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 almost 40 sites, and devices have been approved to treat uterine fibroids, bone metastases, and the prostate. But 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. “In ten years, Japan has the potential to be a leading market in the world for focused ultrasound,” said Insightec’s Country Manager for Japan, Yair Bauer. “The functional neurosurgeons in Japan are very open to new non-invasive technologies. They do not want to make incisions, and we can offer a value proposition to hospital administrators.”
Learn more about how FUS may revolutionize neurosurgery in Japan >
Treating the Prostate
SonaCare Medical installed their first Sonablate system in Japan in 1998, and they now have more than 15 systems in operation there. SonaCare 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. Read More about Research in Japan >
Regulatory Filing for Essential Tremor
In January, Insightec submitted an application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to approve ExAblate Neuro to perform functional neurosurgery through the intact skull for the treatment of tremor. Calling the submission “an important milestone in focused ultrasound becoming a standard of care for patients with neurological disorders,” Insightec CEO Maurice R. Ferré, MD, stated that they will continue to develop the technology for “a wide range of clinical indications.” Yair Bauer added, “Ultimately, our goal is to make our ExAblate Neuro treatment accessible for Japanese people suffering from neurosurgical disorders, so they can take advantage of this high-end non-invasive treatment option.”
Five Brain Investigational Systems Already in Place
Five ExAblate Neuro systems have been installed in Japan, including the new low frequency 220-kHz platform, which was developed to access lesions in more varied anatomic locations and treat larger volumes of tissue. Dr. Taira and his team at Tokyo Women’s Medical University participated in the Pivotal Study to evaluate ExAblate for thalamotomy to treat essential tremor, collecting some of the data that are being considered for approval globally.
Because Japan is a country that invests heavily in new technology, it has installed a large number of CT and MRI machines. Supported by physicians and hospitals, this innovative market seeks to be the first in providing widespread adoption of such technologies to their patients.
Lesioning as Established Practice
Unlike in the West, where brain lesioning for movement disorders is performed less often, the practice is more widely used and accepted in Asia. Insightec expects that functional neurosurgeons will welcome focused ultrasound as a non-invasive approach for tremors and other disorders. “The functional neurosurgeons that are using our systems have experience in both lesioning and deep brain stimulation,” says Bauer. “To them, focused ultrasound is just another way to perform the lesions. They understand exactly what is going to happen in terms of targeting and treatment outcome.”
An Aging Population
Similar to the US, Japan is aging, with people over age 65 representing an increasingly larger percent of the population, with lengthening life expectancy. In the past, patients with movement disorders have suffered in silence, refraining from seeing a doctor because the mentality has been to not complain about the symptoms. But now there is a new trend toward seeking treatment, especially for outpatient non-invasive procedures. The need to treat these patients could potentially be met by focused ultrasound, and the functional neurosurgeons “are looking for ways to not make incisions,” says Bauer.
Insightec is working diligently to advance brain research throughout Japan. Investigators are looking at protocols beyond movement disorders to treat brain tumors and more. “The neurosurgery program is just beginning, and they are excited for the opportunity for new innovation,” said Bauer. “Insightec has the potential to expand our neuro program slowly, step by step, working with the leading functional neurosurgeons in Japan. We have a strategy for regulatory approval, reimbursement, and marketing. I’m cautiously optimistic.”
Public-Private Collaboration for Research in Japan
Some of the research conducted in Japan relies on public-private collaboration. The experimental FUS systems are installed in private hospitals, and their physicians partner with university hospitals to conduct clinical research. Such private hospitals may perform clinical trials or offer out-of-pocket procedures to patients.
The Foundation’s Research Sites section of our website includes a total of 13 institutions in Japan. Researchers are leading investigator-initiated studies for breast cancer, osteoarthritic bone pain, and will soon start a study in dystonia, among a handful of other indications.
A member of the Foundation’s Research Advisory Committee, Hidemi Furusawa, MD, from Breastopia Namba Hospital, began using the Insightec system to treat patients with breast cancer in 2004. Since then, he and his group have treated patients under three different protocols. After presenting many updates on this work throughout the years and publishing their results, other sites are now joining the trial.
A group in Kochi is using focused ultrasound to treat osteoarthritic bone pain. In December 2012, the Foundation funded their study to treat osteoarthritic knee pain, and this work was published in 2013. The group, led by Dr. Motohiro Kawasaki at Kochi Medical University Hospital, is now undertaking a new trial to treat back pain from facet arthritis.
In other areas, researchers in Kobe received the magna cum laude poster at the 10th Interventional MRI Symposium for their work in imaging liver deformation, and a group from Showa University Medical Center in Tokyo published a 2014 case study on twin reversed arterial perfusion.
DID YOU KNOW?
Japan played a role in focused ultrasound history. In 1964, Oka and colleagues published the first use of focused ultrasound for an oncology application (thyroid and breast cancer).