A fruitful year is ending for the focused ultrasound community. The momentum of our work has continued to build, and many exciting, unprecedented developments lie ahead.
The Focused Ultrasound Foundation extends our appreciation for the support, collaboration and generosity you have provided during 2012. Thanks to your commitment and dedication, the number of patients who are benefitting from focused ultrasound treatments is steadily growing, and the coming year is poised for success.
May your holiday season be one of peace, joy and inspiration, and may the New Year be successful and fulfilling, both personally and professionally.
Neal F. Kassell, MD Chairman, Focused Ultrasound Foundation
Foundation announces four new Research Awards
Projects focus on head and neck cancers, knee osteoarthritis, pelvic disease and functional brain mapping
The Focused Ultrasound Foundation has selected four new projects to receive $371,800 in funding through its Research Awards Program, a major and increasingly competitive source of financial support for pioneering focused ultrasound studies. Considered highly promising, the projects could lead to new focused ultrasound treatments for knee osteoarthritis, head and neck cancers and pelvic disease and could facilitate focused ultrasound-mediated functional neurosurgery.
Two newly funded projects are clinical trials that will soon recruit patients. Another is a technical project that will enable the fast-tracking of new treatments for pelvic disease. The fourth project is a preclinical investigation of a pulsed method that could increase the accuracy of transcranial treatments. This project falls into the award program's "high risk" category, a designation for research that could have a profound impact on the advancement of the field of focused ultrasound, yet is deemed too risky to qualify for funding from other sources. Profiles of these four projects will run in future issues of this newsletter.
4Q12 Focused Ultrasound Foundation Research Awards
Funding Category & Amount
Pain Alleviation of MR-guided Focused Ultrasound Surgery Treatment for Painful Medial Compartment of Knee Osteoarthritis
Motohiro Kawasaki, MD, PhD
Kochi Medical School, Japan
MR-guided High Intensity Focused Ultrasound for Squamous Cell Carcinoma of the Head and Neck - A Pilot Study of Safety and Feasibility
Justin W. Lee, MD MSc
Sunnybrook Health Sciences Centre, Canada
MR-Directed Focal Hyperthermia for Pelvic Disease
Chris Diederich, PhD
University of California San Francisco, USA
FUS-mediated Functional Neuromodulation for Neurophysiologic Assessment
High risk $100,00
Seung Schik-Yoo, PhD, MBA
Brigham and Women's Hospital, USA
Foundation Council welcomes three new members
The Focused Ultrasound Foundation Council has added three new members: Amanda Megargel, John B. "Jack" Syer and Jane "Kitchie" Tolleson. Working closely with Foundation leadership and other Council members, they will provide counsel, organize cultivation events and support fundraising and awareness-building activities.
Amanda Megargel was a Vice President in Corporate Finance at Lehman Brothers, where she worked for six years. After investment banking, she worked in interior design in New York before moving to Charlottesville, Virginia where she has served on numerous non-profit boards, including the Brearley School, St. Anne's-Belfield School, Planned Parenthood of the Blue Ridge, CASA and the Music Resource Center. Megargel received her undergraduate degree from Trinity College and her MBA from Columbia University.
John B. "Jack" Syer completed his military service and launched a transportation business, which he led as CEO. He later became President of a regional private equity firm with interests in consumer products, real estate development and technology. In 1994 he stepped into the role of Executive Director of the University of Virginia Alumni Association, a position he held until 2006. He also played a management role with the predecessor of In Home Health in Tidewater, Virginia. Syer has served on the boards of numerous businesses, non-profit and social organizations. He was president of the Norfolk Academy Board of Trustees and the Virginia Athletic Foundation and is a former board member of the General Hospital of Virginia Beach (now Sentara). Syer is a graduate of the University of Virginia and resides in Gulf Stream, Florida and Charlottesville, Virginia.
Jane "Kitchie" Tolleson moved to Virginia 1970 and established a breeding and racing stable with her husband, John Ewald, Sr. She later founded "The Very Thing," a retail shop which grew into a national mail order business. In the early days of the catalogue industry, she drew on her experience as an assistant to a U.S. Senator from Kentucky and became well-versed in public relations and marketing techniques. She has been actively involved with a number of charitable foundations and educational institutions. Tolleson has served on the Board of Stuart Hall School, Sweet Briar College, the University of Virginia Law School Business Advisory Council and Alumnae Council, and The Thomas Jefferson Foundation. She received her undergraduate degree from Sweet Briar College, and attended the University of Virginia Law School and later Georgetown University. She lives in Charlottesville, Virginia, and Gulf Stream, Florida.
EU regulators clear InSightec's ExAblate to perform brain treatments
The ExAblate Neuro is now approved in Europe to treat essential tremor, Parkinsons disease, and neuropathic pain.
On December 4, InSightec announced that its focused ultrasound brain system – the ExAblate Neuro – has received European CE marking. This designation will allow medical facilities throughout the European Union to use the system to treat patients with essential tremor, Parkinson's disease and neuropathic pain. Because CE marking is recognized beyond European borders, the system could soon be cleared for commercial use in other non-U.S. markets as well.
One of the clinical sites that provided supporting data for InSightec's CE marking application was the University of Virginia where a ground-breaking pilot study funded by the Focused Ultrasound Foundation used the ExAblate Neuro to treat 15 essential tremor patients during 2011-2012.
According to InSightec President Kobi Vortman, PhD, "Results from the clinical studies showed that patients, many of whom suffered for years from neurological disorders, experienced immediate symptom improvement with a high safety profile."
Theraclion's EchoPulse receives CE marking for breast fibroadenoma
French ultrasound device maker Theraclion reports that its EchoPulse ultrasonic ablation system (formerly known as the TH-One) has received CE marking for the treatment of breast fibroadenomas, benign, hormone-dependent tumors that affect 10 percent of women and can be painful and disfiguring. Until now, treatment options have been limited to surveillance and surgery.
David Del Bourgo
Theraclion's Vice President of Sales and Marketing David Del Bourgo says the main advantage of EchoPulse treatment is that it makes no incisions and leaves no scar. "In the breast, this is important," he notes. "Treatment is performed under conscious sedation and is totally extracorporeal, totally noninvasive, no radiation." Treatments are completed in 45 to 60 minutes, depending on the size of the fibroadenoma, and patients return home the same day.
CE marking was based on clinical data for 40 patients and 46 tumors. Del Bourgo notes, "Clinical trial results were excellent. We had 100 percent of patients with volume reduction, quick symptom disappearance and no side effects."
The company's commercialization efforts will target France, Germany, Italy, Spain and the UK. Del Bourgo says there is also strong potential in Russia and Eastern Europe and possible opportunities in the United Arab Emirates, Hong Kong, South Korea and India.
InSightec announces completion of new round of financing, executive changes
Davis, Gentile and Vortman will lead company's next phase of growth
Major changes are underway at InSightec. The company has announced a new team of top executives following the completion of a round of additional financing that yielded $30.9 million from GE Healthcare and other investors. InSightec also said it will open a second U.S. office in southeastern Wisconsin to house its sales, marketing and product management groups; its regulatory and CRO teams will remain in Dallas. The company's R&D and Operations teams will stay in Israel. The new executive team includes:
James (Jim) Davis, Chief Executive Officer. Davis has been a Director of InSightec for three years and previously worked for GE Healthcare where he served as Vice President & General Manager of the MRI business and of the US Diagnostic Imaging Commercial Organization. He also worked for GE Aviation and McKinsey & Company, a global management consulting firm.
Tom Gentile, Chairman of the Board of Directors. Gentile has been President and CEO of GE Healthcare since May 2011. Previously, he was Vice President of GE Aviation's Services Division and held a series of leadership positions in GE Capital's businesses in the US, France and Australia, overseeing key acquisitions, consumer product launches and driving profitable growth. Before GE, Gentile held leadership and strategy positions with McKinsey & Company, CBS Broadcasting, and General Motors.
Kobi Vortman, PhD, President and Chief Technology Officer. Vortman founded and shepherded InSightec since its inception in 1999. He is the former President of Elbit Medical Imaging, which together with GE Healthcare (formerly GE Medical Systems) formed InSightec and remains a major company shareholder. Previously, Vortman served as CEO of Diasonics Vingmend Ultrasound and as General Manager of Elscint Ultrasound Imaging. He also worked for RAFAEL (the Israeli Armament Development Authority) in a variety of areas, including marketing, business development, operations and engineering.
InSightec's new CEO Jim Davis said that the company's current top priorities are:
Drive the clinical adoptionofcommercially available indications – InSightec is commercializing its MR-guided focused ultrasound applications for uterine fibroids and pain palliation from metastatic bone tumors. "Both of these applications can truly have positive impacts on a patient's health. We now need to ensure clinicians can get reimbursed when they perform these procedures," Davis said.
Continue making rapid progress in developing treatments for neurological disorders – Clinical trials are underway using MR-guided focused ultrasound for essential tremor and tremor dominant Parkinson's disease. As Davis noted, "While we are thrilled with our recent CE marking, we are about to embark on some very important clinical trials that will provide additional evidence around the clinical efficacy of the procedures."
Boost awareness of focused ultrasound – A key goal, said Davis, is to "create general awareness, amongst patients, physicians and payers, that MR-guided focused ultrasound is a therapeutic platform that is here to stay, and can offer patients with a completely safe and non-invasive therapy option."
Kona Medical raises another $10 million to advance its focused ultrasound renal denervation device
Company's first clinical trial for Surround Sound system launches in Australia
American medical device-maker Kona Medical has raised an additional $10 million in Series C equity and debt financing to advance development and commercialization of Surround Sound, its noninvasive focused ultrasound renal denervation system designed to treat drug-resistant hypertension. The company had announced completion of a $30 million round of financing for the system in May 2012.
In a related development, the company recently announced the initiation of its first clinical trial, WAVE I, at St. Vincent's Hospital in Melbourne, Australia to evaluate the safety and efficacy of the Surround Sound system. Principal investigator Robert Whitbourn, MD said study results could be available next spring.
Renal denervation is one of the fastest-growing interventional therapies for drug-resistant hypertension, and Kona believes its external focused ultrasound device may offer advantages over other methods. Those methods typically require insertion of an energy-emitting catheter into a renal artery. By contrast, the Surround Sound uses a transducer positioned outside the body to deliver targeted ultrasound energy that "surrounds" the artery and treats the nerves located in the vicinity of the vessel.
The privately-held Kona, which is based in Bellevue, Washington, licensed technology for the Surround Sound from the University of Washington. The technology was developed by UW researchers Jessica Foley, James Little and Shahram Vaezy. Foley is now Scientific Director for the Focused Ultrasound Foundation.
EDAP finalizing PMA filing for localized prostate cancer
EDAP TMS reports that it held a productive pre-PMA meeting in November with the U.S. Food and Drug Administration regarding its Ablatherm-HIFU Phase II/III clinical trial for the indication of low risk, localized prostate cancer. Based on guidance received during the meeting, EDAP is finalizing its PMA file for submission in January 2013.
US HIFU is expanding operations in Indianapolis, Indiana, creating up to 27 jobs by 2015. The company is hiring additional highly-skilled technical staff to support manufacturing, quality assurance and regulatory requirements.
"As we continue to hit development and regulatory milestones that bring us closer to the approval and commercialization of HIFU technologies for the treatment of prostate cancer in the United States, we must continually add new talent and expertise to maintain our technology leadership in the HIFU industry," said company CEO Mike Klein.
Brain tumor clinical trial set to begin at the University of Virginia
Jason Sheehan, MD, PhD
Neurosurgeon Jason Sheehan, MD, PhD and his research team at the University of Virginia are finalizing plans for a clinical trial to evaluate focused ultrasound ablation as a treatment for metastatic brain tumors. Because these tumors are not curable, the treatment goal will be to prolong life expectancy, which is now six to 18 months.
Expected to begin in early 2013, and treat up to six patients, the study will assess the basic safety of InSightec's ExAblate Neuro system. Recruitment will target patients with newly diagnosed or recurrent metastatic brain cancer for whom surgery, radiation, or radiosurgery has not been advised by their treating physician. During the three-month follow up period, patients will be evaluated for general health, neurological changes, and efficacy measurements as well as for device/procedure related adverse events.
The Focused Ultrasound Foundation is funding the study.
Sunnybrook nearing completion of essential tremor clinical trial
Michael Schwartz, MD
In a December 19 press release, Sunnybrook Health Sciences Centre in Toronto announced the treatment of the fifth patient in a clinical trial evaluating the safety and initial effectiveness of focused ultrasound in treating medication-refractory essential tremor. Funded by the Focused Ultrasound Foundation, the study is expected to treat six patients in total and follow their progress for three months.
The incision-free ablation treatments are being performed on one side of the brain to impact essential tremor symptoms – disabling shaking of hands and arms – on the opposite side of the body. Patients remain awake and communicative during treatments, which are performed without general anesthesia.
"We are optimistic about the results we are seeing thus far," said the study's Principal Investigator Michael Schwartz, MD, division head of Neurosurgery at Sunnybrook. Cautioning that more research is needed to determine longer-term effects and clinical efficacy, he adds, "This technology could have far-reaching implications for many brain conditions including brain tumors and other movement disorders."
Andres Lozano, MD
Andres Lozano, MD, a neurosurgeon at Toronto Western Hospital, and co-investigator of the study, observed, "There was a clearly visible and dramatic improvement in tremor in the patient cases seen so far. Improvement in the dominant hand is seen while the patient is still in the MRI scanner. Three months post-procedure there were significant improvements in activities such as writing and drinking from a cup, which were not possible prior to surgery."
Kullervo Hynynen, PhD
The essential tremor study has special significance at Sunnybrook. It is evaluating the ExAblate Neuro, a helmet-like transcranial MR-guided focused ultrasound device that was invented and commercialized by Kullervo Hynynen, PhD, director of Physical Sciences at Sunnybrook Research Institute, in collaboration with industry. Currently, the ExAblate – which is manufactured by InSightec – is the only focused ultrasound system on the market with the capability to perform brain procedures.
Abstracts of the 11 ExAblate talks and 4 posters presented at last month's RSNA meeting are posted on InSightec's website. VIEW
Roundtable discussion: "Focal Therapy for Prostate Cancer"
Touch Medical, European Urological Review, December, 2012
Round table discussion panelist Louise Dickinson, MD was one of the Focused Ultrasound Foundation's 2012 Young Investigator Award recipients.
The edited transcript of a moderated discussion sponsored in August 2012 by International HIFU (a division of US HIFU) is available for downloading or online viewing. During the discussion, "Focal Therapy for Prostate Cancer," participants responded to a series of questions about focal therapy, addressed the concept of focal lesion diagnosis and treatment, and offered opinions about technologies that may impact the evolution of the ‘focal paradigm.'
Discussion participants: Joyce Bomers - Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands Louise Dickinson - University College Hospitals London NHS Foundation Trust, London, UK Jurgen J Fütterer - Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands and MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands Jelle Barentsz -Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands and MIRA Institute for Biomedical Technology and Technical Medicine, University of Twente, Enschede, Netherlands Aaron Katz - Winthrop University Hospital, Stony Brook University School of Medicine, New York, USA Laurence Klotz - Sunnybrook Health Sciences Centre, Toronto, Canada Mark Schoenberg - The Johns Hopkins University School of Medicine, Maryland, USA Osamu Ukimura - The University of Southern California School Medicine, California, USA
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
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).
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 ()