"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?

Introduction
The goal of both a clinical trial and of a patient registry is to produce evidence for scientific advancement, regulatory approval, and/or clinical decision-making. Producing sufficient evidence will yield a best practice or a clinical guideline that establishes a standard of care.

Evidence can be produced in a variety of ways. At the top of the pyramid are clinical trials and prospective cohort studies. A clinical trial provides a test of a hypothesis to produce an efficacy statement that the intervention improves outcomes. It establishes a mechanistic efficacy associated with a clinical outcome and the intervention is safe.

In October 2018, West Virginia University neurosurgeon Ali Rezai, MD, treated the first patient in a groundbreaking US clinical trial for Alzheimer’s disease. A team of 35 medical experts at the Rockefeller Neuroscience Institute, led by Dr. Rezai, performed a phase II trial – for the first time in the United States using focused ultrasound to open the blood-brain barrier and target the hippocampus of a 61-year-old patient with early-stage Alzheimer’s disease. A second patient with Alzheimer’s underwent the procedure in January 2019 at West Virginia University.

The team used Insightec’s focused ultrasound device, Exablate Neuro.

Recently, we caught up with Dr. Rezai to talk about the first patient’s progress and his plans for future applications of focused ultrasound.

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