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efta-efta00593714DOJ Data Set 9Other

FOCUSED

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FOCUSED ULTRASOUND FOUNDATION Focused Ultrasound The Technology Focused ultrasound is an early-stage, disruptive, noninvasive therapeutic technology with the potential to improve the lives of millions of patients with a variety of serious medical disorders by providing an alternative or complement to surgery, radiation therapy, drug delivery and cancer immunotherapy. This game changing technology has the potential to increase the quality and longevity of life and decrease the cost of care for countless patients by transforming the treatment of a range of conditions including tumors of the brain, breast, prostate, liver and pancreas; Parkinson's and Alzheimer's disease and epilepsy; depression and obsessive compulsive disorder; and arthritis and hypertension. With further technological development, laboratory research and clinical trials focused ultrasound could be as revolutionary to therapy as MR scanning has been to diagnosis. Focused ultrasound treats tissue with multiple intersecting beams of high-frequency sound focused accurately on targets deep in the body without damaging surrounding structures, much like beams of light can be focused on a point with a magnifying glass. At the focal point where the beams converge the ultrasound energy induces a variety of biological effects including destroying tissue, delivering drugs in high concentrations, enhancing radiation therapy and stimulating the immune response.The multiple biological effects create the possibility to treat a wide range of disorders. Magnetic resonance or ultrasound imaging is used to identify the targets and guide and control the treatment in real time. The Problem Unfortunately, it can take decades for a new therapeutic technology like focused ultrasound to become mainstream. Every year we shave off that process could reduce death, disability and suffering for countless people. The Focused Ultrasound Foundation The Foundation is a unique medical research, education, and advocacy organization created as the catalyst to accelerate the development and adoption of focused ultrasound. The Foundation is a tax-exempt 501(c)(3) corporation started in 2006. To achieve its goals, the Foundation utilizes an approach that is entrepreneurial, high-impact, high performance, market-driven and results oriented. We advance the field by leveraging opportunities and overcoming barriers, thereby shortening the time from laboratory research to widespread patient treatment as a standard of care. Major initiatives include • Influendng the direction of the field, identifying priorities and defining areas of clinical benefit • Fostering collaboration and stimulating innovation • Providing resources, both financial and human capital • Creating knowledge by organizing, conducting and funding research • Aggregating and sharing knowledge through our website, newsletter, social media, webinars, and open-source journal Overcoming barriers, induding regulatory and reimbursement challenges Cultivating the next generation of researchers by supporting internships and fellowships Convening the community through meetings, symposia, and workshops Increasing awareness through events and media outreach This work is made possible by the philanthropic support of our donors, who recognize the urgent needs of patients, the potential of focused ultrasound and the value of the Foundation's disciplined, entrepreneurial approach. Focused Ultrasound Foundation For more information, visit www.fusfoundation.org or contact, Nora Seilheimer, 1230 Cedars Court , Suite 206 I Charlottesville, VA 22903 I EFTA00593714 Mechanisms of Action 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 Thermal ablation Mechanical cellular damage Microvascular disruption DRUG DELIVERY Increased vascular permeability Localized drug release from nanoparticles Disruption of cell membranes IMMUNOMODULATION RADIOSENSITIZATION Release of tumor antigens Increased immunotherapeutic delivery Increased immune cell trafficking to tumors Non-lonLting alternative to radiotherapy Tissue preconditioning Adoption Status This chart portrays the global status of focused ultrasound as it evolves to widespread adoption. The number of indications is increasing rapidly, but most are in the early stages of development =1=1= Neurological 'on Futurn DeprySaiWr .... OCD Atinomers IMe., no • ElOrirrniv MM M ,setkOCODN)ks M. Murrouue Wen>, no Sfrcke ME liennwylic ?eon IngeereCi NOvoq. S A V M . , Musculoskeletal MEM. ooi.,;.0 °vow.. . MIMES 00000rIreeis MOMS 04C 005400?‹, MO AMOY APOP, ve Sociciklis Spool Cord Injury Sneral lomon Ontological rwoll < LKIerry liver COnCw Poucreolic [grow Soli Dixon rumen &On kenCIS Perliolrk NEVOISCrtrury,., hood & Neck Omer lung Cancer adorn taxer Bowel cancer Coun Come. v.xnusiecy cance• Women's Health Viet e I r.ory. Wen411 tec.ccenc.ennt LilorVro AtIonomyout lut)01PrerrOuCv el SLrGerr OrcryanCcncet Cardiovascular MOO Wenn • MIMS • MEMM • ono n ono ma • mu on pctecyslic Ovarian SOUVOMO MEI 4, 3 t Deep "en Throntolo Noon bock Hi hl Yerpormaoi Amen, Nem, Stolid Per 100.0., Urolosecal Proyfule Co-cer • kidney cancer Milan V/ Barron neuritic trrporru.z. . *COO (Wei infiv Acute NOM., Net Velvocele 810cIrlei Cain-' Endocrine Disorders MMM. Miscellaneous Mae • me ICA woe) nn tcusee !Avian, rasters r ZIS to anti te usono rot ret voters 'caner Board of Directors Neal F. Kassel', MD Chaim's\ Founder:FocusedUltrasound Foundation Former Co-Chair of Neurosurgery, University of Virgrna Dorothy N. Batten Founder, 'Thrive Initiative Former Director, Larxlmark Cornmunkations.inc LodewijkJ.R. deVink Founcing Partner, Blackstone Healthcare Partners, LLC Former Chairman &CEO,Warner-Lamtert Eugene V. Fife Founding PrincipalVawterCapItalLLC Former Chairman,Goldman Sachs Ind John FL Grisham Author William A. Hawkins, Ill Former Chairman & CEO, Medtronic Daniel P. Jordan, PhD President Emeritus, Thomas Jefferson Foundation. Inc. Edward J."Ned" Kelly, Ill Former Chairman. Institutional Clients Group. Cliigroup Edward D. Miller, MD Former CEO. Johns Hopkins Medicine Frederic H. Molt MD Co-Founder, Intuitive Surgical Chairman & CEO, AWIS Surgical Robotics, Inc. Council Steve H. Rusckowski President and CEO, Quest Diagnostics Inc. Former CEO. Philips Healthcare Charles Steger, PhD Former President, Virginia Tech Andrew C. von Eschenbach, MD President, Samaritan Health Initiative Former Comftssioner, U.S Food and Drug Administration Former Director. National Cancer Institute Cad P. Zeithamt PhD Dean, University of VIrgina's hldntrre School of Commerce The Foundation's Council is a group of passionate, enthusiastic advocates who connect us to the greater community, share our story, and promote our mission. Jane P Batten, Co-chair Charles H. Serlheimer, Jr., Co-chair John B. Adams, Jr. Ellen Block Charles F. Bryan, Jr. PhD T. Michael Cashman Nancy J. &Thomas N. Chevming Marguerite& Norwood Davis Diane Heller Cecelia S. Howell Dean L. Kamen Ann Kingston Syaru Shirley Lin, PhD Amanda Megargel Lonna & Tony Mendez Alice H. Siegel Michael Milken Aaron Stern, MD, PhD Pamela Minetti, MBA Howard & Fred i Stevenson Paula E Newcomb Jane Tolleson Wyndham G. Robertson Meredith Jung-En Woo, PhD Mary Lou Seilheirner Linda K. Zecher Kimberly Skelly 3.112017 EFTA00593715

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