This year has brought the field of focused ultrasound to a critical inflection point, with the technology quickly evolving from a research tool to a valued clinical solution primed for commercial adoption. We are proud to be a driving force for this important transformation.
One of the greatest milestones for patients and the technology was achieved when the Food and Drug Administration cleared a brain system to treat essential tremor, joining uterine fibroids, bone metastases, and the prostate as approved treatments in the US. There are now systems approved around the world to treat nearly 20 diseases. With Medicare agreeing to reimburse ET treatment, a critical step toward widespread utilization has been achieved.
Watch as an essential tremor patient is treated at Stanford
Our Foundation continues to advance the next wave of progress. The 5th International Symposium this August attracted a record crowd of clinicians and scientists to share key data and build collaborations. This year, we further expanded opportunities by supporting the first clinical trial for epilepsy, building momentum for enhancing immunotherapy to treat many cancers, and organizing a clinical trial for Alzheimer’s. We also recognized the invaluable contributions of key institutions by naming Stanford, Sunnybrook, and the University of Maryland as Centers of Excellence in 2016.
In addition to extending the frontiers of science, it is also our mission to educate the public about the potential to transform the future of medicine. John Grisham’s book, The Tumor, has surpassed all expectations, with more than 750,000 books distributed in just a year.
Thank you for being a part of this passionate community that will ultimately help improve the lives of millions of patients. We look forward to accelerating progress in 2017!
The Focused Ultrasound Foundation Team
"Focused ultrasound is an amazing technology that is creating a revolution in the treatment of many diseases." – Governor Bush
Governor Jeb Bush Visits Foundation
The Foundation was honored to host former Florida Governor Jeb Bush on November 21 and highlight the tremendous potential of focused ultrasound and the Foundation’s role in advancing this important technology.
Accompanying Governor Bush were several colleagues and fellow Floridians including Alberto and Olga Beeck who launched the Beeck Center for Social Impact and Innovation at Georgetown University.
"We congratulate our board member, Andy von Eschenbach, who as former head of the FDA and director of the NCI, had the vision, relationships, and tenacity to help define and drive the 21st Century Cures Act to fruition." – FUSF Chairman Neal Kassell, MD
21st Century Cures Act Signed by Obama
President Obama has signed into law the 21st Century Cures Act. This sweeping legislation will bring US health care innovation infrastructure into the 21st Century, deliver hope for patients and loved ones, and provide resources for researchers to uncover the next generation of cures.
"21st Century Cures is the most transformational legislation impacting biomedical research since the National Cancer Act of 1971. It provides essential resources for critical programs like the Cancer Moonshot, precision medicine, and brain research. More importantly, its many policy provisions will enhance and accelerate the discovery, development and delivery of innovative lifesaving interventions," says Dr. Andrew von Eschenbach.
2016 has been a year of tremendous growth in the field of focused ultrasound. Your support, enthusiasm, and advocacy have enabled us to advance our mission and improve patients’ lives.
We rely on the generous support of donors to continue our important work. We recently received two unsolicited $1 million pledges of unrestricted funds to be matched 1:1. One of these challenges has been met, and we hope you will help us meet the other, which will double the impact of your contribution.
Thank you for the important role you play in advancing the field. If you have any questions or ideas, please contact Nora Seilheimer.
Merkin Fellow Cyril Lafon with Jean-Yves Chapelon
Ablatherm is EDAP's ultrasound-guided transrectal FUS system for treating prostate tissue. It was approved by the FDA in 2015. Focal One is their system for focal therapy.
INSERM Director Visits Foundation, Provides Research Update
Jean-Yves Chapelon, PhD, is Research Director at INSERM’s LabTAU in Lyon, France and leads a collaborative project between INSERM (the French equivalent of the NIH) and the French FUS company EDAP TMS. He visited the Foundation to update us on the history and current status of Ablatherm technology for treatment of prostate cancer.
Since the first prototype in 1993, Ablatherm has evolved to provide both first line and salvage prostate therapy for patients around the world. Dr. Chapelon emphasized that HIFU has a favorable risk profile, with recent studies showing 94% to 99% cancer free survival rates in patients who were treated more than 10 years ago.
Interest in research related to focused ultrasound continues to grow at the Radiological Society of North America annual meeting, with special sessions dedicated to the technology as well as 21 FUS-based abstracts, up from 18 last year.
A special session entitled “Emerging Technology: High Intensity Focused Ultrasound – Opportunities and Challenges” was featured at the meeting.
“The Radiology community is traditionally very open to innovation, and focused ultrasound is the most exciting innovation in our field at the moment,” said Alessandro Napoli, MD, PhD, Assistant Professor of Radiology at Sapienza University of Rome, and one of the panelists. “The brain and musculoskeletal applications are garnering a lot of interest right now.”
Northern Light: Thunder Bay a Shining Research Site
The Thunder Bay Regional Health Research Institute (TBRHRI) is a new center located in a remote area of Canada that is already contributing to the field of focused ultrasound in the region and around the world. The Regional Health Sciences Centre created the research institute as a joint venture to help advance its academic research mandate and strengthen its role as a leader in healthcare innovation and delivery.
The FUS team within the TBRHRI Imaging Guided Interventions program is working with industry and government funders to take their innovation to patients everywhere. Thunder Bay is one of only three Philips Healthcare high intensity focused ultrasound (HIFU) sites in Canada, and is a valued member of the Philips’ HIFU research users’ community, advancing their software system for sites around the world.
Two proposals for musculoskeletal studies have recently been selected to receive Foundation funding.
Mario Fabiilli, PhD, and his team at the University of Michigan will investigate "Patterning of bone regeneration via ultrasound activation of heat shock-responsive gene switches." This project will use FUS combined with cells containing heat-activated gene switches to rebuild bone loss. Their theory is that this approach will more closely mimic normal bone growth.
At UCSF, Roland Krug, PhD has been funded for "Safety and Effectiveness of Sacroiliac Joint Palliation in Swine using MRgFUS." While the FDA has safety concerns about treatment near the spine, the palliation of lower back pain by targeting the sacroiliac joints (SI) is a very promising new application. This study will seek to determine the safety and effectiveness of FUS for SI joint ablation using a swine model. If successful, this could quickly be translated to humans.
Research Update: Neuromodulation and Functional Imaging
A Foundation-funded research project has led to a three-year R24 grant from the National Institutes of Health BRAIN Initiative. Charles Caskey, PhD, and his team at Vanderbilt University submitted their final report on “Noninvasive targeted neuromodulation and functional imaging.”
Their non-invasive, localized neuromodulation technique could someday be used to map brain circuits, diagnose disease, assist neurosurgery, or provide treatment. Under the NIH grant, they will continue to modulate the brain with FUS and visualize the effects using functional MR imaging.
Researchers at Columbia University found improved cognition and increased efficacy of psychoactive drugs while studying the effect of FUS on visual-motor decision-making. See Focused Ultrasound Enhances Sensorimotor Decision-making in Monkeys on bioRxiv.
With assistance from Foundation scientists, neurosurgeons at Swedish Medical Center in Seattle sought to determine the feasibility of using FUS to treat epilepsy. See MR–guided Focused Ultrasound for Temporal Lobe Epilepsy: A Laboratory Feasibility Study in the Journal of Neurosurgery.
Could focused ultrasound provide the energy for cardiac pacing in conscious patients? A group of French researchers designed and tested a new device. See Non-invasive Cardiac Pacing with Image-guided Focused Ultrasound in Scientific Reports.
JTU Article of the Month – Focused Ultrasound Symposium Abstracts
Abstracts from the Foundation’s 2016 Symposium have now been published in a special supplement to the Journal of Therapeutic Ultrasound. The presentations covered neurological, liver/pancreas, breast, immunotherapy, cardiovascular, and emerging applications, representing the great progress made in the past decade and the promising future for the field.
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Medgadget.com interviewed Dr. Kim about this study.
Children’s National and Celsion Launch Targeted Drug Delivery Clinical Trial for Childhood Tumors
Researchers at Children’s National Health System are starting the first clinical trial using targeted drug delivery for children with tumors. The study will be conducted with Celsion Corporation’s ThermoDox, which encapsulates the chemotherapy agent doxorubicin in tiny heat-sensitive liposome bubbles. Investigators will use focused ultrasound to heat the liposomes and release the chemotherapy directly to the tumor and surrounding area, thus concentrating the therapy on the cancer while minimizing systemic effects.
“There is currently no known cure for many patients with refractory recurring solid tumors, despite the use of intensive therapy, so we need to identify new, smarter therapies that can improve outcomes,” said AeRang Kim, MD, PhD, Oncologist with Children’s National.
EDAP Receives Prestigious Galien Prize for Focal One
Honoring major innovative therapies or drugs introduced to the public market that promote significant advances in healthcare research, the prestigious 2016 Prix Galien, in the Medical Device category, has been awarded to EDAP for its Focal One HIFU device. The jury reviewed 120 candidates and selected nominees among six categories. The Prix Galien is the world’s highest accolade for pharmaceutical research and development, named after Claude Galien, the father of modern medicine and pharmacology.