• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Top News
    CMS Establishes New Payment for Pelvalon’s Eclipse System

    Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy

    Resonetics Leases New Manufacturing Space in Costa Rica

    Seisa Medical Acquires ProtoQuick and Peridot

    Masimo Device is Useful in Assessing Respiratory Status of Pediatric Tracheostomy Patients
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Transporting Treatment: An Examination of Tubing Technologies

    Outward Appearance: Reviewing Surface Treatment Options

    Face to (Virtual) Face: Telemedicine Now and Post-Pandemic

    Voices for Medtech: AdvaMed and MDMA Leaders Share Thoughts

    Digitize Your QMS via an Enterprise Cloud Platform
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Home Is Where the Heart (Valve) Is

    CGM: Digital Health Meets a Very Large Opportunity

    Biomechanical Engineer, Heal Thyself

    Optimizing MIM in Medical Device Manufacturing

    PPE and Diagnostics: Sourcing Domestically and Speeding Time to Market
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    maxon

    Medicoil

    Creganna Medical, part of TE Connectivity

    Forefront Medical Technology

    K-Tube Technologies
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    Three Future Trends and Opportunities in Quality Assurance

    Adopting a Data-Driven Quality Model

    Digital Transformation for Quality and Manufacturing

    Digging into the Cardiac Arrhythmia Monitoring Device Market

    EMS Providers Supplying More Than Electronics to Customers
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    MW Life Sciences

    FUTEK Advanced Sensor Technology Inc.

    maxon

    Medicoil

    Medbio LLC
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • Podcasts
    • Resources
    • eBook
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    CarThera Receives FDA Approval for Phase 1/2a Trial in Glioblastoma

    SonoCloud ultrasound device will be tested for the first time at U.S. clinical sites.

    CarThera Receives FDA Approval for Phase 1/2a Trial in Glioblastoma
    The SonoCloud is designed to temporarily open the blood-brain barrier (BBB), potentially improving the penetration of therapeutic agents into the brain to increase efficacy. Image courtesy of CarThera.
    Related CONTENT
    • The FDA Wants to Bring Manufacturing ‘Home’
    • RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    • FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    • FDA OKs Masimo’s Rad-G Pulse Oximeter
    • FDA Clears Scientia Vascular's Zoom Wire
    CarThera07.09.19
    CarThera, a French company that designs and develops innovative ultrasound-based medical devices to treat brain disorders, has announced that the FDA has granted approval to launch a Phase 1/2a clinical trial in the U.S. with its SonoCloud-9 ultrasound device in recurrent glioblastoma (GBM) patients treated with carboplatin.
     
    CarThera’s low-intensity pulsed ultrasound device, the SonoCloud, is designed to temporarily open the blood-brain barrier (BBB), potentially improving the penetration of therapeutic agents into the brain to increase efficacy. The company recently reported the results of a Phase 1/2a glioblastoma trial in France (Pitie Salpetriere Hospital at AP-HP) with its first generation device, the SonoCloud-1.
     
    Its next-generation device, the SonoCloud-9, brings a nine-fold increase in coverage of the tumor and surrounding infiltrative areas. A phase 1/2a clinical trial aiming at measuring the  safety, tolerance, and efficacy of repeated openings of the BBB by SonoCloud-9, before infusion of carboplatin in 27 patients, has already started in France (Paris and Lyon) and will soon be up and running at the MD Anderson Cancer Center in Houston and at the Northwestern Memorial Hospital in Chicago.
     
    “We are excited to initiate this clinical trial in the U.S. to evaluate the potential of the SonoCloud-9 device for glioblastoma patients,” said Dr. Alexandre Carpentier, inventor of the technology and founder of CarThera. “Our first clinical study confirmed the safety and feasibility of this solution. We believe it represents a major step forward in the treatment of GBM.”
     
    This phase 1/2a study in France, conducted by Dr. Ahmed Idbaih, is a preliminary step in the development of the SonoCloud-9 for glioblastoma. A pivotal trial should start at the end of next year in Europe and in the U.S. This should lead to marketing approvals in these regions.
     
    “We are delighted with the FDA approval of our SonoCloud-9 study in GBM patients and are looking forward to expanding our activities in the U.S.,” said Frederic Sottilini, CEO of CarThera. “The appointment last month of Pascal E. R. Girin as our U.S.-based chairman of the board, our new subsidiary in Boston, and a number of translational research programs with renowned U.S. research institutes show our commitment to bringing our innovative technology to U.S. patients with brain tumors.”
     
    According to the company’s estimates, each year 250,000 patients worldwide are diagnosed with a brain tumor. Each year about 3 in 100,000 people develop glioblastoma. It is the second most common central nervous system cancer after meningioma. In the U.S., the National Cancer Institute estimates that over 23,000 adults will be diagnosed in the United States with brain and nervous system cancer in 2019. 
     
    The SonoCloud is the only tool capable of easily and repeatedly opening the BBB to allow for enhanced concentrations of therapeutics into the brain.
     
    “Therapeutic ultrasound research has significantly increased in importance over the last decade. We are delighted that we can now introduce our ultrasound technology to U.S. clinical and research centers. We believe that this is a significant step in developing this technology for use with a wide range of therapies for treatment of brain diseases,” said Michael Canney, scientific director at CarThera.
    Related Searches
    • blood
    • tumor
    • clinical study
    • system
    Related Knowledge Center
    • Neurological
    • Electronics
    Suggested For You
    The FDA Wants to Bring Manufacturing ‘Home’ The FDA Wants to Bring Manufacturing ‘Home’
    RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device
    FDA OKs SentiAR FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System
    FDA OKs Masimo’s Rad-G Pulse Oximeter FDA OKs Masimo’s Rad-G Pulse Oximeter
    FDA Clears Scientia Vascular FDA Clears Scientia Vascular's Zoom Wire
    FDA Authorizes First Point-of-Care COVID-19 Antibody Test FDA Authorizes First Point-of-Care COVID-19 Antibody Test
    FDA OKs Surmodics FDA OKs Surmodics' Pounce Thrombus Retrieval System
    FDA Launches the Digital Health Center of Excellence FDA Launches the Digital Health Center of Excellence
    Acutus AcQMap Catheter Cleared by FDA Acutus AcQMap Catheter Cleared by FDA
    FDA OKs Varian FDA OKs Varian's Eclipse v16.1 Proton Therapy Treatment Planning Software
    FDA Approves Expanded Use of Roche FDA Approves Expanded Use of Roche's CINtec PLUS Cytology Test
    FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data FDA Publishes COVID-19 Molecular Dx Test Comparative Performance Data
    HD Medical Awarded FDA Clearance for HD Steth HD Medical Awarded FDA Clearance for HD Steth
    FDA OKs Minnetronix FDA OKs Minnetronix's MindsEye Neurosurgical Access Platform
    FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector FDA Clears KA Imaging’s Portable Dual-Energy X-Ray Detector

    Related Breaking News

    • Neurological
      Encora

      Encora's Tremor Reducing Wristband Gains Breakthrough Status

      Indicated to provide temporary hand tremor relief in adult essential tremor or Parkinson's patients.
      Sam Brusco, Associate Editor 03.31.21

    • Neurological | Patient Monitoring
      FDA OKs Brain Scientific

      FDA OKs Brain Scientific's Next-Gen NeuroCap EEG Headset

      NeuroCap's advanced EEG electrode array obtains rapid EEGs in routine clinical and research settings.
      Sam Brusco, Associate Editor 03.10.21

    • Neurological
      Medtronic Receives FDA Approval for Expanded MRI Labeling

      Medtronic Receives FDA Approval for Expanded MRI Labeling

      Updated MRI Guidelines allow for a wider range of MRI scan parameters and shorter wait time between MRI scans.
      Charles Sternberg, Assistant Editor 02.18.21


    • Neurological
      FDA OKs electroCore

      FDA OKs electroCore's gammaCore nVNS for Adolescent Migraine

      It’s now cleared for most forms of primary headache.
      Sam Brusco, Associate Editor 02.16.21

    • Neurological
      FDA Approves Axonics

      FDA Approves Axonics' 3rd-Gen Implantable Neurostimulator

      Upgrades its embedded software and the patient remote control’s functionality.
      Sam Brusco, Associate Editor 02.16.21

    • Cardiovascular | Neurological
      Cerus Endovascular

      Cerus Endovascular's Contour Neurovascular System Gains Breakthrough Status

      Indicated for the treatment of intracranial aneurysms.
      Sam Brusco, Associate Editor 02.12.21


    • Neurological
      Nēsos Earbud Receives Validation for Treatment of Rheumatoid Arthritis

      Nēsos Earbud Receives Validation for Treatment of Rheumatoid Arthritis

      New study shows promising efficacy and safety profile for novel ‘e-mmunotherapy’ approach to disease treatment.
      Charles Sternberg, Assistant Editor 02.02.21

    • Neurological
      Boston Scientific

      Boston Scientific's Vercise Genus DBS Earns FDA Approval

      Fourth-generation DBS portfolio features full-body MR conditional devices.
      Sam Brusco, Associate Editor 01.22.21

    • Neurological
      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Cognito Therapeutics’ Lead Product Receives FDA Breakthrough Device Designation

      Next-generation digital therapeutic is designed for the treatment of Alzheimer’s disease.
      Business Wire 01.14.21


    • Neurological
      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson

      Medtronic Begins Adaptive Deep Brain Stimulation Trial for Parkinson's

      First-of-its-kind study tests automated therapy that responds to brain signals in Parkinson's patients.
      PR Newswire 01.14.21

    • Neurological | Surgical
      FDA OKs ClearMind Biomedical

      FDA OKs ClearMind Biomedical's Axonpen Neuroendoscope

      Requires only a narrow channel of 6.5mm through the skull for insertion into the brain.
      PR Newswire 01.12.21

    • Diagnostics | Neurological
      FDA OKs Abbott

      FDA OKs Abbott's First-of-Its-Kind Rapid, Handheld TBI Test

      Produces a result within 15 minutes after a plasma sample is inserted.
      Abbott Laboratories 01.11.21


    • Neurological
      BioSerenity Achieves FDA Clearance for Wearable Device System

      BioSerenity Achieves FDA Clearance for Wearable Device System

      Neuronaute EEG System and IceCap bring comprehensive remote electroencephalography monitoring services to people living with neurological disorders.
      PRNewswire 01.07.21

    • Electronics
      Hermetic Solutions Acquires Cristek Interconnects

      Hermetic Solutions Acquires Cristek Interconnects

      Complements Hermetic Solutions’ engineered component and microelectronic packaging solutions.
      Hermetic Solutions Group 01.06.21

    • Cardiovascular | Neurological | Surgical
      FDA OKs Rapid Medical

      FDA OKs Rapid Medical's Steerable Neurovascular Guidewire

      Provides efficient access in difficult neuro and peripheral vascular procedures.
      Business Wire 01.04.21


    Trending
    • Portable, Home-Use Device Quickly Measures Inflammation Levels
    • Cheetah Medical Introduces Noninvasive Monitoring System
    • Face Mask Filters 98 Percent Of COVID-19 Particles
    • Diagnosing The IVD Market: An Interview With TEAM Technologies
    • Top 10 Trends In The Medical Device And Equipment Industry
    Breaking News
    • CMS Establishes New Payment for Pelvalon’s Eclipse System
    • Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy
    • Resonetics Leases New Manufacturing Space in Costa Rica
    • Seisa Medical Acquires ProtoQuick and Peridot
    • Masimo Device is Useful in Assessing Respiratory Status of Pediatric Tracheostomy Patients
    View Breaking News >
    CURRENT ISSUE

    April 2021

    • Transporting Treatment: An Examination of Tubing Technologies
    • Face to (Virtual) Face: Telemedicine Now and Post-Pandemic
    • Outward Appearance: Reviewing Surface Treatment Options
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Kyowa Hakko Launches Heat-Treated Probiotic Strain for Eye Health
    CGA-7 Green Coffee Extract by Vidya Herbs Achieves Self-Affirmed GRAS Status
    Nutritional Complex Evidenced to Reduce Preterm Birth
    Coatings World

    Latest Breaking News From Coatings World

    Chromaflo Technologies to Sponsor and Exhibit at the North American Pultrusion Conference 2021
    Barentz Expands Canadian CASE Team
    Shepherd Color Company Opens Sales Office in China
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    CMS Establishes New Payment for Pelvalon’s Eclipse System
    Varian, Google Cloud Partner to Bring Convenience to Cancer Therapy
    Resonetics Leases New Manufacturing Space in Costa Rica
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Frontage Expands Capabilities at its Clinical Site in Secaucus, NJ
    Ascendia Pharmaceuticals Poised for Expansion
    Bora Pharmaceuticals Adds Roller Compaction Capabilities
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    Revlon Unveils New Fragrances Featuring Megan Thee Stallion & Sofia Carson
    Henkel Management Board Welcomes Wolfgang König
    Mielle Organics Gets a Major Investment
    Happi

    Latest Breaking News From Happi

    Nature’s Beauty Debuts Vegan Natural Body Care at Walgreens
    Estée Lauder Expands Beautiful Fragrance Collection
    Guangzhou Builds Beauty Park To Woo L'Oréal, Estée Lauder
    Ink World

    Latest Breaking News From Ink World

    SE-DA Invests in Kornit Presto S
    Kumon North America Adds Speedmaster XL 106 from Heidelberg
    Iron Oxide Pigments Market to Register 4.7% CAGR from 2021 to 2028: GVR
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Dantex elevates Joseph Sanchez to digital business development manager
    Mactac's Kevin Clunie joins TLMI panel
    MacDermid announces two new global sales roles
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Precision Textiles Offers Biodegradable Medical Fabric
    Northshore Launches Megamax Briefs in New Colors
    Essity Acquires Distribution Rights to Sorbact in Australia and New Zealand
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    New Biosealant Could Stabilize Cartilage, Boost Healing After Injury
    Google Executive Joins SeaSpine's Board of Directors
    HSS and LimaCorporate Open Provider-Based 3D Design and Printing Facility
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Tive Multi-sensor Tracker Solo 5G Relies on Sensirion SHT33
    VTT in 2020: Successful Year Despite Globally Challenging Times
    Lux Research: 3D Printing Market to Reach $51 Billion in 2030

    Copyright © 2021 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login