State of the Technology
While focused ultrasound is currently in the early stages of development and adoption, it has the potential to transform the treatment of a variety of serious medical conditions.
All indicators point toward the evolution of this platform technology into a robust medical field, with the pace of research and development, publications, patient treatments and the number of device manufacturers all increasing rapidly in the past few years.
Research, Development, and Commercialization
Some applications of the technology are approved for commercial use and are available in medical treatment centers around the world. Other uses are still undergoing research, with opportunities for patients to participate in clinical trials at leading medical research institutions. Even more potential uses of the technology are in the early stages of technical research.
The following charts summarize the state of research and regulatory approval of focused ultrasound for over 75 medical conditions around the globe.
Status by disease category
Medical Literature and Scientific Exchange
The volume of peer-reviewed publications on focused ultrasound research has increased exponentially in the last decade, with over 500 articles published in 2016. The number of citations in the literature has also increased dramatically, with 17,000 in 2016.
The number of papers presented at scientific meetings is on the rise, particularly at conferences dedicated to focused ultrasound.
There are currently 35 companies located around the globe that are dedicated to the research and manufacturing of focused ultrasound systems with a range of guidance systems and specialization. This innovative industry is very young, as only five manufacturers were established by the year 2000, and the remaining have been established in the years since.
There are more than 580 commercial focused ultrasound treatment sites around the globe, with a majority in Europe and Asia. in addition, there are 316 research sites around the globe. This number has grown 86% since 2014.
Research Site Growth and by Region
Trends in Pre-clincal and Clinical Research SitesTwenty-two new pre-clinical reserach sites were added in 2016, and the nearly half of the total 123 sites are in North America. Following a similar trend, 14 new clinical research sites were added last year. Regionally, clinical research sites are split more evenly between North America, Europe and Asia.
There have been nearly 168,000 patients treated with focused ultrasound, and 80% of these treatments have been for prostate diseases and uterine fibroids. Though brain treatments make up only a small portion of the total, the range of brain conditions treated is indicative of where the field is headed.
Over the past three years. patient treatments worldwide have nearly doubled.
The number of diseases being researched and treated using focused ultrasound has doubled in the last five years, with an overall shift toward clinical work and regulatory approval.
Focused ultrasound was first conceptualized in 1950, but clinicians abandoned the technique due to a lack of imaging capabilities. First-in-human treatments using focused ultrasound have exploded in the past decade, and we expect to see the numbers continue to grow.
Twenty-two conditions currently have regulatory approval by various agencies around the world, and that number has increased dramatically in the last decade. Regionally, Europe and Asia top the list.