Potential Boon to Future Regulatory Approval of Non-thermal Brain Applications Also Wins Prestigious Research Prize
The Roberts Prize for the best article published in Physics in Medicine and Biology was recently awarded to Costas Arvanitis, Margaret Livingstone, and Nathan McDannold from Brigham and Women's Hospital and Harvard Medical School in Boston for their article “Combined Ultrasound and MR Imaging to Guide Focused Ultrasound Therapies in the Brain.”More than a way to monitor focused ultrasound (FUS), such as FUS-induced blood-brain barrier disruption, their work could likely be a key to demonstrating the level of safety required by regulatory agencies who will review focused ultrasound treatment of brain conditions.
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Patients from Across the Country Participating in Essential Tremor Trial
The University of Maryland’s pioneering Neuroscience Center in Baltimore is poised to become a leading hub for focused ultrasound research. They recently began treating patients in the pivotal trial to treat essential tremor using InSightec’s Exablate Neuro system.
Neal F. Kassell, MD, Chairman of the Focused Ultrasound Foundation, authored two recent articles on the future of the technology and what it might mean for the healthcare paradigm.
Institute now studying Essential Tremor, Parkinson's, and Tumors
North Carolina scientist Paul Dayton, PhD is in the final stages of a Foundation-funded study on the use of nanodroplets to improve the efficiency of focused ultrasound ablation.
The following release was issued by The Hospital for Sick Children (SickKids) on August 6, 2014. View the release in their press room.
TORONTO – A patient at The Hospital for Sick Children (SickKids) is the first child in North America to have undergone a specialized procedure that uses ultrasound and magnetic resonance imaging (MRI) to destroy a tumour in his leg without piercing the skin. Doctors used an MRI to guide high-intensity ultrasound waves to destroy a benign bone tumour called osteoid osteoma. The lesion had caused 16-year-old Jack Campanile excruciating pain for a year prior to the July 17 procedure. By the time he went to bed that night, the athletic teen experienced complete pain relief.
The following article appeared on Medscape.com. View the original story here.
A US Food and Drug Administration (FDA) advisory panel voted yesterday not to recommend approval of a high-focus ultrasound technology to treat low-risk prostate cancer with less erectile dysfunction.
The technology, Ablatherm Integrated Imaging High Intensity Focused Ultrasound (HIFU), has been used in other countries in 40,000 patients for 15 years. It would be the first device of its kind to be approved in the United States.
But members of the Gastroenterology and Urology Panel of the FDA's Medical Devices Advisory Committee voiced a range of concerns about lack of data available from the technology sponsor's research results that were presented as part of its US premarket approval (PMA) application. HIFU is marketed in Europe by EDAP TMS, a French company operating in the United States as EDAP Technology.
The company is seeking premarket approval for HIFU as indicated for primary treatment of individuals with low-risk, localized prostate cancer.
In the end, a majority of panel members voted no to the question regarding a reasonable assurance that the treatment is safe. Panel members voted unanimously against reasonable assurance that it is effective.
HIFU is a robotic technology that consists of a treatment module that connects a control console to an endorectal probe device. After a patient is anesthetized, aurologist robotically controls the probe for insertion into the rectum, and the device delivers ultrasonic energy to a focused portion of the prostate.
High-intensity waves from an ultrasound imaging transducer in the probe generates intensive heat (85° - 95° C) and causes ablation of cancerous tissue while preserving the apex, sphincter, and rectum, with a lower rate of erectile dysfunction.
A rocky regulatory path developed almost from the start, however, for HIFU in the United States. A nonrandomized trial intended to be a pivotal study that began in 2006 to test HIFU against cryotherapy terminated in 2010 because of the company's inability to enroll enough patients, particularly for cryotherapy.EDAP then conducted a meta-analysis of HIFU and cryotherapy results in the medical literature, plus a review of comparisons of a European HIFU registry with surgery in the US Veterans Administration study Prostate Cancer Intervention vs Observation Trial (PIVOT).
EDAP presenters at the hearing said the "body of evidence" supports the approval of HIFU in the United States. They said that the benefits of a noninvasive, localized therapy with precise energy delivery outweigh the risks for urinary obstructive morbidity and that side effects from HIFU treatment are "not dissimilar" to those of other prostate cancer treatments, including radiation therapy.
FDA presenters, however, went through EDAP's submission documents point by point, citing deficiencies, such as lack of information and potential safety concerns, including a 28% cumulative positive biopsy rate 2 years after HIFU treatment among individuals in the nonrandomized trial.
Regarding the lack of information, Johathon P. Jarow, MD, of the FDA's Office of Hematology and Oncology Products, said, "Absence of evidence is not the same as evidence of absence," and that it was not clear whether HIFU treatment is better than doing nothing for the low-risk patients.
The treatment does have its supporters, though. In the public hearing portion of the meeting, Pascal Rischmann, MD, professor and chair of urology, andrology, and renal transplant at Université Paul Sabatier in Toulouse, France, said that the treatment is safe and effective, that it preserves erectile function in more than 90% of patients through nerve sparing, and that it is cost- effective. He said he has used HIFU in more than 350 patients between 2006 and 2014.
Prostate cancer survivors also recommended approval during the public hearing.
Inderbir Gill, MD, chair of the University of Southern California, Los Angeles, Institute of Urology, and a monitor of the HIFU trial, told panel members that HIFU is certaintly not perfect but that all ablation technologies have similar biopsy rates.
"It's about patient choice," he said. He pointed out that HIFU has a track record of 40,000 patients during a 15-year period and that it has never been suspended or taken off the market.
But the FDA officials maintained that the benefit of HIFU is unclear and that the risk is substantial, although they acknowledged that EDAP's efforts had been constrained by practical difficulties associated with conducting trials for prostate cancer.
Stephen R. Kraus, MD, of the University of Texas Health Science Center in San Antonio and a temporary voting member, said he was concerned about the "murkiness" of the data, or "trying to use other trials to make up for the lack of recruitment. Murkiness is the absolute reason we need a controlled trial."
Consumer representative Mildred D. Fennal, PhD, RN, of the International Nurses Education Consortium in Tallahassee, Florida, said, "If anything, it sounds like they're trying to save all the work that's been done" and that maybe they should have reorganized early on and tried something else.
The advisory committee members have disclosed no relevant financial relationships.
View EDAP's official press release. Documents provided at the meeting will soon be available as well on their website.
View more coverage from Bloomberg.
The receipt of a significant gift from Dr. Richard Merkin has allowed the Foundation to create a unique fellowship opportunity for international researchers. Applications are now being accepted. For information on the application process, contact Matt Eames, PhD, Director of Extramural Research, .
FORTUNE has published two fantastic articles about the potential of focused ultrasound.
A group of 24 researchers from 14 organizations met March 3-4 in Charlottesville to inventory the current state of the field, identify important applications, and chart a course for the first clinical use of FUS–induced neuromodulation. Participants represented academia, industry, government, and the Foundation.
New Scientist, an international science magazine based in London, has featured a groundbreaking new study that could treat brain tumors using a combination of focused ultrasound and drug therapy. This story builds on the publication's previous coverage of focused ultrasound technology.
Kullervo Hynynen, a medical physicist at Sunnybrook Research Institute in Toronto, Canada, will begin a study to investigate the use of focused ultrasound to reversibily open the blood brain barrier, – the protective layer around blood vessels that shields our brain against outside threats. The study hopes that once the barrier is open, microbubbles filled with chemotherapy agents will be able to enter and treat brain tumors.
If successful, the team thinks that this procedure might also one day be used to treat Alzheimer's disease.
Read the full story.
Richard Price, University of Virginia biomedical engineering professor, and his colleagues at Johns Hopkins University are working together to open the blood-brain barrier and allow drug-bearing nanoparticles into the brain tissue. Their goal is to provide a new treatment for gliobastomas, the most common form of brain cancer.Price has developed a technique to breach the blood-brain barrier using microbubbles. By applying low-frequency ultrasound, one can cause the bubbles to oscillate, disrupting the blood-brain barrier. However, this is only the first challenge in treating gliobastomas.Brain cells are tightly packed, hindering therapeutic agents from diffusing through the brain. Here, researchers at Johns Hopkins stepped in, developing a nanoparticle coated in polyethylene glycol, enabling it to disperse freely. “We joined forces with John Hopkins because we each had a technology that addresses one of the two big physical barriers to drug delivery in the brain,” Price said. “We decided to put the two technologies together and see if that combination can actually produce efficacy.”Learn more about what these breakthroughs might mean for brain cancer treatment. Read the full story as it appeared in UVAToday and InTheCapital.
A new InSightec study to determine feasibility and safety of using the ExAblate System to treat localized, low-risk prostate cancer has begun in California. Jeffrey Wong, MD, Professor and Chair of the Department of Radiation Oncology and Associate Director of the Prostate Cancer program at City of Hope in Duarte, California is the principle investigator at City of Hope. The study will begin enrolling at the Mayo Clinic in Rochester, Minnesota, and other locations. City of Hope is the first U.S. site to treat a patient enrolled in this study.
Patients who are interested in this study, should contact Maria Brooks at City of Hope (626) 256-4673 ext 64402,
CHARLOTTESVILLE, VA (May 13, 2014) – Carl Zeithaml, Dean of UVA’s McIntire School of Commerce has been elected to the Board of Directors of the Focused Ultrasound Foundation. “I love innovation and big, ambitious ideas that are designed to help people and make the world a significantly better place,” said Dean Zeithaml. “The efforts of the Focused Ultrasound Foundation certainly qualify on all dimensions. Based on results to date, the potential is enormous. I am very excited to lend my time and expertise and to connect the Foundation with my network to spread interest in their visionary work.”
“We are honored to welcome Dean Zeithaml to our Board of Directors,” said Neal F. Kassell, M.D., chairman of the Focused Ultrasound Foundation. “With his expertise in healthcare and global strategic management, he will provide invaluable insight as the Foundation works to advance focused ultrasound therapies in the U.S. and around the globe.”
Lian Zhang, MD, gastroenterologist with the Clinical Center for Tumor Therapy, Second Affiliated Hospital of Chongqing University of Medical Sciences, met with Alan Matsumoto, MD, Co-Director of the UVA Focused Ultrasound Center.Dr. Zhang is a leading clinician in the field, having been involved with focused ultrasound for more than 10 years. Chongqing Haifu’s focused ultrasound system is currently approved in China and Europe to treat uterine fibroids, breast cancer, liver cancer, kidney cancer, soft tissue tumors, and pain control for pancreatic cancer and bone metastases. The technology is quite established for uterine fibroids, with more than 100 Chongqing Haifu systems in OB/GYN offices around China.
HistoSonics, Inc. is a Michigan-based company that is using the non-thermal histotripsy mechanism of focused ultrasound to treat benign prostatic hyperplasia (BPH). Although BPH causes an enlarged prostate, it does not lead to cancer-the unwanted cells need to be removed when they cause irritation or obstruction. VortxRX is the company's investigational, image-guided, system for treating BPH. A pilot clinical trial is currently underway in North America to test the system’s safety and initial effectiveness.Q&A With HistoSonics Chairman & CEO Tom Davison, PhD
Q. How did you get involved in starting HistoSonics? I was introduced to the University of Michigan (UM) Department of Tech Transfer in late 2007. UM asked me to help evaluate several medical device technologies in their patent portfolio, including histotripsy. Because of my experience in therapeutic ultrasound businesses (UltraCision and Sontra), UM asked me to review the histotripsy program to determine whether it should be licensed or had the potential to support a stand-alone business. At the completion of the consulting assignment, I acquired an option to license the histotripsy technology and intellectual property. After several years of planning, HistoSonics was founded in December 2009.
An alternative method of tissue fractionation--boiling histotripsy--has been developed in a unique collaboration between and the University of Washington (UW) in Seattle and Moscow State University (MSU) in Russia. Drs. Vera A. Khokhlova, Lawrence A. Crum, and the growing UW/MSU teams have developed the method that uses longer (millisecond instead of microsecond) duration focused ultrasound pulses to generate a millimeter-sized boiling bubble (instead of a cavitation cloud) through tissue heating by shocks. Two papers that detailed their groundbreaking work were published in Ultrasound in Medicine and Biology and the Journal of the Acoustical Society of America.
Virginia Senator Mark Warner vowed that he would go back to the Capital recharged to advocate for focused ultrasound after touring the UVA Focused Ultrasound Center and the Focused Ultrasound Foundation on March 19.
Speakers at the European Congress of Radiology (ECR) Annual Meeting in Vienna, Austria, lauded the potential for Focused Ultrasound to be one of the most important treatment options on the horizon. MedicalPhysicsWeb.com reported on the conference, speaking with leaders in the focused ultrasound field about the key applications discussed.
Uterine fibroids remains the most widely approved application of focused ultrasound, with the potential to help countless women. Discussion centered on ideas to overcome the slow adoption rates to date.
7th Space, an online portal covering news and headlines, has featured an article published in the Journal of Therapeutic Ultrasound (JTU). The JTU is the official publication of the International Society for Therapeutic Ultrasound and the Focused Ultrasound Foundation, which was recently chosed to be indexed on PubMed.
The article, authored largely by scientists and researchers at the Foundation, offers a snapshot of the field of focused ultrasound and its progress in the past decade.
The Foundation’s Council is now under increased “surveillance” with the addition of retired Central Intelligence Agency (CIA) officers Jonna and Tony Mendez. Together the couple has more than 50 years of service to the United States, and both are decorated heroes. Tony is also an author and award-winning painter; Jonna is a fine art photographer, a consultant/lecturer, and an author. ARGO, one of Tony’s autobiographical books, became an Academy Award-winning movie.
The Focused Ultrasound Foundation has published its January 2014 Focused Ultrasound Global Perspective report, a comprehensive overview of the state of the technology, including facts and figures on approved indications, manufacturers, research centers, and treatment sites. This report will serve as a trusted resource for academia, government, industry, and investors, enabling them to monitor progress in the field and guide decision making.The report is now available on our website. An update will be produced every six months, identifying significant research and commercialization trends for the technology.
A major milestone in the evolution of the field of focused ultrasound has been achieved. The first treatment in a 20-patient pilot study assessing the feasibility, safety, and preliminary efficacy of MR-guided focused ultrasound for dyskinesia in Parkinson's disease was successfully performed in Korea. This groundbreaking study is being funded in partnership with the Michael J. Fox Foundation.
Focused ultrasound physics pioneer Professor Gail ter Haar, head of the Foundation’s Center of Excellence at the Institute of Cancer Research (ICR) in London, traveled with Foundation staff to Washington to deliver a presentation to the U.S. Food and Drug Administration (FDA) on her team’s work in quality assurance and standardization of high intensity focused ultrasound.
The Focused Ultrasound Foundation lost a dear friend, ardent supporter, and charter Council Member with the death of Edgar M. Bronfman on December 21, 2013. In addition to his philanthropic support, Mr. Bronfman generously supported the Foundation with his time and his extensive and brilliant business acumen. He will be dearly missed.
As reported in the current issue of Nature Neuroscience, scientists on Dr. William J. Tyler’s research team at Virginia Tech were interested in using focused ultrasound to noninvasively modify human brain function. They targeted sensory areas of the brain and were surprised by their findings: low-intensity focused ultrasound significantly improved function by decreasing impulses to the median nerve in the arm thereby enhancing the patients’ ability to discriminate between different kinds of stimulation. Secondly, they were impressed that the focused ultrasound could target smaller, more specific areas in the brain as compared to other neuromodulation technologies.
Focused ultrasound pioneer Dr. Wladyslaw Gedroyc has been named Clinical Editor-in-Chief of the Journal of Therapeutic Ultrasound(JTU), replacing start-up editor Dr. Arik Hananel.
A consultant radiologist, Dr. Gedroyc is recognized worldwide as a pioneer in the development of noninvasive patient treatments using MR-guided focused ultrasound. Much of Dr. Gedroyc's ground-breaking work involved the treatment of uterine fibroids, pancreatic tumors, and liver tumors. He is currently investigating a focused ultrasound application to alleviate the severe back pain associated with facet joint disease.
In October, Dr. Jeff Elias of the University of Virginia awed the TEDx Charlottesville audience of nearly 1,000 as he spoke about the transformational effects of focused ultrasound, including "before and after" video of his patients eating, writing, and reaching while living with essential tremor. See the talk that brought the crowd to its feet.
Focused ultrasound treatment for Parkinson's disease was featured as the cover story in the December issue of Practical Neurology.
The article consisted of a Q&A with Dr. Binit B. Shah, MD, Assistant Professor, Neurology, Parkinson's Disease and Movement Disorders Division at University of Virginia.
Additional research is being conducted around the world on breast cancer and breast fibroadenoma. For example, collaboration between Philips and Utrecht University Medical Center in the Netherlands is using an innovative system that has been designed specifically to treat breast tissue.
Focused ultrasound research presentations made an impressive showing at this year’s RSNA annual meeting. A remarkable 27 sessions featured research on focused ultrasound ablation and/or drug delivery to treat many different diseases, including breast cancer, bone metastases, pancreatic cancer, prostate cancer, melanoma, uterine fibroids, and osteoid osteoma.
The Foundation’s External Research Awards Program has approved two new proposals for funding. One project is from the high-risk track, and the other is from the clinical indication track.
The high-risk project is led by Zhen Xu, Ph.D., from the University of Michigan and will study the use of the mechanical effects of focused ultrasound to break up the blood clots that cause deep vein thrombosis. The clinical indication project is a pilot study in pediatric osteoid osteoma led by Michael Temple, M.D., at SickKids Hospital in Toronto.
The Philanthropy Journal, an online site that publishes news on fundraising, innovation, and technology in the philanthropic community, recently featured an article by the Foundation on our model to accelerate adoption of medical technology.
The British Broadcasting Corporation (BBC) visited the University of Virginia earlier this year to document a patient being treated as part of the ongoing Parkinsonian Tremor clinical trial, led by UVA Neurosurgeon W. Jeffrey Elias, MD and funded by the Focused Ultrasound Foundation.
Results of a study presented today at the annual meeting of the Radiological Society of North America (RSNA) suggest MR-guided focused ultrasound (MRgFUS) may offer a safe, noninvasive treatment option for breast cancer.
Radiology Today magazine featured a balanced article detailing the uses of focused ultrasound to treat a wide variety of disorders such as uterine fibroids, bone mets pain, essential tremor, Parkinson's disease, and more.
Kona Medical, Inc. is pioneering the use of focused ultrasound (FUS) to noninvasively treat hypertension through ablation of the renal nerves. Renal nerves are located near the renal arteries supplying blood to the kidneys and can play a significant role in regulating blood pressure. Recent clinical data have shown that ablation of renal nerves can result in profound and lasting reduction in hypertension in patients whose blood pressure is not adequately controlled by medication.
Experts who gathered at the June Brain Workshop were successful in identifying major opportunities and challenges for expanding the area in the brain that can be treated with focused ultrasound. Event details, including issues discussed and long-term projects, were reported in ourJuly newsletter.
The Annual Meeting of the American Society for Radiation Oncology (ASTRO) was held in Atlanta on September 22-25, 2013. This meeting is the largest assembly of radiation oncology physicians and researchers in the world. Focused ultrasound has a growing and important role in clinical research in radiation oncology, and highlights included:
1. J. E. Meyer from the Fox Chase Cancer Center presented their work on the pain palliation of bone metastases using focused ultrasound. Their retrospective analysis showed breast cancer metastases as having the best response rate (87%), which may impact future patient selection and treatment decisions.
Kona Medical’s two ongoing WAVE studies demonstrated the ability of focused ultrasound to noninvasively reduce blood pressure in patients with drug-resistant hypertension. Renal nerve ablation with their focused ultrasound—based Surround Sound™ Renal Denervation System produced clinically significant drops in both systolic and diastolic blood pressure. For the combined studies, 73% of patients experienced a clinically significant drop in systolic blood pressure of 10 mmHg or more at three months and 81% at six months with no device-related serious adverse events. As impressive as the drop in blood pressure, the WAVE II study also uses a dosing pattern that reduced therapy time from 13 minutes to 3 minutes.
InSightec Ltd, a leader in MRI guided Focused Ultrasound therapy, has announced that Robert Sigal, MD, PhD, has taken over the role of President and Chief Commercial Officer. He will be responsible for all the commercial aspects of InSightec, reporting to Dr. Kobi Vortman, CEO and Founder of InSightec Ltd.
The Foundation’s patient advocacy program, Fibroid Relief, has been garnering nationwide media coverage of a newly published survey that found that uterine fibroids cause significant fear and morbidity and can compromise workplace performance. It also found that women prefer treatment options that are not invasive and protect fertility (like focused ultrasound).
The Foundation is pleased to announce that Ellen H. Block has joined our Council. Members of the Foundation Council serve as goodwill ambassadors, advance our message, and connect us to other people who should hear our story. Ellen is a registered occupational therapist, small business owner, and an active philanthropist from Palm Beach, Florida. She is engaged in a wide range of societal and community-related issues locally, nationally, and globally.
More than 200 clinicians and scientists from Europe and across the globe gathered in Rome this month for the Focused Ultrasound Therapy - 2nd European Symposium, which was supported by the Foundation.
“The symposium more than met our goals of sharing knowledge and stimulating new ideas,” said symposium co-chair Alessandro Napoli, MD, PhD, of Sapienza University of Rome. “The meeting helped to establish and consolidate relations, foster discussion of research approaches, and fuel advances in the field.”
As a true testament to the potential of focused ultrasound to change medicine, TWO out of 15 companies selected by Fierce Medical for their top 15 innovators of the year are focused ultrasound companies: InSightec and Kona Medical.
The National Cancer Institute has awarded Dennis Parker, PhD, and his team of researchers at theUtah Center for Advanced Imaging Research (part of the University of Utah School of Medicine) funding to further their work using focused ultrasound to treat breast cancer. After completing successful initial studies funded by the Focused Ultrasound Foundation, the Utah group was able to secure this prestigious R01 award to continue this promising work.
The first essential tremor patient in the pivotal trial for the ExAblate Neuro Focused Ultrasound System has been treated at Stanford, and the study is starting at the University of Virginia, Swedish Neuroscience Institute in Seattle, and Yonsei University Medical Center in Seoul, Korea.
The trial is a multicenter, double-blinded, randomized study to evaluate the efficacy and safety of treatment using the ExAblate Neuro in medication-refractory essential tremor patients. The study builds upon promising pilot studies funded by the Focused Ultrasound Foundation that demonstrated the preliminary safety and effectiveness of FUS in treating target areas deep inside the brain. These studies were published in the New England Journal of Medicineand The Lancet Neurology.
On September 4, more than 100 researchers, clinicians, and students from 14 departments attended the UVA Focused Ultrasound Center Evening Symposium.
Presentations from experts covered a wide range of topics, including developments in MRI technology for focused ultrasound (FUS) applications, FUS-mediated drug delivery, and clinical and pre-clinical brain studies. The symposium also highlighted novel applications, such as exploring the use of FUS to aid traditional immunotherapy and treat osteoarthritic pain (see related story in our September 2013 Newsletter). This work showcases not only the versatility of the technology, but the breadth of indications on the horizon in FUS research.
The Foundation is now seeking applicants for the Richard Merkin Visiting Fellowship in Focused Ultrasound, created by Richard Merkin, MD, to foster collaboration between the Foundation and other institutions .
The Fellowship in Focused Ultrasound is open to any mid-career or senior scientist or clinician from industry or academia around the world to work with the technical and scientific team at the Focused Ultrasound Foundation in Charlottesville, Virginia for about 12 months. The position will foster collaboration between the Foundation, the Fellow's home institution, and other institutions and will be paid through an annualized stipend of $150,000.
The Focused Ultrasound Foundation and the Kinetics Foundation organized a workshop in September to discuss the state of the technology, current challenges, and future research directions for using focused ultrasound to reversibly open the blood-brain barrier to allow the delivery of drugs directly to the brain for treatment of cancer, Parkinson’s disease, Alzheimer’s disease, and other central nervous system disorders.
Feng Wu, MD, PhD, has been selected as Honorary President of the 4th International Symposium on Current and Future Applications of Focused Ultrasound to be held October 12-16, 2014 in Bethesda, Maryland.
Wu has been a steadfast champion of focused ultrasound for more than 25 years. To date, his teams in China have treated more than 50,000 tumor patients, the largest population of focused ultrasound-treated patients in the world. Now living in England, Wu is a Focused Ultrasound Consultant and Senior Clinical Scientist at Oxford University. He is a leading researcher in the field, having published more than 200 papers. In 2013, he was awarded the International Society for Therapeutic Ultrasound’s William and Francis Fry Award for his outstanding contributions to the field.
An article in Dotmed daily news, an online site which follows medical devices and the industry, featured this story on the use of focused ultrasound to treat brain disorders like essential tremor, OCD, and Parkinson's disease:
The first essential tremor patient in the pivotal trial for the ExAblate Neuro Focused Ultrasound System has been treated at Stanford, and the study is starting at the University of Virginia, Swedish Neuroscience Institute in Seattle, and Yonsei University Medical Center in Seoul, Korea.
Focused Ultrasound Foundation, Royal Philips, The Institute of Cancer Research, and The Royal Marsden collaborate in centre to accelerate progress and establish global standards for focused ultrasound treatment ̶ enhancing patient care around the world
LONDON – September 5, 2013 – The Focused Ultrasound Foundation and Philips have entered into an innovative public-private collaboration with The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust. The partnership will create a focal point for ultrasound therapy research at The Institute of Cancer Research (ICR) and The Royal Marsden in London under the international Focused Ultrasound Foundation Centers of Excellence Program.
The New England Journal of Medicine published the promising results of a pilot trial on the use of transcranial MR-guided focused ultrasound to treat patients with essential tremor (ET).
The results indicate that focused ultrasound can safely and effectively treat targeted areas deep in the brain. The study included 15 patients with essential tremor that could not be managed by medication who underwent a completely noninvasive unilateral thalamotomy using an investigational focused ultrasound device. The study was led by W. Jeffrey Elias, MD, (shown above with the ET patients) neurosurgeon at the University of Virginia, and funded by the Focused Ultrasound Foundation.
Good overview article about some of the many applications of therapuetic ultrasound from Dotmed.com Daily News, an online journal about medical devices and technology.
Held in Shanghai, China from May 12-15, the 2013 meeting of the International Society of Therapeutic Ultrasound (ISTU) drew about 200 attendees and devoted an entire day to clinical presentations, indicating the society’s increasing emphasis on patient applications of therapeutic ultrasound.
Feng Wu, MD, PhD received the 2013 Fry Award, which is given annually to an individual who has made outstanding contributions to therapeutic ultrasound. Wu is a HIFU Consultant and Senior Clinical Scientist at Oxford University in the United Kingdom.
Craig H. Meyer, PhD has received a $100,000 Research Award from the Focused Ultrasound Foundation to develop a new real-time method for performing three-dimensional MR temperature mapping, a technique that could have a major impact on the safety, efficacy and procedural efficiency of focused ultrasound treatments.
“MR temperature mapping is an integral element of MR-guided focused ultrasound surgery. However, acquisition of the MR images required for calculating a temperature map is time consuming. At present, it is not possible using conventional non-accelerated MR techniques to acquire and reconstruct 3D temperature maps in real time,” explains Meyer, an associate professor of Biomedical Engineering and Radiology at the University of Virginia.
CHARLOTTESVILLE, VA (June 20, 2013) – The Focused Ultrasound Foundation has hired Pamela Minetti as Director of Development. Prior to joining the Foundation, Ms. Minetti was a leading member of the financial services and technology practices at Boyden Global Executive Search in New York.
The Focused Ultrasound Foundation was recently awarded a $600,000 grant by The Michael J Fox Foundation for Parkinson’s Research to help fund a pilot study of focused ultrasound for the treatment of dyskinesia in Parkinson’s disease. The study will investigate the feasibility, safety and preliminary effectiveness of focused ultrasound as a non-invasive method to destroy a small volume of targeted tissue in the brain to improve motor symptoms and reduce the involuntary movements (dyskinesia) faced by Parkinson’s patients.
Grant Will Fund Study to Evaluate Focused Ultrasound for Treatment of Dyskinesia in Parkinson’s Disease
CHARLOTTESVILLE, VA – (June 18, 2013) – The Focused Ultrasound Foundation (FUSF) has been awarded a $600,000 grant by The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to help fund a pilot study to determine the feasibility, safety and preliminary efficacy of magnetic resonance-guided focused ultrasound for the treatment of dyskinesia in Parkinson’s disease (PD).
A high-dose of ultrasound targeted to painful bone metastases appears to quickly bring patients relief, and with largely tolerable side effects, according to new research presented by Fox Chase Cancer Center scientists at the 49th Annual Meeting of the American Society of Clinical Oncology on Monday, June 3.
Ultrasound Symposium Agenda - Tuesday, August 6
Session 1: Clinical Delivery and Advanced Novel Technologies/Strategies
Moderators: Chang Ming Charlie Ma, Fox Chase Cancer Center and Cyril Lafon, INSERM, University of Lyon
8:00 AM Clinical Delivery and Advanced Novel Technologies/Strategies
Presenters: N. Sanghvi, A. Hananel, M. Hurwitz, C. Moonen
Researchers from the Bonn University Hospital in Germany have filed a patent application for a focused ultrasound method that reduces impairment of cardiac function after an acute heart attack. In the method, microbubbles are injected into the bloodstream following a heart attack. When the bubbles reach the heart, stimulation with focused ultrasound causes them to oscillate and ameliorate the muscle damage that normally occurs after cardiac arrest.
From the level of traffic at its booth to the “Best Poster” honors bestowed on two abstracts featuring its HIFU treatment for prostate cancer, focused ultrasound device maker EDAP TMS reported a “heightened level of interest and enthusiasm” among physicians and others attending the 2013 meeting of the American Urological Association (AUA) in May. Now in use in 29 countries, EDAP’s prostate cancer treatment device – the Ablatherm – is awaiting regulatory approval in the U.S.
Patients with localized prostate cancer are receiving treatment in a new clinical study assessing the safety of a transurethral ultrasound ablation system developed by Toronto-based Profound Medical Inc. The system, which uses a specially designed wand to deliver thermal ablative therapy, operates under MR guidance. It works on a variety of MRI platforms, can be moved from scanner to scanner and treats the whole prostate gland in one session.
First patient trial at Swedish Medical Center will be for essential tremor
One of the most prestigious neuroscience centers in the world is gearing up to become a major clinical force in MR-guided focused ultrasound brain research. Swedish Neuroscience Institute (SNI) at the Cherry Hill campus of Swedish Medical Center in Seattle, Washington, USA will soon treat patients with essential tremor as part of an upcoming Phase III multicenter randomized trial and is considering studies for epilepsy, Parkinsonian tremor, metastatic tumors and intracerebral hemorrhage.
On May 6, the Focused Ultrasound Foundation hosted an awareness-building event near its headquarters in Charlottesville. Attendees included the Foundation’s Board of Directors, Council and staff as well as focused ultrasound clinicians, researchers, patients, donors and supporters.
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