded the European Union's CE Mark in December 2015, and in February 2017 the US Food and Drug Administration (FDA) approved its participa- tion in the Expedited Access Pathway (EAP) program. Pre-market clinical trials to evaluate the ongoing safety and performance of the device are taking place in the United States and Europe. How MobiusHD works The MobiusHD device is implanted inside the carotid artery, where it amplifies the signals sent to the artery's baroreceptor nerves, prompt- ing these nerves to alert the brain continuously that the patient's blood pressure is very high. The brain responds by signalingthe blood vessels to dilate, which reduces blood pressure. "It's the brilliant mind of Yossi Gross that allowed this to come forward," says Stern. "He had a simple idea that if you can impact the barore- ceptors, you can potentially modulate blood pressure in these patients." Stern established the com- pany in Mountain View, California, where he had access to former MEND employees. They determined the implant's final shape and delivery system. "When people look at our technology, they say 'Wow, that is so simple.' It's the same reaction I had when I first saw it," says Stern. Dr. BrianWilliams, director of NIHR University College London Hospitals Biomedical Research Centre and co-pri- mary investigator in Vascular Dynamics' worldwide clinical trial, said Mobius HD technol- ogy "may provide an impor- tant solution for patients who have not benefited from other device- or drug based treat- ments. We are enthusiastic about the product's potential as we have seen tremendous results in early studies in the US and Europe." The other primary inves- tigator is Dr. Gregg Stone, director of cardiovascular research and education for Columbia University Medical Center/New York-Presbyteri- an Hospital and co-director of medical research and edu- cation at the Cardiovascular Research Foundation. Looking ahead When Stern took over Vas- cular Dynamics in November 2011, the currentwisdom held that ablation of the renal ar- tery was the best bet for curing resistant hypertension. About 50 companies attempted to commercialize that solution. but it ultimately sputtered out as did another approach that involved placing leads on the internal carotid sinus to pace blood pressure. According to Stern, 0nly five companies are now work- ing toward a non-pharmaceu- tical solution for resistant hypertension. The one rival closest to Vascular Dynam- ics' solution is CVRx, whose Barostim Neo implantable device modulates the baro- receptor electrically to reduce the symptoms of heart failure. The Minnesota-based com- pany has raised hundreds of millions in investment. How- ever, says Stern, the current prototype is expensive, requir- ing surgery that lasts two to three hours, and the battery must be replaced every 24-36 months at a cost of $20,000. "We're a very simple, mini- mally invasive procedure," says Stern, referring to the 50-minute implant proce- dure under local anesthesia to thread MobiusHD via a catheter from the groin to the carotid artery. Trials to date have shown that upon discharge, Mobi- usHD patients' clinical blood pressure is down about 36 points. Ambulatory blood pressure, measured in the course of a patient's daily life. is reduced by about 20 points at six months with a concurrent reduction in blood pressure seen to be stable in patients for over three years. Just how long the reduction continues is the subject of further studies. Vascular Dynamics has16 fulltime employees and about 15 contractors around the world. The company recently won another $10 million in funding, bringing its total raise to about $33 million. Stern Says more money will be raised in coming months for ongoing trials. The team also plans to study the impact of MobiusHD in heart failure. 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