June 24, 2022 - Carthera System Granted Breakthrough Device Designation - and more news

The Breakthrough Devices Program was established in 2018...

June 24, 2022

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Carthera’s SonoCloud-9 System Designated as a Breakthrough Device
  • The US FDA has granted Breakthrough Device designation to Carthera's innovative therapeutic ultrasound device for glioblastoma, the SonoCloud-9.
  • The Breakthrough Devices Program was established in 2018 to allow fast-tracking of certain novel devices and expedite patient access to treatments.
  • According to the company, the ruling was based on positive preliminary clinical data in patients with recurrent glioblastoma.
Foundation News
Garry Choy, MD, MBA, Joins Foundation’s Council
  • Dr. Choy is Senior Vice President and Deputy Chief Medical Officer of Clinical Systems in the Office of Medical Affairs at UnitedHealth Group.
  • He previously served as faculty at Harvard Medical School.
  • The Council provides strategic advice, assists with raising funds, and builds awareness.

State of Research Update: Focused Ultrasound for Diabetes
  • Kelsie Timbie, PhD, the Foundation’s Scientific Program Manager, provides an overview of current research in focused ultrasound for diabetes.
  • Recent preclinical research suggests that focused ultrasound neuromodulation could prevent or reverse Type 2 diabetes.
  • The video was presented during the Foundation’s recent Board of Directors meeting.
Symposium News
Register Now for Symposium 2022
  • Join us this October at the world’s leading forum for sharing the latest translational and clinical advances in focused ultrasound.
  • We encourage you to join us in-person, but there is a virtual registration option and discounted student rates.
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Patient News
Clinical Trial Results Support HIFU Focal Therapy for Prostate Cancer
  • Data from Memorial Sloan Kettering Cancer Center indicate that targeted high-intensity focused ultrasound (HIFU) can be effective for patients with intermediate-risk prostate cancer.
  • Researchers likened focal therapy with HIFU to a “male lumpectomy.”
  • The article also shares the story of a patient who had successful HIFU treatment in 2016.

Alzheimer’s Disease Clinical Trial Adds Sites in Florida
  • Launched in 2018, the trial is investigating focused ultrasound–induced blood-brain barrier opening in people with Alzheimer’s disease.
  • The number of participants has been increased, and three sites in Florida have now joined the study.
  • The original enrollment sites in West Virginia, New York, and Ohio are also seeking patients.

More Patient News
HIFU: Not All Fibroids Require Surgery as Treatment – Expert | Daily Trust (Nigeria)
Marbella Hospital Pioneers HIFU Ultrasound Therapy for the Treatment of Thyroid Nodules | EuroWeekly
Research News
Foundation-Funded Research Update: Focused Ultrasound for Limb Loss Pain
  • Researchers at The Israel Institute of Technology investigated whether focused ultrasound could be used to alleviate chronic pain occurring after limb amputation.
  • Physicians applied focused ultrasound to six stump neuromas in five participants.
  • The team struggled to reach ablative temperatures, but the treatment temporarily decreased pain intensity.

Constantin Coussios, PhD, Recognized in Queen’s Birthday Honours List
  • Professor Constantin Coussios has been appointed as an Officer of the Most Excellent Order of the British Empire (OBE) for his services to biomedical engineering.
  • The OBE is the second highest ranking order below the orders of knighthood.
  • Prof. Coussios is Director of the Institute of Biomedical Engineering and the Statutory Chair of Biomedical Engineering at Oxford University.

Meeting Report: International Symposium of Therapeutic Ultrasound (ISTU)
  • The 21st Annual International Symposium of Therapeutic Ultrasound (ISTU) was held June 7–10, 2022, at the University of Toronto.
  • Awards were given for contributions to the field, early career research and clinical investigations, and student achievements.
  • Five new board members were elected.

Meeting Report: Acoustical Society of America (ASA) 2022
  • The 182nd meeting of ASA was held May 23–27, 2022, in Denver, Colorado.
  • Sessions related to focused ultrasound included bacterial infections, brain, cardiovascular, drug delivery, cancer immunotherapy, musculoskeletal, oncology, optic, renal, and technical applications.
  • Meaghan O’Reilly, PhD, received the R. Bruce Lindsay award.

Meeting Report: International Society for Magnetic Resonance in Medicine (ISMRM) 2022
  • The joint annual meeting of the ISMRM and two other leading magnetic resonance societies was held in London May 7–12.
  • Thirty-two focused ultrasound-related abstracts addressed neurological, drug delivery, musculoskeletal, oncology, pediatric, technical, and women’s health applications.
  • We thank Allison Payne, PhD, for assisting with this summary.

Focused Ultrasound Included in Epilepsy Pipeline Conference
  • On June 5–6, the Epilepsy Foundation hosted its 2022 Pipeline Conference.
  • This meeting is designed to showcase the latest developments in the epilepsy pipeline from preclinical to US Food and Drug Administration approval.
  • Vibhor Krishna, MD, presented information on focused ultrasound treatments for epilepsy.

UVA Invests $75 Million in Neuroscience Research, Including Focused Ultrasound
  • The University of Virginia (UVA) has announced a $75 million interdisciplinary effort to help pioneer life-changing advances in neuroscience.
  • The initiative will, in part, explore the use of focused ultrasound to breach the blood-brain barrier.
  • To assist with research, UVA will hire 20 faculty members and 15 postdoctoral researchers.

More Research News
Sunnybrook Hospital Refining 'Life-changing' MRI-guided Focused Ultrasound Treatment for Brain Disorders | The Star
Industry News
European Medical Device Regulation – One Year Experience
  • In May 2021, the European Union implemented the Medical Device Regulation (MDR), and reviews are mixed.
  • This blog by Thomas Andreae, PhD, the Foundation's Ambassador in Europe, examines the MDR’s impact on focused ultrasound’s technological development.
  • The Foundation encourages European focused ultrasound companies and other stakeholders to submit comments on the issues at hand.

More Industry News
Insightec Appoints New Member to Board of Directors: Global Healthcare and Technology Leader, Omar Ishrak, Joins Insightec Board | Insightec
Second System ONE-M Delivered to Medical Clinic in Poland | TooSonix
Theraclion: HIFU and their Use in Immune-oncology Presented at the Annual Scientific Meeting of the Society of Interventional Radiology in Boston | Business Wire
Theraclion Launches New Robotics Vein Platform | BioWorld
Immunotherapy and Breast Cancer: A Webinar
  • Tuesday, June 30, at 12:00 pm Eastern
  • Learn about advances in this complex field from Breast Cancer Alliance (BCA) research grant recipients.
  • Hosted by BCA

Making Gas to Remove Gas: Acoustic Droplet Vaporization for Reperfusion Injury
  • Thursday, July 28, at 11:00 am Eastern
  • Featuring Kevin J. Haworth, PhD, FAIUM, from the University of Cincinnati
  • Hosted by the International Society for Therapeutic Ultrasound

Recent Webinars & Podcasts
Dissecting the Brain with Sound and Magnets | Hosted by the International Society for Therapeutic Ultrasound (1 hour) 
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Upcoming Events
June 30, 2022 Immunotherapy and Breast Cancer: A Webinar | WEBINAR

July 10-14, 2022 American Association of Physicists in Medicine (AAPM) Annual Meeting, Washington, DC

July 28, 2022 Making Gas to Remove Gas: Acoustic Droplet Vaporization for Reperfusion Injury | WEBINAR

August 14-19, 2022 Gordon Research Conference – In Vivo Ultrasound Imaging, Ventura, CA

August 22-23, 2022 Society for Image-Guided Neurointerventions (SIGN) 2022, Warwickshire, UK

September 15-18, 2022 European Association of Neuro-Oncology (EANO) 2022, Vienna, Austria

September 26-28, 2022 iTRUSST - 3rd Focused Ultrasound Neuromodulation Symposium (FUN) 2022, Mainz, Germany and VIRTUAL

October 10-13, 2022 IEEE International Ultrasonics Symposium, Venice, Italy

October 13-15, 2022 Veterinary Cancer Society Annual Conference 2022, Norfolk, VA

October 23-28, 2022 8th International Symposium on Focused Ultrasound, Bethesda, MD

December 8-11, 2022 International Symposium on Biomolecular Ultrasound and Sonogenetics (ISBUS), Pasadena, CA