INSIGHTEC Receives CE Mark for Exablate Neuro for Siemens Healthineers MRI Scannersby Siemens Healthineers and INSIGHTEC

Erlangen, Germany|2018-12-11

Not for publication in the USA

  • New MRI compatibility holds potential to expand patient access around the world to incisionless brain surgery

Siemens Healthineers, a leader in medical technology and diagnostic and therapeutic imaging, and INSIGHTEC®, a global medical technology innovator of incisionless surgery, today announced the CE clearance of Exablate Neuro™ compatible with Magnetom Skyra, Prisma and Prisma Fit scanners from Siemens Healthineers. Exablate Neuro uses focused ultrasound for treatments deep within the brain with no surgical incisions. MR imaging provides a complete anatomical survey of the treatment area, patient-specific planning and real-time outcome monitoring throughout the treatment.

“INSIGHTEC and Siemens Healthineers are working in partnership to transform patient care,” said Maurice R. Ferré, MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. “This milestone is key to expanding patient access to incisionless brain surgery using focused ultrasound.” The CE mark includes approval for treatment of medication-refractory essential tremor, tremor-dominant Parkinson’s disease and neuropathic pain. FDA approval for the Exablate Neuro compatibility with MRI scanners from Siemens Healthineers to treat medication-refractory essential tremor was received on October 1, 2018. “We welcome a new era of advanced MRI-guided therapy in the neuro space,” said Arthur Kaindl, Ph.D., Head of Magnetic Resonance at Siemens Healthineers. “The cooperation with INSIGHTEC is the latest example of our open innovation strategy. Through close collaboration with clinical experts and partner companies we make great strides in expanding precision medicine.”

Clínica Universidad de Navarra (CUN) in Pamplona, Spain is the first institution in Europe to successfully treat patients with Exablate Neuro compatible with MRI scanners from Siemens Healthineers. CUN is renowned academic institution with a history of innovative research and clinical treatment for neurological movement disorders. “Focused ultrasound is a highly precise, yet minimally invasive procedure for treating essential tremor,” commented Dr. Jorge Guridi, Head of Neurosurgery Department of Clínica Universidad de Navarra. “This presents a major opportunity for improvement in quality of life for a large group of patients who do not want traditional open surgery.”

Siemens Healthineers enables healthcare providers worldwide to increase value by empowering them on their journey towards expanding precision medicine, transforming care delivery, improving patient experience and digitalizing healthcare. A leader in medical technology, Siemens Healthineers is constantly innovating its portfolio of products and services in its core areas of diagnostic and therapeutic imaging and in laboratory diagnostics and molecular medicine. Siemens Healthineers is also actively developing its digital health services and enterprise services.
In fiscal 2018, which ended on September 30, 2018, Siemens Healthineers generated revenue of €13.4 billion and adjusted profit of €2.3 billion and has about 50,000 employees worldwide.
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INSIGHTEC is a global healthcare technology innovator transforming patient lives through incisionless brain surgery using MR-guided focused ultrasound. The company’s award-winning Exablate Neuro™ is used by neurosurgeons to perform the Neuravive™ treatment to deliver immediate and durable tremor relief for essential tremor patients. Research for future applications in the neuroscience space is underway in partnership with leading academic and medical institutions. INSIGHTEC is headquartered in Haifa, Israel, and Miami, Florida, with offices in Dallas, Tokyo and Shanghai.
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This press release contains forward-looking statements regarding, among other things, statements pertaining to expectations, goals, plans, objectives, and future events. INSIGHTEC intends such forward-looking statements to be 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 can be identified by the following words: “may,” “can,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “promise,” “continue,” “ongoing,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements are based on the current estimates and assumptions of our management as of the date of this press release and are subject to risks, uncertainties, changes in circumstances, assumptions, and other factors that may cause actual results to differ materially from those indicated by forward-looking statements, many of which are beyond INSIGHTEC’s ability to control or predict. Given these uncertainties, undue reliance should not be placed on these forward-looking statements. INSIGHTEC does not undertake any obligation to release publicly any updates or revisions to these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.

“Exablate,” and “Exablate Neuro,” as well as the “INSIGHTEC” logo, whether standing alone or in connection with the word “INSIGHTEC” are protected trademarks of INSIGHTEC.

Ulrich Kuenzel
Siemens Healthcare GmbH
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91052 Erlangen
+49 162 2433492

Alyssa Gustafsson
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+1 917 595 306 3