Seattle-based Mirabilis Medical has been granted European CE Mark approval for their robotically assisted non-invasive focused ultrasound system to treat uterine fibroids. The ruling comes after the company completed their first clinical trial, safely and successfully treating 73 women in Mexico with an average active treatment time of less than 10 minutes each.
The company has also been cleared by the FDA to conduct their pivotal study in the US, which will start in the second half of 2017 with 180 patients participating at 12 sites.
A leading French researcher has been named the 2017 Richard Merkin Visiting Fellow. In July, Frédéric Padilla, PhD, of the Laboratory of Therapeutic Applications of Ultrasound (LabTAU) in Lyon, France, will begin a 12-month appointment at the University of Virginia and work closely with the Foundation’s scientific team.
Made possible by support from Dr. Richard Merkin, the fellowship is meant to embed an international researcher with the Foundation team and stimulate collaboration.
In 2016, the field of focused ultrasound reached an inflection point, with the technology evolving from research to a clinical tool primed for commercial adoption. The entire focused ultrasound ecosystem – including the numbers of researchers, manufacturers, and treatment sites – is growing at an accelerating pace.
Our 2016 Year In Review Report highlights the Foundation’s work as a driving force for this progress.
The Foundation’s Chief Scientific Officer, Jessica Foley, PhD, was the Keynote Speaker at the annual banquet for the Richmond Joint Engineers’ Council. Speaking to a crowd of 200, Dr. Foley presented an overview of focused ultrasound, the state of the field, and how the Foundation is working to move the technology to patients as quickly as possible.
Every March we recognize Essential Tremor Awareness Month, but for Sunny, the tremors were a constant burden. The Michigan artist was forced to stop her creative pursuits once it became nearly impossible to work with her hands. After 50 years of dealing with the tremors, Sunny received focused ultrasound treatment at Ohio State Medical Center, and now she’s back to drawing and painting. READ MORE > SEE MORE PATIENT STORIES >
New Websites Highlight Essential Tremor Treatment
Following FDA approval of focused ultrasound treatment for essential tremor, two websites now offer information on the “Neuravive” procedure.
Insightec, technology innovator and developer of the device used in Neuravive treatments, has launched a US-based patient site that explains the procedure, features patient stories, and lists treatment sites. Also geared toward US patients, the Essential Tremor Education Center provides information on all treatments, with a focus on Neuravive. Visitors can take interactive quizzes, learn from physician videos, and ask questions.
The Society of Interventional Radiology (SIR) held its 2017 Annual Meeting in Washington, DC, March 4-9. Three focused ultrasound abstracts were presented, describing vascular malformations, pediatric osteoid osteoma, and introducing junior radiologists to the field of focused ultrasound. An NIH poster on prostate imaging prior to treatment also discussed focused ultrasound.
Indiana University Health’s Dr. Michael Koch was voted the top honoree of Indianapolis Business Journal’s annual Health Care Heroes award for his contributions in the field of focused ultrasound. Working with pioneer Naren Sanghvi, Koch began pursuing focused ultrasound to treat prostate cancer in 1998. He has led clinical trials using SonaCare’s Sonablate device, and now offers the treatment clinically.
1st Quarter Research Award – Transcranial Histotripsy
The year’s first research award was granted to a University of Michigan team. Jonathan Sukovich, PhD, will study, localize, and map the bubble clouds, cavitation, and skull reflections created during transcranial histotripsy treatments. Current methods to monitor and localize bubble clouds generated in histotripsy use 2D imaging probes and are inadequate to ensure safety. If successful, this 3D method would allow the use of ultrasound guidance during transcranial histotripsy, paving the way for future clinical applications.
Parkinson’s disease damages dopamine neurons in the brain, but scientists hypothesize that these cells can be repaired. Previous studies found that DNA segments introduced intranasally could produce a dopamine cell survival factor that protects these cells. Researchers at Northeastern University, Brigham and Women’s Hospital, and Copernicus Therapeutics used focused ultrasound and microbubbles to improve upon this concept. Did it work?
Clinical results for focused ultrasound treatment of Parkinson’s tremor are now being presented and published. A case series recently conducted at Rambam Medical Center in Israel is among the first to report results. Focused ultrasound research is also showing promise for priming tumor tissue for enhanced uptake of nanoparticles in Korea and for imagining new treatments for spinal cord injury in China.
With at least 18 bioeffects identified for focused ultrasound, the US Food and Drug Administration (FDA) is interested in the safety and integrity of the vasculature in its path, especially for transcranial procedures. A group from the FDA and other prominent institutions used an earthworm model to conduct a parametric study of the effects of sonication on various vessels’ thresholds for rupture. Their data is offered as baseline for future comparative studies. See the article in the Journal of Therapeutic Ultrasound.
On the heels of their recent CE Mark announcement, we spoke with Mirabilis Medical’s CEO, Jens U. Quistgaard, to learn more about the company, its device, and what’s on the horizon. “This technology has the promise of helping a large number of women worldwide, and I’m glad to be involved with it,” says Quistgaard.
Mike Blue has joined HistoSonics as President, CEO, and member of the Board of Directors. He brings commercial experience in the medical device sector, specifically in interventional oncology. The Michigan company’s innovative tissue-destruction technology in liver cancer and other solid tumor applications is called Robotically Assisted Sonic Therapy (RAST).
HistoSonics also completed the first closing of a Series B financing of $8.3 million to support clinical studies and development of their clinical system for liver cancer. They expect a second Series B closing in the second quarter. READ MORE >
Former LDR Spine executive Noah J. Bartsch has joined EDAP TMS to lead their US Medical, Regulatory, and Quality Affairs operations. He will be responsible for expanding and executing the company’s strategy for adoption and recognition of their focused ultrasound technology. This will include managing FDA developments, initiating reimbursement coverage, and collaborating with opinion leaders. READ MORE >
Theraclion’s Echopulse system has received a Gold “Stevie” award in the "Best New Health & Pharmaceutical Product" category. The Stevie Awards are a high-caliber economic award for the German business world. Also in Germany, the company announced additional reimbursement coverage by BKK VBU. While the insurer covers the treatment for breast fibroadenoma, its members will now also be reimbursed for the treatment of thyroid nodules. READ MORE >