May 2011: FUSF Research Award Disbursements Top $2 Million, New Funding Schedule Set and more...

Dear Reader,

This month we celebrate a major milestone for the Focused Ultrasound Surgery Foundation's Research Awards Program— $2 million in disbursements. We also present profiles of our most recent research award recipients: Wladyslaw M. Gedroyc, M.D. of St. Mary's Hospital in London, UK; Natasha Rapoport, Ph.D. of the University of Utah, USA; Richard J. Price, Ph.D. of the University of Virginia, USA; Mario Ries, Ph.D., of the Laboratory for Functional and Molecular Imaging in Bordeaux, France; and W. Jeffery Elias, M.D., of the University of Virginia, USA.

The $2 million in disbursements encompasses 20 investigator-initiated projects ranging from preclinical research to pilot clinical trials. Research proposals are reviewed by an independent and multidisciplinary Research Advisory Committee, and funding decisions are based on a project's ability to rapidly advance the development of reimbursable clinical indications of MR-guided focused ultrasound.

Since its inception in September 2007, the Research Awards Program has filled a funding void for focused ultrasound researchers by providing "seed money" for highly promising studies. This funding enables researchers to compile the preliminary data needed to apply for the more substantial grants — from government agencies and other sources — needed to move their work toward clinical reality.

The vast majority of Research Award recipients have succeeded in receiving follow-on funding. Five of the eight researchers who have completed their projects — 62 percent — have obtained funding to carry on their work, and two others are pursuing added financial support. With the number of applications and the quality of proposals dramatically increasing, the program's success in jump-starting important advancements in MR-guided focused ultrasound appears likely to continue.

FUS Foundation Research Award Program tops $2 million in disbursements, announces changes to funding cycle

The Focused Ultrasound Surgery Foundation reports that its research award disbursements have exceeded $2 million and funding applications have soared in recent months. To manage the surge in applications, the Foundation has replaced its rolling funding process with a quarterly schedule.

"Ever since our 2010 symposium and the more recent Focal Drug Delivery workshop, the Foundation has been inundated with funding applications," says Hannah Edelen, Research and Fellowship Program Director. "In addition to an increase in the number of applicants, we see a major increase in the quality of the proposals we receive — which I think bodes well for the future of therapeutic focused ultrasound."

Edelen explains that, since its inception in September 2007, the Research Awards Program has accepted applications and announced funding decisions on a rolling basis. "We're still accepting and reviewing abstracts on a rolling basis," she says. "Applicants will receive feedback on their abstracts within ten business days. The big change is that researchers invited to develop a full proposal will be asked to submit their materials by a quarterly deadline."

Submission deadlines for full proposals are July 1, October 1, January 3 and April 1. Edelen expects these dates to remain in effect indefinitely rather than change from year to year.

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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 clinical trial marks the next step in Gedroyc's pioneering efforts to develop a noninvasive treatment for facet joint disease that provides more complete and longer-lasting pain relief than current therapies. He and his team at St. Mary's have already conducted a non-randomized pilot clinical trial in which MR-guided focused ultrasound was used to treat 17 patients suffering from extreme back pain caused by facet joint osteoarthritis. Post-treatment assessments show the treatment is safe and reduces pain and disability by up to 60 percent, as measured by NRS and Oswestry Disability Index scores.

According to Gedroyc, the success of the randomized trial could lead to "a method of treating facet joints with an entirely noninvasive modality."

"No radiation will be involved. Just an MR scan using focused ultrasound," he explains. "The patient would come in, lie down on the table. We would treat probably three facet joints on each side, and they will walk out. And we anticipate that we could do this in about half an hour or so. If it is long-lasting, then we have a huge potential for improving the way patients are treated, requiring no more injections."

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	Natasha Rapoport, Ph. D.

Natasha Rapoport, Ph.D., a native of Russia and research professor of bioengineering at the University of Utah, knows something of pain and trauma. Her physician father, Yakov, was jailed in 1953, wrongly accused in the infamous, yet fictitious "Doctor's Plot" to assassinate Stalin. Natasha was 14 when she opened the door and her beloved papa was whisked away to be manacled and interrogated. Yakov Rapoport survived, and both father and daughter later wrote memoirs. Yakov has died, and Natasha has traded the Moscow forests for Salt Lake's desert. But she carries on the family scientific tradition in a quest to make currently fatal pancreatic cancer a chronic, or even curable, disease.

Rapoport is the recipient of a $100,000 research award from the Focused Ultrasound Surgery Foundation to study the mechanisms of ultrasound action and its role in delivering cancer drugs to tumors. Her project will combine results from two powerful imaging modalities, MRI and RFP (red fluorescent protein), to study in vivo how the cancer drug paclitaxel is delivered by ultrasound to effectively kill pancreatic cancer cells. "My goals and the goals of the Foundation are so much alike," Rapoport says. "I want to see my development getting into clinical trials and hopefully into clinical practice."

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	Richard J. Price, Ph. D.

Richard J. Price, Ph.D. is investigating a novel combination of nanoparticles, microbubbles and focused ultrasound — a combination he believes could effectively treat and possibly cure diseases of the central nervous system, including brain tumors, dementia and Parkinson's disease.

Price is Associate Professor of Biomedical Engineering at the University of Virginia and Research Director of UVA's Focused Ultrasound Center. With a $100,000 research award from the Focused Ultrasound Surgery Foundation, he is studying whether nanoparticles, in combination with microbubbles the size of a red blood cell, can actually deliver targeted therapies across the tight blood brain barrier (BBB) to kill glioblastoma multiforme tumors when oscillated with a focused ultrasound beam. Highly aggressive and deadly, glioblastomas, or GBMs, are the most common form of primary brain cancer and have an extremely poor prognosis.

Besides surmounting the daunting technical challenges of delivering drugs across the BBB, Price's approach will use smaller doses of chemotherapy and deliver higher concentrations of drugs to tumors than current cancer therapies. For patients, the new treatment could mean less systemic toxicity, fewer side effects and more effective therapy.

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	Mario Ries, Ph.D.

Mario Ries, Ph.D., a physicist at the Laboratory for Functional and Molecular Imaging in Bordeaux, France, has been intrigued with the notion of combining non-invasive ablation with MR guidance since 1997. Today, his key ambition is to help the million-plus people who are diagnosed globally with breast cancer every year.

Ries has received a $100,000 research award from the Focused Ultrasound Surgery Foundation to pursue a project he believes will result in a safer and more effective treatment for breast cancer. His objective is to eliminate the technical drawbacks that cause existing high intensity focused ultrasound (HIFU) transducers — devices that convert energy into sound waves and focus the waves on a target — to damage tissue around the breast, including to the thoracic cage, heart and lungs. Ries estimates he is about one year away from knowing whether his proposed solution has scientific merit. If his proposal comes to fruition, it would be about two years before clinical trials could begin.

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	W. Jeffrey Elias, M.D.

The first award supports preclinical research of the safety, feasibility and histology (tissue structure) of MR-guided focused ultrasound compared to other intracerebral lesioning techniques, specifically Gamma Knife radiosurgery and surgical implantation of heating probes. The second award funds a safety and feasibility study of focused ultrasound in treating residual symptoms of people who have undergone deep brain stimulation, which is the primary therapy for Parkinson's disease and similar movement disorders.

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The April 27, 2011 patient education event in Houston, Texas hosted by the Focused Ultrasound Surgery Foundation's patient support organization, Fibroid Relief, was highly successful. Highlights include:

• 180 attendees
• A stellar panel of physicians: John Fischer, M.D., Department of Radiology, St. Luke's Episcopal Hospital; Robert Zurawin, M.D. Associate Professor of Gynecology, Baylor College of Medicine; and Denise Nebgen, M.D., PhD, DDS, Department of Obstetrics and Gynecology, The Methodist Hospital
• Busy exhibit booths from St. Luke's Episcopal, Methodist Hospital, InSightec and Abbott Laboratories (all sponsors)
• A lengthy question-and-answer session with an inquisitive and receptive audience
• Many enthusiastic and gracious comments from the attendees to Fibroid Relief staff at the end of the event
• A strong interest in focused ultrasound therapy, especially in the clinical trial at Methodist Hospital.

The event marked the first time that Fibroid Relief worked in partnership with two focused ultrasound centers, each of which is using a different device to noninvasively treat uterine fibroids. The Methodist Hospital is performing treatments with the FDA-approved InSightec ExAblate System and St. Luke's is a clinical trial site for the Philips Sonalleve System.

Panelists (from left to right) John Fischer, M.D., Robert Zurawin, M.D. and Denise Nebgen, M.D., PhD, DDS engaged in a lengthy question and answer session with the audience.		Event attendees expressed a strong interest in focused ultrasound

During his recent visit to the FUS Center at the University of Virginia, Governor Bob McDonnell (third from left) acknowledged that medical technology is an important component of the state’s economic future. University representatives included (from left to right): FUS Center Research Director Richard J. Price, Ph.D., FUS Center Director James Larner, M.D., Vice Rector Helen E. Dragas, Executive Vice President and Chief Operating Officer Leonard Sandridge, and FUS Center Co-Director Alan Matsumoto, M.D.

Governor Robert (Bob) McDonnell of Virginia visited the Focused Ultrasound Center at the University of Virginia on April 21, 2011 to learn about its innovative technology. The Governor said he also wanted "to find out how we can support and magnify these efforts." Dedicated in September 2009, the center is the first to receive the Focused Ultrasound Surgery Foundation's "Center of Excellence" designation and is a hub for performing multidisciplinary preclinical and clinical research, training and patient treatments at the highest level.

Construction of the UVA center was made possible by a $4.0 million grant from the Commonwealth of Virginia, a $3.1 million donation from the Focused Ultrasound Surgery Foundation and in-kind giving from InSightec, Ltd. and General Electric. The center recently launched the world's first clinical trial in which MR-guided focused ultrasound is used to treat essential tremor. Other clinical trials at the center are evaluating the use of MR-guided focused ultrasound for the palliation of pain associated with metastatic bone tumors and to treat uterine fibroids.

The FUS Center is also offering commercial treatments for uterine fibroids and engaging in a robust preclinical research program for applications such as epilepsy, stroke, Parkinson's disease and targeted drug delivery.

During his visit, Governor McDonnell said, "Medical technology represents perhaps the greatest growth industry in Virginia." He noted that new medical technology is a critically important part of the state's future and could improve the quality of life for patients, cure diseases and improve the economy by creating jobs.

On April 14, the Governor of Brazil's São Paulo state, Geraldo Alckmin, officially inaugurated the new ExAblate System at ICESP, the largest cancer center for adult patients in Latin America. Opened in May 2008, the center provides all stages of care – from diagnosis to rehabilitation – to 6,000 patients a month.

ICESP has been providing treatments with the ExAblate System since February 2011 and is the first site in Latin America using the system for oncology research. According to Marcos Roberto de Menezes, M.D., director of ICESP's diagnostic imaging sector, the system has been used to treat six uterine fibroid patients and five patients participating in a clinical trial for bone metastases. In coming months, the site plans to launch clinical trials for breast cancer and benign bone tumors (osteoid osteoma). "We have a strong interest in research in the field of targeted drug delivery," de Menezes adds.

On April 28, Philips Healthcare celebrated the launch of its Sonalleve system in India. The system is being installed in the Apollo Hospitals chain and at Piramal Diagnostics.

At the launch event, Krishna Kumar, vice president and business head for Philips Healthcare, India, said, "The future of medicine in our view will be image-guided, noninvasive and without radiation, and Sonalleve represents the convergence of these three principles for improving the lives of women with uterine fibroids and people with malignant tumors. The launch of Sonalleve is yet another testimonial to Philips' commitment to bring cutting-edge innovations to solve key healthcare challenges like tumors that face India."

Dr. Prathap C. Reddy, the founder and chairman of Apollo Hospitals observed, "I am really happy that such a technology has been brought by Philips – it is safe and radiation-free, and a boon for women with fibroids. Apollo will have this technology at all its hospitals."

A special highlight of the 2011 International Society of Therapeutic Ultrasound meeting, held in New York City from April 11-13, was the awards ceremony honoring three researchers:

• Kullervo Hynynen, Ph.D., Sunnybrook Health Sciences Centre, Toronto, Canada — winner of the William and Frank Fry Award for outstanding contributions to therapeutic ultrasound
• Jean François Aubry, Ph.D., Institut Langevin (ESPCI), Paris, France — winner of the Fred Lizzi Early Career Award
• Yao-Sheng Tung, a Ph.D. candidate in Biomedical Engineering, Columbia University, New York City, USA — winner of the Nadine Barrie Smith Student Award for exemplary achievements

The meeting, which received sponsorship support from the Focused Ultrasound Surgery Foundation, drew approximately 300 attendees and featured 250 presenters. ISTU plans to make conference proceedings available online to its members.

ISTU President Larry Crum, Ph.D. announced that the 2012 meeting will be held in Heidelberg, Germany and that the group's 2013 meeting will be held in Shanghai, China. Dates and further details are yet to be announced.

	Roberto Passariello, M.D.
	Neal F. Kassell, M.D.

The call for abstracts is set to open on May 30 and close on July 29 for the 1st European Symposium on MR-guided Focused Ultrasound Therapy. Organized by the Department of Radiology of the University of Rome La Sapienza, the symposium will be held September 22 and 23, 2011 in Rome.

Directed to physicians of various sub-specialties, physicists and basic scientists throughout the European Community, the symposium seeks to bridge the gap between basic research and clinical activity. Topics being covered by its faculty of global thought leaders and researchers include: technology, brain, breast, bone tumors, liver, pancreas, prostate, uterine fibroids, targeted drug delivery. The symposium will conclude with an oncology round.

Serving as Symposium Presidents are Roberto Passariello M.D., Professor of Radiology and Chairman, Department of Radiology at Sapienza University of Rome and Neal F. Kassell, M.D., Professor of Neurosurgery at the University of Virginia and Founder of Focused Ultrasound Surgery Foundation, which is a conference sponsor.

In addition to Passarriello, the symposium organizing committee consists of two other members of Sapienza's Radiology Department: Carlo Catalano, M.D., Vice Chair and Head of CT and MR Sections and Alessandro Napoli, M.D., Ph.D., Head of MR-guided FUS Unit.

Complete information about the symposium >

	During a recent lecture at the University of Virginia, IMSaT Deputy Director Sandy Cochran, Ph.D. (right) posed with UVA FUS Center Director James Larner, M.D. (center) and FUS Foundation Focal Drug Delivery Program Director Joy Polefrone, Ph.D. (left).

Instructors will be Alex Volovick and Osnat Dogadkin from InSightec, who work at the IMSaT as part of the Nanoporation project.

Course participation will be limited to six hands-on students and 14 observational registrants. Tuition is £300 for students and £100 for observers.

Registration for the MR-guided focused ultrasound course can be completed via the University of Dundee Online Shop. Questions about the course can be directed to Dr. Rachel Toomey at Dundee.

Information about Scottish Image-Guided Intervention Week can be obtained by emailing interventionweek@dundee.ac.uk

Questions and comments about this newsletter should be sent to the Foundation's Director of Communications, Ellen C. McKenna (emckenna@fusfoundation.org)