InSightec's ExAblate Device Approved in Japan for Fibroids
InSightec Ltd. announced today that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved the company’s ExAblate® MR-guided Focused Ultrasound (MRgFUS) system for the treatment of women with uterine fibroids.
“We are very pleased that the Japanese Ministry of Health has approved the ExAblate system and that women in Japan will now have access to a noninvasive treatment option for uterine fibroids,” said Dr. Kobi Vortman, President and Chief Executive Officer of InSightec. “The approval was based on a growing body of evidence showing that ExAblate is a safe, effective, and durable treatment for this widespread, life-impacting condition. ExAblate is an outpatient procedure and patients normally return home the same day and to work within one to two days compared to lengthy hospitalizations and recovery times associated with more invasive procedures such as hysterectomy, myomectomy or UAE.”
The 9th Annual International Society of Therapeutic Ultrasound (ISTU) met recently in Aix en Provence, France and featured 128 speakers, dozens of technical posters, and brought together hundreds of experts in the field of focused ultrasound research. The meeting, sponsored in part by the FUS Foundation, is the premier yearly conference highlighting the engineering and technical work done to allow focused ultrasound to treat a myriad of medical conditions. Particularly exciting was the number of young and talented investigators that are leading the wave of new advances and applications. Also exciting was the large presence of equipment manufacturers showcasing their latest advancements including Philips, InSightec, Siemens, Haifu, Supersonic Imagine, and Profound Medical.
Featured prominently at the meeting was the more established use of focused ultrasound in heating targeted areas of the body to destroy diseased tissue and the conference included the latest advances in using the technology to treat uterine fibroids, prostate cancer, breast cancer, brain tumors, and other diseases. One of the tumor types receiving particular attention this conference were liver tumors which require special techniques to pass the ultrasound beams through the rib cage and visualize and track the liver while in motion due to the patient’s respiration. In addition to the use of focused ultrasound to ablate diseased tissue non-invasively, there was more emphasis than ever on the non-thermal applications of focused ultrasound in areas such as targeted drug delivery and the disruption of clots found in stroke patients.
Some highlights of the ISTU meeting observed by members of the Foundation staff include the following:
Speakers from Arizona to Zurich Join in Research Symposium to Mark Opening of Focused Ultrasound Center at UVA
To celebrate the opening of UVA’s new Focused Ultrasound Center, an international array of speakers joined in a research symposium on September 14. The symposium featured presentations from the UVA team that will run the center and lead its research efforts, together with lectures by visiting speakers from Houston, London, Arizona, and Zurich.
First Human Trials for MRI-guided Trans-urethral Ultrasound Technique for Prostate Cancer: Profound Medical Inc.
The first human proof-of-concept study has begun at Sunnybrook Health Sciences Centre, Toronto, Canada.
Supported by an independent research grant, research scientists at Sunnybrook Health Science Centre, led by Chief of Urology, Dr Laurence Klotz, MD, have successfully begun the first human, proof-of-concept study for treating prostate cancer using their novel MRI-guided, trans-urethral ultrasound technique.
After extensive testing of the technology in mathematical, gel, and pre-clinical models, the potential new treatment is now undergoing trials in a number of patient volunteers to affirm its safety, accuracy, and precision.
The core intellectual property from this technology has been exclusively licensed to Profound Medical Inc. of Toronto, Canada, to accelerate commercialization under the guidance of the FDA and Health Canada.
“We commend the team at Sunnybrook for their exemplary research and clinical work. It’s a significant moment in the company’s history, as well as potentially having a major impact on how prostate cancer patients may be treated in the next decade. We can expect to proceed as planned with human clinical feasibility trials in the USA and Canada in the near future with our medical device,” stated Paul Chipperton, CEO of PMI.