Canadian Government Agency Recommends FUS for Fibroids
Deems it a cost-effective, least invasive treatment option
The Ontario Health Technology Advisory Committee (OHTAC) has recommended focused ultrasound (FUS) as a possible “cost-effective strategy” and a “safe and effective, noninvasive, uterine-preserving” option for women seeking treatment for uterine fibroids. A new evidence review by Health Quality Ontario (HQO) led to this recommendation by OHTAC, finding FUS offers significant improvement in fibroid symptoms and rapid post-procedure recovery for women, with a rare occurrence of complications and a low risk of needing further treatments. A companion economic analysis concluded that FUS could result in an annual savings of up to $4.15 million for Ontarians.
These findings by HQO and OHTAC are an important step in recognizing the body of evidence that supports the efficacy and cost benefit of the technology. “We were pleased and not surprised to see that after a thorough review of the evidence, OHTAC found FUS to offer significant treatment advantages for women, including possible fertility preservation, at a reasonable cost," said Foundation Chairman, Neal F. Kassell, MD.
"We expect these reports to facilitate full adoption of FUS in Ontario and help address the challenges to widespread acceptance of the technology globally." – Neal F. Kassell, MD
In response to last month’s groundbreaking preclinical research on focused ultrasound improving memory in Alzheimer’s published in Science Translational Medicine, Jessica Foley, PhD, Foundation Chief Scientific Officer, and Steven T. DeKosky, MD, Chair of the Foundation’s Alzheimer’s Steering Committee, co-published a Letter to the Editor. The letter, which connects the Australian research to previous work using focused ultrasound and microbubbles to open the blood-brain barrier (BBB), emphasizes two important points.
Record Live Audience Tuned in to Fox Foundation Parkinson's Disease Webinar
Information about focused ultrasound reached more than 1,500 participants—our largest live audience to date—during last month’s Michael J. Fox Foundation webinar on treatment advances for Parkinson’s disease. The discussion featured Foundation Chairman Neal F. Kassell, MD describing the potential of focused ultrasound for treating the disease and current clinical trials. The webinar has since been downloaded by an additional 800+ viewers and is archived on the website.
Suzanne LeBlang, MD
Suzanne LeBlang Named Chief Medical Officer
The Foundation welcomes a leading focused ultrasound clinician to the team as Chief Medical Officer. Suzanne LeBlang, MD, is a neuroradiologist and an early adopter of focused ultrasound who has used the technology to treat research and commercial patients for more than 10 years. Dr. LeBlang will organize working groups to devise clinical protocols, serve as a liaison to the clinical research community, and represent the Foundation at medical conferences.
Bringing the Future into Focus, the Foundation’s 2014 Annual Report is now available online. It highlights strides made in research for brain disorders, cancer and pediatric conditions as well as our role in convening the community, increasing awareness, overcoming barriers, and cultivating the next generation.
Research Published on FUS Delivering Genes to the Spinal Cord
Nature’s Gene Therapy journal has published pioneering work on the use of focused ultrasound to deliver genetic material across the blood-spinal cord barrier (BSCB). The research, titled “Gene Delivery to the spinal cord using MRI-guided focused ultrasound” was conducted by Kullervo Hynynen and collaborators at the University of Toronto and Sunnybrook Research Institute. The article describes their use of FUS in combination with microbubbles to transiently open the BSCB, enabling gene delivery in a rat model. Similar to their work utilizing FUS to open the blood–brain barrier for the treatment of Alzheimer’s disease, this innovative preclinical study helps pave the road for the potential to treat spinal cord injuries, infections, and tumors.
A 13th Century church was the setting for ISTU 2015
"The meeting was a great forum for leading scientists and clinicians in focused ultrasound to interact. We had close to 200 abstracts on topics, including modeling and physics, guidance, systems development and clinical applications." – Chrit Moonen, PhD, ISTU 2015 Committee Chair
ISTU: Clinical Highlights, Aubry Named President
Approximately 250 attendees gathered at the historic Dom church in Utrecht, The Netherlands for the International Society for Therapeutic Ultrasound's (ISTU) recent symposium. Presentations included updates from several ongoing clinical and technical studies. Jean-Francois Aubry, PhD, who spent more than a year as a Fellow at the Foundation, was chosen as the next President of ISTU.
Scientific highlights included:
Eye opening plenary lectures on neuromodulation by Shy Shoham, PhD (Technion) and on immunotherapy by Gosse Adema, PhD (Radboud University Medical Center), who called for multidisciplinary teams to explore this area.
Presentations on topics such as boiling histotripsy and the use of a toroidal transducer were given to address the need for larger and faster volume ablations.
Exciting advances in blood brain barrier (BBB) disruption were presented with applications such as drug and gene delivery. Disruption of the BBB has the potential to treat a wide range of neurological disorders including Alzheimer’s disease and brain tumors.
Other meeting highlights included the application of focused ultrasound for uses beyond thermal ablation: sonoporation, thrombolysis, and drug delivery.
Progress in Drug Delivery Models Presented at STM 2015
The thermosensitive drug delivery session included four abstracts on the use of focused ultrasound to treat various forms of cancer and potential pediatric applications during the Society for Thermal Medicine’s Annual Meeting held April 14-17 in Orlando. Clinically, one group is planning a validation study for using focused ultrasound-induced hyperthermia to improve the effects of chemotherapy and radiation. Translational research in pediatric applications could produce a clinical platform, and scientific presentations covered software innovations, and a motion phantom for preclinical liver research.
The presence of imbedded gold nanoparticles (GNPs) can amplify tumor tissue’s sensitivity to radiation therapy and potentially alter the course of treatment for many different types of cancer. Can focused ultrasound induce hyperthermia to improve the imbedding process? In the final report from a 2013 High-Risk Track Foundation Research Award submitted by MD Anderson Cancer Center Principle Investigators Sunil Krishnan, MD, and Jason Stafford, PhD, the answer is “Yes.”
JTU Article of the Month: Bone Mets MR Thermometry
“Quality of MR thermometry during palliative MR-guided high-intensity focused ultrasound treatment of bone metastases” has recently been published in The Journal of Therapeutic Ultrasound. This work from the Utrecht group warns clinicians who are treating patients with bone mets to consider the effects of patient motion artifact on image quality when interpreting MR images. The open-access article is on the JTU website.
Enter AdvaMed's 2015 Medtech Innovator Competition
Do you have an early-stage company looking for exposure and funding? A new MedTech Innovator Competition will identify and reward four outstanding medical device companies at AdvaMed 2015. Finalists will compete for $300,000 in prizes and the opportunity to interact with industry executives and venture capital investors for business development.
Theraclion Achieves Breast Fibroadenoma Treatment Reimbursement in Germany
Two large German health insurance companies have now subscribed to coverage for focused ultrasound treatment of breast fibroadenoma. In addition to BKK Continentale, the Betriebskrankenkasse Verkehrsbau Union (BBK VBU) will also cover treatment with the Echopulse® system.
Bone Metastases Reimbursement Expands in US
Blue Cross Blue Shield North Carolina and Horizon Blue Cross Blue Shield of New Jersey have published updates to their focused ultrasound coverage policy and are now providing benefits for INSIGHTEC’s ExAblate® procedure as a treatment option for patients suffering painful bone metastases. This coverage expansion includes more than 3.8 million members.
"SonaCare is now the only HIFU manufacturer with this broad degree of certification in Europe." – Dave Hernon, SonaCare
SonaCare Makes Regulatory Advances in US and Europe
SonaCare Medical is filing a De Novo grant with the US FDA for its Sonablate® 500 system for the transrectal ablation of prostatic tissue while also continuing to pursue its Pre-Market Approval (PMA) application. In Europe, the CE Mark has been broadened for the Sonatherm and Sonablate systems. CEO Mark Carol explained, “…the new CE Mark allows physicians to explore using [these devices] to ablate any benign or malignant tissue they deem clinically appropriate, such as skin, breast, thyroid, prostate, pancreas, liver, kidney, via whatever path they deem desirable…”
HEpatocellular CArcinoma Multi-technological ("HECAM") is a 5-year, €41.0 million collaborative project coordinated by GE Healthcare to develop innovative new therapies for liver cancer. The consortium of industry, academic, and clinical leaders will pursue new ways to diagnose, image, and treat liver cancer. EDAP is joining the group to develop a novel focused ultrasound treatment for the disease.