Each year, the Foundation team surveys stakeholders to assess the field of focused ultrasound around the world. The newly released 2021 State of the Field Report documents the progress that is only possible through the hard work, time, and resources of everyone in our community.
New this year, the report provides an in-depth analysis of all areas of research, including the cumulative number of mechanisms of action by indication and stage of research. We have also included a detailed look at industry trends, regulatory approvals, and investments in the field.
Read on for key highlights from the report.
In the Report
Focused Ultrasound in 2020: By the Numbers
Last year, focused ultrasound researchers began investigating 11 new indications. Four of these new indications were in the clinical trial stage, and six indications overall advanced to first-in-human clinical trials in 2020.
In industry news, 2020 saw nearly triple the amount of investment dollars in the field compared to 2019. The addition of six new companies and 214 commercial treatment sites in the past year is further proof that the field is transitioning from “if” the technology will be widely adopted to “when” it will occur.
Women’s Health and Cancer Continue to Lead Patient Treatments
In 2020, there were more than 80,000 new patient treatments, bringing the total cumulative number of patients treated to nearly 375,000. More than half of the treatments in the past year were for cancer. In all, patient treatments for uterine fibroids, pancreatic tumors, and liver tumors dominated the field. Within the brain category, essential tremor treatments made up more than 80% of the annual tally.
Regulatory Approval of Focused Ultrasound Expands Globally
Overall, focused ultrasound is approved worldwide for 34 indications. No new indications were granted regulatory approval in 2020, but many indications earned regulatory approval in new geographic regions, further expanding the global nature of focused ultrasound technology.
This year’s report includes a breakdown of these approvals by region and manufacturers for each indication. Prostate cancer is used below as an example.
Reimbursement Remains a Hurdle for Focused Ultrasound
As regulatory approvals for focused ultrasound treatments gain traction around the world, reimbursement for these procedures is not yet available in most countries. For the first time this year, we report on the global scale of reimbursement for focused ultrasound procedures. In the chart below, essential tremor and uterine fibroids — two of the most widely covered treatments — are used as examples.
Mechanisms of Action: Multiple Pathways to a Breakthrough
Glioblastoma and pancreatic cancer remain two of the most devastating diagnoses, with survival generally measured in months. It is not surprising that, on a global scale, research in these areas is investigating multiple mechanisms of action (MOA), each representing hopes for a breakthrough in care.
Veterinary medicine offers a unique opportunity to expand research and commercial focused ultrasound applications into a market with reduced regulatory burdens while also collecting data in naturally occurring disease models to support human clinical trials.
Although a relatively new field for focused ultrasound, veterinary clinical trials have demonstrated that the therapy is easily tolerated and effective in the treatment of soft tissue sarcomas. Ongoing clinical work will investigate focused ultrasound’s utility against other aggressive cancers, including osteosarcoma, bladder cancer, and brain cancer.