Focused Ultrasound Surgery Foundation

I recently participated in an FDA-sponsored satellite symposium related to Focused Ultrasound-mediated Targeted Drug Delivery (FUS-TDD).  The symposium was the afternoon following the close of the 2010 Accelerating Anticancer Agent Development and Validation Workshop, a 3-day post-graduate workshop for clinical and translational investigators interested in designing effective strategies to develop new anticancer agents. 

Familar faces included two members of the FUS-TDD Core Stakeholder group, Prof. Andreas Melzer of Dundee University and Nathan McDannold, Ph.D. of Brigham and Women's Hospital, as well as Yoav Medan, D.Sc., M.B.A. of InSightec.  In addition, Richard Frank, M.D., PhD. from GE Healthcare presented an excellent overview of the optimal approach to collaboration with academics, the NIH, FDA and Industry that could assure proper evaluation of drug delivery agents in order to gain commercial success.

The Symposium offered an important opportunity to present the concept of Image guided Mediated Targeted Drug Delivery, of which FUS-TDD is a key example, to the FDA for potential inclusion in the full workshop in the future.  This may have been the initial step in engaging in dialogue involving the FDA, academics, and the national labs about the optimal process for evaluation of nanoparticle and drug delivery agents.  I believe that our work at the Foundation will positively contribute to developing this dialogue and consequently support the FUS-TDD communtiy in its path to successful clinical applications.

Late last week, Israeli blogger Mouli Cohen wrote about the use of MR-guided focused ultrasound to treat stroke (see his blog here).

Cohen wrote about the work being done by Thilo Hoelscher M.D. at the University of California at San Diego. Dr. Hoelscher is conducting FUS Foundation-funded research using InSightec's high-intensity focused ultrasound (HIFU) system, the ExAblate.

Dr. Hoelscher's research aims to prove the technology's capability to non-invasive break-up ("lyse") stroke-causing blood clots in the brain, thus restoring blood flow. Once this HIFU technology is proven, he says "drugs like tPA won't be necessary."

To read more about Dr. Hoelscher's FUS Foundation fellowship, click here.

Professor Daniel Jeanmonod faced a packed meeting room at the Philadelphia convention Center on May 3 when he presented his much-anticipated results treating 12 patients in Zürich using transcranial MR-guided focused ultrasound (TcFUS). Many neurosurgeons in the audience at the Stereotactic and Functional Neurosurgery Session of the 2010 annual meeting of the American Association of Neurological Surgeons were there mainly for his presentation.

He reported on 18 ablative lesions performed in 12 patients using transcranial central lateral thalamotomy with the Exablate 4000 (Insightec Ltd, Haifa). All patients suffered from chronic therapy-resistant neuropathic pain, including some who had failed prior radiofrequency lesioning.   Real-time MR image monitoring (thermometry) was performed in awake patients, allowing for on-line control of targeting parameters, precision and safety.

His work confirmed the high level of precision in lesion placement (< 1.0 mm) that had been previously reported (Martin E. et al., Annals of Neurology 66(6):858-861, 2009).  Skull heating was minimal.

Peri-lesional edema appeared on MRI within 48 hours, but was resolved at the time of the 1-month MRI.

The Foundation congratulates Toronto-based Profound Medical, Inc., winner of the prestigious, 2010 Ontario Premier’s Catalyst Award for “Start-up Company with the Best Innovation.” The Ontario government will also invest C$ 200,000 in further developing the company’s investigational MR-guided focused ultrasound device for treating prostate cancer.

The company is in the midst of securing financing to accelerate clinical trials in North America, Canada and the European Union.

Paul Chipperton, CEO of Profound Medical, noted, “We have met the FDA, we have our sites selected, and we are working with literally the most experienced and best clinicians in the world. Once additional financing has been secured, the company is prepared to immediately hire 6-10 new employees to make this happen. We can’t wait to embark on our next phase of growth!”

To read the complete press release issued today by Profound Medical, click http://www.profoundmedical.com/May19%202010%20PR.html