After nearly 20 years of activity in the country, focused ultrasound may now be positioned for commercial success in Japan. There are systems installed at approximately 40 sites, and devices have been approved to treat uterine fibroids, bone metastases, and the prostate. However, reimbursement has been scant with limited usage outside the investigator-led research setting. The regulatory approval of systems to commercially treat the brain and prostate cancer may be the inflection point needed to establish the path for widespread adoption.
Treating the Brain Insightec recently filed for regulatory approval to treat tremor with their ExAblate Neuro system. “The functional neurosurgeons in Japan are very open to new non-invasive technologies," said Insightec’s Country Manager for Japan, Yair Bauer. "They do not want to make incisions, and we can offer a value proposition to hospital administrators.”
"In ten years, Japan has the potential to be a leading market in the world for focused ultrasound." –Yair Bauer
Treating the Prostate SonaCare Medical installed their first Sonablate system in Japan in 1998, and they now have more than 20 systems in operation there. They will soon apply for regulatory approval for prostate ablation, opening up the potential to treat cancer along with benign prostatic hyperplasia (BPH). As many as 5,000 patients have been treated in Japan with Sonablate for prostate cancer.
SonaCare’s leading Japanese site is headed by Dr. Toyoaki Uchida, Tokai University, Hachioji Hospital, and the team’s largest clinical series for prostate cancer was recently published by the Journal of Urology. “Currently, the number of prostate cancer cases in Japan is roughly equivalent to that of the US,” says SonaCare CEO Mark Carol, MD, “But unlike the US where the incidence is declining, in Japan it is increasing.”
Advancing Focused Ultrasound Research While Insightec and SonaCare are making progress on the regulatory front, Japanese researchers have been leading important studies in breast cancer, osteoarthritic bone pain, and other applications of the technology.
The Focused Ultrasound Foundation is looking for a Chief Clinical Officer to join our team. This person will ideally be an MD or PhD with a strong track record of academic and/or industry experience in biomedical research or medical device development. Please forward the job description to anyone you think may have an interest in this position. Thank you!
With just six months until the 2016 meeting, we are now accepting abstracts related to pre-clinical, translational, or clinical research that involves the use of image-guided focused ultrasound. Topics of interest include applications in neurosurgery, oncology, pain management, women's health, and other emerging areas.
Apply Now for Young Investigator Awards Graduate students, research fellows, clinical fellows, and junior faculty are encouraged to apply for the Foundation’s Young Investigator Awards to attend the Symposium and present data among focused ultrasound luminaries. LEARN MORE ABOUT THE AWARDS >
In January, Foundation Chairman Neal F. Kassell, MD, joined Toby Cosgrove, CEO of the Cleveland Clinic, Deborah DiSanzo, General Manager of IBM Watson Health, and other visionaries for “Courageous Conversations Regarding Healthcare Access, Quality Care, and Affordability,” at the Hilton Head Institute’s Summit on Healthcare.
The presentations and moderated panel discussions explored new ways to overcome the obstacles that prevent the US from doing more with its healthcare dollar. Dr. Kassell’s presentation “Curing with Sound,” was among those that discussed the intersection of healthcare and technology. “The value of focused ultrasound for treating disease, improving outcomes, and decreasing costs needs to remain in the forefront of our work,” said Kassell. “It is an example of a technology that plays perfectly into the new healthcare paradigm.”
"The author famous for legal thrillers just published a free book whose hero is a medical device called focused ultrasound." – Washington Post
Washington Post Covers Grisham’s The Tumor
John Grisham’s latest book, The Tumor, earned a front page spot on Tuesday’s Style section of the Washington Post. Reporter Michael Rosenwald, who also covered Tony Mendez at our Symposium, sat down with Grisham, learning that his motivation was about raising awareness. “The Tumor has the potential to one day save or prolong millions of lives,” says Grisham. Foundation Chairman, Neal Kassell, agrees: “I couldn’t think of a better way, in one fell swoop, to create awareness for this technology.”
The book, which debuted for free on Amazon last month, has been gaining momentum, earning better than a 4-star rating. Over 150,000 copies have been distributed, and that number is climbing.
Research Update: Histotripsy Standards and Lysis of Deep Vein Thrombi
With the eventual goal to use focused ultrasound to dissolve chronic deep vein blood thrombi, Kenneth B. Bader, PhD, and his colleagues at the University of Cincinnati recently completed a study to develop standards to regulate microbubble cloud formation during histotripsy pulses. The three-part project was successful in first assessing the area, location, and type of microbubble activity and ablation during histotripsy using passive cavitation imaging. The second portion of the project developed an analytic mathematical model to predict the extent of the microbubble cloud. Phase three evaluated the efficacy of using histotripsy in conjunction with thrombolytic agents to enhance blood clot lysis. Are they close to translating their data to a clinical setting?
This month’s roundup includes studies in brain disorders, immunology, and women’s health. Is it feasible to use focused ultrasound to treat temporal lobe epilepsy? Can scientists deliver GDNF plasmids across the BBB to potentially treat Parkinson’s disease? How does focused ultrasound compare to DBS in treating ET?
"This initial work is very encouraging and needs to be investigated in a larger series of patients and in other functional disorders…" – Rees Cosgrove
JTU Article of the Month – A New Target for Essential Tremor
A Swiss group is testing a new neurological target for treating essential tremor (ET). In their study, Gallay and colleagues used focused ultrasound to perform cerebellothalamic lesioning in 21 ET patients, with three of the patients receiving bilateral treatment after one year. Did these scientists find a new bilateral approach for patients with therapy-refractory essential tremor? Read more at the new Journal of Therapeutic Ultrasound website.
“Using this technique, a dramatic improvement in contralateral hand tremor control was observed in most patients without significant side effects or complications. Importantly, the staged bilateral lesions improved ipsilateral and contralateral tremor control, albeit in only three patients, without the serious adverse neurological consequences typically seen with bilateral VIM thalamotomies,” says G. Rees Cosgrove, MD, Director, Epilepsy and Functional Neurosurgery, Brigham and Women's Hospital, Harvard Medical School.
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HistoSonics Partners with Ethicon in Tumor Treatment
A new project developed through the Johnson & Johnson Innovation Center pairs Ethicon Endo-Surgery with HistoSonics to develop a solid tumor treatment modality to mechanically homogenize and destroy targeted tissue through histotripsy. According to the press release, although surgical resection remains the gold standard for solid tumors, approximately 85 percent of patients are not candidates for surgery, particularly those with cancers of the liver and pancreas.
In London, a new Echotherapy Center used EDAP’s Echopulse system to treat three patients with symptomatic breast fibroadenomas. The clinic will also offer treatment for benign thyroid nodules.
Theraclion Submits the First “Forfait Innovation” in France
Theraclion is the first company to submit an application for “Forfait Innovation,” a new reimbursement mechanism created by the French Ministry of Health to accelerate market adoption of novel technologies.
SonaCare Launches Real-Time Remote Monitoring
SonaCare Medical has introduced Sonalink, a remote monitoring system to provide physician training and support. Experienced support personnel at SonaCare headquarters can remotely monitor an entire HIFU procedure and interact with the physician and OR staff in real-time to answer questions and provide training and guidance. Sonalink is included on all Sonablate systems and provided at no extra charge.
Alpinion Receives CE Mark for ALPIUS 900
The Korean-based Alpinion Medical Systems’ ALPIUS 900 ultrasound-guided HIFU system for the treatment of uterine fibroids has received the CE Mark. It has been approved in Korea since 2014. According to the press release, the ALPIUS 900 includes an innovative water-cooling technology to prevent skin burns, a tool for pre-checking the focal point, a multi-channel transducer, and an average one-hour treatment time.
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