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INSIGHTEC Announces Peer Reviewed Publication of Phase 2b Focused Ultrasound Prostate Cancer Study i

Thursday, June 23, 2022 (0 Comments)

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INSIGHTEC ANNOUNCES PEER REVIEWED PUBLICATION OF PHASE 2B FOCUSED ULTRASOUND PROSTATE CANCER STUDY IN THE LANCET ONCOLOGY JOURNAL

Study of 101 patients found that Insightec' Exablate Prostate system is a safe and effective treatment option for intermediate risk prostate cancer.

HAIFA, Israel and MIAMI, June 23, 2022 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced the publication of its multicenter prostate cancer focal therapy study in The Lancet Oncology journal. The study, entitled "MRI-Guided Focused Ultrasound (MRgFUS) Focal Therapy for Intermediate-Risk Prostate Cancer: A Phase 2b Multicentre Study", showed that the Insightec Exablate Prostate system was a safe and effective treatment option compared to radical prostatectomy for patients living with intermediate risk (grade 2 or 3) prostate cancer.

The Insightec Exablate Prostate system is the only technology that used highly focused sound waves to destroy targeted tissue in the prostate under Magnetic Resonance Imaging (MRI) guidance for high resolution visualization of the patient's anatomy for precise targeting and real-time temperature monitoring.

This study was the basis of the FDA 510K clearance to treat prostatic tissue, in which more than 90% of the patients with intermediate-risk prostate cancer had negative biopsy results in the area of procedure. The study showed also that the vast majority of the safety events were Mild or Moderate.

"Exablate Focused Ultrasound has been shown to provide effective control of locally-confined prostate disease in select patients based on 24-month biopsy outcomes," said Behfar Ehdaie, MD, MS, Trial PI, and urologic surgeon at Memorial Sloan Kettering Cancer Center. "Precision ablation together with MR imaging and thermal feedback may enable men to consider a tissue preserving approach and defer or avoid radical therapy."

"Insightec is committed to exploring the full potential of focused ultrasound technology through intensive research and innovation," said Maurice R. Ferré, MD, Insightec CEO and Chairman of the Board. "We are proud of this study and the promise it holds for the future of prostate treatment and patient care."

The Insightec Exablate Prostate system received 510(k) FDA clearance in November 2021, making way for the system to be offered to patients in a commercial facility and for further clinical studies.

To read the full article in The Lancet Oncology journal:

https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(22)00251-0/fulltext

To read more about Exablate Prostate FDA 510K clearance:

https://insightec.com/insightec-announces-fda-clearance-for-exablate-prostate/.

To read more about Exablate Prostate's first US commercial patient treatment:

https://insightec.com/first-us-commercial-patient-treated-for-prostate-disease-with-insightec-incisionless-focused-ultrasound-system/

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.

Insightec Media Contact:

G&S Business Communications for Insightec

Marjani Williams

[email protected]

(312) 648-6700, ext.2108

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