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INSIGHTEC, INC.

🇺🇸United States
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

85

Active:16
Completed:33

Trial Phases

4 Phases

Phase 1:10
Phase 2:4
Phase 3:4
+1 more phases

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (79 trials with phase data)• Click on a phase to view related trials

Not Applicable
61 (77.2%)
Phase 1
10 (12.7%)
Phase 2
4 (5.1%)
Phase 3
4 (5.1%)

EMBRACE Tremor BiFUS

Not Applicable
Recruiting
Conditions
Essential Tremor
First Posted Date
2025-05-16
Last Posted Date
2025-05-20
Lead Sponsor
InSightec
Target Recruit Count
100
Registration Number
NCT06974916
Locations
🇩🇪

Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH), Kiel, Germany

🇮🇹

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy

🇪🇸

HM CINAC- Hospital Universitario HM Puerta del Sur, Móstoles, Spain

and more 1 locations

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 Applicable
Recruiting
Conditions
Parkinson Disease
Interventions
Procedure: Exablate MRgFUS subthalamotomy
Drug: Best Medical Treatment
First Posted Date
2024-09-04
Last Posted Date
2025-06-18
Lead Sponsor
InSightec
Target Recruit Count
72
Registration Number
NCT06584383
Locations
🇨🇱

Pontificia Universidad Catolica de Chile, Santiago, Chile

🇩🇪

Universitätsklinikum Schleswig-Holstein, Campus Kiel (UKSH), Kiel, Germany

🇪🇸

HM CINAC- Hospital Universitario HM Puerta del Sur, Móstoles, Spain

and more 1 locations

Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric Diffuse Intrinsic Pontine Gliomas (DIPG)

Phase 1
Recruiting
Conditions
Brain Tumor
Interventions
Device: Exablate
First Posted Date
2022-11-29
Last Posted Date
2025-04-30
Lead Sponsor
InSightec
Target Recruit Count
10
Registration Number
NCT05630209
Locations
🇺🇸

Children's National Medical Center, Washington, District of Columbia, United States

🇺🇸

Nicklaus Children's Hospital, Miami, Florida, United States

Blood Brain Barrier (BBB) Disruption Using Exablate Focused Ultrasound With Doxorubicin for Treatment of Pediatric DIPG

Phase 1
Recruiting
Conditions
Brain Tumor
Interventions
Device: Exablate
First Posted Date
2022-11-14
Last Posted Date
2025-04-30
Lead Sponsor
InSightec
Target Recruit Count
10
Registration Number
NCT05615623
Locations
🇨🇦

Sunnybrook Research Institute, Toronto, Ontario, Canada

MR-guided Focused Ultrasound Plus GCase

Not Applicable
Recruiting
Conditions
Parkinsons Disease
First Posted Date
2022-10-04
Last Posted Date
2024-10-18
Lead Sponsor
InSightec
Target Recruit Count
14
Registration Number
NCT05565443
Locations
🇨🇦

Sunybrook Research Institute, Toronto, Ontario, Canada

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News

Insightec Receives FDA Approval for Bilateral Focused Ultrasound Treatment in Advanced Parkinson's Disease

The FDA has approved Insightec's Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients with advanced Parkinson's disease, expanding therapeutic options for over 50,000 patients.

Genomic Testing Emerges as Critical Tool in Brain Cancer Treatment, Experts Emphasize

Comprehensive genomic profiling is crucial for brain cancer patients, enabling personalized treatment approaches and identification of actionable mutations like NTRK fusions, according to Dr. Manmeet Ahluwalia.

Insightec's Exablate Prime Receives FDA Approval for Use with Philips MRI Systems

Insightec's Exablate Prime system has gained FDA approval and CE mark for integration with select Philips MRI systems, expanding access to non-invasive treatments.

Insightec's Exablate Prime Receives FDA and CE Mark for Philips MRI Integration

Insightec's Exablate Prime system has been approved by the FDA and has received CE Mark for integration with select Philips MRI systems, expanding access to focused ultrasound treatments.

MRI-Guided Ultrasound Shows Promise for Bilateral Essential Tremor Treatment

A multi-center clinical trial demonstrates the safety and efficacy of bilateral high-intensity focused ultrasound for essential tremor.

FDA Approves Insightec's Exablate Neuro for Advanced Parkinson's Disease Treatment

The FDA has approved Insightec's Exablate Neuro focused ultrasound system for treating advanced Parkinson's disease patients with mobility, rigidity, or dyskinesia symptoms through incisionless pallidotomy.

Focused Ultrasound Successfully Opens Blood-Brain Barrier in ALS Patients: Groundbreaking Trial Results

Sunnybrook researchers have demonstrated the safety of using focused ultrasound to temporarily open the blood-brain barrier in ALS patients, marking a world-first clinical achievement published in Nature Communications.

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