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.
Our robust scientific program consisted of more than one hundred and seventy presentations and posters – an increase of over 50 percent from our 2010 symposium.
The symposium's key take-away messages were:
Focused ultrasound has never been more promising. The technology, the science and the commercialization of focused ultrasound is marching forward at an accelerating rate. As a platform technology, focused ultrasound has multiple mechanisms of action, and there has been tremendous progress in understanding these mechanisms and how to use them to treat a growing number of diseases and conditions.
We're at risk of hitting a brick wall because of public policy issues. The public policy issues that are confronting the field of focused ultrasound include regulatory, research, funding, reimbursement, intellectual property ownership and tax codes. Symposium keynote speakers, Dean Kamen and U.S. Senator Mark Warner, urged the focused ultrasound community to become engaged – to raise our voices – regarding in these issues. This is a call to action for all of us. Engaging in these issues has become essential to delivering new focused ultrasound treatments to patients.
Federal funding for medical research is likely to decrease in the current economic environment. For the foreseeable future, we will be operating in an environment that is different than what's been in place for the last 10-20 years, a period during which the NIH budget increased seven percent annually. Moving forward, a decrease in federal funding for medical research is extremely possible. Because of current economic realities, the focused ultrasound community needs to find ways to work smarter, to be more efficient and to better utilize federal funding resources. We must collaborate more. Increased collaboration is the ultimate force multiplier for intellectual capital and is the primary stimulant for innovation.
During the weeks and months ahead, the Focused Ultrasound Foundation will keep you informed about our activities and key developments in these three important areas. Working together, we can continue to accelerate the advancement of focused ultrasound therapies and ensure that this revolutionary technology is widely available to patients in the shortest time possible.
Neal F. Kassell, MD Chairman, Focused Ultrasound Foundation
Keynoters Dean Kamen and Senator Mark Warner issue call to action
Keynote speakers at the 3rd International Symposium on Focused Ultrasound – medical device inventor Dean Kamen and U.S. Senator Mark Warner – expressed a common concern: The time has come for the focused ultrasound community to advocate for support from public policymakers and other stakeholders.
U.S. Senator Mark Warner of Virginia
BACKGROUND: Holds more than 440 U.S. and foreign patents for innovative medical devices and other inventions such as the Segway. Founder of DEKA Research and Development Corporation, which develops radical new technologies for diverse applications. Founder of FIRST, an organization that motivates young people to understand, use and enjoy science and technology. MORE ABOUT DEAN KAMEN
BACKGROUND: Founder of cell phone company Nextel Communications, successful venture capitalist and former Governor of Virginia. Elected to the U.S. Senate in 2008, he serves on the Commerce Committee, which has partial oversight of the FDA, and is a member of the "Gang of Eight," a bipartisan group that is committed to establishing a $4 trillion deficit reduction plan. MORE ABOUT SENATOR WARNER
CALL TO ACTION: "Any new technology faces the barriers of complacency, inertia, status quo and vested interests. That's always a reality, but in the case of healthcare where conservatism is really very, very strong, the focused ultrasound community – which is on the edge of breakthroughs in lots of areas – needs to devote some serious resources to educating all the other stakeholders and the public. If they don't, they're going to find they have beautiful science fair projects that will not become a standard of care anytime soon, and that's a big problem.
"I think the focused ultrasound community must educate our political leadership, our regulatory leadership, our medical community, our reimbursement community and the insurance community, about the possibilities of its amazing technology. It's time to create among all the decision makers a real understanding of what the benefits are and what the risks are. If people really understand the potential benefit against the realistic risk, I think decision-making would get much better. If it got better, society would benefit."
CALL TO ACTION: "Even if we speed up the FDA regulatory process, we still have the basic questions: who's going to put the money in at the front end? Will there be public investment in research? On some level, it has to be public investments. However, current plans being laid out will cut the NIH budget by more than 75%. If you believe in the value of public investment in R&D, if you believe that the NIH is an important component of how we are going to get focused ultrasound and other medical technologies into the hands of the public, if you believe that National Science Foundation funding is an important component, if you believe that there is a world outside of private donors and private corporations for public support for research, then your voices need to be heard. Your voices need to be heard in terms of being willing to call out stupid stuff in conversations among friends and anywhere else and fighting back against the anti-science bias that we see in many of our policymakers. Your voices need to be heard in continuing to advocate, not just with each other, but with your policymakers because politicians will actually listen."
New online site can help FUS community speak out regarding sequestration
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.
To follow-up on the "call to action" the focused ultrasound community received from both Dean Kamen and Sen. Mark Warner at the symposium, I encourage everyone in the FUS community who is concerned about the potential long-term impacts of these cuts to take time to access this new site and make their voices heard by contacting members of Congress and other influential stakeholders.
In his welcome message to 2012 symposium attendees, Focused Ultrasound Foundation Chairman Neal F. Kassell, MD noted that serving as "an incubator for collaboration" was the meeting's most important role. Collaboration is of paramount importance, he explained, because it is the "force multiplier" that will enable the focused ultrasound community to maximize and leverage its resources to rapidly advance the entire field.
Focused ultrasound experts conduct media briefing
A briefing for journalists was held at the 3rd International Symposium for Focused Ultrasound. The goal was to educate the media about focused ultrasound technology and the latest developments in the field. Held on Monday, October 15, the briefing was conducted by five leading focused ultrasound experts:
Neal Kassell, M.D.,Chairman, Focused Ultrasound Foundation, USA
Provided an overview of focused ultrasound technology and its overarching benefits, specifically the benefits that make it a viable treatment for Parkinson's disease.
Jeff Elias, M.D., Assistant Professor of Neurosurgery, University of Virginia, USA
Discussed thenew clinical trial evaluating focused ultrasound as a treatment for tremor-dominant Parkinson's disease.
Jaron Rabinovici, M.D., Department of Obstetrics and Gynecology, Chaim Sheba Medical Center, Israel
Explained the use of focused ultrasound to treat uterine fibroids and preserve a woman's fertility, as well as a new effort to establish a registry for uterine fibroid patients treated with focused ultrasound.
Wladyslaw Gedroyc, M.D., Director and Consultant Radiologist, Radiology Department, St. Mary's Hospital, Imperial College, UK
Described efforts to develop focused ultrasound-mediated targeted drug delivery therapies for cancer, as well as his pioneering use of the technology in treating liver, bone and pancreatic tumors.
Brad Wood, M.D., Director of the Center for Interventional Oncology, National Cancer Institute, USA
Addressed the potential of focused ultrasound to enable the delivery of powerful chemotherapy drugs directly to tumors.
Symposium Book Want to review the 170+ abstracts presented at the 3rd International Symposium on Focused Ultrasound? All abstracts and conference details are available in this year's 236-page Symposium Book.
Symposium Presentations Most of the 2012 symposium's 70+ oral presenters have given the Focused Ultrasound Foundation permission to convert their talks into audio-over-slide videos. The first group of these videos is now available for viewing, and more will be posted in coming weeks.View Symposium presentation videos
Electronic and print versions of 2012 Symposium proceedings are now in production and will be available in the near future. Look for an availability announcement in the next issue of this newsletter.
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.
The challenge ahead is to raise $20-25 million during the next three years. The majority of these funds will be invested in research with an emphasis on Parkinson's disease, brain tumors and liver cancer. Our immediate goal is to raise $5 million to continue the current pace of progress.
The Foundation is extraordinarily grateful for the generosity and vision of its supporters who exemplify how venture philanthropy can advance medical research and embody the entrepreneurial spirit of the Foundation and of the pioneering researchers, manufacturers, physicians and others in the focused ultrasound community.
FDA approves focused ultrasound system to treat pain from metastatic bone cancer
When it comes to pain relief, bone cancer patients in the U.S. now have a new treatment option: focused ultrasound. Last month, the FDA approved InSightec's ExAblate MRI-guided Focused Ultrasound System to treat pain associated with metastatic bone tumors. The approval allows treatment of patients who either do not respond to radiation or cannot undergo it, a category that includes about 30 percent of those with metastatic bone cancer.
InSightec's Pre-Market Approval application reviewed by the FDA was based on data from an international, multi-center randomized clinical trial led by radiation oncologist Mark Hurwitz, MD. At the time of the study, Hurwitz was affiliated with the Brigham and Women's Hospital in Boston; he is now Director of Thermal Oncology and Vice Chair of the Radiation Oncology Department at Thomas Jefferson University in Philadelphia.
"Results from the clinical study showed that ExAblate therapy significantly reduces pain caused by bone metastasis," Hurwitz says. "Patients also reported lasting improvement in well-being and function, along with a decrease in the need for medication."
The approval marks the second ExAblate indication green-lighted by the FDA: the system was approved in 2004 to treat symptomatic uterine fibroids. Outside the U.S., commercialization of the system has been advancing more rapidly – the ExAblate has European CE marking for uterine fibroids, bone metastasis and adenomyosis. Twenty hospitals in Europe and the Asia-Pacific now offer ExAblate as a palliative therapy for bone metastasis.
Neurosurgeon W. Jeffrey Elias, MD and his team at the University of Virginia are once again charting new territory for focused ultrasound. As a follow-up to their ground-breaking and successful essential tremor pilot clinical trial, they have launched a new study using focused ultrasound to treat patients with tremor-dominant Parkinson's disease. To be eligible for the study, patients must have symptoms that remain disabling despite optimal doses of medication.
So far, the study has treated four patients and is expected to enroll 26 more. The trial is following a randomized double-blinded protocol, and patients do not immediately know if they are receiving an actual focused ultrasound treatment or a sham procedure.
Dr. Elias and his study team gathered outside the UVA Focused Ultrasound Center in October 2012 following the first patient treatment in the clinical trial for tremor-dominant Parkinson's disease.
The randomization process will ultimately assign 20 patients to the study's treatment arm and 10 to the sham group. Three months after-treatment, assignments will be "un-blinded" and sham arm patients will be eligible to crossover into the treatment group.
On October 8, Royal Philips Electronics announced that its investigational MR-guided focused ultrasound system had treated the first breast cancer patient in a pilot clinical trial at the University Medical Center Utrecht (UMC) in the Netherlands. The company described the design of the new device as "optimized for the anatomy of the female breast."
The study is expected to treat nine more patients with localized breast tumors in coming months. Treatments are not intended to destroy tumors. Instead, they are assessing the image quality, safety and precision of the Philips system. Patients are receiving single or multiple noninvasive focused ultrasound sonications and subsequently undergo a conventional surgical procedure for tumor removal.
The UMC study team gathered for this photo following the first breast cancer patient treatment with a new focused ultrasound system from Philips.
In an interview with the Focused Ultrasound Foundation, UMC study team member, Roel Deckers, PhD, said that the trial has attracted a lot of media attention and public interest, which has been overwhelming. "The recruitment of patients is going very fast," he reported.
Deckers said that preparations are underway for a multi-center Phase 2 clinical trial and that the ultimate goal is for the system to perform complete breast tumor ablations.
Maurice van den Bosch, MD, an interventional radiologist at UMC, is leading the study. Funding is being provided by the Center for Translational Molecular Medicine – a public-private partnership for Netherlands-based translational research – and by Philips and the Netherlands Organization for Health Research and Development.
November 25-30 98th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA 2012 – Patients First), Chicago, USA
December 5 Abstract submission deadline for the Society of Thermal Medicine 30th Annual Meeting (STM 2013 – Focusing on Heat, April 17-21), 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).
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: 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
Focused Ultrasound Foundation | 1230 Cedars Court, Suite F | Charlottesville VA | 22902 Questions and comments about this newsletter should be sent to the Foundation's Director of Communications, Ellen C. McKenna ()