INSIGHTEC RECEIVES FDA IDE APPROVAL FOR PROSTATE CANCER COMPARATIVE STUDY USING HIGH INTENSITY FOCUSED ULTRASOUND TECHNOLOGY

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Jun 30, 2022, 10:06 ET

Study will evaluate the safety and efficacy of the treatment with the Exablate Prostate system compared to active surveillance of prostate cancer

HAIFA, Israel and MIAMI, June 30, 2022 /PRNewswire/ -- Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, today announced that it has received FDA approval for an investigational device exemption (IDE) for a clinical comparative study of the Exablate Prostate system used to treat diseased prostate tissue. This study will evaluate the safety and efficacy of focal treatment using high intensity focused ultrasound when compared to active surveillance in men living with prostate cancer.

The Insightec Exablate Prostate system uses sound waves to ablate, or destroy, targeted tissue in the prostate. The treatment is performed under Magnetic Resonance Imaging (MRI) guidance for high resolution visualization of the patient's anatomy for precise targeting and real-time temperature monitoring. The single session treatment does not require incisions and allows patients to quickly return to normal activity with minimal complications.

"We are excited to continue this important research that can impact on the standard of care for prostate cancer treatment," said Behfar Ehdaie, MD, MS, a urologic surgeon at Memorial Sloan Kettering Cancer Center, and principal investigator for the study. "Exablate Focused Ultrasound has been shown to provide an accurate, safe, and effective option to engage the prostate gland directly in select patients based on 2-years biopsy outcomes. The new trial will build on this success and help further enhance treatment options."

"At Insightec, we are committed to the next generation of prostate cancer research and patient care," said Maurice R. Ferré, MD, Insightec CEO and Chairman of the Board. "Through technological innovation and medical advancements, there has been significant progress made in treating the prostate over the last decade, but we're not done yet. Our goal for this study is to demonstrate the clinical benefits of Exablate Prostate and provide patients with the opportunity for improved quality of life outcomes."

A previous Insightec-sponsored clinical trial led by Memorial Sloan Kettering Cancer Center for the Exablate Prostate system reported minimal damage to adjacent structures and low rates of impact on potency and continence, supporting function and quality of life for patients. The new comparative study builds on the evidence of this clinical trial and aims to further enhance prostate treatment options and improve clinical outcomes.

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. In January 2022, the system was used to treat prostate disease in its first US commercial patient.

Results from the new study will define the role of focal therapy to delay and avoid radical therapy for men with prostate cancer and support expanded clinical adoption of the technology and increased access for patients through insurance reimbursement.

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.

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Insightec media contact:
G&S Business Communications for Insightec
Marjani Williams
[email protected]
+1 (312) 648-6700, ext.2108

SOURCE Insightec