It is the most powerful sound you will never hear, but a sound that could save your life. Sooner or later, you, a friend, or a pet, will develop a condition that could be treated with focused ultrasound.
Focused ultrasound is an early-stage but rapidly-evolving, revolutionary, therapeutic technology with the potential to transform the treatment of many medical disorders by using ultrasonic energy to target tissue deep in the body noninvasively.
Focused ultrasound is being researched as an alternative or complement to traditional surgery and radiation therapy. It is also a new way to deliver drugs more effectively and to enhance cancer immunotherapy. It has the potential to be an outpatient therapy with no incisions, meaning a more rapid recovery and fewer complications such as infection, hemorrhage, or tissue damage.
How It Works
The principle is analogous to using a magnifying glass to focus beams of light to burn a hole in a leaf. With focused ultrasound, an acoustic lens is used to concentrate intersecting beams of ultrasound on a target deep in the body with precision and accuracy, causing a profound effect at point of convergence while adjacent tissue is spared.
It is the integration of two innovative technologies. Magnetic resonance or ultrasound imaging is used to target the tissue to be treated, guide, and control the treatment in real time.
Depending on the design of the lens and the ultrasound parameters, the target can be as small as 1×1.5mm or as large as 10x16mm in diameter. Where each of the individual beams passes through the tissue, there is no effect. But, at the focal point, the convergence of the multiple beams of focused ultrasound energy results in many important biological effects, creating the possibility of treating a variety of medical disorders.
Mechanisms of Action
Focused ultrasound is a platform technology that can produce multiple biological effects. Today, there are 30 identified mechanisms of action by which the technology can impact tissue, creating the possibility to treat a variety of disorders.
Pierre Curie and his brother, Jacques Curie, discovered the piezoelectric effect in certain crystals in Paris, France, leading to the evolution of high frequency echo-sounding techniques.
First Ultrasound Device
French professor Paul Langevin and Swiss physicist Constantin Chilowsky developed a high-frequency ultrasonic device called a hydrophone, which was used in German U-boat and submarine surveillance.
Paul Langevin Discovery
Paul Langevin discovered that a water tank insonated with high-intensity ultrasound killed fish immediately, and certain observers experienced “a painful sensation on plunging the hand in this region.”
First Thought of Therapeutic Use for Ultrasound
H. Freundlich, K. Collner, and F. Rogowski suggested the application of ultrasound to therapeutically heat tissue.
First Focusing of Ultrasound
Johannes Gruetzmacher found that an ultrasound could be focused when he placed a concave surface to a piezoelectric generator.
First Tissue Lesion
John G. Lynn et al. proposed the idea that ultrasound could be intensely focused to produce extreme heat and non-invasively destroy targeted diseased tissue within the body. They were able to produce lesions deep in bovine liver without damaging surrounding tissue.
First Focused Ultrasound Device
Brothers William and Francis Fry and a research team developed a focused ultrasound device that mechanically aligned four focused ultrasound generators to produce a pinpoint lesion without damage to the surrounding tissue.
First Preclinical Study
John G. Lynn and Tracy J. Putcham were able to destroy cerebral tissue in animals using focused ultrasound. They treated 37 animals in all and found well-circumscribed lesions on physical examination of the areas.
First Therapeutic Use
Lars Leksell designed a specially adapted frame and ultrasound transducer for the purpose of focused ultrasound lesioning and successfully used it on patients to treat psychiatric disorders. He eventually abandoned the method due to lack of imaging and the need for craniotomies.
First Focused Ultrasound Meeting
The first major symposium on Ultrasound in Biology and Medicine was held at the University of Illinois to examine phenomena of how ultrasonic energy interacted with and acted upon biological materials.
Focused Ultrasound as Lobotomy Alternative
Petter A. Lindstrom studied the effects of focused ultrasound-mediated lesioning as an alternative to a lobotomy procedure in patients with carcinomatosis and cancer-related pain.
The “Fathers” of Focused Ultrasound
Brothers William and Francis Fry performed a partial ablation of the basal ganglia after a craniotomy using focused ultrasound.
First Research Group Dedicated to Focused Ultrasound
William Fry, Francis Fry, and Reginald C. Eggleton founded the Interscience Research Institute to develop high-intensity ultrasound instrumentation to treat neurological disorders and computer-based, low-intensity ultrasound instrumentation for visualization of soft tissue.
Focused Ultrasound and the Brain
Russell Meyers and William Fry utilized focused ultrasound to treat numerous human patients suffering from various brain pathologies, in particular Parkinson’s disease.
First Cancer Application
M. Oka reported on the successful use of focused ultrasound to treat thyroid and breast cancers.
First Brain Cancer Treatment
Dr. Robert Heimburger was the first neurosurgeon to use a focused ultrasound device to treat brain cancer, under ultrasound guidance.
HIFU Ablative Research by Francis Fry and Colleagues
Between 1972 and 1984, Francis Fry and colleagues continued to carry out laboratory research on focused ultrasound for solid tumors in preclinical models.
First FDA Approval
Coleman and Lizzie developed the Sonocare CST-100 Therapeutic Ultrasound System which was designed to treat glaucoma. It was the first focused ultrasound system to earn FDA approval. However, it was ultimately outdated by laser surgery.
Focused Ultrasound for BPH
N. Sanghvi et al. developed and implemented a clinical protocol for focused ultrasound treatment of benign prostatic hyperplasia.
Focused Ultrasound for Brain Tumors
A. Guthkelch and K. Hynynen et al. reported on the treatment of malignant brain tumors with focused ultrasound hyperthermia and radiation.
First Combination with MRI
K. Hynynen et al. proposed the use of noninvasive focused ultrasound using magnetic resonance imaging to guide and monitor tissue damage. The term Magnetic Resonance Guided Focused Ultrasound (MRgFUS) was first coined.
First Blood-brain Barrier Application
K. Hynynen et al. first described a controlled, reversible, and reproducible manner of opening the blood-brain barrier, monitored by MRI.
Transcranial Research
K. Hynynen and F. Jolesz demonstrated the feasibility of using a large phased array applicator for through skull focusing and ablation and proposed the benefits of using cavitation for through skull treatments.
First Volumetric Hyperthermia with MR-guided Focused Ultrasound
C. Moonen and colleagues demonstrate volumetric heating for local hyperthermia with MR-guided focused ultrasound and real time temperature feedback in preclinical studies.
First Focused Ultrasound Society
The International Society for Therapeutic Ultrasound (ISTU) was formed to increase and diffuse knowledge of therapeutic ultrasound to the scientific and medical community.
Breakthroughs in Brain Research
K. Hynynen et al. determined that focused ultrasound plus microbubbles can disrupt the blood brain barrier (BBB), a historically major obstacle in the treatment of brain diseases.
G. Clement and K. Hynynen demonstrated noninvasive focusing through human skull using a phased array and CT based planning algorithm.
First Clinical Trials in Women’s Health
C. Tempany et al. performed the first clinical trial of uterine fibroids using INSIGHTEC’S Exablate system and found the procedure feasible and safe.
F. Wu et al. performed the first focused ultrasound clinical trial for breast cancer, concluding it could be effective, safe, and feasible in the extracorporeal treatment of localized disease.
Focused Ultrasound and Immune Response
H. Zheng et al. found focused ultrasound treatment may evoke a strong immune response to combat residual tumor cells and suppress remote metastasis in cancer patients.
First US Approval of an MRgFUS Device
The FDA approved INSIGHTEC’s Exablate 2000 to treat uterine fibroids.
Foundation Began
The Focused Ultrasound Foundation was founded in Charlottesville, Virginia, to help accelerate the development and adoption of focused ultrasound.
First Brain Clinical Trial
Z. Ram et al. initiated a clinical trial to treat patients with recurrent gliomas and demonstrated that it was a potentially effective way of destroying tissue.
Demonstrating Drug Delivery
L. Treat et al. demonstrated chemotherapy delivery (Doxil) into the brain.
Philips Enters the Industry
Philips unveiled MRgFUS system Sonalleve, initially used to treat uterine fibroids.
First Focused Ultrasound Foundation Symposium
The Focused Ultrasound Foundation hosted the first biennial Focused Ultrasound Symposium, October 6-7, 2008, in Tyson’s Corner, Virginia. The meeting attracted 300 attendees from around the world.
Focused Ultrasound for Pain
E. Martin, D. Jeanmonod et al. conducted successful clinical trials that used focused ultrasound targeting the thalamus to treat neuropathic pain.
First Movement Disorder Trial
W. Elias et al. successfully treated the first 15 patients with essential tremor at the University of Virginia in a pilot trial. All patients noted a significant decrease in their tremors.
Regulatory Wins
The FDA approved focused ultrasound for the treatment of pain from bone metastases.
Theraclion’s EchoPulse received CE marking in Europe to treat breast fibroadenoma.
Addressing Challenging Cancers
M. Aryal, Y. Zhang et al. demonstrated that focused ultrasound can enhance delivery of anti-cancer drugs (Doxirubicin) and have a therapeutic effect on gliomas in a rat model.
HF. Gao et al. performed the first clinical trial using focused ultrasound to treat local advanced pancreatic cancer.
Focused Ultrasound for Bone Cancer Pain
Hurwitz et al. demonstrated that MRgFUS is a safe, effective, and noninvasive treatment for alleviating pain resulting from bone metastases.
First Pediatric Patient in North America
The first pediatric osteoid osteoma (bone tumor) was treated in a clinical trial conducted by The Hospital for Sick Children (SickKids) and Sunnybrook Health Sciences Centre. The Foundation funded the trial.
First Depression Clinical Trial Begins
The first patient with depression was treated in a focused ultrasound clinical trial led by Jin Woo Chang, MD, at Yonsei University College of Medicine in Seoul, Korea.
First-in-Man Hyperthermia Treatment with MR-guided Focused Ultrasound
W. Chu, in the Department of Radiation Oncology at Sunnybrook Health Sciences Centre in Toronto, reported the feasibility and safety of MR-guided focused ultrasound hyperthermia in a pilot study on 10 patients with recurrent rectal cancer.
Approvals to Treat the Prostate
Two focused ultrasound devices – EDAP’s Ablatherm Robotic HIFU and SonaCare Medical’s Sonablate 450 – earned FDA approval to ablate prostate tissue. This technique could be used to treat conditions like prostate cancer and BPH.
John Grisham’s Focused Ultrasound Book
John Grisham wrote “The Tumor,” a book about the potential for focused ultrasound, to raise awareness of the technology. In a year, more than 800,000 copies were distributed.
In 2019, the audiobook version of the book was released, pushing the number of total books distributed over 1 million.
Essential Tremor Approval
Insightec’s Exablate Neuro device is approved to treat essential tremor in the US and Canada. The Centers for Medicare and Medicaid Services subsequently assigned the procedure a payment level, the first step toward Medicare reimbursement.
First Focused Ultrasound Pediatric Brain Tumor Clinical Trial Begins
A team at Nicklaus Children’s Hospital in Miami, Florida, treated the first patient in a pediatric and young adult brain tumor study.
First Alzheimer’s Disease Trial
The first clinical trial for Alzheimer’s disease began in Toronto, Canada. The trial was one of the first to explore using focused ultrasound to temporarily disrupt the blood-brain barrier (BBB).
Partnering on Immunotherapy
The Foundation and the Cancer Research Institute partnered to further focused ultrasound and immunotherapy combination approaches to treat cancer.
The first clinical trial combining focused ultrasound with an immunotherapy drug also began for patients with metastatic breast cancer in Virginia.
Veterinary Applications
The Foundation launched a veterinary program and funded initial trials in canine cancer and wound healing.
Profound Medical Transforms Industry
Toronto-based Profound Medical announced that it will acquire Philips’ Sonalleve MR-HIFU business.
First Histotripsy Clinical Trial
A first-in-human clinical trial – the “THERESA” study – took place at three sites in Barcelona, Spain, under the direction of Joan Vidal-Jové, MD, PhD, Head of Focused Ultrasound Ablation Oncology at Barcelona University Hospital.
Focused Ultrasound Drug Delivery Clinical Trial Published
The first clinical trial demonstrating local drug delivery using focused ultrasound and temperature sensitive liposomes was performed in Oxford and published in Lancet Oncology in 2018.
Neurological Clinical Trials
A multisite clinical trial to treat the motor symptoms of Parkinson’s disease began at Weill Cornell in New York.
University of Maryland researchers began the first US trial to open the blood-brain barrier in brain tumor patients.
FDA Approval for Parkinson’s Disease
On December 18, 2018, Insightec’s Exablate Neuro device earned approval from the US Food and Drug Administration (FDA) to treat patients with tremor-dominant Parkinson’s disease.
Clinical Trial Results Published on Opening Blood-Brain Barrier
Clinical trial results using Carthera’s SonoCloud-1 ultrasound implant to open the blood-brain barrier (BBB) prior to chemotherapy in patients with recurrent glioblastoma were published.
A clinical trial also showed it is possible to safely use MR-guided focused ultrasound to open the BBB in patients with ALS.
Ultrasound Device Earns FDA Approval to Treat the Prostate
Profound Medical’s TULSA-PRO® device earned US Food and Drug Administration (FDA) approval to ablate prostate tissue. This is the first transurethral ultrasound device approved in the US, and it allows physicians to predictably ablate whole-gland or partial prostate tissue.
Reimbursement Wins
In February, the US Centers for Medicare and Medicaid Services (CMS) began covering focused ultrasound for tremor-dominant Parkinson’s disease for many patients in the Southeast.
In July, CMS began covering focused ultrasound for essential tremor nationwide. By 2023, private payors like Aetna, Blue Cross Blue Shield, and Anthem reimbursed the procedure.
First Focused Ultrasound “Unicorn”
A $150 million funding round made device manufacturer, Insightec, the first focused ultrasound unicorn (a privately held company valued over $1 billion.)
Focused Ultrasound for Psychiatric Disorders: Clinical Trial Results Published
Researchers at Sunnybrook Health Sciences Centre published data indicating that focused ultrasound is safe and effective in addressing the symptoms of treatment-resistant major depression and obsessive-compulsive disorder (OCD).
First Liver Tumor Clinical Trial Begins in the US
HistoSonics received approval to begin its first clinical trial in the US investigated the safety and efficacy of using the company’s Edison platform to noninvasively and mechanically destroy liver tumors. The company began a similar study in Europe in early 2021.
Focused Ultrasound Approved to Treat Osteoid Osteomas
The US FDA approved Profound Medical’s Sonalleve MR-guided focused ultrasound system for the treatment of painful bone tumors – called osteoid osteomas. This was the first focused ultrasound regulatory approval to directly impact pediatric patients, and it was the sixth indication to earn approval in the US.
Regulatory Updates for Parkinson’s and the Prostate
The US FDA expanded its 2018 approval of focused ultrasound to treat tremor-dominant Parkinson’s disease to include the treatment of patients with advanced Parkinson’s disease suffering with mobility, rigidity, or dyskinesia symptoms.
The FDA also cleared Insightec’s Exablate Prostate focused ultrasound system to ablate prostate tissue.
World-First for Metastatic Breast Cancer
In a first-in-world clinical trial, researchers at Sunnybrook Health Sciences Centre in Toronto, Canada, demonstrated that MR-guided focused ultrasound can be used to safely deliver antibody therapy to breast cancer that has metastasized to the brain.
Focused Ultrasound and Liquid Biopsies
Results of a first-in-human study found that focused ultrasound increased the amount of brain tumor biomarkers in the blood. The results suggest that focused ultrasound could reduce the need for invasive brain tumor biopsies and allow better monitoring of glioblastoma treatment responses.
Pioneering Clinical Trials
Researchers at West Virginia University have treated the first patient in a first-in-the-world clinical trial investigating focused ultrasound to address opioid use disorder.
Theraclion also received approval for its first US trial to noninvasively address varicose veins using their SONOVEIN device.
Focused Ultrasound for Veterinary Applications
A Foundation-funded clinical trial determined that focused ultrasound can safely ablate subcutaneous solid tumors in dogs.
A team in Virginia also found that histotripsy safely and effectively treated the targeted volumes within osteosarcomas in client-owned dogs.
Breakthroughs in Parkinson’s Disease
Researchers in Spain used focused ultrasound to open the blood-brain barrier (BBB) in people with Parkinson’s dementia.
Clinical trial results investigating focused ultrasound to address a possible underlying cause of Parkinson’s disease were published. Researchers in Toronto tested the safety and efficacy of focused ultrasound–induced BBB opening to deliver enzyme replacement therapy.
New Brain Tumor Clinical Trials
In Milan, researchers will use sonodynamic therapy (SDT) in patients with newly diagnosed glioblastomas.
Four sites across the US and Canada began a clinical trial to investigate focused ultrasound’s role in enhancing immunotherapy for non-small cell lung cancer that has spread to the brain.
Researchers in Washington, DC, began a clinical trial using SDT to address diffuse intrinsic pontine gliomas.
University of Oxford Named a Center of Excellence
The Focused Ultrasound Foundation has designated the University of Oxford a Center of Excellence in focused ultrasound. Oxford has become Europe’s fifth Center of Excellence and eleventh worldwide.
US FDA Clears Focused Ultrasound for Liver Tumors
The US Food and Drug Administration (FDA) has cleared HistoSonics’ Edison histotripsy platform to treat liver tumors. This is the ninth clinical indication for which focused ultrasound has been FDA cleared.
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