INSIGHTEC SECURES FDA APPROVAL AND CE MARKING FOR EXABLATE® PRIME ON PHILIPS MR SYSTEMS

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Nov 21, 2024, 08:00 ET

Philips' MRI scanners are now compatible with Insightec technology to treat patients suffering with essential tremor (ET) and Parkinson's disease.

HAIFA, Israel and MIAMI, Nov. 21, 2024 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using focused ultrasound to transform patient care, today announced the dual achievement of U.S. Food and Drug Administration (FDA) approval and CE Mark of its Exablate Prime system with certain Philips MR systems. This approval expands the accessibility of non-invasive MR-guided focused ultrasound treatments for patients and healthcare providers.

Exablate Prime is able to be integrated with select, compatible Philips 1.5T and 3.0T Ingenia systems, Philips Ambition 1.5T, Philips Elition 3.0T, as well as Philips MR 7700 3.0T.

"This is the result of a dedicated collaboration between Insightec and Philips," said Insightec Chief Executive Officer and Chairman of the Board, Maurice R. Ferré. "We are proud of adding Philips to our extended family. Our goal is to make these groundbreaking solutions accessible to more treatment centers, ultimately benefitting patients with cutting-edge care."

Focused ultrasound, which was pioneered by Insightec, is FDA approved and CE Marked to treat essential tremor and some symptoms of Parkinson's disease. The procedure is performed in a single, outpatient procedure with many patients showing immediate improvement with minimal or no complications.

About Insightec

Insightec is a global healthcare company creating the next generation of patient care by realizing the therapeutic power of acoustic energy. The company's Exablate Neuro platform focuses sound waves, with the guidance of MRI, to provide tremor treatment to patients with medication-refractory essential tremor and Parkinson's disease. 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, with offices in Dallas, Shanghai, and Tokyo.

Forward-looking Statements:

This document contains forward-looking statements regarding, among other things, plans, expectations, and future events. 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. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. Any forward-looking statement is based on information available to Insightec as of the date of the statement. All written or oral forward-looking statements attributable to Insightec are qualified by this caution. Insightec does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Insightec's expectations.

"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.

Insightec Media Contact:
G&S Business Communications for Insightec
Marjani Williams
[email protected]
(312) 648-6700, ext.2108

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SOURCE INSIGHTEC