INSIGHTEC ANNOUNCES EXABLATE PRIME AVAILABILITY IN EUROPE -THE NEXT GENERATION OF MR-GUIDED FOCUSED ULTRASOUND

Insightec reaffirms its position at the forefront of the medical technology industry with improved functionality, safety features, and efficiency to its flagship product, setting new benchmarks in the field with unparalleled achievements.

HAIFA, Israel and MUNICH, April 16, 2024 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced the CE approval and European launch of Exablate Prime, a significant enhancement to the Exablate Neuro platform. Based on customer input and feedback, Exablate Prime is the culmination of over 10 years of significant research and development designed to increase precision, efficiency, and experience of the surgeon – and the patient.

Like its predecessor, Exablate Prime enables incisionless neurosurgery as an outpatient procedure to provide relief to people living with movement disorders, such as essential tremor and Parkinson's disease. New improvements include an enriched user interface and enhancements to optimize productivity. Specific improvements include:

• Intuitive user interface: designed with guided workflows, automated steps, and a streamlined UI
• Automated calculations: Intelligent algorithms for one-click skull-density-ratio (SDR) calculations, automatic fusion and AC/PC identification, and efficient no-pass region detection
• Intuitive and informative therapy delivery: temperature-driven control enabled by an accurate temperature prediction algorithm
• Increased specificity and control: Precise targeting and lesion shaping with sub-millimetric targeting control and advanced shaping masks
• Real-time monitoring: cumulative thermal dose overlays
• Enhanced planning & support: improved cyber security, PACS connectivity, remote planning, and troubleshooting
• Improved visualization and image management: automatic MR scan acquisition, intelligent targeting tools, and larger MR data sets in one planning session

The system also boasts an optional, upgraded 3T head coil for improved imaging and 3D thermal spot visualization.

"Our unwavering commitment to enhancing patient care through innovative technology led us to develop Exablate Prime," said Maurice R. Ferre, M.D., CEO and chairman of the board of Insightec. "Although Exablate Neuro has revolutionized the field of neurosurgery, Exablate Prime takes it to entirely new levels, pushing the boundaries of what is possible. We couldn't be more proud of the end result – Exablate Prime is the future of incisionless neurosurgery."

"With the growing number of European countries supporting focused ultrasound as viable treatment option for essential tremor, Exablate Prime is truly exciting," commented Giuseppe Carbone, vice president of Insightec Europe. "We are confident it will make even more of a positive impact to empower Europeans living with essential tremor and Parkinson's disease – as well as their physicians."

To ensure Exablate Prime met the needs of working neurosurgeons, it was tested first in Rambam Hospital in Haifa, Israel where suggestions for improvement were implemented. It was then tested in the US by Oregon Health and Science University.

"We were proud to lead the validation pilot study for Prime and be a design partner with Insightec," said Dr. Lior Lev Tov, senior neurosurgeon at Rambam Hospital. We truly appreciate the great improvements it brings to the treatment."

Exablate Prime is available for sale in the US and Europe. For more information about Exablate Prime or to schedule a demonstration, please contact marketing@insightec.com 

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, safely guided by 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.

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