This month, the US Food and Drug Administration (FDA) broadened treatment options available to the millions of women who suffer from uterine fibroids. First, the FDA approved a more advanced next generation ExAblate system for fibroids. In addition, the FDA removed the “family complete” requirement, confirming that women who want to maintain their fertility can use FUS to treat their fibroids.
“The new version of the ExAblate system gives physicians greater control and more flexibility in treating fibroids with a clearer 3D view of the ongoing procedure,” said Alan H. Matsumoto, MD, Radiology Chairman at the University of Virginia. “With this new technology, treatment time is reduced, allowing for treatment of more fibroid tissue in a given time.”
The loosening of the fertility restrictions is based on clinical data from 118 patient pregnancies after undergoing treatment with ExAblate. “This is a major breakthrough in the treatment of symptomatic uterine fibroids. Gynecologists can now offer patients a treatment that is not only non-invasive and uterus sparing, but with the new labeling, this treatment is also an option for women who are not family complete,” said Haywood Brown, MD, Chairman of Obstetrics and Gynecology at Duke University School of Medicine.
“Many women with fibroids are interested in protecting their fertility, and we are pleased to be able to assure them that focused ultrasound is a safe and effective option to consider prior to conceiving,” said Justine Atkinson, Executive Director of Fibroid Relief.
Reimbursement Update While the regulatory changes will help with improving the treatment and attracting women, focused ultrasound is still not consistently reimbursed in the US. The Foundation is participating in the design of two new studies to generate long-term data for private payers:
The Affordable Care Act: Promises, Perils, and Politics
Join us for the Foundation’s next interactive webinar on Friday, October 30, at 11:00 am Eastern as Professor Carolyn Engelhard, a leading expert in health policy at the University of Virginia, will cover the basics of the United States Affordable Care Act (ACA).
The presentation will include an overview of ACA structure and a brief history of the challenges to the act. Engelhard will provide an update of its current status, including enrollment numbers for the new insurance exchanges. We will discuss who is still left out and why, along with the political implications of the act and how the health care debate will affect the 2016 presidential election.
As we work to accelerate this innovative technology toward widespread adoption, companies, physicians, and patients must be aware of how shifts in the US healthcare paradigm will affect the future.
Lafon is a biomedical engineer and physicist who is currently the Research Director of the Laboratory of Therapeutic Applications of Ultrasound at the French Institute of Health and Medical Research (INSERM).
The topics and panel discussions at the meeting demonstrated the rapid expansion of conditions that can be treated with focused ultrasound, including promising data on pancreatic cancer. – Foundation Chairman Neal F. Kassell, MD
Clinical Treatments Featured at European Symposium
More than 180 international focused ultrasound experts gathered in London at the Royal Geographic Society for the 3rd European Symposium on Focused Ultrasound Therapy, held October 15-16. The robust agenda concentrated on current and developing clinical applications and featured expert panels describing the details, successes, and challenges of performing individual procedures.
“Other meetings have covered the scientific basis of the technology,” said symposium organizer Wladyslaw Gedroyc of St. Mary's Hospital/Imperial College NHS Trust in London. “The presentations at this year’s conference truly highlighted the current state-of-the art from a clinical perspective. The indications, the specific procedures, and current challenges created the core of the material presented to the attendees.”
Foundation Intern Chanzhu Jin attended the Korean meeting
Korean Society of Therapeutic Ultrasound Holds Inaugural Conference
The inaugural scientific conference of the Korean Society of Therapeutic Ultrasound (KSTU) was held at Yonsei Severance Hospital on September 19. One of the Foundation’s 2015 interns, Chanzhu Jin, joined the group of 80 neurosurgeons, neurologists, scientists, and engineers to enjoy 9 lectures, 10 abstract presentations, and a special lecture by University of Washington pancreatic cancer expert Joo Ha Hwang, MD, PhD.
Justine Atkinson (front right) participated on the patient advocate panel
COMPARE-UF is a multi-year collaboration between PCORI and AHRQ designed to enable patients and their clinicians to make informed decisions about uterine fibroid treatment options--including focused ultrasound.
COMPARE-UF Stakeholders Meet
Fibroid Relief Executive Director Justine Atkinson attended the first in-person meeting of the Stakeholder Advisory Group for the new nationwide Comparing Options for Management: Patient-Centered Results for Uterine Fibroids (COMPARE-UF) registry in Baltimore this month. The meeting was attended by patient advocates, industry, payers, FDA, and HHS.
Key topics of discussion included:
COMPARE-UF study progress
Barriers and solutions for patient recruitment and retention
Strategies to bolster the COMPARE-UF social media footprint
Atkinson participated in a panel discussion with other patient advocates in which she shared key findings from the 2013 Fibroid Relief patient survey and stressed the need to focus patient messaging on early detection to minimize fibroid growth while maximizing the number of possible treatment options available to women.
The first patient has been treated in a 10-patient pilot clinical trial to determine the feasibility and safety of using focused ultrasound to treat depression. Neurosurgeon Jin-woo Chang, MD, PhD, at Yonsei University College of Medicine in Seoul, Korea, used Insightec’s ExAblate Neuro system to successfully ablate the anterior limb of the internal capsule, a well-established neurological target for treating severe depression. The non-invasive procedure was performed safely and without complications.
London Hospital Initiating Brain Trials, Pioneering Drug Delivery
St. Mary’s Hospital in London will soon have the first focused ultrasound brain system in the UK. Leading radiologist Wladyslaw (Wady) Gedroyc recently secured funding from the Imperial College Hospital Charity for the Insightec ExAblate Neuro system.
While they have approval for an essential tremor trial beginning later this year, Dr. Gedroyc is also pioneering new applications of the technology. A three-year, £1.25 million research grant enabled him and his team to develop a new theronostic (therapy and diagnostic) approach using focused ultrasound to direct drugs to tumors and boost their concentration for delivery. They are also in the process of patenting two new drugs and are working with Global Acorn to raise capital to commercialize the agents.
In September, essential tremor patient Stephen Palovchik became the first to be treated using focused ultrasound at Ohio State University's Wexner Medical Center. The site joins five additional locations that are currently participating in the essential tremor continued access program.
The medical community calls it benign essential tremors, but if you have it, it’s not a benign condition.– Stephen
Elisa Konofagou, PhD, and her team at Columbia University have received one of seven new Defense Advanced Research Projects Agency (DARPA) grants to investigate the use of various types of energy sources to modulate neural activity. The Columbia group will study the underlying mechanisms for using focused ultrasound to activate and inhibit neurons. DARPA commissions advanced research for the US Department of Defense, and their new Electrical Prescriptions (ElectRx) Program is working to find non-medicinal ways to treat disease by modulating the activity of peripheral nerves.
Understanding the way that Alzheimer's disease cripples the brain and then designing an affordable treatment is what drives the work of Jürgen Götz, PhD. His ideas to combine focused ultrasound, immunology, and medications are leading to big discoveries, as we reported earlier this year. To learn more about the scientist behind these exciting advances in Alzheimer’s disease treatment, we interviewed University of Queensland Professor Jürgen Götz, PhD, about his ongoing work, collaborations, and achievements.
Recently published papers looked at skull-related issues in transcranial focused ultrasound, brain treatment envelope expansion using low-intensity, non-thermal, cavitation-enhanced ablation, and a fascinating history of the development of focused ultrasound in the 1950s.
JTU Article of the Month: Deep Bleeder Acoustic Coagulation
Collaboration between Siemens and Larry Crum’s team at the University of Washington produced a two-part publication that describes their project developing and testing a focused ultrasound cuff system for the US army to use in the field to detect and effectively cauterize deep bleeding from limb injuries. Deep Bleeder Acoustic Coagulation (DBAC) Part I and Part II highlight the current issue of The Journal of Therapeutic Ultrasound.
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American men have been traveling overseas for focused ultrasound treatment of prostate disease for years. They will now have access to this innovative therapy in the US. – Foundation Chairman Neal F. Kassell, MD
Focused ultrasound has been successfully used to treat a wide variety of prostate diagnoses, including benign prostatic hyperplasia (BPH), partial or whole gland ablation for prostate cancer, and recurrent prostate cancer. In fact, more than 50,000 men around the world have been treated with focused ultrasound for prostate cancer. It is the leading clinical application of the technology -- more than 50% of the patients who have undergone focused ultrasound therapy worldwide had prostate diseases.
Focused ultrasound is already approved in Europe to treat essential tremor, Parkinsonian tremor, and neuropathic pain, and we look forward to US patients having access to this groundbreaking technology. – Foundation Chairman Neal F. Kassell, MD
Next Step Toward US Approval for ET Treatment
The results of the pivotal trial of focused ultrasound for treating essential tremor using Insightec’s Exablate Neuro have been submitted to the FDA for premarket approval. The FDA has granted an expedited review process for this submission.
“FDA approval would represent an important step in the path toward focused ultrasound being widely available as a non-invasive alternative for treating patients with essential tremor, and eventually other serious neurological disorders,” said Neal Kassell, MD.
Insightec’s application is based on the experience treating 76 patients with essential tremor in a pivotal trial conducted at eight centers in the US, Canada, Korea, and Tokyo. Patients in the study were randomly assigned to undergo focused ultrasound or sham (no) treatment, and were assessed at 6 and 12 months following the procedure. Patients who had no response to the sham treatment were later allowed to undergo focused ultrasound treatment.
This study was funded through a partnership between Insightec, the BIRD (US-Israel Binational Industry R&D) Foundation, and the Focused Ultrasound Foundation.
…We are pleased to be moving on to our next milestone of a larger multi-jurisdictional study of 110 patients at 10 clinical trial sites in 2016. – Steve Plymale, Profound’s CEO
Profound Medical Presents Successful 12-Month Phase I Outcomes Data
Successful 12-month data from the TULSA-PRO Phase I Clinical Trial were presented at last week’s meeting of the European Symposium on Focused Ultrasound Therapy. Profound’s TULSA prostate treatment system was used to treat 30 patients with low/intermediate risk, organ confined prostate cancer. The study leaders described accurate treatment planning, precise control, and a well-tolerated side effect profile. The next phase will be a pivotal clinical trial.