The diffusion or adoption of a new therapeutic medical device technology occurs exponentially – and focused ultrasound (FUS) is proving to be no exception. In fact, the field of focused ultrasound has been gathering momentum and growing at a rate that has vastly exceeded any of our expectations.
When we started the Foundation in 2006, for example, there were only a few focused ultrasound manufacturers; today there are nearly 50. There are also now more than 130 FUS clinical indications in various stages of development (with 25 regulatory approvals worldwide, including five by the FDA in the US), 19 mechanisms of action, approximately 700 research sites, more than 650 treatment sites, and more than 250,000 patients to date worldwide who have been treated. As I have recently said, we are now at the inflection point of the adoption curve for this innovative, revolutionary, disruptive technology.
As a surgeon-scientist at The Ohio State Wexner Medical Center, Dr. Krishna has expertise in the translational applications of neuroimaging relevant to neuromodulation and functional neurosurgery. He investigates imaging-based therapies (specifically focused ultrasound and image-guided deep brain stimulation) and discovers neuroimaging correlates of efficacious neurostimulation. His imaging modalities of interest include diffusion tensor imaging (quantitative, deterministic and probabilistic tractography) and functional magnetic resonance imaging.
Recently, Dr. Krishna wrote this informational blog for patients and their families who want to know more about focused ultrasound therapy as a potential treatment option for essential tremor and tremor-dominant Parkinson’s disease.
"There is nothing more difficult to take in hand, more perilous to conduct, or more uncertain in its success, than to take the lead in the introduction of a new order of things." – Niccolò Machiavelli
In the dozen or so years since the Focused Ultrasound Foundation was established, there have been countless exciting developments – including first-in-world and first-in-human achievements – in the field of focused ultrasound that are demonstrating the potential of this early-stage, disruptive, noninvasive therapeutic technology to treat a wide range of serious medical disorders. Each phenomenal accomplishment, which can involve literally hundreds of people and many years of painstaking effort, finds us closer to achieving our goal of helping millions live longer, healthier lives.
Narendra Sanghvi is the chief scientific officer at Sonacare Medical. He is the cofounder of Focus Surgery Inc. and a pioneer in the field of focused ultrasound technology. Sanghvi is the inventor and developer of the Sonablate® HIFU device by Sonacare Medical for the treatment of prostate disease. Sanghvi also served at the Indiana University School of Medicine as an associate professor in the Department of Physiology and Biophysics and senior research scientist at Indianapolis Center for Advanced Research (ICFAR), where pioneering work for the development of echocardiography, breast ultrasound imaging, and prostate treatment with ultrasound was performed. Sanghvi worked with Professor Frank J. Fry to develop the first clinical focused ultrasound image-guided device for the treatment of brain cancer in 1972 that was used for the treatment of glioblastoma by Robert F. Heimburger, MD.
Last October, Sanghvi received the Focused Ultrasound Foundation's 2018 Visionary Award. This award is given every two years at our Symposium to recognize an individual who has created a larger vision for what the future of focused ultrasound may hold and whose effort, passion, and persistence have been crucial to advancing the field.
Recently, we caught up with Sanghvi to talk about his life's work.
The scientific community has been aware of the existence of a publication bias since the 1950s. What is a publication bias, and how does this affect science? This form of bias arises when the outcome of an experiment determines whether the results are published. On the surface, this doesn’t sound terrible. Shouldn’t exciting, unexpected results take precedence over a study demonstrating that treatment A doesn’t work? Unfortunately, this is the sort of thinking that has created a stigma around negative data.
As students, we are taught that the scientific method is king. If your experiment is well designed and controlled, your data will either prove or disprove your hypothesis. If your experiment is well designed and controlled, your data should be worthy of publication, regardless of the outcome. Unfortunately, this is not the case. Studies have shown that negative results (those that fail to prove the researcher’s hypothesis) are three times less likely to be published (yes, we recognize the potential irony here). Why is this a problem?