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.

More importantly though, we are also witnessing a sea change as the field transitions from an environment that has been primarily research-oriented, to one that is now becoming much more focused on commercialization and patient treatment. This is a much-anticipated shift and an indicator of just how far we have come – and yet for those of us committed to the goal of accelerating the adoption of focused ultrasound, this transition also reminds us that we’re not there yet, and there is much important work to be done to transform our vision into a reality.

commercializaon graphic
The evolution of technologies like focused ultrasound occurs in a continuum, starting with invention, followed by innovation, then development, distribution, and finally – often decades later – to adoption as a standard of care. The first three stages – invention, innovation and development – are collectively considered the R&D phase. The distribution stage is where focused ultrasound is today (though R&D for newer, life-changing FUS applications of course continues in parallel), with the technology now being offered to patients in a limited number of centers – approximately 650 out of a possible worldwide market of 10,000. This is important progress to be celebrated. And yet, to fulfill our shared vision of truly creating a revolution in therapy that will affect literally millions of people with serious medical disorders around the globe in the shortest time possible, we need to achieve widespread utilization. We need to be in the “adoption as a standard of care” phase of the continuum. And getting there is dependent on one key factor: the commercial success of focused ultrasound manufacturers.

Three recent milestones have validated our notion that the field is transitioning from R&D to clinical adoption. In December 2017, Koch Disruptive Technologies – a major industrial organization known for identifying and funding innovative and emerging companies – was the primary investor in a $150 million Series E funding round for Insightec, one of the leading companies in the field, allowing Insightec to further commercialize its approved indications and continue groundbreaking research in key neurologic areas. A second milestone occurred in April when FUS manufacturer HistoSonics closed on a venture capital funding round of $54 million, notably led by two major health care companies – Varian Medical Systems and Johnson & Johnson Innovation LLC – giving “instant credibility to potential end users as it begins sales,” according to media coverage. And the third indicator that the field is maturing also took place in April, when for the first time in the history of focused ultrasound an institutional investor/analyst conference took place. Hosted by FUS manufacturer Profound Medical in New York, NY, the highly successful event attracted more than 50 financial analysts and institutional investors from around the world, who gathered to learn more about this promising technology. These three milestones have undoubtedly put us closer to achieving our goal of transforming millions of lives with focused ultrasound.

So where are we now in the coming of age story of this platform technology? We are witnessing a growth phase among manufacturers, as many companies are still joining the field, and a large percentage are small, not yet profitable, and seeking financing. Our sense is that there is an abundance of capital available now to invest in focused ultrasound, the technology is becoming widely recognized among analysts and investors for its potential, and they are wisely responding in kind. We expect that further investment in focused ultrasound will likely lead to a consolidation phase among manufacturers in the coming years – a process analogous to what happened in the magnetic resonance imaging field 35 years ago when several dozen small MR companies eventually consolidated into three major vendors, and the technology went on to transform diagnosis in healthcare. Focused ultrasound is following a similar path and is slowly but surely on its way to evolving into a robust medical field and revolutionizing therapy.

Decades is simply too long for patients and their families to wait for medical breakthroughs. The Foundation has the opportunity to favorably alter the trajectory of the adoption curve, and we are closer than ever before. If we can help accelerate the adoption of focused ultrasound, we can save lives. What could be more important?

Additional Resources
The Digital Dividend: First Mover Advantage – Harvard Business Review (PDF)
Why Collaboration Is Critically Important to Propelling Focused Ultrasound Forward – And What the Foundation Is Doing About It – Blog by Neal F. Kassell, MD, Founder and Chairman
Collaboration: Commercialization in the Evolving Focused Ultrasound Landscape – Blog by Emily White, MD, Director of Operations
Collaboration: Fueling a Changing Focused Ultrasound Landscape – Blog by Jessica Foley, PhD, Chief Scientific Officer

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Neal F. Kassell, MD, is the founder and chairman of the Focused Ultrasound Foundation.

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