Industry Press Releases

INSIGHTEC receives the CE mark for Exablate Neuro

Thursday, Dec 13, 2018

New MR Compatibility

Has the Potential to Enable More Patients Across the Globe to Achieve Cut-Free Brain Surgery Siemens Healthineers, a leading provider of medical technology and diagnostic and therapeutic imaging, and INSIGHTEC®, a global innovator in cut-free surgery, today announced that Exablate Neuro ™ CE approved, compatible with Siemens Healthineers Magnetom Skyra, Prisma and Prisma Fit 3 Tesla scanners. Exablate Neuro uses focused ultrasound for cutting-free treatments deep in the brain. MR imaging provides a complete anatomical overview of the treated area, allowing patient-specific planning and real-time outcome monitoring throughout the treatment.

"INSIGHTEC and Siemens Healthineers are partnering to improve patient care," said Drs. Maurice R. Ferré, CEO and CEO of INSIGHTEC. "This milestone is critical to enabling more patients access to cut-free brain surgery with focused ultrasound."

The CE mark includes approval for the treatment of drug-resistant essential tremor, tremor-dominant Parkinson's disease and neuropathic pain. FDA approval for the compatibility of Exablate Neuro with Siemens Healthineers MR scanners for the treatment of drug-resistant essential tremor was granted on October 1, 2018.

"This is the beginning of a new era of advanced, MR-guided therapy in neurology," said Drs. Arthur Kaindl , Head of Magnetic Resonance Imaging at Siemens Healthineers. "Working with INSIGHTEC is the latest example of our open innovation strategy, and we are making great strides in expanding precision medicine through close collaboration with clinical experts and partner companies."

Clínica Universidad de Navarra (CUN), Pamplona, ??Spain, is the first facility in Europe to treat patients with Exablate Neuro and compatible MR scanners from Siemens Healthineers. CUN is a renowned academic institution that has long been researching and treating neurological disorders. "Focused ultrasound is a high-precision, yet minimally invasive, treatment for essential tremor," says Dr. Jorge Guridi , Head of the Neurosurgical Department of the Clínica Universidad de Navarra . "For many patients who do not want a traditional open procedure, this procedure is a great opportunity to improve the quality of life."

Siemens Healthineers


Siemens Healthineers is helping healthcare providers worldwide achieve more on their way to developing precision medicine, redesigning healthcare, improving the patient experience, and digitizing healthcare. As a leader in medical technology, Siemens Healthineers continues to develop its product and service portfolio. This applies to the core areas of imaging for diagnostics and therapy as well as for laboratory diagnostics and molecular medicine. In addition, the offerings in the field of digital health services and hospital management are constantly being developed in cooperation with the operators.

In fiscal year 2018, which ended on September 30 , 2018 , Siemens Healthineers achieved sales of € 13.4 billion and adjusted earnings of € 2.3 billion, with approximately 50,000 employees worldwide. Further information can be found at .

INSIGHTEC is a global healthcare innovator that is changing the lives of patients through cut-free brain surgery with MR-guided focused ultrasound. INSIGHTEC's award-winning product Exablate Neuro ™ is used by neurosurgeons for Neuravive ™ treatments to provide immediate and sustained tremor treatment for essential tremor patients. In collaboration with leading academic and medical institutions, future applications in the field of neurology are being researched. INSIGHTEC is headquartered in Haifa ( Israel ) and Miami ( Florida ) and also has offices in Dallas , Tokyo andShanghai . For more information, visit us at .

This press release contains forward-looking statements that include expectations, objectives, plans, objectives, and future events. INSIGHTEC believes that such forward-looking statements are covered by the "Safe Harbor" provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Reform Act of 1995. In some cases, forward-looking statements may be identified by the following words: "may," "may," "becomes," "could / could," "would / would," "should / should," "expect," "intend" , "plan", "anticipate", "believe", "estimate", "predict" "project", "potential", "promise", "continue", "continuous" or by the contrary of these terms, or equivalent terminology; however, not all forward-looking statements include such words. These statements are based on current estimates and assumptions made by our management at the time of this press release. They are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that could cause actual results to differ materially from those set forth in the forward-looking statements, many of which are beyond the control and guidance of INSIGHTEC , Given these uncertainties, no undue reliance should be placed on these forward-looking statements.



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