The Gray Sheet, a cornerstone medical device publication for the healthcare industry, touts promising data on FUS for essential tremor and recognizes the Foundation's unique model in supporting research.
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Charlottesville, VA – The Focused Ultrasound Foundation, Royal Philips Electronics (NYSE: PHG, AEX:PHIA) and InSightec Ltd today announced that they are collaborating with leading clinicians in the field and support the establishment of a multicenter registry to evaluate MR-guided focused ultrasound treatment for uterine fibroids (also known as uterine leiomyomas).
The 15 patients who enrolled in the Focused Ultrasound Foundation-funded essential tremor (ET) study at the University of Virginia are true medical pioneers. Prior to their focused ultrasound treatment, most had lived with ET for decades. All had become severely disabled by it. Each believed they had run out of viable treatment options until learning about the promise and possibilities of focused ultrasound. Bravely stepping forward to join the study, each identified three outcomes they wanted to experience.
AANS PRESS RELEASE Embargoed until April 29, 2013, 2:30 p.m. CDTContact:John A. IwanskiDirector of Member and Public Outreach(847) 378-0517 |
Subjects of Phase I Study of Transcranial MR-guided Focused Ultrasound Thalamotomy See Reduced Tremor,Improved Quality of Life
NEW ORLEANS (April 29, 2013) — Research findings offered today during the 81st American Association ofNeurological Surgeons (AANS) Annual Scientific Meeting show that the use of transcranial MR-guided focused ultrasoundfor producing a thalamotomy can have significant positive effects on subjects suffering from essential tremor.
When James Drake, MD submitted his proposal for the “Chase an Idea” grant, pediatric focused ultrasound was the idea he wanted to chase. Drake, the chief of neurosurgery at the Hospital for Sick Children (SickKids) in Toronto, Canada, understood the potential of focused ultrasound and was eager to explore its use in children. Receipt of that grant, from the Centre for Brain and Behavior at SickKids, provided the means to establish the Center for Image Guided Innovation and Therapeutic Intervention (CIGITI) with Drake at the helm.
One of Billy R. Williams’ most cherished possessions is a photo album chronicling the day he made medical history by becoming the first person in the world to undergo focused ultrasound treatment for essential tremor. “I always wanted to be Number 1 at something, and this was it,” he says of his participation in the Focused Ultrasound Foundation-funded pilot essential tremor study at the University of Virginia. His treatment experience, which has been reported in print and video interviews, has inspired thousands and offered new hope to others in the essential tremor community.
Many of the 15 patients who participated in the Focused Ultrasound Foundation-funded pilot essential tremor study at the University of Virginia have stepped forward to share their story with the news media. By doing so, they have added a new dimension to the role patient participants play in advancing a promising new medical technology. Their courage and their stories have touched people around the world and spurred interest in using noninvasive sound waves instead of scalpels to treat movement disorders.
April 29, 2013 - University of Virginia neurosurgeon W. Jeffrey Elias reported today that one-year clinical data indicates that essential tremor patients treated with noninvasive transcranial focused ultrasound experienced significant disability reduction and improved quality of life. The research, which was funded by the Focused Ultrasound Foundation and presented at the annual meeting of the American Association of Neurological Surgeons, showed that patients experienced a 67 percent reduction in their dominant hand tremor scores and an 83 percent improvement in their disability scores.
The encouraging results of the Focused Ultrasound Foundation-funded essential tremor Phase I pilot clinical trial at the University of Virginia have led to planning for the next data-gathering step required for regulatory approval: a global, multi-site pivotal Phase III study to evaluate the safety and efficacy of transcranial MR-guided focused ultrasound in treating essential tremor. Device maker InSightec, Ltd., which is sponsoring the study, has obtained U.S. Food and Drug Administration approval for a double-arm protocol and expects as many as eight sites and 72 patients to participate.
Robert C. Khayat, JD, LLM, served as the 15th Chancellor of the University of Mississippi, from 1995 until 2009. Under Khayat’s leadership, the University was named 23rd among the nation’s public universities, and was ranked in the top ten places to work in higher education. Khayat was also a professor at the University of Mississippi School of Law and President of the NCAA Foundation.
The growing field of therapeutic ultrasound welcomes its first open access journal
Open access publisher BioMed Central is proud to announce the launch of Journal of Therapeutic Ultrasound in partnership with the Focused Ultrasound Foundation and the International Society for Therapeutic Ultrasound.
Therapeutic ultrasound is a fast growing field and all parties involved believe that having a dedicated open access journal in this area can only speed up the development and eventual adoption of this important clinical tool by the wider medical community.
Focused ultrasound has the potential to be an alternative or complement for radiation therapy, the means to dissolve blood clots, and a way to deliver drugs in extremely high concentrations to a precise point in the body. It has the potential to treat a variety of serious medical disorders, including cancer, uterine fibroids, essential tremor, Parkinson’s disease, epilepsy, and neuropathic pain.
“Focused ultrasound technology has enormous potential to improve the quality of lives for millions around the world,” noted Neal F. Kassell, M.D., Chairman and Founder of the Focused Ultrasound Foundation. “The research reported in the Journal of Therapeutic Ultrasound will be central to advancing the field and will help accelerate the progress of focused ultrasound towards clinical adoption.”
Journal of Therapeutic Ultrasound encompasses all aspects of therapeutic ultrasound, namely, the stimulus, inhibition, or modification of tissue function or structure via insonification. Led by Editors-in-Chief Arik Hananel, Focused Ultrasound Foundation, USA and Robert Muratore, Quantum Now LLC, USA, with an international editorial board consisting of the best in the field of focused ultrasound, this open access, peer-reviewed, online journal focuses mainly on translational and clinical research.
Deborah Kahn, BioMed Central’s Publishing Director said, "We’re very pleased to welcome the Focused Ultrasound Foundation and the International Society for Therapeutic Ultrasound as new publishing partners to BioMed Central, and we share their excitement in launching the Journal of Therapeutic Ultrasound within our growing list of society journals."
The launch edition includes two research articles. One looks at the impact of vaporized nanoemulsions on ultrasound-mediated ablation. If these results can be replicated in the clinic, microbubbles could improve the efficiency of high intensity ultrasound treatment of solid tumors. An editorial on ‘The Journal of Therapeutic Ultrasound - broadening knowledge in a rapidly growing field’ by Editors-in-Chief Arik Hananel and Robert Muratore, is also featured.
All Article-Processing Charges (APC) for the journal are currently covered by the Focused Ultrasound Foundation.
Media ContactRebecca FairbairnPublic Relations Manager, BioMed CentralTel: +44 (0) 20 3192 2433Mob: +44 (0) 7825 257423Email:
PMI initiates Transurethral Ultrasound Ablation (TULSA) clinical trial for novel, minimally invasive device for localized prostate cancer treatment
TORONTO, April 25, 2013 /CNW/ - Profound Medical Inc. today announced the commencement of its Health Canada approved, multi-center TULSA (Transurethral Ultrasound Ablation) clinical trial for its minimally invasive, novel ablation device used to facilitate prostate cancer treatment. In the world's first procedure of its kind, a patient was treated in a collaborative effort with London Health Sciences Center, Ontario, Western University, and the Lawson's Health Research Institute. The Canadian trial will include the treatment and one-year monitoring of 30 patients with localized prostate cancer. The device presents the potential for significantly improved clinical outcomes and a marked departure from current methods by virtue of its ability to treat the whole gland in one session with unprecedented accuracy and minimal side effects.
TIRAT CARMEL, Israel, Apr. 18, 2013 – InSightec Ltd. announced today that the US Centers for Medicare & Medicaid Services (CMS), a federal agency within the US Department of Health and Human Services (HHS), has created a new billing code for MR guided focused ultrasound treatment of pain palliation of metastatic bone lesions and has established a Medicare payment rate for hospital outpatient departments.
Alessandro Napoli, MD and his colleagues at the University of Roma La Sapienza in Italy are establishing a solid reputation as clinical trail-blazers for focused ultrasound. Their latest clinical study is the first to use MR-guided focused ultrasound to treat patients with unresectable, locally advanced pancreatic cancer. The study, which is expected to enroll 15-20 patients, is exploring the feasibility and clinical performance of MR-guided focused ultrasound ablation in palliating pain and controlling tumors. Four patients have received treatment to date and will be followed for up to 12 months.
In contrast to high-intensity focused ultrasound (HIFU), which implies high-power and high-temperatures for short durations, focal HT relies on feedback control to maintain a much lower temperature rise (39-45° C) in larger contiguous regions over timeframes that can range from 15 to 60 minutes. Chris Diederich, PhD and his colleagues at the University of California San Francisco have a new use in mind for their site’s focused ultrasound device (InSightec’s ExAblate 2100 Prostate System). With a $100,000 research award from the Focused Ultrasound Foundation, they plan to modify the MR-guided ablation system so it can be used to deliver focal hyperthermia (HT) – a therapy that heats up tissue and is known to enhance clinical response to radiation therapy and chemotherapy.
U.S. start-up HistoSonics, Inc. is preparing to launch clinical trials using its noninvasive pulsed ultrasound technology to treat benign prostatic hyperplasia (BPH), an age-related condition that, over time, affects nearly all men. Estimates indicate that 50% of men over 50 and 80% of men over 80 have BPH. More than two million Americans have the condition and about 400,000 are treated surgically for BPH each year.
The year 2013 has gotten off to a solid start for device maker EDAP TMS with a steady stream of positive business and research news. The company has introduced its new Focal.One device for prostate cancer and is progressing in its quest for U.S. regulatory approval of its Ablatherm-HIFUsystem for localized prostate cancer.
Executives of EDAP and SonaCare Medical – two focused ultrasound device makers that are engaged in commercialization activities – say healthcare trends are creating a unique opportunity for their companies and for men with localized prostate cancer.
Faster Cures interviewed the Focused Ultrasound Foundation's Scientific Director Jessica Foley, PhD at last year’s Celebration of Science. Want to know what Jessica envisions for future generations of scientists and researchers and the challenges they may face with today’s economic shortcomings?
On Monday, March 25, 2013, Canadian TV (CTV) broadcast a follow-up report about Tony Lightfoot, a man who had been severely debilitated by essential tremor for more than a decade. He was the fourth patient treated in the Focused Ultrasound Foundation-funded Essential Tremor Pilot Study at Sunnybrook Health Sciences Centre in Toronto.
The Lancet Neurology has published the early findings of the Focused Ultrasound Foundation-funded essential tremor clinical trial at Sunnybrook Health Sciences Centre in Toronto. The study, which was published online ahead of print, covered four patients treated between May 2012 and January 2013. The MR-guided focused ultrasound treatments, which were designed to impact tremor in one hand, resulted in immediate and sustained tremor improvements. Mean tremor scores decreased by 89.4% at one month and by 81.3% at three months, when the follow-up period concluded. Reported side-effects included post-operative paraesthesias (tingling) in one patient and deep vein thrombosis in another.
Due to numerous requests, the abstract deadline has been extended one last time. The deadline for submission will be March 21 at 11:59 PM Pacific Daylight Time US. The abstract review process will be conducted during this time to process abstracts already received so we ask that you please not try to revise these abstracts. This will provide responses to those authors that submitted previously. Authors submitting abstracts during this extension period are encourage to submit as soon as possible to obtain a timely review, particularly those requiring travel documentation. Thank you to all those who have submitted their abstracts already and we look forward to a great meeting in Shanghai.
Guofeng Shen, Program Committee Chair
Brian Fowlkes, ISTU Secretary
13th International Symposium on Therapeutic Ultrasound scheduled for May 12-15 in Shanghai, China.
Dean Kamen, an inventor, entrepreneur, philanthropist and advocate for science and technology, has joined the Foundation Council. As a keynote speaker during the Foundation’s 3rdInternational Symposium in October 2012, Kamen described focused ultrasound as “an amazing technology” and stressed the importance of advocacy in moving the field forward.
The Focused Ultrasound Foundation lost one of its most dedicated and passionate supporters in January 2013 when Cornelia Keller died from the consequences of a decades-long battle with multiple brain and spinal cord tumors. Widely recognized as a human rights activist, philanthropist, conservationist, historic preservationist, loving mother and devoted friend, Neil was also the founding donor of the Foundation's Brain Program. Her particular interest was in developing focused ultrasound as a noninvasive treatment for brain tumors.
On February 1, 2013, Focused Ultrasound Foundation Chairman Neal Kassell, MD briefed members of the Allied Health Caucus, a bipartisan group of Virginia lawmakers who meet weekly to discuss health issues. Kassell opened his remarks with an overview of focused ultrasound technology and of the Focused Ultrasound Foundation. He then provided a status report for the University of Virginia (UVA) Focused Ultrasound Center of Excellence, a facility funded by a public/private partnership involving the Commonwealth of Virginia, the Foundation, UVA and device-maker InSightec Ltd.
Disbursements from the Focused Ultrasound Foundation's Research Awards Program passed the $3 million mark this month with the selection of two new funding recipients. (See chart for details.)
Since its launch in September 2007, the Research Awards program has become a major and increasingly competitive source of financial support for pioneering focused ultrasound studies. To date, the program has provided nearly $3.2 million in funding to 31 projects exploring applications ranging from uterine fibroids, pelvic disease and knee osteoarthritis to cancers of the brain, breast, head, liver, neck and prostate.
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.
Foundation-funded pilot studies in U.S. and Canada laid groundwork for new trial
The trial will be a double-blinded, and patients will randomly be assigned to either a treatment or control (sham treatment) group. The study’s follow-up period will be one year.InSightec Ltd. announced on February 19, 2013 that the U.S. food and Drug Administration has approved the protocol for its pivotal Phase III clinical trial for treatment of essential tremor using the company’s ExAblate Neuro system. Intended to provide the safety and efficacy data needed for FDA pre-marketing approval, the multi-center study is expected to begin in mid-2013 and will be led by University of Virginia neurosurgeon W. Jeffrey Elias, MD.
InSightec’s ExAblate Neuro receives the go-ahead from FDA to begin its pivotal Phase III trial for Essential Tremor
February 19, 2013 (Tirat Carmel, Israel). InSightec Ltd announced that it has received FDA approval to begin its pivotal Phase III clinical trial for treatment of essential tremor using ExAblate® Neuro. This trial is intended to provide the safety and effectiveness data about the use of ExAblate® Neuro in order to support FDA pre-marketing approval.
“Tremors and their treatment” was the topic of a Grand Rounds talk given on January 9, 2013 at the National Institutes of Health Clinical Center by University of Virginia neurosurgeon, W. Jeffrey Elias, MD. During the hour-long presentation, Elias described the differences between Parkinson's tremor and essential tremor and provided an overview of surgical treatments for those conditions. He brought along two patients, one of whom has Parkinsonian tremor and was treated with Deep Brain Stimulation (DBS).
LYON, France, Feb 01, 2013 (GLOBE NEWSWIRE via COMTEX) -- EDAP TMS SA EDAP, the global leader in therapeutic ultrasound, announced today the submission of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) on January 31, 2013 for the Company's Ablatherm-HIFU (High Intensity Focused Ultrasound) for treatment of low risk, localized prostate cancer. EDAP's PMA submission includes data from the ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the Company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.
Colleagues in the focused ultrasound community are grieving the loss of George A. Holland, MD, a leading American interventional radiologist who was an expert in magnetic resonance imaging and minimally invasive treatment of solid organ tumors. As Director of MRI at the Lahey Clinic in Burlington, Massachusetts, Holland helped pioneer the use of focused ultrasound in treating uterine fibroids and was the first to manually interleave treatment spots, a technique that is now a standard of care.
At the time of his death on January 1, 2013, Holland was Director of Cardiovascular Radiology at the University of Rochester Medical Center in Rochester, New York, where he had worked since 2009. Active in professional organizations, he served as chair of the Steering Committee for the Interventional Oncologic Registry and was on the Interventional Oncology Task Force of the Society for Interventional Radiology’s research committee.
Holland received a B.S. in neuroscience from Colgate University and earned his medical degree from the University of Pennsylvania School of Medicine, where he also completed his residency and fellowship training.
Written by Ellen C., McKenna
The Focused Ultrasound Surgery Foundation has awarded a $232,808 research award to Wladyslaw M. Gedroyc, M.D. of St. Mary’s Hospital in London for a two-year randomized clinical trial comparing MR-guided focused ultrasound with radiofrequency ablation in the treatment of back pain caused by facet joint disease.
The study, which is expected to enroll 224 women between 18 and 50 years old, represents the next leg of Philips’ journey toward FDA approval of its Sonalleve MR-HIFU system as a treatment for uterine fibroids, benign tumors that affect 20-50 percent of pre-menopausal women over 30 years old.Three sites are now recruiting uterine fibroid patients for a Phase II/III study assessing the safety and efficacy of the Sonalleve MR-guided focused ultrasound system manufactured by Philips Healthcare. The study – Philips Pivotal Clinical Trial for MRI-HIFU of Uterine Fibroids– is now recruiting patients at St. Luke’s Episcopal Hospital in Houston, Texas, USA, Sunnybrook Health Sciences Centre in Toronto, Ontario, Canada and Samsung Medical Center in Seoul, Korea. Patient recruitment is pending at two other U.S. study sites, Johns Hopkins Hospital in Baltimore, Maryland and the University of Chicago in Chicago, Illinois.
Motohiro Kawasaki, MD, PhD and his colleagues at Kochi Medical School in Japan have received $100,000 from the Focused Ultrasound Foundation’s Research Awards Program to study the safety and effectiveness of MR-guided focused ultrasound in alleviating pain and improving mobility for elderly patients with knee osteoarthritis (OA).
According to Kawasaki, knee OA is one of the most common disabling arthritic conditions in the elderly. While surgery and a continuum of non-surgical treatments are available – physical therapy, medication, and injections – some patients continue to live with severe pain and disability because surgery is too risky or too frightening and because other treatments do not work for them.
The pipeline for clinical studies using focused ultrasound to treat brain conditions is more robust than ever. Neal Kassell, MD, chairman of the Focused Ultrasound Foundation says this is key to his positive 2013 outlook for the field of focused ultrasound.
Asserting that the brain is the most complex and most difficult organ to treat, he says, “Developing safe and effective treatments for brain conditions is the best way to validate focused ultrasound technology and to accelerate its application throughout the body. It doesn’t take an enormous leap of faith to understand that if you can treat something deep in the brain with extreme precision and accuracy—safely and effectively—in a patient who’s wide awake, with no anesthesia, that you can use focused ultrasound in other areas of the body.”
Theraclion receives CE marking approval for its ultrasonic device EchoPulse, in the non-invasive treatment of breast fibroadenomas;
Fibroadenoma is the most widely spread breast benign tumor;
EchoPulse has already been validated in European clinical trials.
"The CE marking widens the use of our technology in the major area of breast fibroadenoma. Our technology can now be offered to all women suffering from this pathology in Europe. They can benefit from a non-invasive outpatient treatment without general anesthesia which puts an end to the embarrassment and anxiety triggered by this kind of tumor.Non-invasive focused ultrasound surgery guided by real-time ultrasound imaging is consistent with the logic of developing lesser invasive treatments and a reduction of health costs. This market authorization in Europe will allow us to grow by creating non-invasive surgery centers based on our resulting echotherapy solution within leading hospitals and clinics. Other tumors beside breast fibroadenomas will be treated in a non-invasive manner in the near future,” says Jean-Yves Burel, CEO of Theraclion.
Tirat Carmel (December 4, 2012). InSightec Ltd. announced that its transcranial focused ultrasound system, ExAblate Neuro, has been awarded the European CE mark for the treatment of neurological disorders in the brain including essential tremor, Parkinson’s disease and neuropathic pain.
The Therapeutic Ultrasound Winter School is scheduled for March 17-22, 2013 in Des Houches, France
Topics will range from an introduction to the physics and biophysics necessary to understand therapeutic ultrasound techniques to their clinical application. The school will provide a current overview of the field as a contextual background for the work of participants and encourage discussion and shared consideration of different approaches to understanding ultrasound therapy.
Session organizers are:
Gail ter Haar, The Institute of Cancer Research, London, UK
Vera Khokhlova, Moscow State University, Moscow, Russia
Mathieu Pernot, Institut Langevin, Paris, France
Jean-François Aubry, ESPCI, Paris, France
The abstract submission deadline for the Society of Thermal Medicine 30th Annual Meeting (STM 2013– Focusing on Heat) is December 5.
The meeting will be held April 17-21 in Aruba.
STM 2013 will cover all areas of thermal medicine and place added emphasis on focused ultrasound- based thermal therapies. Keynote speakers include Kullervo Hynynen, PhD (University of Toronto), Bradford Wood, MD (NIH) and Amato Giaccia, MD (Stanford University).
Update from Jessica L. Foley, PhD, Scientific Director, Focused Ultrasound Foundation
FasterCures has launched Sequestration Station, an online destination for relevant and up-to-date news, resources, facts, and FAQs about how sequestration – or automatic government spending reductions - could impact medical research. These automatic spending cuts will take effect in January 2013 unless Congress acts soon.
By all standards, the 3rd International Symposium on Focused Ultrasound was a success. Attendees included more than 350 people from 25 countries (40% from outside the US). They came from academia, industry, the NIH and FDA and included clinicians, scientists and philanthropists.
Since January 2012, $5 million in new commitments have been contributed to the Foundation. These contributions include leadership gifts of $1 million or more from the Robertson Foundation and two anonymous donors. The total amount contributed since the Foundation's inception in 2006 is nearly $40 million.
These funds are being invested in high-potential research projects and programs and are helping to fill the funding gap between early-stage research and commercialization. This gap, sometimes called "the valley of death," can cause life-saving ideas like focused ultrasound technology to languish.
On October 30, the AANS Neurosurgeon reported, "The Focused Ultrasound Foundation has announced a new clinical trial investigating the use of focused ultrasound technology to treat patients with tremor-dominant Parkinson’s disease. Funded in part by the Foundation, the study has treated its first two patients at the University of Virginia to evaluate the noninvasive technology’s safety and effectiveness in alleviating medication-resistant Parkinsonian tremors."
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Virginia Senator Mark Warner gave the keynote address for the Diane and David Heller Lecture at the 2012 Focused Ultrasound Symposium on October 16th in Bethesda, MD.
Focused ultrasound researchers are encouraged to submit abstracts to the 11th International Stereotactic Radiosurgery Society Congress which is scheduled for June 16-20, 2013 in Toronto, Canada. Abstract guidelines and submission 11th International Stereotactic Radiosurgery Society Congress
The Journal of Gene Medicinehas e-published ahead of print a preclinical study about a novel gene delivery method and a novel strategy for treating liver tumors. A team of Chinese researchers report succeeded in inhibiting liver tumor growth and improving survival time by combining high intensity focused ultrasound ablation with ultrasound-targeted microbubbles loaded with the herpes simplex virus thymidine kinase gene.
InSightec, Ltd. announced today that its ExAblate MRI-guided Focused Ultrasound system has received FDA approval to treat pain associated with bone metastasis. This is the second FDA-approved use of the ExAblate, which gained regulatory approval in 2004 for the treatment of symptomatic treat uterine fibroids.
European Radiology has e-published ahead of print the results of a Foundation-funded pilot clinical trial in which Evan M. Weeks, MD and his colleagues at St. Mary’s Hospital in London used focused ultrasound to successfully treat 18 patients with low back pain caused by facet joint osteoarthritis.
A report published on Oct 17, 2012 on medicalphysics.com spotlighted four presentations given at the 3rd International Symposium on Focused Ultrasound that was hosted from October 14-17, 2012 by the Focused Ultrasound Foundation.
Elisa Konofagou, PhD envisions a day when effective treatments and cures are available for neurodegenerative diseases such as Alzheimer's, Parkinson's, multiple sclerosis and amythrophic lateral sclerosis (ALS). Toward that end, she has been researching noninvasive ways to temporarily open the protective blood-brain barrier that now limits the delivery of most systemically-administered treatments for those diseases.
The Focused Ultrasound Foundation is supporting her work via a $100,000 research award that will enable Konofagou, an associate professor of Biomedical Engineering and Radiology at Columbia University in New York, to conduct a study that will explore the use of focused ultrasound in opening the blood-brain barrier opening to facilitate drug delivery in neurological and neurodegenerative diseases.
“The underlying hypothesis of this study is that delivery of therapeutic molecules is safe and effective through the blood-brain barrier using focused ultrasound,” Konofagou explains. “Our preliminary results have shown that the FUS technique can induce blood-brain barrier opening entirely noninvasively, selectively and be monitored with MRI at sub-millimeter resolution in vivo.” During the study, Konofagou will test and demonstrate delivery of neurotrophic factors to the hippocampus and putamen regions of the brain and assess the safety of the focused ultrasound method.
October 8, 2012
A record-setting 170 papers have been accepted for presentation at the 3rd International Symposium on Focused Ultrasound, and the final program is now available online.
Based in Seoul, Korea, Alpinion Medical Systems has been offering ultrasound devices since 2007. Half of its 185 employees are R&D engineers, indicating the company’s strong focus on product development and innovation.
Alpinion has three core technologies: diagnostic ultrasound; ultrasound transducer technology and therapeutic ultrasound. It entered the therapeutic ultrasound market in 2011 with the introduction of its first high intensity focused ultrasound product, the VIFU 2000. A year earlier, the company opened an office in Seattle, Washington to focus on R&D for the VIFU 2000 and to expand sales in North America. Alpinion also has sales offices in Germany and China.
Forbes Magazine called him a “$1 billion fund-raiser,” an apt moniker for Howard Stevenson, Sarofim-Rock Baker Professor Emeritus and former Senior Associate Dean at Harvard Business School, Director of Publishing and Chair of the board for Harvard Business Publishing Company and Vice-Provost of Harvard University.
Having earned his MBA and Doctoral degrees at Harvard Business School, he built the school’s entrepreneurial management program, leveraging experience gained through involvement with a number of public and privately held companies and during the last 35 years in various leadership positions at Harvard.
Billed as “three days to change the world,” the September 7-9 Celebration of Science event in Washington, DC brought together more than 1,000 of the world’s most brilliant and influential individuals. In panels and talks, they gathered to share ideas and deliver the message that America should recommit itself to bioscience.
Focused ultrasound researchers are encouraged to submit abstracts to the 11th Biennial International Stereotactic Radiosurgery Society Congress which is scheduled for June 16-20, 2013 in Toronto, Canada.
The meeting will bring together professionals from around the world who are dedicated to the field of Radiosurgery, Stereotactic Body Radiotherapy and Novel Ablative Therapies for Brain tumours, such as focussed ultrasound.
November 4: 2013 is the ISRS Congress abstract submission deadline.
Abstract guidelines and submission
A cover article in The Journal of Applied Physics describes how a team of researchers at Penn State Materials Research Institute designed and computationally tested a device constructed of a manmade metamaterial that can manipulate a variety of sound waves. Expected to benefit almost all current sonic and ultrasonic applications, the invention could lead to more accurate and efficient high intensity focused ultrasound therapies.
Emily McDuffie has joined the Focused Ultrasound Foundation as Development Associate and is supporting fundraising efforts and invitational events for donors. Prior to joining the Foundation, McDuffie spent six years in program management and development for Children, Incorporated, a non-profit child sponsorship organization. She is a 2006 graduate of Randolph-Macon College in Virginia.
Seung-Schik Yoo, PhD, of Harvard Medical School and Ulsan National Institute of Science and Technology in Korea, and his colleagues have been pioneering the use of focused ultrasound in the neuromodulation of brain function, a pulse-mode approach they believe holds great therapeutic potential.
In a preclinical study published in the Journal of Controlled Release, Harvard Medical School researchers investigated the kinetics of blood-brain barrier permeability and drug delivery following single and double focused ultrasound sonications. They found that delivery of the chemotherapy agent, doxorubicin, was significantly greater when one focused ultrasound sonication was used and 1.5-fold higher when a second sonication was administered ten minutes later. Study data suggests that MRI contrast agent Gd-DTPA may be useful as a surrogate tracer in estimating drug delivery to the brain following focused ultrasound-induced blood-brain barrier disruption.
Jessica Foley, PhD has joined the Focused Ultrasound Foundation as Scientific Director. She is returning to the focused ultrasound community after completing a one-year American Association for the Advancement of Science (AAAS) Science and Technology Policy Fellowship at the National Science Foundation in Washington, DC. Prior to that, she spent three years working for InSightec as Neuro Projects Manager and Clinical Marketing Manager.
French focused ultrasound device maker, EDAP TMS SA, reports that the two-year follow-up phase has concluded for its multi-center U.S. Phase II/III clinical trial for the indication of low risk, localized prostate cancer. Data analysis is now underway, and the company is preparing a comprehensive Premarket Approval (PMA) submission, which is the next step in the FDA approval process.
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FasterCures has announced the availability of its new The Research Acceleration and Innovation Network (TRAIN) Inventory. The inventory, which lists the Focused Ultrasound Foundation, catalogues the operational and partnering practices of nonprofit disease research foundations, particularly those with a venture philanthropy focus. FasterCures says the inventory is designed to help potential collaborators better understand the landscape of disease research foundations and engage in meaningful partnerships with them.
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Two internationally renowned clinical experts have joined the Focused Ultrasound Foundation’s Movement Disorders Steering Committee, the advisory group that is guiding focused ultrasound research related to Parkinson’s disease, essential tremor and other movement disorders.
Don't miss out on early bird discounts that can save up to $100 on registration fees for the 3rd International Symposium on Focused Ultrasoud.
Sponsored by the Focused Ultrasound Foundation, the syposium is the only global forum dedicated to image-guided focused ultrasound and will be held October 14-17, 2012 in Bethesda, Maryland.
Discounts end at midnight EDT on August 31, 2012.
On July 23 and 24, the Focused Ultrasound Foundation's Brain Program hosted its first invitational mini-workshop to tackle important imaging problems with the help of a world-class team of MR experts from academia and industry. This highly successful workshop was a collaborative problem-solving session that generated solutions for improving the efficiency and safety of transcranial focused ultrasound treatments.
"Some of the solutions identified during the workshop will be applied in the very next brain patient procedure," says John Snell, PhD, Brain Program technical director. "The solutions are expected to reduce treatment time by improving the quality of the MRI scans."
Graham Rolph, California Polytechnic State University, Class of 2016Major: Aeronautical EngineeringSummer project: Install a Picture Archiving and Communications System; co-register MR and CT data with the National Cancer Institute
“Being able to see the cutting edge of the medical science was what excited me about being a summer intern at the Focused Ultrasound Foundation.”
Matthew Hantzmon, Northwestern University, Class of 2015Major: Chemical EngineeringSummer project: Finding the most accurate calculation for lesion volume
“Prior to this summer, I was interested in finding an internship where I would be able to apply what I had previously been learning in my engineering classes at school. I wanted to be able to see examples of what type of careers similar engineers actually have. I was also very excited about the ability to work with other engineers who had somewhat different education backgrounds."
Alisha Geldert, University of Virginia, Class of 2015Major: Biomedical engineeringProject: Develop an adaptive model to predict temperature elevation of brain tissue based on skull parameters
“As I began learning about focused ultrasound and its uses, I became fascinated by its potential to change the nature of surgery and other healthcare procedures. I wanted to gain a deeper understanding of the technology and contribute to its development, as well as help the Foundation in its mission to promote and accelerate the adoption of focused ultrasound. I found that this internship would give me a good taste of both engineering and medical research.”
Richard (JT) Booth, Harvey Mudd College, Class of 2015Major: Computer Science/EngineeringSummer project: Determine a measure for how well a skull resists being heated by the FUS brain system
“FUSF provided an opportunity to work on a nearly open research question and apply what I've learned already in a problem-solving environment.”
Yiqi Cao, University of Virginia, Class of 2015Major: Biomedical EngineeringSummer project: Investigating the potential of sonodynamic therapy
“I was interested in working with the Focused Ultrasound Foundation because of its unique business model that sits at the nexus of scientific research and clinical application. As an engineering student, I am passionate about not only technology but also the responsible and effective integration of it in society. Therefore, I am interested in translational medicine to help produce tangible benefits for patients in the clinical setting.”
On July 23 and 24, the Focused Ultrasound Foundation’s Brain Program hosted its first invitational mini-workshop to tackle important imaging problems with the help of a world-class team of MR experts from academia and industry. This workshop was a highly successful collaborative problem-solving session that generated solutions for improving the efficiency and safety of transcranial focused ultrasound treatments.
“Ultrasound foundation speeds medical advances” is title of an interview with Dr. Neal Kassell in today’s issue of C-ville Weekly. The article provides an excellent overview of the Focused Ultrasound Foundation’s history, mission and unique approach to venture philanthropy. READ ARTICLE
ANDOVER, MA and LAWRENCEVILLE, NJ -- (Marketwire) -- 08/07/12 -- Royal Philips Electronics (NYSE: PHG) (AEX: PHI) and Celsion Corporation (NASDAQ: CLSN) today announced that the U.S. Food and Drug Administration (FDA) has provided clearance to initiate a clinical study supporting a joint development program for Celsion's ThermoDox® combined with Philips' Sonalleve MR-HIFU (MR-guided high intensity focused ultrasound) technology for the palliation of painful metastases to the bone caused by lung, prostate or breast cancers. The companies expect to initiate a Phase 2 study in this indication in the second half of 2012.
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Sarasota, Florida-based PanAm HIFU has opened a prostate cancer treatment site at Amerimed Hospital in Cancun, Mexico. The new site represents a partnership between PanAm and EDAP TMS SA, manufacturer of the Ablatherm-HIFU system, which is approved in Europe and generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.
The Cancun center is PanAm’s second offshore site; the first is in London, England. Medical Director Ronald E. Wheeler, MD, explained that PanAm’s new facility will satisfy increasing patient demand and serve as a HIFU technology training site for American physicians “in preparation for [Ablatherm’s] U.S. approval.” READ PRESS RELEASE
The Focused Ultrasound Foundation’s first designated Center of Excellence at the University of Virginia will be receiving an added $1.5 million for research over two years from the Commonwealth of Virginia. As a participant in the public-private partnership that created the UVA Center in 2009, the Commonwealth had previously provided $4 million in support.
The International Society for Therapeutic Ultrasound has completed arrangements to have the proceedings of its 2012 meeting in Heidelberg, Germany published online in an open access format by the American Institute of Physics. The Society is inviting everyone who delivered oral and poster presentations at the meeting to submit an extended abstract of up to six pages in length using the ISTU 2012 AIP template.
ISTU is building a website for registering and uploading papers, and will soon provide access information to 2012 presenters. The submission deadline is September 2, 2012.
Matt Eames, PhD to succeed Hannah Edelen, JD
Matt Eames, PhD, Brain Program senior project engineer, is stepping in to lead the Research Awards Program succeeding Hannah Edelen, JD, who is leaving the Focused Ultrasound Foundation at the end of July. Eames will assume a new title, Director of Extramural Research, to encompass his accountabilities for research awards and for the Brain Program research he will continue doing. Eames will oversee the research awards funding cycle set to begin with the August 2 submission deadline for full proposals. He will also organize the next quarterly meeting of the Program Funding Committee which will select new research award recipients.
Patient recruitment is underway at St. Peter’s Hospital in Melbourne, Victoria for a clinical trial assessing the safety of a focused ultrasound system in treating patients with drug-resistant hypertension. Manufactured by privately-held, US-based Kona Medical, the system is designed to noninvasively ablate renal nerves, which play a significant role in determining blood pressure. Entitled, “A Feasibility Study: A Safety Evaluation of Renal Denervation Using Focused Therapeutic Ultrasound on Patients With Refractory Hypertension,” the study is expected to treat as many as 20 patients between now and September 2013 and follow them for 24 weeks. Principal Investigator is Robert Whitbourn, MD. Further information can be obtained by emailing Catherine Peeler at
The Breast Cancer Society of Canada has donated $1 million to speed the development of a new microbubbles and ultrasound treatment for advanced localized breast cancer, an aggressive form of the disease that typically affects women 35-45 years old and has an extremely high mortality rate. The society provided the funding to the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto where pre-clinical studies are determining if combining microbubbles and ultrasound make breast tumors more responsive to chemotherapy and radiation. READ PRESS RELEASE
Researcher interest in the 3rd International Symposium Focused Ultrasound has reached unprecedented levels, reports Neal Kassell, MD, chairman of the Focused Ultrasound Foundation. “We’ve received 50 percent more abstracts than in previous years,” he says. “Young Investigator applications have nearly quadrupled since the 2nd International Symposium in 2010.”
Through a visiting associate professorship funded by the Focused Ultrasound Foundation, one of the world’s leading ultrasonic therapy experts will spend the next eleven months collaborating with focused ultrasound researchers at the University of Virginia and with the Foundation’s Brain Program team. Jean-Francois (Jeff) Aubry, PhD, will be taking a leave of absence from Institut Langevin in Paris, France to engage in research that could improve focused ultrasound treatments for the brain. He will be an Associate Professor in UVA’s Department of Radiation Oncology from August 2012 through July 2013.
EDAP TMS SA of Lyon, France has relocated its Chief Executive Officer Marc Oczachowski to the US. "The U.S. market is critically important for EDAP," said Philippe Chauveau, Chairman of the company’s Board of Directors. "We see significant growth drivers in the US, both in the lithotripsy market and in continuing to drive our Ablatherm-HIFU program toward FDA submission, targeted for fourth quarter 2012." The realignment impacted the accountabilities of the company’s Chief Financial Officer Eric Soyer and Japanese subsidiary CEO, Jean Francois Bachelard. NEWS RELEASE
American medical device-maker Kona Medical, Inc. has raised $30 million in venture financing to advance development and commercialization of an ultrasound system to treat drug-resistant hypertension. The device is designed to noninvasively ablate renal nerves, which play a significant role in determining blood pressure. According to the company, recent clinical data have shown that renal nerve ablation can result in profound and lasting reduction in hypertension in patients whose blood pressure is not adequately controlled by medication. The privately-held Kona is based in Bellevue, Washington. READ REPORT
EDAP TMS SA reports that patients with prostate cancer are being successfully treated at the St-Augustin Urology Clinic in Bordeaux, France utilizing the company’s Ablatherm High Intensity Focused Ultrasound system. Dr. Thierry Piechaud, partner and urology surgeon at the clinic, noted, "We are very enthusiastic about adding the Ablatherm-HIFU device to our therapeutic arsenal. We believe HIFU has developed a clear lead among other current technologies as a new approach and a modern concept of non-invasive treatment for early stage prostate cancer which preserves patient quality of life." EDAP reports that there are 278 Ablatherm installations worldwide.
US biotech Celsion, Inc. will design and conduct a clinical trial in partnership with Oxford University (UK) to evaluate the use of its heat-activated drug, Thermodox, and ultrasound-guided high intensity focused ultrasound in treating patients with metastatic liver cancer. Patient treatments are expected to begin later this year. The study is supported by the National Institute for Health Research Oxford Biomedical Research Centre. It will be conducted as a multi-disciplinary collaboration between Celsion, the Oxford University Institute of Biomedical Engineering and the Oxford University Hospitals NHS Trust.
Accelerating the development and commercialization of innovative image-guided therapies for cancer and heart disease is the goal of a major initiative announced last month. Sunnybrook Research Institute (University of Toronto) will lead the project with $6.91 million in funding from the Canadian government. Project partners will include Western University (Ontario, Canada) and 19 industry partners, who were not identified. The goal of the project is to develop, test and license four new image-guided therapies: ultrasound surgery, magnetic resonance imaging intervention; an early feedback system for chemotherapy patients; and a hybrid optical/ultrasound catheter for imaging of coronary atherosclerosis. READ PRESS RELEASE
The Face-time column in a recent issue of the AANS Neurosurgeon featured an interview with Focused Ultrasound Foundation Chairman Neal F. Kassell, MD. Conducted by Jason Sheehan, MD, PhD, a neurosurgeon at the University of Virginia, the interview touched upon Kassell’s career in neurosurgery, his business pursuits and his commitment to advancing focused ultrasound technology. READ STORY
During a June 2 golf tournament, 91-year-old Doris McArdle stepped up to the tee and took a full swing, typical of her approach to life. Nineteen months ago, McArdle was struggling with acute pain and discomfort caused by a large benign pancreatic tumor. Thanks to a series of fortuitous events and a vast amount of personal courage, she travelled to St. Mary’s Hospital in London where she received focused ultrasound treatment on a compassionate care basis. READ STORY
In an in-depth interview, Todd Mainprize, MD discussed MR-guided focused ultrasound and his efforts to use this exciting technology in treating brain tumors. Mainprize is a neurosurgeon at Sunnybrook
Hospital in Toronto and is a Surgeon Scientist affiliated with The Arthur and Sonia Labatt Brain Tumour Research Centre. READ STORY
In a recent email, Sherilyn Conn of Arlington, Texas wrote: “As a perfectly healthy female, who found it necessary to retire as media director of a major Texas school district because of essential tremor, I am thrilled every time I read of the progress of Focused Ultrasound Surgery through the work of its foundation. I watch and pray in hope of what this will mean to my sons, one whom now exhibits the beginning systems of ET, and for my young grandsons, who may face these problems in their adult years knowing there is a solution! Thank you, thank you, thank you for your newsletters. They literally thrill my soul!”
HealthHub, a blog from Brigham & Women’s Hospital, recently profiled the institution’s National Center for Image-Guided Therapy. The blog acknowledged the center’s Co-Principal Investigators Ferenc Jolesz, MD and Clare Tempany, MD for their pioneering work in MR-guided focused ultrasound. Also acknowledged was Nathan McDannold, PhD, leader of a research program that is studying focused ultrasound in treating brain tumors, chronic pain and tremors and in opening the blood-brain barrier to facilitate drug delivery. The center’s is also investigating focused ultrasound treatments for breast and bone tumors and cardiac arrhythmias. READ BLOG
Recent comments by executives of EDAP TMS and US HIFU indicate that interest in focused ultrasound treatment for prostate cancer is increasing among members of the American Urological Association. Marc Oczachowski, Chief Executive Officer of EDAP TMS, said that the company “experienced record attendance and exceptional enthusiasm from U.S. urologists” at its exhibit booth at the AUA meeting, which was held May 19–23, 2012 in Atlanta. He noted that “awareness levels are building” as the company prepares for to submit its Ablatherm-HIFU filing to the US FDA later this year.
Mike Klein, US HIFU Chief Executive Officer said, "We have an unprecedented number of meetings scheduled at AUA.” He added that the company, which is conducting US clinical trials of its Sonoblate system, was “actively seeking insight from urologists to guide the development of HIFU technologies to further enhance the safety and efficacy and identify areas of interest to focus studies and clinical trials for a wide range of applications." READ PRESS RELEASE
During a June 9 workshop hosted by the Foundation’s Liver and Pancreas Program, 20 experts in the usage and research of focused ultrasound for liver ablation met to solidify views and formulate treatment recommendations.
Attendees, who included clinicians, scientists and industry representatives, developed a definition of “the clinical unmet need in the management of liver tumors." They also mapped out recommended structures for pilot and pivotal clinical trials and technical specifications for a liver treatment device. This information is expected to be published as either a white paper or a peer-reviewed article.
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