August 2014: First Pediatric Bone Tumor Treatment and More...

Two champions of innovation, Andrew von Eschenbach, MD, and Rick Hamilton, will deliver keynote addresses at the Symposium, applying their unique experiences to the opportunities for and future of focused ultrasound. The pair joins device entrepreneur Frederic Moll, MD, to round out the Symposium's headliners.

Dr. von Eschenbach is the only person to have led both the US Food and Drug Administration (FDA) and the National Cancer Institute (NCI). Rick Hamilton, IBM's Cloud Offering Evangelist and Master Inventor, is an innovation authority and the company's most prolific inventor, holding more than 550 US patents.

"Discovery research has led to astounding breakthroughs in our understanding the mechanisms of disease. That emerging knowledge is being rapidly translated into innovative technologies that can help restore health. Focused ultrasound exemplifies such progress as it pioneers the application of physical energy to modulate biology."
– Andrew von Eschenbach, MD

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The Foundation has published its Summer 2014 Focused Ultrasound Global Perspective report, a comprehensive overview of the state of the technology, including facts and figures on:

• approved indications
• manufacturers
• research centers
• treatment sites

This bi-annual report enables academia, government, industry, and investors to monitor progress in the field.

Institute now studying Essential Tremor, Parkinson's, and Tumors

Swedish Neuroscience Institute (SNI) in Seattle is quickly becoming one of the leading brain research centers in the world for focused ultrasound.

SNI recently announced that they have joined an ongoing study at the University of Virginia to assess focused ultrasound to treat tremor associated with Parkinson's disease. Additionally, a new trial at SNI will examine whether focused ultrasound could help contain brain tumor growth and allow for more time between additional therapies compared to stereotactic radiosurgery and chemotherapy.

	Patients who are interested in finding out more about these studies should contact SNI at (206) 320-3070 or Focusedultrasound@swedish.org

"SNI is one of the few locations in the world where focused ultrasound is being studied at this level. These efforts exemplify our ongoing mission to deliver leading edge treatment for brain and spinal conditions. We are honored to be a pioneer in this field and are eager to produce translational results," said David Newell, MD, Chief of Neurosciences. Foundation Chairman Neal F. Kassell, MD, agrees: "We are privileged to have Swedish Neuroscience Institute advance the use of focused ultrasound in this region."

The SNI team has been participating in the Essential Tremor Study since the summer of 2013. A story about the Institute's work aired yesterday on HealthLink, the health news segment of their local NBC affiliate, KING-5.

Scientist Discusses his Promising Foundation-Funded Research

North Carolina scientist Paul Dayton, PhD is in the final stages of a Foundation-funded study on the use of nanodroplets to improve the efficiency of focused ultrasound ablation.

	Our new Investigator Profile series highlights Foundation-funded research and the experts who are leading the way in developing focused ultrasound

The nanodroplets assessed in the preclinical study were able to rapidly increase heating by more than 25 degrees Celsius at the target without peripheral heating. The results suggest that their nanodroplets are sufficiently stable to enhance FUS ablation for at least 1.5 hours, avoid skin burns, and are a better option over microbubbles. These nanodroplets could potentially reduce FUS procedure times by as much as five-fold by more quickly ablating a larger region of tissue without compromising safety.

READ A Q&A ABOUT THE PROJECT AND HOW DR. DAYTON THINKS NANODROPLETS MAY ONE DAY FACILITATE FUS TREATMENT OF CANCER ►

According to a new press release, University of Virginia (UVA) researchers are now actively looking for women with benign breast tumors (called fibroadenomas) to participate in their focused ultrasound study.

WVIR-29, the local NBC affiliate, reported the story. In their interview, UVA radiologist Dr. Carrie Rochman said, "We're using the ultrasound machine to guide us to the mass and the same ultrasound machine to then focus the energy at enough power that it destroys the tumor from within. So the end result is no scar for a patient."

Recent focused ultrasound research covers a variety of applications. In oncology, two interesting studies looked at pancreatic cancer (safety and a comprehensive case review), and one discovered improved outcomes for localized prostate cancer. Cavitation-induced thrombolysis work is gaining ground, and another group provides cost-effectiveness data for uterine fibroid ablation.

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On July 30th, a US Food and Drug Administration advisory panel met to review data and vote on whether to recommend approval of EDAP-TMS's Ablatherm focused ultrasound system for the treatment of low risk prostate cancer. The panel voted that the risk of the treatment was too high for the limited efficacy demonstrated, that there is not reasonable assurance that the system is effective, and that the benefits do not outweigh the risks based on the evidence presented.

Not surprisingly, EDAP's leadership is disappointed with the ruling, and issued a full statement in response, including these points:

• Ablatherm-HIFU has a proven safety record through its approval and use in Europe, Canada, Russia, Brazil, Mexico, and South Korea.

• Ablatherm has treated more than 40,000 prostate cancer patients worldwide since its initial CE Mark approval in 2000.

• The French Ministry of Health recently approved HIFU reimbursement for primary care patients at the same level as surgery.

• The Panel seemed to agree that the current approval path for new treatments for low risk prostate cancer is prohibitive and that existing therapies, if evaluated on today's requirements, would be unlikely to qualify for a positive vote.

Last month, the FDA advisory panel made a highly unfortunate ruling that, based on data presented by EDAP, there is not reasonable assurance that the Ablatherm focused ultrasound device is safe and effective for the treatment of low risk localized prostate cancer. The device has been approved in Europe since 1999, and 40,000 patients around the world have been treated with the system to date.

It is important to keep in mind that the overarching issue is with the patient population and the study design, and not the focused ultrasound technology. Pragmatically, the burden is very high for a clinical trial to demonstrate an improvement in outcome in patients with low risk prostate cancer, whether the treatment is focused ultrasound, cryotherapy, radiotherapy, etc. As noted by a panel member, thousands of men would have to be followed for 30 years to prove efficacy. In addition, EDAP had significant difficulty recruiting for the cryotherapy control arm, having to change their study plans after five years of trying to enroll patients.

The problem confronting the urological community is that there are a substantial number of patients who are not comfortable with the watchful waiting paradigm after they are diagnosed with low-grade prostate cancer. An increasing number of these patients who have the financial wherewithal are seeking treatment outside of the United States. The vexing issue is how to reconcile the disconnect between the desire of patients to be treated with a lack of availability of the technology in the US due to regulatory hurdles...

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Last month, Celsion Corporation announced that Dr. Costas Arvanitis of Brigham and Women's Hospital and Harvard Medical School has been awarded a $1 million Career Development Award from the NIH Center for Biomedical Imaging and Bioengineering. The grant, titled "Controlled Delivery and Release of Chemotherapy in Brain Tumors with Focused Ultrasound" will be used for preclinical studies to evaluate Celsion's heat-activated liposomal encapsulation of doxorubicin (ThermoDox®) in combination with focused ultrasound for the treatment of brain tumors.

The US Food and Drug Administration has developed a National Medical Device Curriculum (NMDC) to educate students, entrepreneurs, and scientists about the agency's process for evaluating medical devices. NMDC is now available online and currently includes these four areas:

• Regulatory Pathways for Medical Devices: Choosing the Right One
• Freedom From Unacceptable Risk: Making a Case for Safety Assurance and Risk Management
• Bringing an Innovative Device to Market: Premarket Approval (PMA) of Medical Devices
• An Innovative "Me-Too" Idea: Premarket Notification - 510(k) Medical Device Submissions