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Research Awards Update: Nine Preclinical Projects Initiated in the Fourth Quarter of 2022

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Key Points The Foundation’s Research Awards Program initiated nine preclinical studies from October through December 2022, the fourth quarter of last year. The funded projects address brain, bone, low back pain, and breast cancer applications of focused ultrasound. The Foundation’s Research Awards Program initiated nine new preclinical studies from October through December 2022, the fourth quarter of last year. The funded projects address brain, bone, low back pain, and breast cancer applications of focused ultrasound. “All of the preclinical brain projects are linked to an initiative that came out of the May 2021 glioblastoma workshop,” said Lauren Powlovich, MD, the Foundation’s Associate Chief Medical Officer. “The aim of this group of projects is to identify a method to better quantify the amount of drug delivered to brain tissue after blood-brain barrier opening (BBBO). We are meeting quarterly to discuss progress and new ideas.” Each newly initiated project is listed below. Brain Preclinical Probing the Abilities of Contrast-Enhanced MRI to Track Microbubble-Enhanced Focused Ultrasound Nano-Medicine Delivery in the Brain and Brain Tumors led by Costas Arvanitis, PhD, at the Georgia Institute of Technology For this project, researchers will determine how to confirm therapeutic delivery of nanoparticles to the brain during microbubble-enhanced focused ultrasound (MB-FUS) procedures. The goal is to improve the delivery of therapeutic nanoparticles to brain tumors by studying optimal nanoparticle properties and methods to confirm nanoparticle delivery in the brain and brain tumors. Mapping Drug Concentrations After Blood-Brain Barrier Disruption Using MALDI Mass Spectrometry Imaging led by Nathan McDannold, PhD, at Brigham and Women’s Hospital For this project, researchers will explore the use of matrix-assisted laser desorption/ionization (MALDI) mass spectrometry to quantify the amount of therapeutic delivered to brain tissue after BBBO, then creating specific calibration curves to compare with the MRI images. The goal is to identify a method to better quantify the amount of drug delivered to the brain tissue following BBBO. PET-Labeling and Testing of Paclitaxel Nanoformulations with Microbubbles and Focused Ultrasound led by Graeme Woodworth, MD, at the University of Maryland School of Medicine For this project, researchers will determine whether PET-labeling of nanoparticle therapeutics could enable quantitative visualization of localized nanoparticle delivery during microbubble-enhanced blood-brain barrier opening with clinical focused ultrasound systems in advanced preclinical models of glioblastoma. Mapping of Antibody and Liposome Permeability into the Brain Following Focused Ultrasound Treatment Through T1/T2w Dynamic Contrast-Enhanced (DCE) Magnetic Resonance Imaging led by Antonios Pouliopoulos, PhD, at King’s College Hospital in London For this project, the research team will confirm focused ultrasound–mediated delivery of antibody- and liposome-based therapies by delivering two MR-labelled model drugs across the blood-brain barrier (BBB) and then conducting DCE MRI scans to determine the extent of drug delivery within the tissue. Evaluation of MRI Visualization of Focused Ultrasound–Induced Blood-Brain Barrier (BBB) Opening in White Matter led by Meghan O’Reilly, PhD, at Sunnybrook Health Sciences Centre For this project, researchers will determine how to improve drug delivery to white matter in the brain. Contrast-enhanced MRI is used to assess changes in BBB permeability following focused ultrasound treatment but the contrast enhancement in white matter is lower than in grey matter, so research is needed to be able to use MRI visualization for both applications. MRI Compatible Optical-Driven Focus Ultrasound for Neuromodulation led by Chen Yang, PhD, at Boston University Ultrasound neural modulation is an emerging noninvasive neuromodulation tool. The goal of this project is to develop a compact, MRI-compatible, optically driven focused ultrasound source for ultrasound neural modulation with a broader accessibility than standard focused ultrasound systems. Its application in noninvasive brain modulation and its efficacy in treating epilepsy in a mouse model will be demonstrated. Body Ultrasound-Triggered Gelation to Treat Discogenic Lower Back Pain led by Constantin Coussios, PhD, at the University of Oxford This one-year collaborative study will combine the materials engineering expertise at Imperial College with the biomedical ultrasound expertise at the University of Oxford to optimize material formulations and focused ultrasound exposure parameters with the objective of translating these techniques for percutaneous nucleus pulposus replacement. Doing so would offer a new minimally invasive day case procedure to treat discogenic lower back pain and restore spinal function. Patterning of Mesenchymal Stem Cell Differentiation for Bone Regeneration Using Focused Ultrasound–Mediated Hydrogel Stiffening led by Mario Fabiilli, PhD, at the University of Michigan For this project, researchers will use focused ultrasound to alter the stiffness of a custom acoustic responsive scaffold (ARS) and stimulate bone regeneration. The ARS contains mesenchymal stem cells encapsulated within hydrogels The hydrogel acts as a surrogate for the native extracellular matrix. The studies seek to demonstrate a proof-of-concept for implanting ARS at the site of bone loss. Preclinical High-Intensity Focused Ultrasound (HIFU) Treatment of Breast Adenocarcinoma Using a Noninvasive Toroidal Transducer led by David Melodelima, PhD, at Inserm LabTAU For this project, researchers will determine whether HIFU ablation of breast adenocarcinoma is feasible and effective with a toroidal transducer. The group will use a clinical device that has previously been effective for liver metastases and pancreatic tumors. Learn How to Apply for a Research Award >
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Donor Profile: Cassiopeia Foundation and Ethan Miller

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Key Points Ethan Miller has been a principal in his family-run Cassiopeia Foundation for more than 20 years. The Cassiopeia Foundation has supported focused ultrasound research for Alzheimer’s disease and other neurodegenerative disorders. The Cassiopeia constellation Ethan Miller has been a principal in his family-run Cassiopeia Foundation for more than 20 years. He grew up in Radnor Township, Pennsylvania, outside of Philadelphia. After graduating from Haverford College with a BA in Economics in 1976, Ethan earned his law degree from the University of Pennsylvania Law School in 1979, and then practiced business law for over 25 years in St. Louis, Baltimore, and Charlottesville, VA. Today, he owns and operates an upstream oil and gas company based in Lafourche Parish, Louisiana. What was the reason for your support of the Focused Ultrasound Foundation?Cassiopeia’s first grant to the Focused Ultrasound Foundation was to support its work in the treatment of Alzheimer’s disease. Our giving honors Cassiopeia’s founder, Patricia Jones Edgerton, who was afflicted with Alzheimer’s for over a decade before her death. We were, and continue to be, excited about the potential for focused ultrasound to transform the treatment of Alzheimer’s and other neurodegenerative diseases including ALS, Parkinson’s, Huntington’s disease, dystonia, and essential tremor. We first heard Dr. Neal Kassell speak about the potential benefits of focused ultrasound treatment at a gathering of potential funders in 2006 or so. Neal and the Focused Ultrasound Foundation team have been in the forefront of developing and popularizing ultrasound treatment in the United States and elsewhere in the world.  How does the Focused Ultrasound Foundation fit within your approach to philanthropy?Our approach to philanthropy is to find and support the best people. I first met Neal Kassell when he came to the University of Virginia Department of Neurosurgery in 1984, nearly 40 years ago, and have followed his career. Neal is not only brilliant but a visionary as well. Our approach is to identify people like Neal, provide them with necessary resources, and then stand back and watch. A lot of traditional philanthropy is risk averse. We recognize that risk-taking is required to achieve breakthroughs in medicine (and elsewhere). We are not afraid of risk and believe that the potential benefits of focused ultrasound treatments are worth taking risks for. The Cassiopeia Foundation has made hundreds of grants totaling many hundreds of millions of dollars in its 20 plus year history. I am personally proudest of the two grants we have made to the Focused Ultrasound Foundation. We are honored to support Neal Kassell and the Focused Ultrasound Foundation in their mission.
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The Top 10 Focused Ultrasound News Stories from 2022

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What was the most exciting focused ultrasound news in 2022? Last year’s most-read articles shared news about Parkinson’s disease and adult and pediatric brain tumors. Readers were also interested in breakthrough applications of focused ultrasound, commercialization, reimbursement, and celebrity interest in the technology. Focused Ultrasound for Parkinson’s Dementia: First-in-Human Data PublishedPeople living with Parkinson’s disease sometimes develop memory loss, forgetfulness, trouble concentrating, and eventually dementia. A collaborative team of researchers led by Prof. José Obeso, MD, PhD, successfully used focused ultrasound to open the blood-brain barrier (BBB) in people with Parkinson’s dementia, and the procedure was well tolerated. Read the Article > Focused Ultrasound for Parkinson’s Disease: Results of First Clinical Trial to Deliver TherapeuticsThe results from an early-stage clinical trial investigating focused ultrasound to address a possible underlying cause of Parkinson’s disease were published in Movement Disorders. Nir Lipsman, MD, PhD, led a team that tested the safety and efficacy of focused ultrasound–induced BBB opening to deliver enzyme replacement therapy. The procedure was well-tolerated, and a larger study is being planned. Read the Article > DJ Steve Aoki Shares Potential of Focused Ultrasound in New VideoGrammy-nominated DJ, producer, and philanthropist Steve Aoki released a video illustrating how West Virginia University’s Rockefeller Neuroscience Institute is using focused ultrasound technology to treat conditions like essential tremor, Alzheimer’s disease, and addiction. Watch the Video > New Trial of Focused Ultrasound for Pediatric Brain CancerResearchers at Children’s National Hospital, led by Roger Packer, MD, began a clinical trial to address deadly pediatric brain tumors called diffuse intrinsic pontine gliomas (DIPG). The trial is using focused ultrasound—induced sonodynamic therapy (SDT) to kill tumor cells. Read the Article > The Complex Ecosystem of a Medical Device StartupThis blog series by Mark Carol, MD, addresses the processes, trials, and tribulations involved in bringing a new medical technology like focused ultrasound to market. Read the Blog Post > Medicare Proposes Reimbursement Rate Increase for HIFU Prostate TreatmentsThe US Centers for Medicare and Medicaid Services proposed and approved a rule that increased the reimbursement rate that treatment sites receive for performing focused ultrasound for the prostate. Read the Article > UVA Health, Focused Ultrasound Foundation Partner to Create World’s First Focused Ultrasound Cancer Immunotherapy CenterUVA Health and the Foundation launched the Focused Ultrasound Cancer Immunotherapy Center, the world’s first center dedicated specifically to advancing a focused ultrasound and cancer immunotherapy treatment approach, to revolutionize 21st-century cancer care. Read the Article > Webinar on Focused Ultrasound and Alzheimer’s DiseaseOn World Alzheimer’s Day, the Foundation partnered with USAgainstAlzheimer’s and the Global Alzheimer’s Platform Foundation to host a webinar on focused ultrasound for Alzheimer’s disease. Watch the Webinar > Clinical Trial of Sonodynamic Therapy for Glioblastoma Begins in MilanIn this trial funded by the Foundation, researchers led by Francesco Prada, MD, are using SDT in patients with newly diagnosed glioblastomas, a primary malignant brain tumor. Read the Article > Focused Ultrasound: A Potential Non-Drug Therapy for DiabetesA large, multicenter team of researchers partnered with GE Research to study the use of focused ultrasound neuromodulation for the treatment of diabetes. The results of the preclinical study were published in Nature Biomedical Engineering. Read the Article >
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Molly Hardie Joins Foundation’s Council

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Key Points Molly Hardie is co-chairman of the private family investment company, H7 Holdings, LLC. Molly and her husband, Robert, are longtime supporters of focused ultrasound research. The Council is a dedicated group who provide advice and assist with raising funds and building awareness. The Foundation is pleased to welcome Molly Hardie to its Council, a dedicated group of goodwill ambassadors who work closely with the Board of Directors and staff to provide advice and assist with raising funds and building awareness. With her husband, Robert, Ms. Hardie is co-chairman of H7 Holdings, LLC, a private family investment company that takes significant positions in various asset classes. She is involved in a variety of investments, most notably Keswick Hall in Keswick, Virginia, and The Hermitage Hotel in Nashville, Tennessee. Since 2017, Ms. Hardie has been integral to the renovation and expansion of Keswick Hall. She was actively involved in a large construction project that included the addition of 40 guest rooms, the free-standing Marigold restaurant, and a spa. She also oversaw the construction of five custom homes in Keswick Estate and the creation of a five-acre farm garden. At The Hermitage Hotel, Ms. Hardie was involved in a construction project that included the renovation of the hotel kitchen and restaurant and a full refresh of the public spaces, guest rooms, and luxury suites. Ms. Hardie also oversees H7 Holdings ownership of Clover Hill, LLC, a working cattle farm in Keswick. She has served on the board of several local organizations, including the Virginia Discovery Museum, The University of Virginia (UVA) Health Foundation, and the Peabody School. She was an active member of The Young Families Committee for the Children’s Medical Center at UVA, and she participated in the long effort to plan and build the Battle Building at UVA Children’s Hospital. Ms. Hardie currently serves on the board of the Thomas Jefferson Foundation and is a member of the Albemarle Garden Club. She is an alumna of Dartmouth College and the UVA Medical School. “Molly and Robert have been longtime friends and supporters of the Focused Ultrasound Foundation,” said Foundation Chairman Neal F. Kassell, MD. “They truly understand the potential of the technology and have helped to fund important research in Parkinson’s disease and other neurodegenerative disorders as well as cancer treatment, including cancer immunotherapy. We are thrilled to have Molly as the newest member of the Council.” “I am delighted to join the Council and to use my medical degree to help advance this technology,” said Ms. Hardie. “Robert and I have found the work that the Foundation is doing in cancer immunotherapy to be quite exciting. In addition, we are interested in how focused ultrasound can penetrate the blood-brain barrier and be utilized therapeutically in neurodegenerative and psychiatric diseases. Focused ultrasound shows great promise to extend survival and improve quality of life for patients in the future.”
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Visiting Scholars Work to Accelerate the Field of Focused Ultrasound

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Key Points This fall, an intern and a visiting scholar joined the Foundation and took different approaches toward the same goal of advancing the field of focused ultrasound. Visiting scholar Yi-Hsiu Chen gained preclinical and clinical research experience that will help further the focused ultrasound program at her hospital in Taiwan. Fall intern Imogen Hequet explored machine learning and its intersection with focused ultrasound. Yi-Hsiu Chen is pursuing her PhD in Neuroscience at National Yang Ming Chiao Tung University/Taipei Veterans General Hospital. She joined the Foundation this fall as a short-term research scholar to gain experience that she will take back to her team in Taiwan to help further their focused ultrasound program. During her time at the Foundation, Yi-Hsiu observed preclinical studies and clinical treatments at the University of Virginia and the University of Maryland. Learn More About Her Experience “My experience [at the Foundation was] so amazing,” recalls Yi-Hsiu. “I met so many people here and discussed the research they were interested in and the next step of focused ultrasound research in our hospital in Taiwan. I have learned a lot from people I met here.” Imogen Hequet, a recent graduate of Imperial College of London, worked with the Foundation’s chief technology officer, Rick Hamilton, to explore machine learning and the role that it could play in medicine, specifically in the field of focused ultrasound. Learn More About Her Project “Hopefully something I have done during my internship will help to open conversations about machine learning and areas where it could add value in focused ultrasound,” says Imogen.
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Clinical Trial of Sonodynamic Therapy for Glioblastoma Begins in Milan Yutong Guo, PhD, Named 2022 Andrew J. Lockhart Postdoctoral Fellow Research Awards Update: Five Preclinical Projects Initiated in the Third Quarter of 2022 Whoopi Goldberg Joins Foundation’s Council Lorraine Spurge Joins Foundation’s Council