August 3, 2022 - State of the Field Report 2022

See the report >
August 3, 2022
Focus Feature: 2022 State of the Field Report
2022 State of the Field Report Now Available

Each year, the Foundation team surveys stakeholders to assess the field of focused ultrasound around the world. The newly released 2022 State of the Field Report documents the remarkable progress that is only possible through the hard work, time, and resources of everyone in our community.

As in recent years, the report is made up of three sections: a field overview, the state of research and treatment, and the state of commercialization.

New this year, the report features a breakdown of global sites investigating the various mechanisms of action, an overview of an innovative way focused ultrasound could assist with diagnosis, and detailed case reports on osteosarcomas, breast cancer, and reimbursement in Italy. The report also contains data related to investments in the field by region, a historical analysis of the time it takes to achieve FDA approval, and intellectual property trends.

Read on for key highlights from the report.  
In the Report
Focused Ultrasound in 2021: By the Numbers

In 2021, more than 92,000 patients were treated with focused ultrasound, in part thanks to almost 100 new commercial treatment sites. Eleven new indications were identified, and on the other end of the spectrum, 21 new regulatory approvals were granted in 10 countries. Nearly $400 million dollars were invested in the industry, which grew by 11 new companies. This progress is further proof of the field's transition from “if” the technology will experience widespread adoption to “when” it will occur.  

Patient Treatments Rise Steadily, Led by Uterine Fibroids and Cancer

More than 92,000 patients were treated with focused ultrasound in 2021, bringing the cumulative total to 467,000. The most treated indications have remained largely the same year-to-year, with uterine fibroids and pancreatic and liver tumors at the top of the list. Nearly 3,000 patients were treated for brain disorders, and of those, 95% were treated for essential tremor or Parkinson’s disease.  

Case Study – Breast Cancer

Four focused ultrasound companies have devices dedicated to treating patients with breast cancer, and two of these systems are approved in Asia. In 2021, the other devices – as well as a few novel systems developed by research sites – were being assessed in nine clinical trials in five countries.   

The State of the Field Report also includes in-depth case studies on reimbursement in Italy and osteosarcoma.  

Veterinary Applications Soar 

Last year, a new trial targeting feline sarcomas began, and focused ultrasound was used to treat canine brain tumors for the first time. Also of note, the field is moving beyond ablation, and other focused ultrasound modalities – including histotripsy, sonodynamic therapy, and drug delivery – are now in use in the veterinary space.

The Foundation's Veterinary Program enables veterinarians to offer innovative therapies while simultaneously collecting data that can be used to advance human medicine. We are now working with six veterinary clinical sites around the world, and focused ultrasound clinical trials are addressing almost all of these unmet needs in veterinary medicine.  

Global Landscape is Accelerating Toward Commercialization

As the field continues to shift rapidly into commercialization, the State of the Field Report has evolved to capture this trend. Today, there are nearly 90 focused ultrasound companies, and two-thirds of those are device manufacturers. The majority of the companies are North American–based, but Asian companies have the most regulatory approvals.  

The Timeline to FDA Approval Is Now Within a Decade

The time it takes for a manufacturer to go from a conceptual idea for an indication to FDA approval can be a significant barrier to the success of a therapy – and the company. In the example of focused ultrasound for the prostate, the use of the technology was truly innovative, and the process took nearly three decades. The indications to follow took considerably less time. Essential tremor and Parkinson’s disease were approved in fewer than 10 years.  

Investment Data Help Track Global Trends

Over time, the majority of investments in the field have been in North American companies. Money originating in North America has been primarily invested in North America, and so too in Europe. Surprisingly, most investments coming from Asia have gone toward North American companies. The following chart reflects cumulative investments in the field. 

Patent Data Over Time Reveal Research Insights

In recent years, the number of patents issued in the US has been comparable to those issued internationally. However, a further look into the data reveals that since 2019, 70% of US patents were awarded to corporations, compared to 57% of those from outside the US. This suggests that proportionally more intellectual property outside the US was derived from researchers or academic centers.  

Focused Ultrasound Foundation
1230 Cedars Court
Suite 206
Charlottesville, Virginia 22903