The approval was based on data from a multicenter pivotal study led by W. Jeffrey Elias, MD at the University of Virginia. Seventy-six patients with essential tremor achieved nearly a 50 percent improvement in their tremors and motor function three months after treatment. They retained a 40 percent improvement after one year. More details are available in the FDA’s press release.
Focused ultrasound for essential tremor is available in the US at:
- Brigham & Women's - Ohio State University - Stanford University - Swedish Medical Center - University of Maryland - University of Virginia
“We have reached a critical milestone in focused ultrasound's evolution,” says Foundation Chairman, Neal F. Kassell, MD. “This approval affirms the technology’s ability to safely and accurately treat the brain through the intact skull in an awake patient. The Foundation has long focused on treating brain disorders, as it is a high bar. If you can achieve success in the brain, it is not difficult to imagine treating targets in less challenging organs."
This achievement exemplifies the Foundation’s mission to accelerate development and adoption by fostering collaboration and supporting research. The idea of using focused ultrasound to treat tremors was conceptualized at the Foundation's first brain workshop in March 2009. The Foundation then helped organize and fund a pilot study with Insightec and the University of Virginia that served as the predicate for this larger pivotal study. READ MORE >
Stanford Recognized as a Focused Ultrasound Center of Excellence
In recognition of their leadership in a broad range of focused ultrasound research and treatments, the Foundation is pleased to designate Stanford University its newest Center of Excellence. Directed by Pejman Ghanouni, MD, PhD, and Kim Butts Pauly, PhD, Stanford’s Center consists of a comprehensive slate of clinical care, pre-clinical and clinical research, and engineering.
“The group at Stanford has continually been pushing the envelope for the capacity of the technology,” says Foundation Chairman Neal F. Kassell, MD. “Their risk-taking, yet calculated approach to innovation is a model for the community, and their technical engineering work is among the best.”
Symposium Keynote: John Grisham Interview with CBS’s Chip Reid
Bestselling author John Grisham will join us for a special keynote at the Symposium with award-winning CBS News correspondent Chip Reid. On Wednesday, August 31, Grisham will take the stage with Reid and Dr. Neal Kassell to talk about his interest in focused ultrasound, how he became involved with the Foundation, and his motivation for writing The Tumor.
Grisham, who is on the Foundation’s Board, calls it “the most important book I’ve ever written.” Since its release earlier this year, more than 500,000 copies have been distributed, and it has garnered outstanding media coverage.
Reid has spent nearly 30 years in media, reporting for CBS and NBC on topics ranging from politics to foreign affairs and the war in Iraq. He interviewed Grisham and Kassell for a segment on CBS This Morning, which aired in April.
The Tumor e-book is available for free on Amazon, Barnes & Noble, and Google Play. Free hard copies will be available for Grisham to sign following the discussion.
Leading French Researcher Joins Foundation as Merkin Fellow
Starting this month, Cyril Lafon, PhD, joins the Foundation as the 2016-2017 Richard Merkin Visiting Fellow. Dr. Lafon is the Director of LabTAU, a research laboratory of INSERM – the French National Institutes of Health – located in Lyon. He was selected based on his innovative ideas and proven track record in developing focused ultrasound devices for patient use. “Cyril has a diverse background across several applications,” says Foundation Chairman Neal F. Kassell, MD. “His contributions have led to major advances in neurosurgical, cardiovascular, and ophthalmic devices that were invented in France.” READ MORE >
On July 19, Paul Fishman, MD, Professor of Neurology at the University of Maryland School of Medicine, presented a Foundation webinar on current therapies for Parkinson’s disease. He covered the state of the field for this disease, treatment gaps, and the potential of focused ultrasound to become a treatment option. He addressed ongoing clinical trials for Parkinson’s dyskinesia and Parkinson’s tremor.
Dr. Fishman is planning the first trial of bilateral focused ultrasound treatment of essential tremor and is exploring the delivery of therapeutics to the brain.
The Foundation welcomes Emily White, MD, as Director of Operations. Dr. White will lead efforts to increase efficiency and effectiveness throughout the organization. “I’m honored to be a part of this dynamic, fast paced organization with a broad agenda,” says Dr. White. “Streamlining existing workflows can keep the Foundation nimble and able to incorporate new programming critical to our success.”
“Emily is the perfect fit for our mission,” adds Foundation Chairman Neal F. Kassell, MD. “Her extensive background in clinical medicine, technical start-ups, non-profit management, business development, grant writing, and surgical oncology research will add tremendous value as she interfaces with all aspects of the Foundation’s operations.”
McDannold to Receive Jolesz Memorial Award at Symposium
Nathan McDannold, PhD, has been selected to receive the Ferenc Jolesz Memorial Award. He will be acknowledged during the Sunday evening 10th Anniversary Gala Reception and will also deliver a presentation on his research.
“I am thrilled to receive this award in Ferenc’s name," says McDannold. "He was always a great champion for not only the team here at the FUS laboratory at Brigham but also for the field overall. I am truly honored to be recognized by the Foundation and appreciate everything they have done to support ultrasound research.”
The FDA has invited Foundation staff and representatives from industry, academia, and the patient community to attend a July 22 meeting to discuss the development of a prostate treatment registry.
JAMA Publishes Editorial, FDA Convenes Meeting on Prostate Patient Registry
In an editorial published in the Journal of the American Medical Association (JAMA), Drs. Hu, Laviana, and Sedrakyan suggest that new technologies should be used cautiously until rigorous scientific evidence of safety and efficacy is available. This position is endorsed by the Focused Ultrasound Foundation.
As a case in point, the authors cite the example of focused ultrasound (HIFU) to treat prostate disease. Although HIFU has been used around the world for more than a decade to treat more than 50,000 patients with prostate disease, and the FDA approved SonaCare’s Sonablate and EDAP’s Ablatherm systems to ablate prostate tissue last fall, there is still no definitive evidence as to which patients will benefit and what grades of disease are most appropriate to treat.
Scientists at the University of Washington have received a grant from the National Space Biomedical Research Institute (a NASA-funded group) to develop a handheld focused ultrasound device that can detect and break up kidney stones. The ultimate goal is to use it at the International Space Station.
Whereas their previously designed systems could relocate the stones or use large amounts of energy to break them up, the new system will be designed for the “burst wave lithotripsy” to break the stones apart with smaller, more frequent bursts of ultrasound under ultrasound guidance. The GeekWire story mentions that burst wave lithotripsy may also be useful for stopping bleeding, strengthening bones, and other types of ultrasound surgery.
Focused Ultrasound Work Earns 2016 Tumor Prize
Sara Guerri, PhD, has won the 2016 European Society of Musculoskeletal Radiology “Tumor Prize” with her focused ultrasound research entitled “Magnetic resonance imaging guided high intensity focused ultrasound treatment for painful bone metastases.” She is a part of Dr. Alberto Bazzocchi’s group at the Rizzoli Orthopedic Institute in Bologna, Italy. The Tumor Prize is presented annually by the European Society of Musculoskeletal Radiology, and the work will be published in Skeletal Radiology.
Research Roundup
Interim results from Carthera’s ultrasound dose-escalating phase 1/2a clinical trial using the SonoCloud implantable ultrasound device in patients with recurrent glioblastoma have been published. See Science Translational Medicine.
Elisa Konofagou’s group at Columbia University found that focused ultrasound enhanced distribution and delivery of intranasally administered brain-derived neurotrophic factor, allowing targeted non-invasive delivery straight to the brain. See Scientific Reports.
A German group working with scientists from Chongqing Haifu found that focused ultrasound controlled tumor growth and pain in unresectable pancreatic cancer. See RöFo.
JTU Article of the Month – Cardiovascular Uses for Ultrasound, Microbubbles, and Contrast Agents
Researchers at the University of Nebraska medical center have conducted a data review regarding the use of diagnostic ultrasound in thrombolysis and drug delivery. Could small modifications of current FDA-approved microbubbles further improve their clinical potential? See The Journal of Therapeutic Ultrasound.
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INDUSTRY NEWS
Second Generation Preclinical System Now Available
MEDSONIC LTD is now producing its second generation MRI-guided focused ultrasound robotic system for use in small animal experiments. The latest advancements include its ability to propagate the ultrasound flow from a bottom-to-top approach, and the positioning device has two axes (X range: 10 cm, Y range: 6 cm) with a very small step increment of 0.2 mm. The lightweight unit is currently selling for €25,000.
Motti Zisser will be eulogized at the Symposium by Insightec founder Kobi Vortman
In Memoriam: Motti Zisser
The Foundation is saddened by the passing of focused ultrasound visionary Motti Zisser, who died at the age of 60 after a battle with cancer. The serial entrepreneur became the controlling investor of Insightec when he acquired Elbit Medical Imaging. After visiting Insightec and learning its mission, he became an exceptional supporter and advocate for the technology and was always looking for ways to minimize time from the laboratory to the patient bedside.
Born in Israel to parents that survived the holocaust, Zisser studied in Yeshiva and continued his academic education in economics at the Bar Ilan University, Israel. He was a unique combination of hard core businessman and a dreamer that wanted to improve the human condition. He and his wife, Dr. Bracha Zisser, established and operated a bone marrow bank and funded a hotel for kids recovering from cancer. Motti’s wish to help people coincided with his drive to accelerate everything within Insightec that could improve human health. He is survived by his wife, Bracha, and their five children, David, Hila, Rachel, Naama, and Yoni.
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