INSIGHTEC Receives FDA Approval for Exablate Neuro Compatibility With Siemens Healthineers MRI Scanners
HAIFA, Israel and MIAMI, Florida, September 26, 2018
HAIFA, Israel and MIAMI, Florida, September 26, 2018 /PRNewswire/ --
INSIGHTEC® ,a global medical technology innovator of incisionless surgery, today announced that the U.S. Food and Drug Administration (FDA) has approved Exablate Neuro™ compatibility for the state-of-the-art MRI Scanners Magnetom Skyra, Prisma and Prisma[fit] from Siemens Healthineers to treat patients with essential tremor (ET).
"This important milestone is directly attributed to the commitment and collaboration of the teams at INSIGHTEC and Siemens Healthineers, who met the challenge head-on," said Maurice R. Ferré, MD, INSIGHTEC Chief Executive Officer and Chairman of the Board. "Expansion of MRI compatibility for Exablate Neuro substantially increases the potential reach of incisionless brain surgery for essential tremor patients."
Exablate Neuro uses focused ultrasound to precisely target and accurately ablate tissue deep within the brain with no incisions. More than 1,500 medication-refractory essential tremor patients have been treated around the globe.
"With the compatibility of INSIGHTEC's innovative technology with our MRI scanners, Siemens Healthineers is staying true to its mission of delivering best-in-class diagnostic imaging with advanced therapy solutions in the neurological space," said Christoph Zindel, MD, Senior Vice President and General Manager Magnetic Resonance at Siemens Healthineers. "This joint development underlines our commitment to expanding precision medicine, and paving the way for offering focused ultrasound to more hospitals and patients in our worldwide network."
"Focused ultrasound is an exciting technology, through which radiology and neurosurgery expand efforts together to advance best patient care," said Satoshi Minoshima, M.D., Ph.D., Professor and Chair in the Department of Radiology and Imaging Sciences at the University of Utah Health, where the Exablate is currently being installed on a Magnetom Skyra from Siemens Healthineers. "The expansion of Exablate Neuro to be compatible with Siemens Healthineers MRIs will broaden access for patients to an incisionless treatment option."
Exablate Neuro is FDA approved to treat medication-refractory essential tremor and clinical trials are ongoing to evaluate potential applications in the treatment of various neurological diseases.
For further information on INSIGHTEC, please see https://www.insightec.com/
For more information on the University of Utah Health, visit https://uofuhealth.utah.edu/
INSIGHTEC is a global healthcare technology innovator transforming patient lives through incisionless brain surgery. INSIGHTEC is a global medical 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.
For more information, please visit: http://www.insightec.com
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.
SOURCE INSIGHTEC Ltd