The Foundation conducted a survey of 150 members of the focused ultrasound community on the state of the field prior to the October 2014 Symposium.
Respondents were asked to identify which clinical indications were most likely to improve patients’ quality of life. Neurological and oncological indications are tied for the most votes, with brain tumors, essential tremor, and pancreatic cancer being rated as the top three individual indications. Similarly, respondents were asked to rank the top three bioeffects that are most likely to have long-term therapeutic value. Thermal ablation is ranked first, followed by drug delivery and neuromodulation.
The survey generated input from 150 respondents: 68% from North America, 20% from Europe, and 10% from Asia. We received responses from 74 research scientists, 50 clinicians, 9 device manufacturers, 8 physicists, and 6 patients. More than half of the clinicians are radiologists, 20% are neurosurgeons, and less than 10% are radiation oncologists, neurologists, oncologists, or urologists.
The survey probed which clinical indications were most likely to be commercially successful. At the top of this list are essential tremor, uterine fibroids, and prostate cancer. Interestingly, there is some disparity between indications that would most improve quality of life versus those that would be commercially successful. Pancreatic cancer is third on the quality of life list but 12th on the commercially successful list, while uterine fibroids are 7th and 2nd, and soft tissue tumors are 18th and 7th, respectively.
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Respondents ranked the top three applications of focused ultrasound that they thought were most likely to become commercially successful.
There are several possibilities for the disparities. One is that some diseases, if cured, will have a large impact on the quality of life, but they are relatively rare, which would make them unlikely candidates to be commercially successful. Another possibility is the difference between feasibility and possibility. The indications identified as most likely to be commercially successful are primarily those that are the farthest along the development pathway (on the market in several countries) and are therefore more likely to succeed at this time. On the other hand, the quality of life results reflect the potential of focused ultrasound to treat various diseases, including those in the early research stages, and it is too soon to determine whether they will be commercially successful.
The survey uncovered some division between scientist and clinician views. Both groups are concerned about reimbursement, but physicians are focused on the cost of purchasing and maintaining equipment, while scientists are more concerned about evidence for efficacy and durability. Both groups believe that essential tremor and uterine fibroids are likely to be commercially successful. Scientists indicate that prostate cancer will be successful, whereas clinicians are more optimistic about Parkinson’s tremor as a likely successful indication. The community overall finds the grea technological needs are for brain indications.
The respondents identified the lack of reimbursement, lack of evidence of efficacy/durability, and regulatory approval as the top three obstacles to widespread use of focused ultrasound. This list matches well with the current efforts and priorities of the Foundation, as we are working with manufacturers and researchers to generate evidence on efficacy and durability, and working with the FDA to improve the pathway toward regulatory approval for new FUS devices and clinical indications.