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A new, highly disruptive therapeutic technology called focused ultrasound is slowly but definitively influencing – and on the verge of transforming – standards of care around the globe. This game-changing, noninvasive treatment option for a wide variety of serious medical disorders has the potential to be an alternative or adjunct to surgery, radiation therapy, drug delivery, and cancer immunotherapy, while decreasing cost of care and improving outcomes for millions worldwide. If it sounds too good to be true, it isn’t. Focused ultrasound has been named one of the 50 greatest inventions by TIME magazine, credited with “changing medicine” by Fortune magazine, and just this month was named a top 10 clinical research achievement of 2016 by the Washington, DC-based Clinical Research Forum.
Innovation breeds innovation, but also, modification. Once fully developed and implemented – months to decades from now depending on the clinical indication – focused ultrasound will have widespread impact on healthcare constituents including physicians, treatment facilities, and manufacturers of legacy therapy equipment, among others. This process has in fact already begun. Focused ultrasound will also bring about major change to referral patterns, treatment paradigms, practice guidelines, and equipment acquisition as the technology transitions to a mainstream therapy.
In order to benefit from these changes, stakeholders – perhaps your organization or yourself – must be prepared to enter the field early on. And for many, “early on” means now.
What is focused ultrasound?
Focused ultrasound, or FUS, uses ultrasonic energy to target tissue deep in the body without incisions or radiation. With more than 22 regulatory approvals around the world to date, including five by the US Food and Drug Administration and more than 50 additional clinical indications in various (mostly early) stages of development, FUS may treat a disparate range of diseases including: Parkinson’s; Alzheimer’s; depression; obsessive-compulsive disorder; arthritis; back pain; and, tumors of the brain, breast, prostate, liver and pancreas. It has the potential to be as revolutionary to therapy as magnetic resonance scanning (MRI) has been to diagnosis.
The basic principle is analogous to using a magnifying glass to focus beams of sunlight on a single point to burn a hole in a leaf. With focused ultrasound, multiple intersecting beams of ultrasound energy are concentrated on a target deep in the body with extreme precision and accuracy (sparing adjacent normal tissue). Where each individual beam passes through the body there is no effect. But at the focal point where the beams converge, the focused ultrasound energy induces a variety of biologic effects including: destroying tissue, stimulating the body’s immune response, and enhancing the delivery of drugs. The location of the focal point and the treatment effect is guided and controlled in real time by ultrasound or MR imaging.
Besides patients, who will focused ultrasound affect?
Three healthcare industry groups will be particularly impacted by the widespread adoption of FUS. First, consider the manufacturers of legacy therapy equipment (e.g., linear accelerators for radiation therapy and robotic surgical devices) to which focused ultrasound is an existential threat. These manufacturers would be wise to begin redistributing resources from their traditional product lines now to invest in new FUS technology. Such companies are in fact well-positioned to do so as they already have the functioning sales, marketing, support and distribution channels in place. It is clear that once the medical community broadly understands the capabilities of focused ultrasound, many legacy therapy equipment options will quickly become obsolete.
Physicians will also benefit from entering the FUS field sooner rather than later. In the current environment, many physicians – not all – can unfortunately be motivated by money, time and outcome, in that order. As focused ultrasound advances, they will need to become educated and trained in utilizing FUS technology, and adopt it as part of their practice, even in cases where the economics on a per procedure basis are less favorable than current therapy alternatives. If they choose not to, patients seeking FUS – and demand is growing – will simply find a physician who will. Of note: focused ultrasound centers worldwide are reporting a backlog of several hundred essential tremor patients desiring FUS, and a nationwide study of nearly 1,000 US uterine fibroid sufferers (published in the October 2013 issues of both the American Journal of Obstetrics and Gynecology and the Journal of Women’s Health) found that when presented with fibroid treatment descriptions, the majority surveyed (60%) rated focused ultrasound as their top treatment choice.
Finally, now is also the time for hospitals and clinics to consider becoming early adopters of focused ultrasound. Doing so will enhance their reputation as being on the leading edge of medical care, and will provide a competitive differential over institutions that have not yet acquired FUS technology (see above regarding patient demand and preference). Additionally, offering focused ultrasound will create a halo effect for the hospital or clinic when patients are referred for this cutting-edge treatment and found to not be a candidate; these patients will often choose to stay with the practice and receive an alternative treatment, increasing market share for the institution.
The future is now
We are all aware that medical device development and adoption occurs exponentially; with focused ultrasound we are right now at the beginning of the inflection point of the curve. Our goal is to treat hundreds of thousands of patients annually and we are well on our way, with 15,000 FUS treatments performed worldwide in 2014, approximately 25,000 treatments in 2015, and a more than double increase to 50,000-plus patients treated in 2016. In other words, focused ultrasound is about to evolve 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.
Still, there remains an enormous amount of work to be done, and many barriers to overcome, before the technology becomes a standard of care that can help millions of patients. But we are closer than ever. When the potential of focused ultrasound is realized and it becomes a mainstream therapy, it will result in changes that will benefit countless patients and impact physicians, payers/providers, manufacturers, hospitals/clinics, caretakers, etc., around the globe. It’s coming. It is reinventing care. Are you ready?
Find out more at www.fusfoundation.org.
About the Author: Neal F. Kassell, M.D., is the founder and chairman of the Focused Ultrasound Foundation. He was a Professor of Neurosurgery at the University of Virginia from 1984 until 2016 and was the Co-Chairman of the department until 2006. He received both his undergraduate and medical education at the University of Pennsylvania. In April 2016, Dr. Kassell was appointed by Vice President Joe Biden to the National Cancer Institute’s Blue Ribbon Panel for Cancer Moonshot Initiative. Dr. Kassell has contributed more than 500 publications and book chapters to the literature and is a member of numerous medical societies in the United States and abroad.
The Focused Ultrasound Foundation is a medical research, education, and advocacy organization created as the catalyst to accelerate the development and adoption of FUS, shortening the time from laboratory research to widespread patient treatment.