June 2013: Grant from M.J. Fox Foundation Will Fund Focused Ultrasound Study and more...


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FUSF Newsletter
Volume 56 | June 2013
Also in this issue


Experts push the brain treatment envelope >
Foundation donors contribute online >
Meyers receives Research Award >
Minetti named Director of Development >
OSEL visit >
Fibroid talks can be viewed online >

FUS Instruments introduces new preclinical system >
InSightec is $1 million B.R.A.I.N. Prize finalist >
SonaCare uses SmartTarget in treating prostate cancer >
Mirabilis advancing HIFU system for fibroids >
Focal.One receives CE Mark for prostate cancer treatment >
2014 FDA panel meeting expected for Ablatherm >

Neurosurgery meeting spotlights transcranial focused ultrasound studies >
Chinese FUS community has strong showing at ISTU 2013 >
Study shows FUS brings relief to bone metastases patients >

Local Organization Targets Shaking Caused By Parkinson's >


2nd European Symposium on Focused Ultrasound Therapy >


The 1st Yangtze International Summit of Minimally-invasive and Noninvasive Medicine >
2013 American Association of Physicists in Medicine Annual Meeting >
25th Conference of the International Society for Medical innovation and Technology >
Michael J. Fox Foundation 7th Annual PD Therapeutics Conference >
Funding news:
Grant from M.J. Fox Foundation will fund focused ultrasound study

"As we move forward, our goal is to build innovative collaborations with other stakeholders such as the MJFF. We believe this is the most effective approach to rapidly advance new treatments for patients with unmet medical needs."

- Neal Kassell, MD




The Focused Ultrasound Foundation has received a $600,000 grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to help fund a pilot patient study to determine the feasibility, safety and preliminary efficacy of magnetic resonance-guided focused ultrasound for the treatment of dyskinesia in Parkinson's disease.

"This study will open up a new frontier for focused ultrasound therapy," said Foundation Chairman Neal Kassell, MD. "The Michael J. Fox Foundation is strategic with how they allocate their donor dollars, and we are pleased they are helping assess focused ultrasound as a potential treatment of dyskinesia in patients with Parkinson's."

Dyskinesia is a difficulty or distortion in performing voluntary movements and is probably the most challenging of the drug therapy complications faced by Parkinson's disease patients, affecting their quality of life. Study patients will include those who have failed medical therapy, who are not candidates for surgery or who choose not to undergo surgery.



The area in red indicates where thermal ablation is highly possible. The green area shows the remaining intracranial volume, a new frontier for focused ultrasound.

How far can the brain treatment envelope be pushed?

During an invitational workshop convened this month by the Focused Ultrasound Foundation, leading academic focused ultrasound researchers explored the possibilities and challenges of expanding the areas of the brain that can be safely and effectively treated with the ablative energy of focused ultrasound.

"The treatment envelope workshop was a dynamic and well-attended forum where clinicians, researchers and industry representatives gathered for two days to discuss the future of focused ultrasound technology for the treatment of brain disorders," reported the Foundation Brain Program Technical Director John Snell, PhD. "The attendees created a research roadmap that will address the current technical limitations of currently deployed clinical systems so that in the near future we will be able to address a wider selection of important brain indications like epilepsy and brain tumors."

Topics discussed during the meeting included: definition of treatment envelope, issues and importance; clinical experience and treatment envelope measurements; where do we go from here; roadmap for increasing the treatment envelope; and new projects needed to expand the treatment envelope.

More detailed coverage of the meeting will appear in next month's issue.


"I know what an impact the use of Focused Ultrasound can have on the medical community and, of course, those who are ill."

- Karen Harris Donor


Foundation donors can now contribute online

One of the newest features of the Focused Ultrasound Foundation's home page is a small green copy block on the upper right. Labeled, "Make a Gift," the clickable button represents a new channel through which Foundation donors can contribute to our work.

The first donor to access the new feature was Karen Harris. She's following focused ultrasound developments on behalf of her husband, who is impaired by essential tremor. In a note to the Foundation, Harris wrote:

"I can't help but think of an old episode of STAR TREK when Bones (the doctor) refers to the "barbarians" in the 20th century who actually cut into their patients. At the time, not cutting seemed like an impossibility under any circumstances, but obviously with the current technology, the potential seems endless. We will continue to monitor the progress of the Foundation; I have told many people about it and they have all been thrilled to know there is hope for them and their loved ones."

Announcing our 2Q13 Research Award recipient – Craig Meyer, PhD
Project could impact safety, efficacy and clinical efficiency of focused ultrasound treatments
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. Meyer, who is an associate professor of Biomedical Engineering and Radiology at the University of Virginia, will initially develop the method for use in brain applications.
Pamela Minetti is new Director of Development
Pamela Minetti has joined the Focused Ultrasound Foundation as Director of Development, succeeding Kimberly Skelly who has returned to James Madison's Montpelier as Executive Vice President for Advancement. In her new role, Minetti will collaborate with the Board of Directors, the Council and staff to promote awareness of the Foundation and to advance all fundraising activities.

The Foundation team met with the OSEL Ultrasonics team on June 6


Foundation explores potential collaboration with FDA scientific team
On June 6, members of the Ultrasonics team from the FDA's Office of Science and Engineering Laboratories (OSEL) visited Focused Ultrasound Foundation headquarters to exchange information about current projects and explore potential collaborations. The group also toured the Focused Ultrasound Center of Excellence at the University of Virginia. "The meeting was very productive, and we identified several potential collaborations that should help us to better serve the FUS community," reports Foundation Scientific Director Jessica Foley, PhD.


"The Future of Fibroid Treatment" videos are available online
The Focused Ultrasound Foundation's patient support organization, Fibroid Relief, has expanded its online content to include videos geared toward medical professionals. The first group of videos was shot at the "The Future of Fibroid Treatment" symposium sponsored by Fibroid Relief in May 2013. The videos feature experts from the Cleveland Clinic, Baylor College of Medicine and Sheba Medical Center discussing patient needs, the role of focused ultrasound as a non-invasive treatment for uterine fibroids and the goals and purpose of the global RELIEF patient registry. The registry will track long-term outcomes of uterine fibroid patients treated with focused ultrasound.

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RK 300 System

FUS Instruments introduces small bore preclinical imaging system
FUS Instruments of Toronto has announced the availability of a new small bore preclinical imaging system, the RK 300. The high intensity focused ultrasound device fits in a 70 mm diameter MRI bore and can be used to perform noninvasive hyperthermia, ablation and blood brain barrier opening. The RK 300 includes image guided targeting software, an integrated computer controlled high precision two axis positioning system, and a calibrated focused ultrasound transducer.
InSightec is $1 million B.R.A.I.N. Prize finalist

Focused ultrasound device maker InSightec has been named one of ten finalists competing for the $1 million B.R.A.I.N. Prize that will be awarded in October 2013 by the nonprofit organization Israel Brain Technologies (IBT). An acronym for Breakthrough Research And Innovation in Neurotechnology, the B.R.A.I.N Prize will recognize an individual, group or organization for a recent breakthrough in the field of brain technology.

The finals phase and awards ceremony for the prize will take place at BrainTech Israel 2013, an international brain technology conference that IBT is hosting in Tel Aviv from October 14 to 15.


Mark Emberton, MD of University College London led clinical studies using SmartTarget software.

SonaCare adds SmartTarget software to its prostate cancer device
During the American Urological Association meeting in May, SonaCare Medical showcased the new SmartTarget registration and fusion software developed at University College London in the United Kingdom. The software, which combines and displays diagnostic information from MR-imaging with live ultrasound images to enable targeted prostate treatment, will be integrated into SonaCare's Sonablate 500 HIFU system, which is now approved for use in more than 30 countries outside the U.S.
Mirabilis raises $7 million to advance HIFU system for uterine fibroids
U.S.-based Mirabilis Medica has raised $7 million in new financing to advance research and development of its high-intensity focused ultrasound (HIFU) system for the treatment of uterine fibroids. The company, which said it may raise an additional $6 million in this round of financing, is conducting clinical studies outside of the United States. The Mirabilis system has not been approved for sale or use in the U.S.
Focal.One system receives CE Mark for prostate cancer treatment
EDAP TMS announced on June 18, 2013 that it received the CE Mark (European regulatory approval) for its Focal.One, a robotic HIFU device that performs a focal targeted treatment for prostate cancer. The CE Mark positions the system for full commercialization in Europe and in many other countries.

Marc Oczachowski

FDA panel meeting expected in 2014 for Ablatherm prostate cancer device

EDAP Chief Executive Officer Marc Oczachowski has provided a regulatory update on its Pre-Market Approval Application (PMA) for the Ablatherm-HIFU system, which treats prostate cancer. "The 100-day meeting with the FDA, held on June 3, provided a discussion forum with the FDA regarding our PMA application. Based on this meeting as well as the FDA's device review process and associated 'Review Clock', EDAP anticipates a panel meeting next year," he said.

EDAP submitted the PMA in February 2013 after completion of a multi-center U.S. Phase II/III clinical trial. If approved by the FDA, the Ablatherm will be the first focused ultrasound system cleared in the U.S. to treat prostate cancer. The system is approved and being commercialized in Europe.

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Jin Woo Cheng, MD and W. Jeffrey Elias, MD

Nir Lipsman, MD

Neurosurgery meeting spotlights transcranial focused ultrasound

High intensity focused ultrasound was a hot topic at this year's meeting of the World Society of Stereotactic and Functional Neurosurgery, held in Tokyo from May 27-30. The opening day Breakfast Session was entitled, "High Intensity Focused Ultrasound," and featured a distinguished roster of clinical researchers: Professor Jin Woo Cheng, MD of Yonsei University Medical Center in Korea, W. Jeffrey Elias, MD of the University of Virginia in the U.S. and Nir Lipsman, MD of Sunnybrook Health Sciences Centre Canada.

Later in the morning, Elias opened the conference with a talk, "MR-guided Focused Ultrasound Thalamotomy for Essential Tremor - One Year Results." At lunchtime, Cheng championed HIFU during a debate entitled, "The Future of Ablative Neurosurgery." During the afternoon, Lipsman presented, "Magnetic Resonance Guided Focused Ultrasound for Unilateral Thalamotomy in Medication Refractory Essential Tremor."

Following the talks, InSightec's Director of Neuro Programs Eyal Zadicario reported, "There was great interest in focused ultrasound and lots of debate on its clinical role. This was groundbreaking for FUS technology. Recognized as a promising technology that may revolutionize the field of functional neurosurgery, FUS is now on the front stage with anticipation for more progress in the future."


2013 Fry Award recipient Feng Wu, MD, PhD

ISTU agenda includes more clinical studies
Feng Wu, MD receives 2013 Fry Award
Held in Shanghai, China from May 12-15, the 2013 meeting of the International Society of Thermal 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.

Joshua E. Meyer, MD led Fox Chase study

Fox Chase study shows focused ultrasound brings relief to patients with painful bone metastases

On June 3, scientists from Fox Chase Cancer Center in Philadelphia reported that a high-dose of ultrasound targeted to painful bone metastases appears to quickly bring patients relief, with largely tolerable side effects. Data reported during the 49th Annual Meeting of the American Society of Clinical Oncology showed that 67 percent of 107 patients treated with focused ultrasound said their pain was "much improved" within days of their procedure and that relief continued through the end of the three-month follow-up period. In comparison, 20 percent of 35 patients who received a "sham" treatment reported some pain relief.

Study author was Joshua E. Meyer, MD, attending physician in the Radiation Oncology Department at Fox Chase. Co-authors include Mark Hurwitz, MD, Pejman Ghanouni, MD and Suzanne LeBlang, MD.

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TV station reports on Foundation's Parkinson's research (June 19, 2013, CBS-19, Charlottesville, Virginia) – Focused Ultrasound Foundation team members Matt Eames, PhD and Pamela Minetti, MBA provided a background on focused ultrasound, Parkinson's disease, dyskinesia and the new clinical studies that will be funded with a $600,000 grant received from the Michael J. Fox Foundation for Parkinson's Research.

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2nd European Symposium on Focused Ultrasound Therapy, Rome, Italy, October 10-11, 2013 Abstract submission deadline is July 15, 2013 and acceptance notifications will be received no later than July 31. Abstracts can only be submitted electronically through the symposium web site.

The symposium program will include scientific presentations and invited lectures on technological, pre-clinical and clinical applications of MR-guided focused ultrasound. Other aspects of the meeting will include lively group discussions, a poster session, walking tours and learning workshops devoted to clinical, technical, regulatory and reimbursement topics. Registration and information.


July 13-14, 2013
The 1st Yangtze International Summit of Minimally Invasive and Noninvasive Medicine, Chongqing, China

Message from the Organizing Committee

"We sincerely hope that more participants from North America will attend this year's summit, which will significantly enhance the communication and collaboration among North America, Asia and Europe in the field of minimally invasive and noninvasive medicine."


A follow-up to the 1st International Summit of Noninvasive Ultrasound Treatment in 2009, the Yangtze International Summit provides a forum where clinicians, physicians, specialists will share practical experience of minimally invasive and noninvasive medicine and discuss exciting advancements and improvements in clinical applications.

Topics will include radiofrequency ablation (RFA), transcatheter arterial embolization/ transcatheter arterial chemo-embolization (TAE/TACE) and HIFU therapy, including HIFU treatment for uterine fibroids and adenomyosis, liver, pancreatic cancer, bone tumors, et al. Discussions will include the formation of a professional society and promotional strategies. The summit is accepting abstracts for clinical and basic research using HIFU and ultrasound therapy for tumor and non-tumor diseases. For more information about this program, contact Nick Yin of Chongqing Haifu Medical Technology Co., Ltd.

For more information about this program, contact Nick Yin of Chongqing Haifu Medical Technology Co., Ltd.

August 4-8, 2013
2013 American Association of Physicists in Medicine Annual Meeting, Indianapolis, Indiana, USA

Members of the focused ultrasound community attending this meeting will not want to miss the Ultrasound Symposium on Tuesday, August 6.

September 5-7, 2013
25th Conference of the International Society for Medical Innovation and Technology (SMIT), Baden-Baden, Germany

October 24, 2013
Michael J. Fox Foundation 7th Annual PD Therapeutics Conference, New York City, NY, USA

This year's conference is chaired by Dr. Warren Olanow and is being held in partnership with The New York Academy of Sciences. The program will feature innovative MJFF-funded research and highlight research advances in several areas that impact Parkinson's disease therapeutic development. About 250 academic and industry researchers are expected to attend.

The Focused Ultrasound Foundation is among the select MJFF funding recipients invited to present posters of their work at the conference. The Foundation's poster will be based on the MJFF-funded project, "A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Unilateral Pallidotomy in the Treatment of Dyskinesia of Parkinson's Disease."

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Focused Ultrasound Foundation | 1230 Cedars Court, Suite F | Charlottesville VA | 22902

Questions and comments about this newsletter should be sent to Ellen C. McKenna (emckenna@fusfoundation.org)