March 2013: New Men’s Healthcare Treatments Tap the Power of Focused Ultrasound and more...

MEN'S HEALTH UPDATE

New treatments for prostate disease are using focused ultrasound’s various bio-effects, including ablative heating (shown in image), cavitation and hyperthermia. Prostate cancer and benign prostatic hyperplasia (BPH) are among the major health challenges facing men today. As the following articles indicate, manufacturers and researchers are tapping the various capabilities – also known as mechanisms of action – of focused ultrasound to develop innovative and noninvasive treatments for these conditions. Two vendors, EDAP and SonaCare Medical (formerly US HIFU), are commercializing devices that use the ablative heating power of high intensity focused ultrasound (HIFU) to destroy prostate tumors. Device-maker HistoSonics is developing a system to treat BPH using cavitation, a process in which pulses of focused ultrasound induce the formation of microbubbles that liquify targeted tissue. A third approach, currently in the early stages of development at the University of California San Francisco, is using focused ultrasound to induce focal hyperthermia – a therapy that heats tissue to enhance clinical response to radiation and chemotherapy. Focal HT, which holds great promise as a treatment for prostate and pelvic conditions, involves lower temperatures, larger treatment areas and longer timeframes than ablative HIFU therapy. Beyond the groups profiled in this issue, it is important to acknowledge that other focused ultrasound manufacturers have ablative treatments under development for prostate cancer – including InSightec, Philips Healthcare and Profound Medical. Future issues of this newsletter will cover major advances that occur in these treatments. Read about focused ultrasound mechanisms of action >

View video >View video > Executives of EDAP and SonaCare Medical – two focused ultrasound device makers that are engaged in commercialization activities – say healthcare trends are creating a unique opportunity for their companies and for men with localized prostate cancer. Read more >

EDAP CEO Marc Oczachowski with Ablatherm product display.

Device maker EDAP TMS is off to a solid start in 2013 with a steady stream of positive business and research news boding well for its commercialization efforts. This month, the company introduced its new Focal.One device for prostate cancer and announced early progress in its quest for U.S. regulatory approval of its Ablatherm-HIFU system for localized prostate cancer. Additionally, three new long-term studies demonstrate that treatments performed with the Ablatherm offer high survival rates for men with prostate cancer.
Read more >

Sonablate HIFU system

SonaCare Medical (formerly U.S. HIFU) is preparing for growth. According to Chief Development Officer Mark Carol, MD, the company plans to add the world’s largest healthcare market – the U.S. – to the list of countries where its Sonablate system is cleared to treat prostate cancer. The company is also gearing up to commercialize its Sonatherm system, a laparoscopic HIFU surgical ablation device that has received 510(K) clearance from the U.S. Food and Drug Administration to treat organs other than the prostate. Read more >

BPH will be the first indication for the Vortx RX system.

U.S. start-up HistoSonics, Inc. is preparing to launch clinical trials using its noninvasive pulsed ultrasound technology to treat benign prostatic hyperplasia (BPH), an age-related condition that, over time, affects nearly all men. The company’s technology – histotripsy – represents a new use of focused ultrasound energy and could someday replace the surgical and minimally invasive procedures commonly used to treat BPH. Read more >

UCSF collaborators include (left to right) Viola Rieke, PhD, Chris Diederich, PhD, Eugene Ozhinsky, PhD, John Kurhanewicz, PhD and Vasant Salgaonkar, PhD.

Chris Diederich, PhD and his colleagues at the University of California San Francisco are converting their focused ultrasound system from an ablative device to one that delivers focal hyperthermia – a therapy that heats up tissue to enhance clinical response to radiation and chemotherapy. Funded by a $100,000 research award from the Focused Ultrasound Foundation, the project could lead to new treatments for the prostate and pelvic sites, such as the cervix and rectum. Read more >

ET AWARENESS MONTH

At its meeting next month, the American Association of Neurological Surgeons will give "spotlight" status to the presentation of final data from the Focused Ultrasound Foundation-funded essential tremor clinical trial at the University of Virginia. The study’s principal investigator W. Jeffrey Elias, MD will describe the impact that MR-guided focused ultrasound treatment had on 15 patients who were followed for one year.

Protocol approval has been received from the U.S. Food and Drug Administration, and InSightec is now engaged in site selection for its global, multi-site pivotal Phase III clinical trial for the treatment of essential tremor. The double-arm study, which will evaluate the safety and efficacy of the company’s ExAblate Neuro system, is expected to begin in mid-2013. Principal investigator is W. Jeffrey Elias, MD, who led the Focused Ultrasound Foundation-funded pilot study at the University of Virginia.

The ExAblate received CE-marking in December 2012 for the treatment of essential tremor, Parkinson's disease and neuropathic pain. InSightec said it will use pivotal study data to seek FDA pre-marketing approval of the system.

Michael Schwartz, MD

The Lancet Neurology has published the early findings of the Focused Ultrasound Foundation-funded essential tremor clinical trial at Sunnybrook Health Sciences Centre in Toronto. The study, which was published on March 21, 2013 online ahead of print, covered four patients treated between May 2012 and January 2013. The MR-guided focused ultrasound treatments, which were designed to impact tremor in one hand, resulted in immediate and sustained tremor improvements. Mean tremor scores decreased by 89.4% at one month and by 81.3% at three months, when the follow-up period concluded. Reported side-effects included post-operative paraesthesias (tingling) in one patient and deep vein thrombosis in another.

The study, which will treat six patients in all, is being led by Michael Schwartz, MD, division head of Neurosurgery at Sunnybrook.
Read study abstract >

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Foundation and industry partners will launch uterine fibroid patient registry at May symposium

To support the worldwide adoption and availability of focused ultrasound treatments for uterine fibroids, the Focused Ultrasound Foundation is partnering with device makers InSightec, Ltd. and Philips Healthcare to establish the RELIEF registry, which will be introduced on May 6, 2013 at a special symposium during the annual meeting of the American Congress of Obstetricians and Gynecologists (ACOG) in New Orleans.

The symposium will feature experts from the Cleveland Clinic, Baylor College of Medicine and Sheba Medical Center. Topics will include patient needs, the role of focused ultrasound as a non-invasive treatment and the goals and purpose of the global RELIEF registry, which will track long-term outcomes of uterine fibroid patients treated with focused ultrasound.

Ground-breaking study treats locally advanced pancreatic cancer

Alessandro Napoli, MD

Alessandro Napoli, MD and his colleagues at the University of Roma La Sapienza in Italy are establishing a solid reputation as clinical trail-blazers for focused ultrasound. Their latest clinical study is the first to use MR-guided focused ultrasound to treat patients with unresectable, locally advanced pancreatic cancer.
Read more >

April 17-21, 2013

STM 2013 - Focusing on Heat, Society for Thermal Medicine's 30th Annual Meeting, Westin Resort & Casino, Aruba
STM 2013 will cover all areas of thermal medicine and place added emphasis on focused ultrasound- based thermal therapies. Keynote speakers include Kullervo Hynynen, PhD (University of Toronto), Bradford Wood, MD (NIH) and Amato Giaccia, MD (Stanford University).

April 27 - May 1, 2013

American Association of Neurological Surgeons 81st Annual Scientific Meeting, New Orleans, USA
One of this year’s spotlighted talks will be the presentation by W. Jeffrey Elias, MD of the final data from the Essential Tremor Pilot Study funded by the Focused Ultrasound Foundation. The talk is scheduled for Monday, April 29.

May 6, 2013

Uterine Fibroids Symposium, New Orleans, USA
On May 6, the Focused Ultrasound Foundation and its industry partners, InSightec, Ltd. and Philips Healthcare, will host a special symposium for clinicians. It will introduce the new RELIEF registry for uterine fibroid patients treated with focused ultrasound. Symposium topics will include patient needs, the role of focused ultrasound as a non-invasive treatment and the goals and purpose of the RELIEF registry.

The symposium will be held in conjunction with the 61st Annual Clinical Meeting of the American Congress of Obstetricians and Gynecologists (ACOG) from May 4-8 in New Orleans.

May 12-15, 2013

13th International Symposium on Therapeutic Ultrasound, Shanghai, China
Experts from around the world will lecture on some of the most exciting developments in therapeutic ultrasound. Topics will include: Modeling and Physics, Bioeffects of Ultrasound and Thermal Therapy, Standards and Safety, Animal Models & Systems, Transducers and Devices, Treatment Planning and Control, Non-Invasive Monitoring and Assessment, Nanotechnology & Microbubbles, Therapy System Development, Drug and Biotherapeutics Delivery, Neuromodulation/Ablation of the Brain, Sonothrombolysis, Ultrasound Thermal Therapies, Ultrasound Non-thermal Therapies, Novel Therapeutic Systems and Strategies and Clinical Studies.

May 23 - 24, 2013

First Course on Focused Ultrasound in Research and Therapy, Istituto Nazionale di Ricerca Metrologica (INRIM), Turin, Italy

For more information about this program, which is being organized by the Italian Association of Medical Physics (AIFM), contact Gianni Borasi.