Continue reading >
Charlottesville, Virginia, April 21, 2020 – The Focused Ultrasound Foundation has announced that former BlackRock executive Patrick Edelmann has joined the team as Managing Director. His responsibilities include: spearheading the Foundation’s initiatives with Emily White, MD, to facilitate commercialization of the technology; launching our Institutional Giving program with Ann Taylor to include family offices, corporate foundations, and community foundations; and leveraging our Veterinary Program on a path to widespread utilization for the treatment of companion animals.
A collaborative group led by Gail ter Haar, PhD, and Elizabeth Respasky, PhD, recently completed a two-year pancreatic cancer immunotherapy project titled, “Defining Basic Properties of Physical Immunotherapy using HIFU and Immune Checkpoint Inhibition.”
Sonogenetic Modulation of Cellular Activities Using an Engineered Auditory-Sensing ProteinTaiwanese scientists recently engineered a biological system for using focused ultrasound to remotely control living cells.
The Foundation receives many inquiries about the various applications of focused ultrasound. We want to share some of the most commonly asked questions to help our community quickly locate the information they need.
Does the Foundation conduct patient consultations or treat patients?Our main function is to identify and fund research projects in order to make focused ultrasound therapies more readily available to treat patients. We do not conduct patient consultations, nor do we treat patients. We are sometimes able to help connect people with physicians who can either consult with them and their families or provide focused ultrasound treatments.
Is the Foundation operated by the government or owned by manufacturers?No, the Foundation is an independent, tax-exempt organization that is entirely supported by donations with the goal of helping advance focused ultrasound to be available to treat patients in the shortest time possible. We are a small organization, and we do our best to steward our resources to advance the field of focused ultrasound. Read more about the Foundation.
Like everyone, we at the Foundation are preoccupied with the COVID-19 pandemic and its health and economic consequences, which are rapidly evolving. Despite this, we all remain deeply committed to accomplishing our mission of accelerating the development and adoption of focused ultrasound.In the interest of everyone's well-being, essentially the entire Foundation team is working from home. We are all healthy, well-connected, and productive; all of the Foundation's programs, initiatives, and activities are operating close to normal. Please don't hesitate to interact. We are here for you, and we’re in this together.Be safe. Be well.Neal F. Kassell, MDFocused Ultrasound Foundation Chairman
Foundation Chairman Neal F. Kassell, MD, addresses expectations.
Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients of NIH Funding | National Institutes of Health
CMS Announces Relief for Clinicians, Providers, Hospitals, and Facilities Participating in the Quality Reporting Programs in Response to COVID-19 | Centers for Medicare & Medicaid Services (March 22, 2020)
Coronavirus (COVID-19): Small Business Guidance & Loan Resources | US Small Busines Administration Treasury, IRS and Labor announce plan to implement Coronavirus-related paid leave for workers and tax credits for small and midsize businesses to swiftly recover the cost of providing Coronavirus-related leave | Internal Revenue Service (March 20, 2020)
Coronavirus (COVID-19) Update: FDA Issues Guidance for Conducting Clinical Trials | US Food & Drug Administration (March 19, 2020)
CMS Releases Recommendations on Adult Elective Surgeries, Non-Essential Medical, Surgical, and Dental Procedures During COVID-19 Response | Centers for Medicare & Medicaid Services (March 19, 2020)
White House Task Force
Centers for Disease Control and Prevention
National Institutes of Heath
World Health Organization AdvaMed COVID-19 Medtech Resource Center
Resources for Small Business Innovation Research (SBIR)/Small Business Technology Transfer (STTR) Companies Impacted By COVID-19 | Small Business Administration (April 2, 2020)
Paycheck Protection Program FAQs for Small Businesses | US Senate Committee on Small Business and Entrepreneurship (March 30, 2020)
Coronavirus Emergency Loans - Small Business Guide and Checklist | US Chamber of Commerce (March 30, 2020)
Coronavirus (COVID-19): Small Business Guidance & Loan Resources | US Small Business Administration Treasury, IRS and Labor announce plan to implement Coronavirus-related paid leave for workers and tax credits for small and midsize businesses to swiftly recover the cost of providing Coronavirus-related leave | Internal Revenue Service (March 20, 2020)
How the Treasury Department is Taking Action: CARES Act | US Department of the Treasury (March 17, 2020)
The Paycheck Protection Program prioritizes millions of Americans employed by small businesses by authorizing up to $349 billion toward job retention and certain other expenses. Small businesses and eligible nonprofit organizations, Veterans organizations, and Tribal businesses described in the Small Business Act, as well as individuals who are self-employed or are independent contractors, are eligible if they also meet program size standards.
Coronavirus: What People with Cancer Should Know | National Cancer InstituteLife with Cancer During the Novel Coronavirus Pandemic (COVID-19) | Cancer Research Institute (March 20, 2020)Ask the MD: Living with Parkinson’s Amid the Coronavirus Pandemic | The Michael J. Fox Foundation for Parkinson's Research (March 20, 2020)
The opioid epidemic is a national crisis. Every day, an estimated 130 people die in the United States from an opiate related overdose. Many of these deaths can be attributed to an initial or current misuse of prescription opioids, often prescribed to treat acute and chronic pain. The US Centers for Disease Control and Prevention (CDC) estimates that the annual economic burden of prescription opioid misuse in the United States alone is $78.5 billion, which includes the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement. About 80 percent of people who use heroin have misused a prescription opiate first. These types of staggering statistics go on, but the point is that the opioid epidemic is a real problem requiring realistic, effective, and timely solutions.
A Multi-faceted ApproachMany different areas need improvement when considering potential solutions to the opioid crisis, and it will likely be advancement in all of them that results in a real progress. Those who already suffer from an opioid misuse disorder need improved access to evidence-based treatment. It is imperative to advance research in overdose therapy, medication-assisted therapy, and opiate abuse risk reduction. Most relevant to the field of focused ultrasound is the establishment and promotion of alternatives to opiate-based medications for the treatment of pain. Another area that has the potential to use focused ultrasound is in the identification and development of new therapies to aid in abstinence from opiates.
Together with its advocacy partner, the Advanced Medical Technology Association (AdvaMed), the Foundation recently hosted a summit on reimbursement strategies for focused ultrasound treatments.
Following the success of last year’s event, the Foundation partnered with the Medical Imaging & Technology Alliance (MITA) to host a second “fly-in” event on Capitol Hill in Washington, DC. On March 10, a passionate group of focused ultrasound patients and physicians joined representatives from the Foundation, MITA, and industry to educate policymakers on the innovative technology.
A recent Centers for Medicare and Medicaid Services (CMS) announcement declared a positive local coverage decision (LCD) for patients undergoing unilateral focused ultrasound thalamotomy for tremor-dominant Parkinson’s disease. Palmetto GBA, a Medicare Administrative Contractor (MAC) covering many states in the Southeast, will now cover the procedure for patients treated on or after February 10.
The 12th International Symposium on Focal Therapy and Imaging in Prostate and Kidney Cancer was held February 9-11, 2020, in Washington, DC. The conference highlighted advances in the real-time image-guided diagnosis and treatment of prostate and kidney cancer. Its interactive scientific program included state-of-the art lectures, video demonstrations, and hands-on workshops delivered by a world-class faculty. The small sessions allowed ample opportunities for networking and exchanging opinions and experiences.
Improving the Trustworthiness, Usefulness, and Ethics of Biomedical Research through an Innovative and Comprehensive Institutional Initiative
An open science center based in Berlin recently published its experiences, approaches, and recommendations for institutions (as opposed to individual scientists) to create initiatives that improve rigor, reproducibility, and transparency in biomedical research. One such initiative pays researchers €1,000 to publish their null results.
The Sontag Foundation is offering a Distinguished Scientist Award (DSA)to an individual with projects that show potential to advance knowledge of causes, cure, or treatment of primary brain tumors and/or brain cancer.
MRgFUS Pallidothalamic Tractotomy for Chronic Therapy-Resistant Parkinson's Disease in 51 Consecutive Patients: Single Center Experience
A Case of Unresectable Pancreatic Cancer with Long-Term Survival in High-Intensity Focused Ultrasound (HIFU) TherapyA patient in Tokyo with pancreatic cancer survived more than four years while undergoing focused ultrasound in conjunction with standard systemic chemotherapy.
Bob Dienst has always been a man of many talents. That is until essential tremor sidelined him from the activities he enjoyed.
After leaving the Army as a helicopter pilot, Bob began a career in law enforcement in 1972 in New Jersey. He first noticed symptoms of essential tremor a year later when his marksmanship scores declined.
New clinical trial data from a Phase I liver cancer study were recently presented at the Society of Interventional Oncology 2020 Annual Scientific Meeting. Timothy Ziemlewicz, MD, Associate Professor at the University of Wisconsin School of Medicine and Public Health, shared positive results from using the HistoSonics robotically positioned histotripsy system to destroy affected tissue in patients with primary and metastatic liver cancer.
A new clinical trial using focused ultrasound to address Alzheimer’s disease has begun at Columbia University in New York. Researchers are investigating the safety and feasibility of using a novel focused ultrasound device in combination with microbubbles to temporarily open the blood-brain barrier (BBB) in patients with Alzheimer’s disease.
The Foundation has launched a multicenter, international registry to evaluate focused ultrasound as a treatment option for patients with pancreatic cancer.
Safety and Feasibility of Multiple Blood-brain Barrier Disruptions for the Treatment of Glioblastoma in Patients Undergoing Standard Adjuvant Chemotherapy
With 25 citations, a Todd Mainprize et al. paper in Scientific Reports was one of the most cited focused ultrasound peer-reviewed publications in 2019.
Beginning on November 20, 2019, the Society for Neuro-Oncology (SNO) sponsored a series of translational research-focused educational conferences in Phoenix, Arizona. Among others,the series included:
Neuromodulation is the reversible stimulation or suppression of neural brain activity and has been extensively studied with transcranial ultrasound stimulation (TUS). Instead of using high-intensity focused ultrasound for ablation of targets, a form of TUS can take neurons that are “sleeping” and wake them up – or take neurons that are firing too much, such as in epilepsy, and slow them down. Neuromodulation uses low-intensity, low-frequency ultrasound (LILFU) to create mild mechanical waves on cell membranes which are transmitted into electrical signals that regulate cellular functions. Until now, the exact underlying mechanisms were unclear.A recent publication by Lee and colleagues has elucidated a main mechanism describing how TUS alters neuronal function entitled, “Ultrasound Neuromodulation via Astrocytic TRPA1”. It details the pathway of how LILFU alters calcium permeability in the astrocytes, supporting cells of the brain, releasing chemical neurotransmitters that in turn activate adjacent neurons. Another publication by Fouragnan et al. published in Nature Neuroscience has expanded our understanding of how different brain areas influence decision making. A key difference that distinguishes this study from previous experiments is that the authors recorded neuronal activity from multiple brain areas simultaneously and during the decision making process. They found that some brain areas simply hold information, whereas others actually influence behavior. The results of this paper support individualized targeted therapy that can be tailored based on patients’ brain activity in various disease states, including anorexia nervosa, obsessive-compulsive disorder, and Tourette's syndrome.
Photo courtesy of Lee, et. al.
With the encouraging completion of a first-in-human feasibility study, French manufacturer Cardiawave presented results from the first 10 patients at large cardiovascular meetings. This innovative start-up’s current clinical trial uses their Valvosoft platform and a completely noninvasive focused ultrasound technique to address aortic heart valve stenosis (narrowing) caused by calcification of the valve leaflets.
A groundbreaking clinical trialfor women with nonpalpable breast cancer is now underway at Institut Bergonié in Bordeaux, France. The pilot study is testing the safety and efficacy of a novel focused ultrasound device, called MUSE, that was designed at built by the Focused Ultrasound Laboratory at the University of Utah in collaboration with Image Guided Therapy in Bordeaux.
The cover of the journal Theranostics recently featured research led by Nathan McDannold, PhD, in the Department of Radiology at Brigham and Women’s Hospital and Harvard Medical School in collaboration with several other departments.
In “Acoustic Feedback Enables Safe and Reliable Carboplatin Delivery Across the Blood-brain Barrier with a Clinical Focused Ultrasound System and Improves Survival in a Rat Glioma Model,”the team used the Exablate Neuro low-frequency clinical transcranial focused ultrasound system to safely, repeatedly, and reliably disrupt the blood-brain barrier (BBB) in a rat model of aggressive glioma. While the BBB was open, the team delivered a non-neurotoxic chemotherapy agent, carboplatin, to the brain in dosages that slowed tumor growth and significantly prolonged survival as compared to treatment with the drug alone.See Theranostics >
This 20-patient clinical trial is using Insightec’s Exablate Neuro device to temporarily and reversibly open the blood-brain barrier (BBB) in glioblastoma (GBM) patients undergoing standard chemotherapy treatment.
After more than 50 years as a NASA safety engineer, Victor Murray has learned to trust science. “My career requires me to find the answers to problems. I was part of the Apollo 13 fix. When something is wrong, there has to be a fix for it.”
During a 2016 brain workshop, Foundation staff asked several research groups to participate in a “volumetric thermometry challenge” to develop and propose novel MRI sequences that could expand the volume of temperature data captured during focused ultrasound brain treatments. As part of his remote research fellowship, Will Grissom, PhD, Associate Professor of Biomedical Engineering at Vanderbilt University, compared and analyzed the submitted sequences to determine which method best met the technical and clinical requirements established at the workshop.
Sacroiliac Joint Ablation Using MR-HIFU
In 2017, the Focused Ultrasound Foundation established the Andrew J. Lockhart Memorial Prize through support of the family and friends of Andrew J. Lockhart, who passed away in 2016 at the age of 39 after a hard-fought battle with cholangiocarcinoma, a particularly virulent cancer affecting the biliary system of the liver and gallbladder. The Prize is intended to support research that could lead to more effective therapeutic interventions for hard-to-treat cancers like the cancer that took his life.
Francesco Prada, MD, has returned to the Istituto Neurologico Carlo Besta in Milan, Italy after two years of working with the Foundation in Charlottesville. Prada is a neurosurgeon who joined the Foundation in July 2017 as our first clinical Merkin scholar and agreed to stay for a year beyond his fellowship as the Foundation’s Brain Program Director. During these two years he also served as Assistant Professor at the University of Virginia (UVA). As he transitions back to his home institution in Milan, Dr. Prada spoke with us about the status of his projects and what he hopes to accomplish in the near future.
In the past several months there has been a strong uptick in interest in the Foundation’s FUS Partners program, launched in April 2018. It is a critical time in the evolution of the focused ultrasound field where success of the commercial sector is becoming more important as the technology progresses toward becoming a mainstream standard of care that can impact the lives of millions of people.
Bracco is one of the world’s leaders in diagnostic imaging. The Bracco Suisse Research Centre was founded in 1989 in Geneva from the spin-off of a research team of The Battelle Institute. Since 2010, the Centre has been devoting its efforts with an efficient process-oriented approach and has achieved a track record of innovations in the ultrasound field. The Bracco Geneva site, which houses both the R&D and Manufacturing Units, represents a key asset for the Bracco Group and a reference point at international level.
Thierry Bettinger, PhD, Bracco Research Center Geneva Director at Bracco Suisse SA, Switzerland. We recently spoke with Dr. Bettinger about this innovative company.
In April 2018, the Foundation and the Medical Imaging & Technology Alliance (MITA) formed a partnership with the goal of raising awareness of focused ultrasound technology among policymakers, payors, and medical specialty societies. The ultimate aim is to reduce barriers to commercialization and increase patient access to focused ultrasound therapies.
French manufacturer, CarThera, recently announced that the FDA has granted approval to begin a US clinical trial of their SonoCloud-9 ultrasound device in patients with recurrent glioblastoma (GBM).
Boiling Histotripsy-induced Partial Mechanical Ablation Modulates Tumour Microenvironment by Promoting Immunogenic Cell Death of Cancers
The Neurovascular Response is Attenuated by Focused Ultrasound--mediated Disruption of the Blood-brain Barrier
On June 20, the US Department of Health and Human Services (HHS) hosted a public hearing in Washington, DC, to seek input from a variety of stakeholders on their "ReImagine HHS: Accelerate Clinical Innovation" initiative.
In a June 10 announcement, EDAP-TMS shared positive news with regard to the billing and reimbursement of their Focal One high-intensity focused ultrasound (HIFU) treatment for prostate cancer. After submitting an application to the American Medical Association (AMA) CPT® Editorial Panel and gaining the support of both the American Urological Association and the American Association of Clinical Urologists, the company has been notified that the AMA established a new Category 1 CPT code* for HIFU ablation of malignant prostate tissue with their Focal One device. The code, which will be described as "ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU) including ultrasound guidance," goes into effect on January 1, 2021.
Three of the Foundation's research award programs announced newly funded projects for the second quarter of the year. The Cancer Immunotherapy Program selected a project that will study a new method using a combination of focused ultrasound and immunotherapy for treating recurrent ovarian and cervical cancer. The Veterinary Program funded a study to determine "time to metastasis" as an initial index of focused-ultrasound-induced systemic antitumor immune effect. The External Awards Program selected two projects that use mechanical ablation to treat brain tumors and pancreatic tumors, and one project that seeks to develop a "needle-less nerve block" technique that would noninvasively deliver pain medication for local anesthesia. Each project is described below.
The joint meeting of the International Society for Therapeutic Ultrasound (ISTU) and the European Focused Ultrasound Charitable Society (EUFUS) was held in Barcelona from June 13-15, 2019. The Foundation supported the meeting, which was ISTU’s 19th Annual International Symposium for Therapeutic Ultrasound and the 5th European Symposium of EUFUS. The meeting drew over 480 international participants from 33 counties with an interest in therapeutic focused ultrasound applications. Several representatives from the Focused Ultrasound Foundation participated in the program, met with industry representatives, and formed numerous collaborations. Foundation Chairman Neal F. Kassell, MD, spoke during the Horizon/Jolesz Lecture, and Director of Clinical Relationships, Suzanne LeBlang, MD, participated in a panel.
More than 85 neuroradiologists, neurosurgeons, neurologists, oncologists, and scientific researchers attended the 2nd meeting of the Society for Image-guided Neurointerventions (SIGN) held June 10-11 in Baltimore, Maryland. Co-sponsored by the Children's Brain Tumour Drug Delivery Consortium, the conference included daily live webinars covering clinical perspectives on drug delivery to the brain and technological advances along with its general sessions.
ESHO, the European Society for Hyperthermic Oncology, held their annual meeting in Warsaw, Poland, from May 22-24, 2019. The conference is centered on clinical hyperthermia, which is commonly achieved with deep regional radiofrequency (RF) heating and either local sensor-based temperature monitoring, or, more recently, noninvasive MRI-based temperature monitoring. In this context, hyperthermia means heating tumor tissue to a temperature range of 41 to 43 degrees C to sensitize the tissue to both radiation and chemotherapy and make these treatments more effective. Alternatively, hyperthermia could be used to trigger local drug release from temperature-sensitive drug carriers, such as liposomes.
Foundation Chairman Neal F. Kassell, MD, and Asia Program Director Jessica Lukens recently returned from a week-long visit to Hong Kong and Taiwan, during which more than 20 meetings were held to discuss the current and potential impact of focused ultrasound in Asia and around the world.
Treatment planning is an important aspect of transcranial focused ultrasound procedures, and the capability to predict patient-specific heating of a target is not currently available clinically.
Focused ultrasound researchers at Columbia University recently published a paper that is garnering attention in the scientific community and beyond. Available in the Journal of Controlled Release, the group led by Elisa Konofagou, PhD, described their groundbreaking preclinical work using focused ultrasound to deliver targeted gene therapy across the blood-brain barrier (BBB) to restore important nerve pathways that are damaged in Parkinson’s disease.
Delivering Focused Ultrasound to Intervertebral Discs Using Time-Reversal
Page 3 of 12