April 2015 - Uterine Fibroid Reimbursement News and more...


April 2015


Canadian Report on FUS for Fibroids


Letter to Editor on Alzheimer's

Alzheimer's Webinar Next Week 

Record Attendance at Parkinson's Webinar

LeBlang Named CMO

$1 Million Grant

2014 Annual Report


FUS Gene Delivery Research Published 

ISTU's Highlights

STM Shows Progress

Foundation Research Award Update

Prostate Workshop

Research Roundup

JTU Article of the Month


Innovator Competition

Theraclion's German Reimbursement

US Bone Mets Reimbursement

SonaCare's Regulatory Advances

EDAP's Liver Cancer Project and more...



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






Cover image permissions.

Letter to Editor on FUS for Alzheimer's Published

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.


Steven T. DeKosky, MD, Professor Emeritus in Neurology, UVA

April Webinar on Alzheimer's Disease

Alzheimer's: Introduction to Disease Pathology & Treatments
Tuesday, April 28, 2015 | 10:00am Eastern US

There is an urgent need for new Alzheimer’s disease (AD) treatment options. Recent preclinical research suggests that focused ultrasound may have the potential to open the blood-brain barrier and reduce the brain plaques that destroy memory. Join us for a webinar with Dr. Steven DeKosky, Chair of the Foundation’s AD Steering Committee, to hear an overview of the pathology of the disease, current methods of treatment, and focused ultrasound’s potential to be a new option.

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.



$1 MILLION Grant: Help Us Double Your Impact!

We have received a $1 Million Challenge Grant to support the important work of the Foundation. Help us secure these funds and double your impact!



2014 Annual Report Now Available

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.



Foundation Research Award Update

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.”


You're Invited: Prostate Cancer Workshop at AUA

Are you attending the American Urological Association annual meeting? If so, please join us May 17 for the “Partial Gland Ablation for Prostate Cancer” workshop. Co-sponsored by AUA, the FDA, and the Society of Urological Oncology, this meeting will convene urologists, researchers, and specialists to discuss focal treatment of prostate cancer. Session details can be found on the conference website.


Research Roundup

Could focused ultrasound ablation be used in a patient with a deep brain stimulation device? A group from UVA worked with Foundation scientists to test the Feasibility and Safety of MR-Guided Focused Ultrasound Lesioning in the Setting of Deep Brain Stimulation.

What is the correct exposure and dose quantity for ultrasound fields in media other than water? Gail ter Haar and her group at the Institute for Cancer Research in London have published framework guidelines in their publication: Towards a Dosimetric Framework for Therapeutic Ultrasound.


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.

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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.

In financial news, Theraclion announced its 2014 year-end results, a new equity line of financing and the opening of its first Asian branch office in Hong Kong.

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…”

In other news, EDAP announced 2014 results and placement of their first Focal One® Device in North America.

EDAP Joins Major Liver Cancer Development Project

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.

Do you have industry news for our newsletter? Tell us about it!
Sunnybrook Funding to Help Improve Quality of Life on Inside Toronto.com 4/14/15

Clinical Trial Offers Hope to Those with Parkinson's on the Virginian-Pilot.com 4/1/15

Revolutionary Focused Ultrasound Still Needs to Address Limitations on CxVascular.com’s Interventional News 3/30/15

A Whole of Population, Multi-user Series of HIFU for Management of Localised Prostate Cancer: Outcomes and Implications on Urotoday.com 3/19/15
May 2-6, 2015 American Congress of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting, San Francisco, CA

May 15-19, 2015 American Urological Association (AUA) Annual Meeting, New Orleans, LA

June 24-27, 2015 European Society for Hyperthermic Oncology (ESHO) Annual Meeting, Austria and Switzerland

June 27-28, 2015 The 2nd North American Gamma Knife Consortium, Cleveland, OH

July 12-16, 2015 American Association of Physicists in Medicine (AAPM) Annual Meeting, Anaheim, CA
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