Insightec Announces Milestone of First Patients Enrolled in the Pivotal LIBERATE Clinical Trial (Liquid Biopsy with Low Intensity Ultrasound in Brain Tumors)

Breakthrough therapy uses focused ultrasound to advance diagnosis and monitoring in glioblastoma

HAIFA, Israel & MIAMI, FL Dec. 15, 2022 — Insightec, a global healthcare company dedicated to using acoustic energy to transform patient care, announced today the first patients have enrolled in the pivotal LIBERATE clinical trial (Liquid Biopsy with Low Intensity Ultrasound in Brain Tumors). Enrollment in LIBERATE marks the start of an international effort to assess safety and efficacy of using Insightec’s focused ultrasound (FUS) platform to temporarily disrupt the blood brain barrier (BBB) to enable liquid biopsies in patients with glioblastoma, the most common primary malignant brain tumor in adults.

The first patients were enrolled in the US and Canada at Mayo Clinic (Drs. Terry Burns MD PhD and Timothy Kaufmann MD MS) and at Sunnybrook Health Sciences Centre (Dr. Nir Lipsman MD PhD).

“Our team at Mayo Clinic is excited to have enrolled the first patient in this pivotal trial,” said neurosurgeon Terry Burns MD PhD. “If successful, this work has the potential to substantially decrease the risk of obtaining the initial diagnosis. Importantly, FUS can be repeated non-invasively, allowing a rare molecular window into individual patient’s brain tumors as they evolve during treatment.”

“We are thrilled to take part in this first global pivotal trial of FUS as a novel, less invasive approach for brain tumor liquid biopsy,” said neurosurgeon Nir Lipsman MD PhD. “This milestone represents a key expansion in applications of this FUS platform, with therapeutic potential ranging from improved diagnostics to enhanced drug delivery.”

“Liquid biopsy is a new approach for noninvasive cancer diagnosis and monitoring in brain tumors,” said Dr. Achal Singh Achrol MD, Chief Medical Officer of Insightec. “Despite remarkable progress in other cancers, liquid biopsy has had limited success in brain tumors due to the presence of the blood brain barrier (BBB). This pivotal trial is designed to assess for the first time the clinical benefit of using low-intensity focused ultrasound (LIFU) to transiently increase the permeability of the BBB and allow passage of region-specific biomarkers to enable incisionless liquid biopsy in brain tumors.”

In the study, blood samples are collected before and after disruption of the BBB to assess for FUS-enabled increases in circulating free DNA (cfDNA). The study also assesses correlation between mutation profiles in the released cfDNA, i.e. circulating tumor DNA (ctDNA), with the mutation profiles in the tumor tissue obtained during standard-of-care invasive surgical resection and/or biopsy.

“This is a potential game-changer in neuro-oncology and would represent a paradigm shift in the treatment and evaluation of patients with brain tumors,” said study Principal Investigator Dr. Manmeet Ahluwalia, MD, MBA, Chief of Solid Tumor Medical Oncology, Deputy Director and Chief Scientific Officer at Miami Cancer Institute, part of Baptist Health South Florida.

“Insightec is committed to supporting these leading physician-scientists at these world-renowned institutions as they seek to advance the field of incisionless neurosurgery,” said Dr. Maurice R. Ferré MD, CEO and the Chairman of the Board of Directors at Insightec. “All of us at Insightec are proud to be supporting the LIBERATE investigators and launch of this pivotal trial is an important step forward in the fight against glioblastoma. Our ultimate goal is, as always, to positively impact patient lives.”

For further information about LIBERATE and to find enrolling locations please visit: https://clinicaltrials.gov/ct2/show/NCT05383872

In addition to the LIFU investigational device in the LIBERATE trial, Insightec also develops and manufactures FDA-approved platforms using high-intensity focused ultrasound (HIFU). These include the Exablate Neuro, approved for the treatment of Essential Tremor and Parkinson’s Disease, and Exablate Prostate, which received FDA 510K clearance for ablation of prostate tissue. (For detailed information about approved indications, see our website at https://insightec.com/regulatory-approvals/). Insightec systems are treating patients in commercially-approved indications at medical centers in over 30 countries. In addition, Insightec continues to support clinical trials with partner institutions across a range of other conditions, including Alzheimer’s disease, opioid abuse, neuropsychiatry, epilepsy and other cancers.

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.

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Forward-looking Statements:

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Insightec Media Contact:

G&S Business Communications for Insightec
Marjani Williams
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(312) 648-6700, ext.2108