Every year, we survey stakeholders to assess and report on the status of focused ultrasound technology. The 2018 State of the Field Report documents the progress that is only possible through the hard work, time, and resources of everyone in the field.
The report includes new charts, graphs, and data summaries. This year, we added sections delineating research sites working with specific mechanisms of action and technical aspects of focused ultrasound. Additionally, there is considerably more content related to the commercialization space – an area crucial to widespread adoption of this technology.
The past five years have seen significant growth in the number of indications under investigation for treatment using focused ultrasound, especially in the neurological, oncological, and musculoskeletal applications.
The number of patients treated with focused ultrasound to date rose to more than 215,000 in 2017, due in part to two Asian manufacturers reporting data for the first time. Uterine fibroids and prostate diseases dominate the list, but brain treatments saw notable increases worldwide. Essential tremor leads with the most treatments in the brain category, followed by Parkinson's disease and neuropathic pain. Alzheimer's disease was added to the list this year as the first-in-human treatments were performed.
Focused ultrasound is a platform technology that affects tissue through multiple mechanisms, thereby enabling the treatment of a wide variety of medical disorders. Tissue destruction – including ablation – is being investigated at the most sites worldwide, followed by drug delivery. Others include histotripsy, neuromodulation, immunotherapy, sonodynamic therapy, clot lysis, and more.
Currently, 15 companies have developed focused ultrasound devices that are approved to treat 27 medical conditionsaround the world. In the last year, thyroid nodules, neuropathic pain, glaucoma, breast fibroadenomas, and uterine fibroids earned regional approvals. Europe and Asia continue to top the list with the most regulatory approvals.
Since the Foundation's founding in 2006, the landscape of focused ultrasound manufacturers has doubled. There are now 34 clinical device manufacturers and 23 companies supporting the field, including distributors and microbubble and OEM suppliers.