Theraclion's first U.S. clinical study using focused ultrasound to treat breast tissue has begun at the University of Virginia. The French ultrasound manufacturer's study will treat women with breast fibroadenoma using the ultrasound-guided Echopulse system. The clinical trial is being led by David R. Brenin, MD, a University of Virginia breast surgeon, and the primary outcomes will be to reduce the volume of the fibroadenoma and improve patient satisfaction. Fibroadenomas are typically painless, benign growths that occur in women age 20-30. If proven effective, noninvasive ablation could prevent surgery and scarring.
"The important message is that these are benign tumors, and the goal is to get rid of the symptoms," said Dr. Brenin, who has already treated the first two patients. Depending on the size of the tumor, the treatment time will be 15 to 90 minutes. The outpatient procedure is performed under conscious sedation, and the patient is able to return home a little more than an hour later. Complete study information is available on clinicaltrials.gov.
Patients who are interested in this study, should contact UVA Research Coordinator Katie Rea at (434) 243-0315 or
Industry executives, regulatory, marketing, and legal experts joined the discussion of reimbursement
Reimbursement Summit Attendees Create Action Plan for Fibroids and Bone Pain Palliation
In an example of the power of collaboration, the Foundation hosted a Reimbursement Summit on May 13th in Charlottesville. The more than 20 attendees included professionals from Philips Healthcare, InSightec, EDAP-TMS, and reimbursement consulting firm ADVI. The group attained their primary objective to develop an integrated action plan to obtain U.S. reimbursement for focused ultrasound treatment of uterine fibroids and palliation of painful bone metastases.
The Foundation's 2014 Symposium moderators were recently announced, including leaders in brain, bone, breast, liver, prostate, uterine fibroids, and emerging applications. Taking place in Bethesda October 12-16, the Symposium will offer a multifaceted exploration of current and future applications of the technology and feature plenary sessions, panel discussions, poster presentations, and exhibits.
The Dean of UVA's McIntire School of Commerce, Carl Zeithaml, has been elected to the Board of Directors of the Foundation. He is an expert in healthcare and global strategic management and brings his interest in international expansion, corporate policy, and organizational transformation experience to the team.
"I love innovation and big, ambitious ideas that are designed to help people and make the world a significantly better place," said Dean Zeithaml. "The efforts of the Focused Ultrasound Foundation certainly qualify on all dimensions. Based on results to date, the potential is enormous. I am very excited to lend my time and expertise and to connect the Foundation with my network to spread interest in their visionary work."
Focused Ultrasound Featured at Society for Thermal Medicine Meeting
At the 31st Annual Meeting of the Society for Thermal Medicine (STM) on May 9th in Minneapolis, the Foundation's Scientific Director, Jessica Foley, PhD, reviewed recent advances of focused ultrasound (FUS) therapy in oncology, the current global adoption and development landscape, and the Foundation's strategy for advancing this field. A particular area of interest at the meeting was the use of hyperthermia – including FUS ablation – to induce an enhanced immune response for more effective treatment of cancer.
New Diseases Treated, New Companies Formed, and Notable Research Advances Highlighted in Annual Report
Last year the field of focused ultrasound gained momentum at an accelerated rate, and the role of the Foundation in catalyzing this growth is now widely recognized. To learn more about the achievements of the Foundation and hear from patients and researchers about the promise of this technology, read the 2013 Annual Report. Highlights include publication of the essential tremor (ET) trial in the New England Journal of Medicine, the start of the ET pivotal trial, the new Center of Excellence in London, and more…
"For a select group of prostate cancer patients, this technology might provide an opportunity to delay the progression or eliminate their cancer with fewer side effects." - Jeffrey Wong, MD
Focal Prostate Cancer Study Begins at City of Hope
A new InSightec study to determine feasibility and safety of using the ExAblate System to treat localized, low-risk prostate cancer has begun in California. Jeffrey Wong, MD, Professor and Chair of the Department of Radiation Oncology and Associate Director of the Prostate Cancer program at City of Hope in Duarte, California is the principle investigator at City of Hope. The study will begin enrolling at the Mayo Clinic in Rochester, Minnesota, and other locations. City of Hope is the first U.S. site to treat a patient enrolled in this study.
At City of Hope, Dr. Wong performed the first treatment in November of last year. He treated the second patient this month, and a third will be treated soon. "The treatments went well – the technology performed well," he said. "We visualized the area to be treated, and the software helped focus on our target tissue." Dr. Wong wrote a blog post after treating the first patient in the study, and Imaging Technology News also wrote a story about the study.
Patients who are interested in this study, should contact Maria Brooks at City of Hope (626) 256-4673 ext 64402, or Connie Sathre at Mayo Clinic (507) 538-0540, .
Dr. Peter Baginsky and his wife Cheryl Hanson traveled to Switzerland for experimental surgery on his glioblastoma brain tumor
Update from California Brain Tumor Patient
"It started as a leap of faith and ultimately turned into a miracle." That is how Cheryl Hanson describes the experience traveling from California to Switzerland in order for her husband, Dr. Peter Baginsky, to undergo focused ultrasound treatment of his aggressive glioblastoma brain cancer. As we reported in March, Peter was the first person to have a portion of his brain tumor thermally ablated through the intact skull using focused ultrasound.
Preliminary results from a 16-patient study in China suggest that ultrasound-guided focused ultrasound ablation is a non-invasive, feasible, and effective method for the treatment of Cesarean Scar Pregnancy (CSP). CSP is one of the rarest forms of ectopic pregnancy. The study will soon be published in the American Journal of Obstetrics and Gynecology. Another Chinese study that used focused ultrasound to treat ectopic pregnancy was published in 2011 in the Scottish Medical Journal.
JTU Article of the Month – First Performance of Pallidothalamic Tractotomy to Treat Parkinson's Disease Dyskinesia
Thirteen patients with Parkinson's were treated with focused ultrasound ablation to create a pallidothalamic tractotomy. In the first published paper about the use of focused ultrasound for this target, the May issue of The Journal of Therapeutic Ultrasound describes this important work that produced successful safety and efficacy results. The researchers also discovered that the pallidothalamic tract requires repeated thermal exposition to achieve full lesioning and, thus, full therapeutic effect.
"The MRgFUS PTT provided similar clinical improvements to Parkinsonian patients as the ones obtained by radiofrequency PTT. There were no post-operative neurological side effects." - Anouk Magara et al.
Celebrating its 10th anniversary this year, Theraclion is a French focused ultrasound company that currently specializes in treating benign breast tumors and thyroid nodules. Their Echopulse system is approved in Europe and available to patients in France, Italy, and Germany. With the start of their first U.S. clinical trial and the recent news that the company has become publicly traded, we interviewed Chief Technology Officer Sylvain Yon, PhD, to discover more about the company's accomplishments, status, and future direction. Sneak peak: Their ultimate goal is to noninvasively treat every kind of tumor.