COMPANY

Insightec

FDA-cleared device company Clinical Phase 3

Profile checked Oct 10, 2026

Keywords: Breast Cancer Essential Tremor Parkinson Disease Brain Tumor Parkinson's Disease Glioblastoma Movement Disorders Glioma Neurologic Manifestations Neurology Neuropathic Pain Recurrent Glioblastoma Alzheimer Disease Tremor Non Small Cell Lung Cancer Benign Centrally-Located Intracranial Tumors Opioid-use Disorder Substance Use Disorders Malignant Glioma Tremor Associated With Tremor Dominant Parkinson's Disease Amyotrophic Lateral Sclerosis Brain Metastases Parkinsons Disease With Dementia Liquid Biopsy Metastatic Brain Cancer Holmes Tremor Wilson's Disease Huntington's Disease Dystonia Tardive Dyskinesia Orofacial Dyskinesias Prostate Cancer Uterine Fibroid Localized Intermediate Risk Prostate Lesions Glioblastoma Multiforme ExAblate Transcranial System Transcranial ExAblate ExAblate ExAblate BBBD

84Trials (company is sponsor)

Raises and deals from press releases

Raise Undisclosed round · $150M · announced Jun 18, 2024 Company release ↗
Source quote
- Jun 18, 2024 · Company release ↗
  “Bridge Group Co-Lead Robust Investor Syndicate HAIFA, Israel and MIAMI , June 18, 2024 — Insightec , a global healthcare company dedicated to using focused ultrasound to transform patient care, today announced it has raised $150 million in equity financing”

Raises announced in these releases: $150M disclosed.

From the company’s own releases; this list is partial. All raises and deals

Timeline

Apr 22, 2025 Trial start Not phased (device or behavioral study): EMBRACE Tremor BiFUS source ↗
Oct 23, 2024 Trial start Not phased (device or behavioral study): Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma source ↗
Aug 1, 2024 Trial start Not phased (device or behavioral study): A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease source ↗
Jun 18, 2024 Raise Undisclosed round · $150M source ↗
Jan 23, 2023 Trial start —: A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Seve source ↗
Jan 4, 2023 Trial start Phase 1/Phase 2: Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG source ↗
Jan 4, 2023 Trial start Phase 1/Phase 2: Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG) source ↗
Dec 31, 2022 Trial start Not phased (device or behavioral study): Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001) source ↗
Nov 30, 2022 Trial start Not phased (device or behavioral study): MR-guided Focused Ultrasound Plus GCase source ↗
Aug 12, 2022 Trial start Phase 3: Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets source ↗
Aug 8, 2022 Trial start Not phased (device or behavioral study): Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors source ↗
Apr 28, 2022 Trial start —: A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease source ↗
Aug 25, 2021 Trial start —: Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients source ↗
May 14, 2021 Trial start Not phased (device or behavioral study): Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD) source ↗
Nov 6, 2020 Trial start Phase 1/Phase 2: Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy source ↗
Oct 13, 2020 Trial start Phase 1/Phase 2: Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM source ↗
Oct 8, 2020 Trial start Not phased (device or behavioral study): Study of MRgFUS Exablate Treatment Following the Neuropathic Pain source ↗
Jul 16, 2020 Trial start Not phased (device or behavioral study): Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease source ↗
Jun 30, 2020 Trial start Not phased (device or behavioral study): Bilateral Treatment of Medication Refractory Essential Tremor source ↗
Dec 19, 2019 Trial start Not phased (device or behavioral study): Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions source ↗
Nov 27, 2019 Trial start Not phased (device or behavioral study): Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs) source ↗
Sep 18, 2019 Trial start Not phased (device or behavioral study): Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases source ↗
Jun 18, 2019 Trial start Not phased (device or behavioral study): A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD source ↗
May 31, 2019 Trial start Not phased (device or behavioral study): A Clinical Trial for the Safety and Effect of MRGuided FUS Subthalamotomy for Medication Refractory Parkinson's Disease source ↗
Apr 25, 2019 Trial start Not phased (device or behavioral study): Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor source ↗
2026-09 Trial start Not phased (device or behavioral study): Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease. source ↗

Showing 25 of 50 dated events.

Upcoming milestones

2026-12 (ESTIMATED) · Not phased · ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Brain Tumors · NCT01473485
2026-12 (ESTIMATED) · Not phased · Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound · NCT02343991
2026-12 (ESTIMATED) · Not phased · MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors · NCT00147056
Dec 30, 2026 (ESTIMATED) · Not phased · Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions · NCT03998657
Dec 31, 2026 (ESTIMATED) · Not phased · A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects · NCT03028246
Dec 31, 2026 (ESTIMATED) · Not phased · Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs) · NCT04197921
Dec 31, 2026 (ESTIMATED) · · Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids · NCT05386615
Jun 1, 2027 (ESTIMATED) · Phase 3 · Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets · NCT05317858

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) Showing 50 of 84

Record	Title	Phase	Status	Start	Primary completion
NCT02794558	Safety and Effectiveness of MR Guided Focused Ultrasound Surgery in the Treatment of Early Breast Carcinomas	Not phased (device or behavioral study)	Completed	May 24, 2005	Mar 1, 2019 (actual)
NCT01620359	Study of ExAblate Focused Ultrasound Ablation of Breast Cancer	Phase 2	Completed	Nov 24, 2010	Apr 14, 2014 (actual)
NCT03935581	Safety and Feasibility of ExAblate Neuro System to Perform Auto-Focusing Echo Imaging in Patients With Essential Tremor	Not phased (device or behavioral study)	Completed	Apr 25, 2019	Apr 28, 2020 (actual)
NCT06974916	EMBRACE Tremor BiFUS	Not phased (device or behavioral study)	Recruiting	Apr 22, 2025	2027-07 (estimated)
NCT07764874	Unilateral and Staged Bilateral Pallidothalamic Tractotomy Using Exablate MRgFUS in Advanced Parkinson's Disease.	Not phased (device or behavioral study)	Not yet recruiting	2026-09	2029-12 (estimated)
NCT05317858	Blood-brain Barrier (BBB) Opening Using Exablate Focused Ultrasound With Standard of Care Treatment of NSCLC Brain Mets	Phase 3	Recruiting	Aug 12, 2022	Jun 1, 2027 (estimated)
NCT02246374	ExAblate Transcranial MRgFUS of the Subthalamic Nucleus for Treatment of Parkinson's Disease	Not phased (device or behavioral study)	Completed	2014-09	2021-05 (actual)
NCT03028246	A Feasibility Safety Study of Benign Centrally-Located Intracranial Tumors in Pediatric and Young Adult Subjects	Not phased (device or behavioral study)	Recruiting	Feb 28, 2017	Dec 31, 2026 (estimated)
NCT04197921	Exablate for LIFU Neuromodulation in Patients With Opioid Use Disorder (OUD) and/or Other Substance Use Disorders (SUDs)	Not phased (device or behavioral study)	Recruiting	Nov 27, 2019	Dec 31, 2026 (estimated)
NCT04002596	Safety and Initial Effectiveness of Transcranial MR Guided Focused Ultrasound for the Treatment of Parkinson's Disease	Not phased (device or behavioral study)	Completed	Feb 6, 2017	Sep 29, 2019 (actual)
NCT06584383	A Prospective, Randomized, Controlled Trial to Test Safety and Effectiveness of Unilateral Exablate MR-guided Focused Ultrasound Subthalamotomy in Patients With Early-Stage Parkinson's Disease	Not phased (device or behavioral study)	Active, not recruiting	Aug 1, 2024	2027-09 (estimated)
NCT05089786	Echo-Focusing in Patients With Treatment-Resistant Neurologic and Psychiatric Indications (EF001)	Not phased (device or behavioral study)	Withdrawn	Dec 31, 2022	Dec 31, 2023 (estimated)
NCT05615623	Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG	Phase 1/Phase 2	Active, not recruiting	Jan 4, 2023	2026-06 (estimated)
NCT05630209	Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)	Phase 1/Phase 2	Active, not recruiting	Jan 4, 2023	2026-06 (estimated)
NCT04998864	Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption in GBM Patients	Not listed	Completed	Aug 25, 2021	Jul 27, 2023 (actual)
NCT03454425	A Study to Evaluate the Safety and Efficacy of ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features	Not phased (device or behavioral study)	Completed	Feb 27, 2018	Jun 15, 2020 (actual)
NCT03465761	Staged Bilateral Exablate Treatment of Medication Refractory Essential Tremor	Not phased (device or behavioral study)	Completed	Jan 3, 2019	Dec 7, 2021 (actual)
NCT03964272	A Feasibility Study on the Safety and Preliminary Efficacy of Bilateral Subthalamotomy Using MRgFUS for Treatment of PD	Not phased (device or behavioral study)	Completed	Jun 18, 2019	Nov 7, 2023 (actual)
NCT04991831	A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Thalamotomy for the Treatment of Medication-Refractory Tremor Dominant Idiopathic Parkinson's Disease	Not listed	Recruiting	Apr 28, 2022	2027-12 (estimated)
NCT04649554	Study of MRgFUS Exablate Treatment Following the Neuropathic Pain	Not phased (device or behavioral study)	Terminated	Oct 8, 2020	Dec 31, 2021 (actual)
NCT04417088	Exablate Blood-Brain Barrier Disruption for the Treatment of rGBM in Subjects Undergoing Carboplatin Monotherapy	Phase 1/Phase 2	Completed	Nov 6, 2020	Nov 30, 2023 (actual)
NCT03321487	Blood-Brain Barrier Opening Using MR-Guided Focused Ultrasound in Patients With Amyotrophic Lateral Sclerosis	Not phased (device or behavioral study)	Completed	Apr 13, 2018	Dec 30, 2021 (actual)
NCT03319485	ExAblate Pallidotomy for Medically-Refractory Dyskinesia Symptoms or Motor Fluctuations of Advanced Parkinson's Disease	Not phased (device or behavioral study)	Active, not recruiting	Feb 9, 2018	Jul 25, 2024 (actual)
NCT05539196	A Post-Approval Registry for Exablate 4000 Type 1.0 and Type 1.1 for Unilateral Pallidotomy for the Treatment of Advanced, Idiopathic Parkinson's Disease With Medication-refractory Moderate to Severe Motor Complications	Not listed	Recruiting	Jan 23, 2023	Jul 31, 2029 (estimated)
NCT03714243	Blood Brain Barrier Disruption (BBBD) Using MRgFUS in the Treatment of Her2-positive Breast Cancer Brain Metastases	Not phased (device or behavioral study)	Completed	Sep 18, 2019	Apr 28, 2022 (actual)
NCT04370665	Blood-Brain-Barrier Disruption With Cerezyme in Patient's With Parkinson's Disease	Not phased (device or behavioral study)	Completed	Jul 16, 2020	Dec 31, 2021 (actual)
NCT03608553	A Study to Evaluate Temporary Blood Brain Barrier Disruption in Patients With Parkinson's Disease Dementia	Not phased (device or behavioral study)	Completed	Nov 26, 2018	Oct 31, 2021 (actual)
NCT03551249	Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption	Not phased (device or behavioral study)	Completed	Mar 26, 2019	Dec 31, 2023 (actual)
NCT05565443	MR-guided Focused Ultrasound Plus GCase	Not phased (device or behavioral study)	Recruiting	Nov 30, 2022	Dec 31, 2027 (estimated)
NCT03739905	ExAblate Blood-Brain Barrier Opening for Treatment of Alzheimer's Disease	Not phased (device or behavioral study)	Completed	Dec 6, 2018	Apr 9, 2025 (actual)
NCT04440358	Exablate Blood-Brain Barrier Disruption With Carboplatin for the Treatment of rGBM	Phase 1/Phase 2	Completed	Oct 13, 2020	Nov 30, 2023 (actual)
NCT03671889	ExAblate Blood-Brain Barrier (BBB) Disruption for the Treatment of Alzheimer's Disease	Not phased (device or behavioral study)	Recruiting	Sep 28, 2018	2028-01 (estimated)
NCT05383872	Blood-Brain Barrier Disruption (BBBD) for Liquid Biopsy in Subjects With GlioBlastoma Brain Tumors	Not phased (device or behavioral study)	Completed	Aug 8, 2022	Feb 21, 2025 (actual)
NCT03100474	Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:	Not listed	Active, not recruiting	2016-12	2026-06 (estimated)
NCT04667715	Safety and Effectiveness of Blood-Brain Barrier Disruption (BBBD) in Subjects With Suspected Infiltrating Glioma	Not phased (device or behavioral study)	Withdrawn	Oct 23, 2024	Oct 23, 2024 (actual)
NCT01473485	ExAblate (Magnetic Resonance-guided Focused Ultrasound Surgery) Treatment of Brain Tumors	Not phased (device or behavioral study)	Active, not recruiting	2011-04	2026-12 (estimated)
NCT02347254	ExAblate Transcranial MRgFUS for Unilateral Pallidotomy for the Treatment of Parkinson's Disease	Not phased (device or behavioral study)	Active, not recruiting	2014-09	2026-06 (estimated)
NCT02343991	Blood-Brain Barrier Disruption Using Transcranial MRI-Guided Focused Ultrasound	Not phased (device or behavioral study)	Active, not recruiting	2014-10	2026-12 (estimated)
NCT02252380	ExAblate Transcranial MRgFUS for the Management of Treatment-Refractory Movement Disorders	Not phased (device or behavioral study)	Active, not recruiting	2015-05	2026-06 (estimated)
NCT00147056	MRI-Guided Focused Ultrasound Feasibility Study for Brain Tumors	Not phased (device or behavioral study)	Active, not recruiting	2012-08	2026-12 (estimated)
NCT03998657	Continued Access of Focal MR-Guided Focused Ultrasound for Localized Intermediate Risk Prostate Lesions	Not phased (device or behavioral study)	Active, not recruiting	Dec 19, 2019	Dec 30, 2026 (estimated)
NCT04112381	Bilateral Treatment of Medication Refractory Essential Tremor	Not phased (device or behavioral study)	Active, not recruiting	Jun 30, 2020	2026-03 (estimated)
NCT05386615	Post-Exablate Pregnancy Outcomes Registry Study: Exablate Treatment of Symptomatic Uterine Fibroids	Not listed	Recruiting	Feb 16, 2016	Dec 31, 2026 (estimated)
NCT04728295	Evaluation of the Safety and Effectiveness of Bilateral Exablate Ablation of the Pallidothalamic Tract (PTT) for the Treatment of the Motor Complications of Parkinson's Disease (PD)	Not phased (device or behavioral study)	Active, not recruiting	May 14, 2021	Mar 28, 2024 (actual)
NCT01657942	Focal MR-Guided Focused Ultrasound Treatment of Localized Intermediate Risk Prostate Lesions	Not phased (device or behavioral study)	Completed	2013-10	2019-10 (actual)
NCT01827904	ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors	Not phased (device or behavioral study)	Completed	2013-05	Feb 24, 2021 (actual)
NCT02289560	Continued Access Protocol: ExAblate Transcranial MR Guided Focused Ultrasound for the Treatment of Essential Tremors	Not phased (device or behavioral study)	Completed	2015-04	Feb 18, 2022 (actual)
NCT04744493	A Clinical Trial for the Safety and Effect of MRGuided FUS Subthalamotomy for Medication Refractory Parkinson's Disease	Not phased (device or behavioral study)	Completed	May 31, 2019	May 31, 2022 (actual)
NCT03712293	ExAblate Blood-Brain Barrier Disruption for Glioblastoma in Patients Undergoing Standard Chemotherapy	Not phased (device or behavioral study)	Completed	Aug 28, 2018	Dec 31, 2023 (actual)
NCT03616860	Assessment of Safety and Feasibility of ExAblate Blood-Brain Barrier (BBB) Disruption for Treatment of Glioma	Not phased (device or behavioral study)	Completed	Oct 16, 2018	Dec 31, 2023 (actual)