January 18, 2017 1:28 PM ET

Healthcare Equipment and Supplies

Company Overview of InSightec Ltd.

Company Overview

InSightec Ltd. develops and distributes the Exablate platform that provides non-invasive treatments for various oncology and gynecology indications. The company offers a neurosurgery solution that includes Exablate Neuro, a non-invasive and image-guided personalized thalamotomy for movement disorders and pain, treated through an intact skull; MR guided Focused (MRgFUS), a non-invasive thermal ablation technique to relieve symptoms caused by uterine fibroids, as well as destroys uterine fibroid tissue using a thermal effect; and a non-invasive and non-ionizing treatment that uses focused ultrasound waves to ablate the target treatment with minimal damage to surrounding tissues. It also provid...

5 Nahum Heth Street

POB 2059

Tirat Carmel,  39120

Israel

Founded in 1999

Phone:

972 4 813 1313

Fax:

972 4 813 1322

Key Executives for InSightec Ltd.

Executive Chairman and Chief Executive Officer
Age: 55
President and Chief Commercial Officer
Founder and Vice Chairman
Chief Financial Officer and Vice President
Vice President of Operations and Quality
Compensation as of Fiscal Year 2016.

InSightec Ltd. Key Developments

CMS Approves INSIGHTEC's Exablate Neuro System for U.S. Coverage for the Treatment of Essential Tremor

Elbit Imaging Ltd. announced that it was informed by INSIGHTEC Ltd. that the Centers for Medicare and Medicaid Services assigned a status to the Exablate Neuro treatment for Essential Tremor, moving it from a non-payable status indicator to one that allows reimbursement. The CMS decision is one of several steps toward gaining appropriate reimbursement for MRgFUS for essential tremor. This Elbit Imaging Ltd. announced that it was informed by INSIGHTEC Ltd. that the Centers for Medicare and Medicaid Services assigned a status to the Exablate Neuro treatment for Essential Tremor, moving it from a non-payable status indicator to one that allows reimbursement. The CMS decision is one of several steps toward gaining appropriate reimbursement for MRgFUS for essential tremor. This needs to be followed by CMS regional offices approval to the reimbursement for the Exablate Neuro treatment, for their patients. According to the CMS's recommendation, the Exablate Neuro was assigned a reimbursement code with a payment level of $9,751. At this stage, INSIGHTEC is unable to estimate the implications of the CMS's recommendation on INSIGHTEC. INSIGHTEC’s Exablate Neuro platform is transforming medicine by presenting a non-invasive treatment alternative that combines two technologies: Focused Ultrasound, which is used to lesion the targeted tissue deep in the brain, and Magnetic Resonance Imaging (MRI), which is used to guide the ultrasound waves to the specific target tissue and provide real-time feedback on treatment progress and outcomes. Essential tremor is the most common movement disorder, affecting millions people worldwide. It is a progressive and debilitating neurological condition that causes a rhythmic trembling of the hands, head, voice, legs or trunk. needs to be followed by CMS regional offices approval to the reimbursement for the Exablate Neuro treatment, for their patients. According to the CMS's recommendation, the Exablate Neuro was assigned a reimbursement code with a payment level of $9751. At this stage, INSIGHTEC is unable to estimate the implications of the CMS's recommendation on INSIGHTEC. INSIGHTEC’s Exablate Neuro platform is transforming medicine by presenting a non-invasive treatment alternative that combines two technologies: Focused Ultrasound, which is used to lesion the targeted tissue deep in the brain, and Magnetic Resonance Imaging (MRI), which is used to guide the ultrasound waves to the specific target tissue and provide real-time feedback on treatment progress and outcomes. Essential tremor is the most common movement disorder, affecting millions people worldwide. It is a progressive and debilitating neurological condition that causes a rhythmic trembling of the hands, head, voice, legs or trunk.

InSightec Signs Non-Exclusive Cooperation Agreement with Siemens Healthcare GmbH

InSightec announced that it signed a non-exclusive cooperation agreement with Siemens Healthcare GmbH, to develop compatibility between InSightec's MRI guided Focused Ultrasound Systems (MRgFUS) and Siemens MRI scanners with the intention to expand the MRgFUS market globally. Under the agreement, the parties will cooperate regarding the performance of R&D, integration, testing and approving the compatibility of the parties' systems. Each party shall be solely responsible, at its own cost, to obtain the regulatory approval for its systems, and InSightec shall be solely responsible, at its sole cost, to obtain the regulatory approval for the combined system. Each party shall bear all of its internal and external costs relating to its performance under the agreement, except that InSightec shall reimburse Siemens an amount agreed upon in the agreement for its R&D costs. The agreement also determines that each party shall act independently in the marketing and sales of its component portion of the combined system, and determines the amount InSightec shall pay Siemens for sales of the combined systems. The term of the agreement is five years from the first commercial sale of the combined system and shall automatically renew for additional one-year periods, unless either party has provided a notice for its non-renewal or of its termination.

INSIGHTEC Receives FDA Approval for its Exablate Neuro System for the Non-Invasive Treatment of Essential Tremor

INSIGHTEC announced that the FDA has approved its Exablate Neuro system for the non-invasive treatment of essential tremor (ET) in patients who have not responded to medication. Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under Magnetic Resonance Imaging (MRI) guidance for real time treatment monitoring. The patient experiences immediate tremor improvement following the outpatient procedure. The treatment carries minimal risk of infection, bleeding or other surgical complications. The treatment requires a single session with no anesthesia, allowing patients to quickly return to normal activity. Essential tremor is the most common movement disorder, affecting more than 5 million people in the United States, and millions more worldwide. Hand tremor is the most common symptom, but tremors can also affect the head, arms, voice, legs, and torso. For these patients, performing everyday tasks presents a challenge and impacts their quality of life. This approval by the FDA was based on clinical data from a randomized, double-blind, multi-center clinical study designed to evaluate the safety and efficacy of non-invasive thalamotomy with MRgFUS. A total of 76 patients were enrolled in the study and randomly assigned to receive the Exablate treatment (56 patients) or the sham procedure (20 patients), the exact same procedure but without any ultrasound energy. Patients in the placebo treatment arm were later allowed to undergo an Exablate Neuro treatment. Patients treated with the Exablate Neuro showed nearly a 50% improvement in their tremors and motor function three months after treatment compared to their baseline score. Patients in the control group had no improvement, and some experienced a slight worsening after the sham procedure before they crossed over into the treatment group. A year following the procedure, the patients who underwent the Exablate Neuro procedure retained a 40% improvement in these scores compared to baseline.

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