The report is compiled through input from surveys distributed each year to focused ultrasound sites and manufacturers around the globe. To ensure that future reports are accurate and comprehensive, please make sure that your organization completes the survey on time.
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To help accelerate the development of focused ultrasound, part of the Foundation’s role is to assess where the field has been, where it is now, and where it is going.
Every year, we survey the community to monitor the pulse of where research is being conducted, what progress is being made across a range of diseases, which sites are providing treatments, and the current regulatory status of different manufacturers’ systems. This work is summarized in our State of the Field Report. This report helps researchers and industry identify collaborators, assists patients in locating treatment sites, and illuminates the potential of the technology for reporters, investors, and others.
This Focus Feature highlights the key statistics and trends in the 2015 Report, which summarizes data gathered in 2014. Focused ultrasound technology is steadily evolving from being used by a select group of innovators at academic centers to making strides in patient care by influential early adopters.
There are currently 28 focused ultrasound manufacturers, 225 research sites, and 391 commercial treatment centers worldwide. More than 8,000 patients were treated commercially or in clinical trials in 2014. To date, nearly 90,000 patients have undergone focused ultrasound treatment. Approved to treat 19 medical conditions in regions around the world, focused ultrasound has been most widely used to treat prostate cancer, uterine fibroids and liver cancer.
Not surprisingly, a majority of focused ultrasound clinical research has been conducted around the most widely approved indications -- uterine fibroids, prostate cancer, and pain from bone metastases. The top emerging areas of clinical research include neurological disorders, tumors of the pancreas, liver and soft tissue, osteoid osteoma, and uterine adenomyosis.
Emerging Clinical Research Indications by Number of Sites
Research is distributed across 225 sites around the world.
While historically the top three areas for pre-clinical research have been uterine fibroids, liver tumors and prostate cancer, the highest growth areas for this early research are stroke and epilepsy, as indicated by the greatest percentage of new research sites. Despite recent growth, the Foundation's perspective is that the role of focused ultrasound in treating stroke will be eclipsed by other technologies.
Robust pre-clinical groundwork is essential for translation of focused ultrasound to the clinic – particularly for brain applications. We expect to see a continued rise in pre-clinical and clinical research for a variety of new neurological indications over the coming years.
Emerging Pre-clinical Research Indications by Number of Sites
There are now nearly 400 commercial treatment sites around the globe, with about half located in Europe. Although North America has more academic research sites than Europe and Asia, the slow pace of regulatory approvals and reimbursement has resulted in a dearth of commercial treatment sites in the region.
Europe leads the way, with devices approved to treat 17 conditions, including several cancers and neurological diseases. Currently, the two uses approved by the US Food and Drug Administration are uterine fibroids and pain from bone metastases.
This is a young industry, with 28 companies that develop focused ultrasound equipment, 18 of which have been founded since 2000. The majority of these manufacturers are using ultrasound for image guidance; there are five companies developing MR-guided systems and four developing systems with both guidance methods.