First Parkinson's patients scheduled for treatment in Foundation-funded study at UVA
Jeffrey Elias, MD
Focused ultrasound research will enter new territory in October when University of Virginia neurosurgeon W. Jeffrey Elias, MD performs the first investigational treatments on patients with tremor-dominant Parkinson's disease. The study, which is being funded in part by the Focused Ultrasound Foundation, will enroll 30 patients and use a double-blinded protocol to randomly assign them to either treatment or control (sham treatment) groups. Designed to evaluate focused ultrasound's safety and preliminary efficacy in treating tremor-dominant Parkinson's disease, the study will follow patients' progress for one year.
Initially, 20 of the 30 study patients will be assigned to the treatment group. The remaining 10 patients will receive a sham treatment. Three months later, the 10 will be eligible to cross over into the treatment group and receive focused ultrasound therapy.
Konofagou receives Foundation Research Award to study FUS-mediated treatment for neurological and neurodegenerative diseases
Elisa Konofagou, PhD
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 preclinical 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.
Fundraising the entrepreneurial way - Howard and Fredi Stevenson join Foundation Council
Howard and Fredi Stevenson
Forbes Magazine called him a "$1 billion fund-raiser," an apt moniker for Howard Stevenson, PhD Sarofim-Rock Baker Foundation Professor and Senior Associate Dean at Harvard Business School, and Director of Publishing and Chair of the board for Harvard Business Publishing Company.
His wife, Fredi, is a powerhouse is her own right. A member of numerous nonprofit boards, she co-founded Summer Search Boston, an organization that supports hundreds of low-income high school youth each year in continuing their education and becoming responsible and altruistic leaders — 100% of participating students have graduated from high school, and 94% have gone on to college.
In addition to the Foundation's philanthropic mission of helping patients, the Stevensons are intrigued by challenges to healthcare innovation. They see focused ultrasound as the kind of novel approach that could transform the treatment landscape for multiple diseases, and as a result, could potentially change the entire medical development paradigm.
Celebration of Science aims to re-energize America's commitment to bioscience
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 from the public and private sectors. In panels and talks, they gathered to share ideas and deliver the message that America should recommit itself to bioscience.
Inspiration for the event came from philanthropist and FasterCures Chairman Michael Milken. He wrote, "Today's bioscience revolution can bring more benefit to the world than all the scientific progress of modern history. It has the potential to address several pressing global challenges — energy, the environment, defense and the supply of food and water. Most important, bioscience is our key to unlocking the causes and potential cures of disease."
The Focused Ultrasound Foundation had several representatives at the event, including Chairman Neal Kassell, MD who participated in a special retreat, "Accelerating Innovation in the Bioscience Revolution," on September 7. Kassell also spoke about focused ultrasound during a panel discussion on September 9, entitled, "Biological Effects of Physical Energy."
Vendor Profile: Alpinion Medical Systems offers a pre-clinical focused ultrasound system
VIFU 2000: Preclinical HIFU System
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.
"Early in our HIFU development, we recognized the need for a preclinical HIFU product to improve research productivity and efficiency," said Yu-chi Chu, Director of Alpinion US. "Our goal is to provide a flexible turn-key ultrasound image-guided HIFU system that enables scientists to expand their research and improve efficiency in developing future clinical applications."
EDAP reports strong revenue growth, plans FDA submission for its focused ultrasound treatment for prostate cancer
On August 30, French focused ultrasound device maker, EDAP TMS SA announced strong financial results for second quarter 2012, which ended on June 30. The company said that year-over-year revenues increased by 61 percent to $7.8 million and were driven by sales of its lithotripsy device.
The company is now seeking FDA approval of its Ablatherm High Intensity Focused Ultrasound System in treating localized prostate cancer. CEO Marc Oczachowski said EDAP is on track to file its Premarket Approval (PMA) submission during the fourth quarter of 2012.
"Our phase I observational pilot study has evaluated an innovative new technique that is both non-invasive and radiation free. It is the first description of this procedure in the literature," noted Weeks, who performed the study as part of his Foundation-funded fellowship. "Our small case series demonstrated that MRgFUS resulted in improvements in both pain scores and functional disability measures at each follow-up time point from 1 week post treatment to 6 months after treatment." He also noted, "In all patients the technique was safe, free of complications, effective and well tolerated."
Study co-authors were Wladyslaw Gedroyc, MD and Michael W. Platt, MD of St. Mary's Hospital, Imperial College Healthcare NHS Trust.
Novel therapy uses FUS to inhibit liver tumor growth
The Journal of Gene Medicine has 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 success 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.
MRI-guided focused ultrasound system could offer Parkinson's relief
On August 20, 2012, DOTmed News reported that InSightec is about to launch a pilot clinical trial at the University of Virginia in which its ExAblate Neuro will be used to treat patients with tremor-dominant Parkinson's disease. The article also noted that GlobalData, a British market research firm, had recently acknowledged focused ultrasound's potential. In a mid-August press release, the firm stated, "There are many potential benefits of focused ultrasound treatment as this procedure is non-invasive, the therapeutic effect is immediate and there is no associated ionizing radiation." GlobalData also predicted that, "ExAblate or a similar technology could, if commercially approved by the FDA, eat into a huge chunk of the neurostimulation market, estimated at $1.8 billion in 2010."
Promising advances - Preliminary results show effectiveness of focused ultrasound technology
The September issue of Virginia Business provided an update on the work of the Focused Ultrasound Foundation and the field of focused ultrasound. Describing the Foundation as "a unique medical research, education and advocacy organization," Neal Kassell, MD said the organization's goal is "totally patient-centric" and that a key activity is promoting collaborations involving academia, industry and sources of funding. "There's no way one party could accomplish what we set out to do," Kassell said.
October 5-6: 2nd International Meeting of the Society for Interstitial Delivery of Therapeutics (SCIDOT), Chicago, IL, USA
Focused Ultrasound Foundation Medical Director Arik Hananel, MD will be a presenter at SCIDOT. The meeting, which will be held at the Sheraton Hotel and Towers will provide broad insight into the latest technological developments regarding medical devices, therapeutic agents, imaging methods and imaging agents in the field of targeted delivery of drugs and novel therapeutic agents to the central nervous system. The latest news from clinical trials will also be presented. More information >
October 14-17: 3rd International Symposium on Focused Ultrasound, Bethesda, MD, USA
Organized by the Focused Ultrasound Foundation, the Symposium is a global forum covering state-of-the-art clinical applications of image-guided focused ultrasound. Topics include applications in: the brain, breast, liver, pancreas and prostate; uterine fibroids and fertility; bone tumors; back and neck pain; and emerging applications. More than 170 oral and poster presentations will address the latest advances using both MRI and ultrasound guidance.
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 ()