• 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
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    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
    Regulatory
    Financial/Business
    Top News
    MPO's Most-Read Stories This Week—Jan. 28

    Alleviant Medical Closes $75M Financing Round

    Know Labs Founder Ron Erickson Named CEO

    Getinge's Recall of Cardiosave Hybrid and Rescue IABPs is Class I

    FDA OKs Tidepool Loop App Connecting CGMs, Insulin Pumps
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    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
    Halkey-Roberts Corporation

    Fusion Biotec Inc.

    Medbio LLC

    Paragon Medical

    Providence Enterprise USA Inc.
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing

    Telemedicine and Connectivity to Drive Material Innovation in the Near Future
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Halkey-Roberts Corporation

    Fusion Biotec Inc.

    Medbio LLC

    Paragon Medical

    Providence Enterprise USA Inc.
    • 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
    • eBook
    • Resources
    • Podcasts
    • 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
    • europe
    • research
    • ceo
    • fda approval
    Related Knowledge Center
    • Electronics
    • Neurological
    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 Editorial

    • Contract Manufacturing
      The FDA Wants to Bring Manufacturing ‘Home’

      The FDA Wants to Bring Manufacturing ‘Home’

      The agency commissioners comment how the need to modernize the critical medical supply chain is long overdue.
      Sean Fenske, Editor-in-Chief 10.01.20

    • RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device

      RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device

      The approval will enable the company to initiate a clinical study of the products for safety and feasibility.
      Globe Newswire 09.30.20

    • Cardiovascular | Surgical
      FDA OKs SentiAR

      FDA OKs SentiAR's Holographic Cardiac Ablation Guidance System

      Allows electrophysiologists to visualize 3D electroanatomic models in real-time, via a wearable headset.
      PR Newswire 09.30.20


    • Patient Monitoring
      FDA OKs Masimo’s Rad-G Pulse Oximeter

      FDA OKs Masimo’s Rad-G Pulse Oximeter

      Rugged handheld device provides clinically proven Masimo SET pulse oximetry and respiration rate monitoring.
      Business Wire 09.28.20

    • FDA Clears Scientia Vascular

      FDA Clears Scientia Vascular's Zoom Wire

      Company is immediately launching the product to customers.
      Business Wire 09.28.20

    Loading, Please Wait..

    Trending
    • Study: Catheter Ablation Significantly Lowers Dementia Risk In AFib Patients
    • Promising Study Results Released For Uncontrolled Hypertension Treatment
    • Abbott's Proclaim XR SCS OK'ed For Diabetic Neuropathy
    • BMP Medical Expands Sterling, Massachusetts Facility
    • FDA OKs Tidepool Loop App Connecting CGMs, Insulin Pumps
    Breaking News
    • MPO's Most-Read Stories This Week—Jan. 28
    • Alleviant Medical Closes $75M Financing Round
    • Know Labs Founder Ron Erickson Named CEO
    • Getinge's Recall of Cardiosave Hybrid and Rescue IABPs is Class I
    • FDA OKs Tidepool Loop App Connecting CGMs, Insulin Pumps
    View Breaking News >
    CURRENT ISSUE

    November 2022

    • MPO's 2022 Year in Review
    • Fine Print: A Discourse on Additive Manufacturing
    • Grab and Go: Examining the Thrombectomy Device Market
    • 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

    Nutrasource Rebrands Clinical Trial Site to Apex Trials
    Kerry Sponsors Upcycled Food Foundation Research Fellowship
    Probiotics Supplementation Reduces Complications in Colorectal Cancer Patients
    Coatings World

    Latest Breaking News From Coatings World

    Epoxytec Announces New Website Launch
    Paints and Coatings Market Worth $212B by 2026: MarketsandMarkets
    Axalta Releases Fourth Quarter and Full Year 2022 Results
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    MPO's Most-Read Stories This Week—Jan. 28
    Alleviant Medical Closes $75M Financing Round
    Know Labs Founder Ron Erickson Named CEO
    Contract Pharma

    Latest Breaking News From Contract Pharma

    SK bioscience Introduces New Global Partnership Model for Vaccines
    Merck's KEYTRUDA Wins Expanded Approval in Non-Small Cell Lung Cancer
    Bone Biologics Engages Avania for NB1 Clinical Trial
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    LVMH Reports Record 2022
    Haircare Brand Uncle Funky’s Daughter Announces Retail Expansion
    TRESemmé Introduces New Pro Infusion Collection
    Happi

    Latest Breaking News From Happi

    Alix Earle, Jonathan Monroe Are Fast-Growing Beauty Influencers on Instagram
    Fragrance Creators Launches First-of-its-Kind Data Insights Program
    The Lip Bar Enters the Skin Care Category with First-Ever Skincare Collection
    Ink World

    Latest Breaking News From Ink World

    Weekly Recap: Sustainability and Pigments, TSCA and Raw Materials Top This Week’s Stories
    Roland DGA Announces Major Expansion of TrueVIS Printer Family
    Neos Expands Production Capacity, European Market Presence
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    Channeled Resources launches blank labels with PET liner
    Infigo partners with Four Pees in Benelux region
    EFI appoints Frank Pennisi CEO, Fiery now an independent business
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Essity’s Sales Grow
    Thinx to Pay up to $5 million to Settle Class Action Suit
    Typar Highlighting New Building Innovations
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    ODT's Most-Read Stories This Week—Jan. 28
    Roche, Sysnav Partner on Movement Tracking Tech for Neuromuscular Disorders
    Orthopedic Braces/Support, Casting/Splints Market to Top $12B by 2030
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    Weekly Recap: Avery Dennison, CES 2023 and Canatu’s LiDAR Deicing Top This Week’s Stories
    Celanese Launches Nine New Conductive Inks
    NREL Develops Thin, Lightweight Layer for Radiation Barrier for Perovskites in Space

    Copyright © 2023 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