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INSIGHTEC, INC.

🇺🇸United States
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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. • The recent FDA approval of vorasidenib (Voranigo) for IDH-mutant gliomas represents a breakthrough in targeted therapy for brain tumors and provides hope for developing additional brain-penetrating drugs. • Clinical trials remain the optimal treatment option for aggressive brain cancers like glioblastoma, with increasing availability in both academic centers and larger community practices.

First Patients Receive Groundbreaking Autologous Stem Cell Treatment for Parkinson's Disease in Phase 1 Trial

• Mass General Brigham launches pioneering Phase 1 trial using patients' own reprogrammed stem cells to replace damaged dopamine neurons in Parkinson's disease, with three of six participants treated successfully. • The innovative treatment converts patients' blood cells into induced pluripotent stem cells (iPSCs), which are then transformed into dopamine neurons, eliminating the need for immunosuppression. • The FDA-approved trial, based on three decades of research at McLean Hospital, will monitor patients for 12 months to assess safety and potential improvements in Parkinson's symptoms.

Hoag Family Cancer Institute Advances Glioblastoma Treatment with Novel Clinical Trials

• Hoag Family Cancer Institute is participating in the LIBERATE study, which uses Focused Ultrasound to temporarily open the blood-brain barrier for liquid biopsies in glioblastoma patients. • The QUILT 3.078 clinical trial, also at Hoag, investigates the combination of N-803, PD-L1 t-haNK cell therapy, and Bevacizumab for recurrent or progressive glioblastoma. • Hoag's approach combines Focused Ultrasound with cell therapy and other modalities, requiring multidisciplinary expertise to improve diagnosis and treatment of glioblastoma. • These trials reflect Hoag's commitment to innovation, offering advanced treatment options and improving the quality of life for glioblastoma patients.

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. • The approval covers Philips 1.5T and 3.0T Ingenia systems, Ambition 1.5T, Elition 3.0T, and MR 7700 3.0T, enhancing treatment options for patients. • Exablate Prime uses MRI-guided focused ultrasound for tremor treatment in medication-refractory essential tremor and Parkinson’s disease patients, offering immediate improvement. • With over 160 systems installed globally and nearly 20,000 commercial applications, this collaboration aims to broaden the availability of cutting-edge care.

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. • The Exablate Prime system is now compatible with Philips 1.5T and 3.0T Ingenia systems, Philips Ambition 1.5T, Philips Elition 3.0T, as well as Philips MR 7700 3.0T. • Focused ultrasound, pioneered by Insightec, is an FDA-approved and CE Marked treatment for essential tremor and some Parkinson's disease symptoms, performed in a single outpatient procedure.

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. • The study, published in JAMA Neurology, showed that second-side treatment is effective with mostly mild side effects. • FDA approved the procedure for the non-dominant side in 2023, expanding treatment options for essential tremor patients. • Patients report significant improvements in quality of life, regaining control in both hands for daily activities.

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. • The groundbreaking technique successfully targeted the motor cortex—a brain region critically affected by ALS—potentially creating a non-invasive pathway for delivering therapeutics directly to affected neural tissues. • Following these promising Phase I results, researchers are preparing to advance to Phase II trials that will involve the delivery of actual ALS therapeutics through the temporarily opened blood-brain barrier.
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