Insightec’s Exablate Neuro is approved in the US, Canada, Europe, Israel, Korea, Japan, and Russia for the treatment of essential tremor. It is also "CE marked" (a manufacturer’s indication that a product conforms with relevant legislation applicable to their product and therefore is permitted for use) to treat Parkinsonian tremor and neuropathic pain. Researchers around the world are working to assess the system in the treatment of several other related movement disorders.
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The Foundation strives to cultivate the next generation of scientists working in the field of focused ultrasound. We are proud to announce that three such young researchers, Guillaume Maimbourg, Sarah Brüningk, and Amirah Aly, have earned awards for their work. Meanwhile, a former Foundation intern, Changzhu Jin, has earned his PhD.
Two proposals have been selected to receive Foundation funding in the 2nd quarter of 2017.
James Keenan, CEO of Artenga, Inc., a Canadian life sciences company, will partner with Sunnybrook Research Institute and the University of Helsinki to investigate “MRgFUS Blood-Brain Barrier Drug Delivery with AAV2 Gene Therapy Microbubble Drug Conjugates.” The team proposes to develop a novel microbubble-drug conjugate with an adeno-associated virus and then use focused ultrasound to deliver the gene therapy to the regions of the brain affected by Parkinson's disease.
Frank Wolfram, PhD
In Germany, Frank Wolfram, PhD, and his team at SRH Waldklinikum Gera have been funded to determine “Accessibility and Benefit of Focused Ultrasound Treatment for Inoperable Lung Cancer Patients, A Retrospective Analysis.” Now that their preliminary data have shown the feasibility for focused ultrasound to treat lung cancer on large animal models via intentional One Lung Flooding (OLF). This study will analyze the charts of inoperable patients (70% of all lung cancer patients) to map tumor location and volume, classify and analyze the pulmonary function to estimate their accessibility to OLF, and therefore determine the future clinical potential of FUS for treatment of primary lung cancer.
On April 24, John Snell, PhD, Technical Director of the FUSF Brain Program, and Pejman Ghanouni, MD, PhD, from Stanford University, led a continuing education course on MR-guided Focused Ultrasound in the Brain. Designed for physicists and engineers, the session aimed to introduce new or emerging MR methods and applications and discuss their clinical potential.
A recently published case study for the University of Virginia’s Frank Batten School of Leadership and Public Policy examines the Foundation as a model for innovation and social entrepreneurship.
Focused ultrasound pioneer, Pejman Ghanouni, MD, PhD, will serve as the Honorary President of the 6th International Symposium on Focused Ultrasound, to be held October 21-25, 2018 in Reston, Virginia.“The field of focused ultrasound is still a tight-knit community, so to have the opportunity to gather and catch up on the latest advances and techniques is an invaluable experience,” says Dr. Ghanouni. “At the Symposium, we’re able to create collegial contacts who we can reach out to with questions as we broaden focused ultrasound’s impact into new indications. It’s an honor to be asked to be a part of the 2018 meeting.”
Charlottesville, VA - May 2, 2017 - Researchers at Sunnybrook Health Sciences Centre in Toronto have begun the world’s first clinical trial evaluating the feasibility and safety of opening the blood-brain barrier (BBB) in patients with Alzheimer’s disease (AD) utilizing focused ultrasound.
Researchers at Nicklaus Children’s Hospitalin Miami, Florida have performed the first procedure in a pediatric and young adult brain tumor study. The trial aims to demonstrate feasibility and safety of using focused ultrasound to ablate a variety of benign tumors located in the central part of the brain in ten patients, ages 8 to 22. Left untreated, these tumors often cause seizures, cognitive delays, or other complications as they grow.
Beginning at age 25, Steve noticed he was losing control of his grip. “I was working a mobile repair service that installed new airbags and interior components in vehicles that had been in a wreck,” he explains. “I started to lose my ability to hold tools, turn screwdrivers, and use wrenches effectively.” After visiting several local neurologists, Steve was referred to Dr. Shannon at Rush University in Chicago and was diagnosed with young onset Parkinson’s disease.
In a World Economic Forum blog post entitled, "We know sound soothes us. But what if it could kill a tumour?" Foundation Chairman, Neal Kassell, MD, writes about the immense potential of focused ultrasound to improve outcomes for patients.
Charles Steger, PhD, president emeritus of Virginia Tech, was recently appointed to the Division of Earth and Life Sciences (DELS) committee of the National Academy of Sciences.
Parkinson’s disease damages dopamine neurons in the part of the brain called the substantia nigra (SN). Scientists hypothesize that these damaged cells can be repaired, and previous studies found that DNA segments that were introduced through the intranasal route of administration could produce a dopamine cell survival factor called glial cell derived neurotrophic factor (GDNF) that protected these cells in the SN. Researchers at Northeastern University, Brigham and Women’s Hospital, and Copernicus Therapeutics conducted a study to use focused ultrasound and microbubbles to improve on this concept.
The Society of Interventional Radiology (SIR) held its 2017 Annual Meeting in Washington, DC, March 4-9. Three focused ultrasound abstracts were selected for SIR 2017: two oral presentations and one poster. Topics covered include vascular malformations, pediatric osteoid osteoma, and introducing junior radiologists to the field of focused ultrasound. An NIH poster on prostate imaging prior to treatment also mentioned focused ultrasound.
For most of her life, Michigan resident Kristin “Sunny” Berry was able to manage her tremors enough to continue her beloved artistic hobbies.
Patients with benign breast tumors may be eligible for a new focused ultrasound–based investigational treatment as part of a pivotal, multi-center clinical study. The trial began last month at the University of Virginia (UVA) Medical Center.
The Focused Ultrasound Foundation is pleased to designate a new Center of Excellenceat the French National Institute for Health and Medical Research (INSERM) in Lyon, France. INSERM Unit 1032, the Laboratory of Therapeutic Applications of Ultrasound (LabTAU), is located within a large medical and research community and conducts significant translational and clinical research with a multi-disciplinary, highly qualified, and complementary team of physicians and scientists.
In a recent article on Forbes.com, Neal F. Kassell, MD discusses the potential of focused ultrasound and his vision for creating the Foundation. “[We want] to become the guiding light for the entire field….to accelerate the development and adoption of this amazing technology,” says Kassell. He then goes on to discuss the hurdles involved in advancing a new therapy and how we plan to take on those challenges. The article was written by Josh Wolfe, who covers innovative entrepreneurs and cutting-edge technologies. READ THE ARTICLE >
Two competitions are underway to recognize leaders in research innovation and entrepreneurship. We encourage those in the focused ultrasound community to apply.
This month, exciting research was published involving focused ultrasound to open the blood-brain barrier to deliver drugs to metastatic brain tumors, treat a rare type of spinal bone cancer, and reduce eye pressure in glaucoma patients.
In a pre-clinical study, a Taiwanese group used focused ultrasound to increase the amount of a chemotherapy drug delivered across the blood-brain barrier to brain metastases. See Pulsed-wave low-dose ultrasound hyperthermia selectively enhances nanodrug delivery and improves antitumor efficacy for brain metastasis of breast cancer in Ultrasonics Sonochemistry.Collaborators in Oxford, UK, present the outcomes from four cases and announce the start of a clinical trial in using focused ultrasound to treat sacral chordoma, a rare type of spinal bone cancer. See High-intensity focused ultrasonic ablation of sacral chordoma is feasible: a series of four cases and details of a national clinical trial in the British Journal of Neurosurgery.Two glaucoma centers in Italy successfully treated 30 patients with focused ultrasound to reduce intraocular pressure using Eye Tech Care’s EyeOP1 device. See High-intensity focused ultrasound treatment in patients with refractory glaucoma in Graefe's Archive for Clinical and Experimental Ophthalmology.
As focused ultrasound becomes more widespread, many more patients’ lives are being transformed – especially those with movement disorders like essential tremor and Parkinson’s.Watch three patients share their stories about how the treatment changed their outlook through the news media.
Most known for advancing focused ultrasound applications in the brain, Insightec announced that it has earned the CE Mark to treat the prostate. The Exablate Prostate system is now cleared in Europe to treat patients with locally confined prostate cancer. Read Insightec's release below.
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.
Read the abstracts >
The Focused Ultrasound 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.
Taiwan-based EpiSonica has secured Taiwan Food & Drug Administration (TFDA) clearance of its ArcBlate MR-guided focused ultrasound system for soft tumor ablation of uterine fibroids, adenomyosis, and palliative pain care. ArcBlate can be used in any commercial MRI system.
More than 40 experts from around the world gathered for the Focused Ultrasound and Immunotherapy Summit, held in partnership with the Cancer Research Institute on October 14. The group met to critically evaluate the current body of evidence, assess the value of ongoing work, and create a roadmap of projects to address any remaining gaps or questions.
Nearly 200 researchers presented their data at the 5th International Symposium on Focused Ultrasound in August. The Symposium is the world's leading forum for sharing the latest translational and clinical advances in focused ultrasound – a groundbreaking non-invasive therapeutic technology. Targeted to scientists, clinicians, and other stakeholders, the conference offered a multifaceted exploration of this emerging field and feature plenary sessions, panel discussions, poster presentations and technical exhibits.
Read the event summary.
You can now view the video presentations and read the abstracts here.
Just a week after undergoing FUS for his tremor at the University of Maryland, Peter Muller visited the Symposium to meet some of the leading researchers in the field and the innovators at Insightec that developed the technology.
The Symposium’s scientific presentations demonstrated that significant progress is being made in advancing FUS as a solution in many fields of medicine, utilizing a variety of biomechanisms. Here are some of the highlights:
The momentum at the Foundation’s 5th International Focused Ultrasound Symposium demonstrates the progression of the technology from a research tool toward a viable clinical treatment. From the record number of investigators attending, to the quantity and quality of clinical trials reported, to the celebration of the first FDA approvals of clinical brain and prostate systems, the meeting ushered in a new era.
The CEO Roundtable on Cancer has accredited the Foundation with the CEO Cancer Gold StandardTM, recognizing our efforts to reduce the risk of cancer for our employees and covered family members.
This year, two returning students were met by a couple of new faces to round out our talented group of summer interns.
In recognition of their leadership in advancing focused ultrasound research for the brain, the Foundation is pleased to designate the University of Maryland as a Center of Excellence.
The prestigious New England Journal of Medicine published the pivotal study that led to the approval of Insightec’s Exablate Neuro focused ultrasound system to treat essential tremor (ET).
Sharon Samuels shares her struggle with essential tremor and gets her quality of life back after focused ultrasound treatment.
The ET patients treated in this study achieved significantly reduced unilateral hand tremor that proved durable at 12 months. The procedure also reduced disability and improved quality of life one year after treatment. The study was conducted at eight centers and led by University of Virginia neurosurgeon Jeff Elias, MD.
“This study represents a major advance for neurosurgery, treatment of brain disease and specifically the treatment of essential tremor,” Dr. Elias said. “For the first time in a randomized controlled trial, we have shown that ultrasound can be precisely delivered through the intact human skull to treat a difficult neurological disease.”
“This publication further affirms to the medical community that focused ultrasound is a safe and effective alternative to treat the brain without incisions or radiation,” says Foundation Chairman Neal Kassell, MD. “Now that Insightec’s system is approved by the FDA, the important next step is to secure the appropriate levels of reimbursement so that leading medical centers will invest in this technology and make it widely available to patients seeking non-invasive options for their tremors.”
Given the challenges of accessing the brain and the high cost, complications, and limitations of some current approaches, we believe that focused ultrasound has the potential to revolutionize the treatment of many brain disorders and ultimately to open up opportunities to rapidly advance applications throughout the body.
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.
The pivotal study was funded by a partnership between the Focused Ultrasound Foundation, Insightec and the BIRD (Israel-US Binational Industrial R&D) Foundation.
Read the University of Virginia's press release >The pivotal trial took place at the following sites:
On Monday, August 22, Virginia Governor Terry McAuliffe visited the Focused Ultrasound Foundation and met with members of the Foundation’s Team, Board, Council, and representatives from the University of Virginia Health System.
Al Jazeera's program "The Cure" follows Sunny, an essential tremor patient at Ohio State University as she undergoes focused ultrasound to ease her tremors.
The 20th International Congress of Parkinson's Disease and Movement Disorders was held June 19-23 in Berlin, Germany with more than 5,000 attendees. Seven focused ultrasound abstractswere presented, including the latest preliminary study data for Parkinson’s tremor and essential tremor.
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 fully endorsed by the Focused Ultrasound Foundation.
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. We sat down with Cyril to discuss how he became interested in focused ultrasound and his work.
On July 11, 2016, the US Food and Drug Administration (FDA) approved focused ultrasound to treat essential tremor. Read the FDA's release below.
The U.S. Food and Drug Administration today approved the first focused ultrasound device to treat essential tremor in patients who have not responded to medication. ExAblate Neuro uses magnetic resonance (MR) images taken during the procedure to deliver focused ultrasound to destroy brain tissue in a tiny area thought to be responsible for causing tremors.
CHARLOTTESVILLE, VA – (July 7, 2016) – The Focused Ultrasound Foundation has recruited Emily White, MD, to serve as Director of Operations. Dr. White will lead an ongoing effort to increase efficiency and effectiveness throughout the organization.
The following is a press release from InSightec announcing essential tremor approval in Canada. View the release on Insightec's website >
Patient selection for high intensity focused ultrasound (HIFU) prostate treatment was featured as one of the opening plenary sessions for the 2016 Annual Meeting of the American Urological Association, held earlier this month in San Diego.
Charles Caskey, PhD, and Will Grissom, PhD, at Vanderbilt University’s Institute of Imaging Science address questions about their site and its important focused ultrasound work. In May 2016, the team at Vanderbilt debuted DIY hardware blueprints and open-source software so that other researchers can build their own systems to conduct pre-clinical MR-guided FUS studies.
Charlottesville, VA, – May 19, 2016 – Former Virginia Tech President Charles Steger, PhD, has been elected to the Board of Directors of The Focused Ultrasound Foundation.
Charlottesville, VA, – April 20, 2016 – Bestselling author John Grisham was featured on CBS This Morning today discussing his free book called The Tumor, a fictional account of how a real medical technology could impact the future of medicine.
Scientists from the Foundation’s Brain Technical Program have joined with the University of Utah on a project to expand the range of neurological disorders that can be treated with focused ultrasound.
This month’s roundup includes studies in brain disorders, immunology, and women’s health. Is it feasible to use focused ultrasound to treat temporal lobe epilepsy? Can scientists deliver GDNF plasmids across the BBB to potentially treat Parkinson’s disease? How does focused ultrasound compare to DBS in treating ET?
Gene Therapy and Immunology
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