As a productive year comes to an end, your hard work, support, and collaboration created many focused ultrasound "firsts" in 2014. Together we have expanded this technology’s depth and breadth.
The focused ultrasound potential for the brain continues to grow and evolve. Not only has enrollment in the essential tremor pivotal study been completed, but also, the first patients with Parkinson’s dyskinesia, glioblastoma mulitiforme, and a metastatic brain tumor have been successfully treated, and the first paper on treating obsessive-compulsive disorder with focused ultrasound has been published. The technology is beginning to expand beyond ablation into neuromodulation, histotripsy, drug delivery, and the opening of the blood-brain barrier.
Researchers also conducted the first pediatric treatments in North America this year, opened a new Center of Excellence in London, and convened at our largest Symposium to date. In the US, regulators are reviewing two focused ultrasound systems to treat prostate cancer, and we are hopeful that the FDA will find a path to approve focused ultrasound as a new treatment alternative for this devastating disease.
Because of you, the number of patients who could benefit from focused ultrasound treatments is growing, and the coming year is sure to be full of breakthroughs, new opportunities, and more challenges to overcome. The focused ultrasound community continues to grow and become more collaborative. In an absolute sense, everything is advancing, but it is still not fast enough.
Thank you for being a part of this community that is so passionate about changing the lives of millions of patients who suffer from debilitating and life-threatening medical conditions.
Report Highlights Quarterly Progress
The Foundation’s Fall 2014 Quarterly Progress Report is now available. This publication includes highlights of research milestones and our effort to foster collaboration and innovation, increase awareness, and overcome barriers. It will be available each quarter in the reports section of our website.
Dong-guk Paeng, PhD
Dr. Dong-guk Paeng Joins Foundation as Merkin Fellow
The Richard Merkin Visiting Fellowship Program will begin on January 1, 2015 with the arrival of Dong-guk Paeng, PhD from Jeju National University in Korea. Dr. Paeng was selected from a competitive pool of applicants based on recommendations and his research experience at several world-class institutions. During his 13-month appointment with the Foundation in Charlottesville, Virginia, Paeng will join the technical brain program, helping to lead efforts to develop safe and effective ways to use focused ultrasound, including histotripsy, to expand the regions of the brain that can be accessed and treated with the technology.
“Until now, it has been mostly the thermal effects of focused ultrasound that have been investigated and applied to the brain. It’s time to explore the mechanical cavitation effects like histotripsy on brain tissue. Although it’s challenging, we hope to open another door to brain therapy with minimal overheating of adjacent tissue and unwanted side effects," said Paeng.
"I am excited to support such a talented scientist as Dong-guk and look forward to his contributions in advancing the development of histotripsy to treat the brain." – Richard Merkin, MD
"These collaborations address some of the thorniest issues in medical research using models that can be scaled and translated across diseases and sectors." – FasterCures
Foundation and Philips Present on Focused Ultrasound at Partnering for Cures Conference
The Foundation’s Reimbursement Working Group was selected for an Innovator Presentation at the 2014 Partnering for Cures annual meeting. Susan Klees, the Foundation’s Director of Communications, and Laurel Sweeney, Philips Healthcare’s Senior Director of Healthcare Economics and Reimbursement, gave a talk on Blazing a Trail for Successful Access to Disruptive Technologies. They showcased the broad versatility of focused ultrasound and the working group’s multi-front effort to achieve widespread access by attaining CPT coding for payment, positive reimbursement policies, and appropriate usage for current and future applications. The presentation also provided an opportunity to share the unique role of the Foundation and its venture philanthropy model.
Focused Ultrasound and The Brain is the featured cover story of this month’s Health Management journal. Foundation Chairman Neal F. Kassell, MD, shares his thoughts on why focused ultrasound is a promising treatment option for brain conditions, which diseases might best respond to focused ultrasound, and the challenges that may block its widespread adoption.
Winter School on Therapeutic Ultrasound - Register Now!
Student Funding Available
The Winter School on Therapeutic Ultrasound will take place in Les Houches, France, March 8-13, 2015. The school explores the rapidly emerging field of therapeutic ultrasound. Participants will gain an understanding of the physics behind the technology, the biological and biophysical effects induced in the body, and the clinical applications of ultrasound therapy.
The Foundation is offering travel support for US students to attend the Winter School. Applicants should send a cover letter, CV, and letter of recommendation from their mentor to Matt Eames at .
"There is a need for non-invasive treatment options for patients with OCD that cannot be managed through medication. Using focused ultrasound, we were able to reduce the symptoms for these patients and help them get some of their life back without the risks or complications of the more invasive surgical approaches that are currently available." – Jin-woo Chang, MD, PhD
In a study of feasibility, safety, and preliminary efficacy, patients with disabling OCD unresponsive to medical therapy were treated by ablating small targets deep in the brain (anterior internal capsule) using the InSightec ExAblate Neuro MR-guided focused ultrasound system. This proof-of-concept study is being conducted with 12 patients by Jin-woo Chang, MD, PhD, at Yonsei University Medical Center in Seoul, Korea. The results of the first four patients with six months of follow-up were published.
Neurosurgeon Jin-woo Chang, MD, PhD, is pioneering focused ultrasound research for neurological and psychiatric disorders. Currently directing the Korean site for the ExAblate essential tremor pivotal trial, he also performed the world’s first focused ultrasound pallidotomy in a patient with Parkinson’s disease as part of the global Parkinson’s dyskinesia study. In addition to movement disorders, Dr. Chang is breaking new ground by conducting the world’s first clinical trials using focused ultrasound to treat psychiatric disorders like obsessive-compulsive disorder (OCD) and depression.
“Dr. Chang has incredible vision for the potential of focused ultrasound and has been invaluable in advancing the field across a range of brain applications," says Foundation Chairman Neal F. Kassell, MD. “No one has shown more courage in trying to improve the lives of large numbers of patients."
This profile explores Dr. Chang’s background in focused ultrasound, next steps for psychosurgery, the status of the technology in Korea, and his election as president of the Korean Neurological Society.
The Radiological Society of North America (RSNA) again featured significant focused ultrasound research at its 2014 annual meeting. A total of 18 abstracts covered a range of diseases, including musculoskeletal tumors, neurological and oncological applications, bone metastases, pancreatic cancer, prostate cancer, and uterine fibroids. In addition to the papers and posters, one entire session was dedicated to focused ultrasound, and the technology was also included in the “Hot Topics" session.
Elisa Konofagou, PhD presented her focused ultrasound research to FDA staff
Focused Ultrasound Research Featured at FDA Seminar
Dr. Elisa Konofagou, Professor of Biomedical Engineering and Radiology at Columbia University, presented her extensive work on the use of focused ultrasound to deliver drugs through the blood-brain barrier (BBB) in a seminar at the US Food and Drug Administration (FDA) on November 19th.
Project Develops New Focused Ultrasound System Capabilities
Drs. Seung-Schik Yoo and Wonhye Lee recently completed their project entitled “FUS-mediated Functional Neuromodulation for Neurophysiologic Assessment in a Large Animal Model," which was funded by the Foundation’s External Research Award program in 2012.
The goal of the two-year project was to develop a comprehensive focused ultrasound environment comprised of advanced imaging and focused ultrasound neuromodulation capabilities. Functional MRI (fMRI) and diffusion tensor imaging (DTI) MRI provide functional and structural brain mapping, and onsite electromyogram (EMG) and electroencephalogram (EEG) activities during treatment with focused ultrasound neuromodulation provide physiologic response information. These capabilities are crucial to evaluating and optimizing neuromodulation sonication parameters.
Does focused ultrasound plus chemotherapy and radiation lead to better outcomes than other treatments for pancreatic cancer? Is focused ultrasound a safe treatment for osteosarcoma? What are the long-term results for uterine fibroid patients 5 years after focused ultrasound treatment? These questions and more were investigated in recently published journal articles.
Current focused ultrasound treatment for the palliation of bone mets consists of multiple single focal point sonications. However, the larger, volumetric ablation techniques that are used to treat fibroids are potentially more energy efficient. This study evaluated the technical feasibility, safety, and initial effectiveness of using volumetric ablation for painful bone metastases.
Medical Device and Diagnostic Industry (MD+DI) News has chosen its top five technologies to watch in 2015, and focused ultrasound is on the list. The article challenges readers to “Imagine if brain tumor removal required only mild sedation and no hospital stay. That’s the promise of focused ultrasound technology.” Bioreabsorbable scaffolds, drug-eluting balloons, next generation sequencing, and mobile medical apps round out the list.
"InSightec is at the forefront of the global shift toward non-invasive surgery that has the potential to improve patient outcomes and reduce morbidity and trauma while also reducing cost." – Maurice R. Ferré, MD
InSightec Appoints Maurice R. Ferré as Executive Chairman of the Board
As announced on December 15th, Maurice R. Ferré, MD, a seasoned medical device executive, will join InSightec’s leadership team as Executive Chairman of the Board of Directors. With more than 20 years of experience in the medical device field, Dr. Ferré most recently served as CEO and Chairman of MAKO Surgical Corp, a transformational robotic surgical company that he co-founded in 2004, IPO'd in 2008, and sold to Stryker Corporation for $1.65 billion in late 2013.
Additionally, as a follow-up to their September financing announcement, the option for existing shareholders to invest additional equity of $3.5 million has been extended through January 30, 2015.