Profound Earns European Approval for Prostate Device
Profound Medical’s TULSA-PRO™, a real-time, MRI-guided, minimally invasive focused ultrasound device, was granted CE approval on April 11 for commercial sale in Europe and other CE Mark jurisdictions. The approval was based on a 30-patient phase I study conducted in the US, Canada, and Europe that demonstrated that TULSA-PRO precisely ablates prostate tissue, with low toxicity and a well-tolerated safety profile. The company will start with launching commercial and clinical activity in Germany, and expand into countries that have modest levels of reimbursement, such as France, Spain, and the UK; and then seek distribution partners for other CE compatible countries.
“This is the first of several regulatory approvals we expect in the next few years,” says CEO Steve Plymale. “I give a lot of credit to our team, who in just eight years since our company was founded, engineered the technology to address the unmet needs of localized prostate cancer treatment. We are excited to provide clinicians and their patients with an option that has the potential for fast recovery and reduced adverse side effects generally associated with the current standard of care for prostate therapy.”
The company plans to hit the ground running with a Center of Excellence program to connect with early adopters. The centers will enable new and prospective customers to get an in-depth understanding of TULSA and offer an accredited CME training program and workshops.
A New Approach to Destroying Prostate Tissue Profound’s technology combines real-time MR imaging with transurethral therapeutic ultrasound and closed-loop thermal feedback control. It provides a highly precise treatment tailored to patient-specific anatomy and pathology. A transurethral ultrasound applicator is inserted and ablates the prostate from inside-out, which, according to the company, could be safer and more effective than a transrectal approach. “What makes us unique is that we have an inside-out approach – we start inside the prostate and heat toward the capsule,” says Plymale. “We don’t need to go near the rectal wall or other structures that are very sensitive and could be damaged by the ablation.”
Guided by real-time MR imaging with temperature feedback, the treatment is conducted with millimeter accuracy, less risk, and a lower morbidity profile than traditional approaches like surgery or radiation. Plymale says that their system is flexible to meet the needs of patients and physicians – “TULSA-PRO will be useful for either focal therapy or whole gland ablation.”
Kassell Appointed to Cancer Moonshot’s Blue Ribbon Panel
Foundation Chairman Neal F. Kassell, MD, has been selected to serve on the National Cancer Institute’s (NCI) Blue Ribbon Panel for Vice President Joe Biden’s National Cancer Moonshot Initiative. Dr. Kassell joins a group of 28 luminaries in science and medicine who will help the NCI inform the scientific direction and goals of the Initiative.
“This Blue Ribbon Panel will ensure that, as NIH allocates new resources through the Moonshot, decisions will be grounded in the best science,” said the Vice President in a press release. “I look forward to working with this panel and many others involved with the Moonshot to make unprecedented improvements in prevention, diagnosis, and treatment of cancer.”
The Foundation has recruited Tim Meakem, MD, to serve as Chief Medical Officer. Dr. Meakem will help cultivate relationships with key physicians and health system leaders as well as oversee the growing number of research projects the Foundation is supporting at leading academic research institutions around the world.
“I am thrilled to be a part of the effort to hasten the availability of focused ultrasound,” says Dr. Meakem. “I look forward to serving as a liaison with researchers, payers, disease-specific organizations, and patient advocacy groups to foster collaboration, establish evidence, and build awareness to pave the path for rapid adoption of this innovative treatment option for many serious diseases.”
John Grisham and Dr. Neal Kassell were on CBS This Morning this week discussing
The Tumor, Grisham’s fictional account of how focused ultrasound could transform the treatment of a variety of serious medical disorders.
Speaking with correspondent Chip Reid, Grisham related why he became involved. “The Tumor is the only book I’ve written that has a potential of advancing a technology that will have a profound impact on the lives of millions of people,” said Grisham. Kassell also sat down with Reid to discuss the technology and the need for increased awareness.
Calling focused ultrasound an obscure medical technology that is “finally getting some high-profile attention,” STAT News wrote an honest and insightful profile of Foundation Chairman Neal F. Kassell, MD. It describes how Kassell’s inspired mission to advance this field has gained the support of Vice President Biden and novelist John Grisham.
Our annual State of the Field Report summarizes where the field of focused ultrasound has been, where it is now, and where it is going. The past year has witnessed tremendous growth, including a remarkable increase of 30% in patients treated in 2015 compared to 2014. These treatments were conducted at 20% more commercial sites than the previous year. The recent US FDA approval of two systems to treat the prostate should further increase the number of commercial sites this year.
The Foundation welcomes abstracts related to translational, pre-clinical, or clinical research that involves the use of image-guided focused ultrasound for neuroscience, oncology, pain management, women's health, and other emerging areas. Review the abstract guidelines, submit an abstract online, and apply for a Young Investigator Award by May 9, 2016.
Mark Nemschoff and Muffin Nemschoff Alschuler
First Siblings Treated with FUS for Tremor
Mark Nemschoff and Muffin Nemschoff Alschuler spent years watching their mother’s quality of life deteriorate as her tremor progressed to where she had great difficulty feeding herself for the last 20 years of her life. And then both of them felt their own tremor progressing and sought relief.
Muffin took medication with moderate success for some time, but Mark was not a candidate for medication and searched for other options. His quest led them to become the first siblings to be treated with focused ultrasound. In 2013, Mark traveled to Switzerland for treatment, and Muffin was treated there in 2014.
"We applied not expecting to get it. I didn’t think there would be enough interest in therapeutic ultrasound. This is a vote of confidence in the potential of the technology." – Gail ter Haar
UK Invests in Creation of FUS Research Network
A consortium of researchers, led by Gail ter Haar, PhD, has earned a prestigious multi-year government grant to build a research network to advance focused ultrasound across the UK. The initiative has been aptly named ThUNDDAR (Therapeutic Ultrasound for Drug Delivery and Ablation Research), and will be supported by a grant of £675,000 over four years.
“We have quite a few different FUS devices in the UK, and the community is small enough that we can all work together. This initiative was designed to generate a critical mass to effectively cross-fertilize ideas. There are 14 institutions interested, with a broad range of experts – including physicians, engineers, chemists, biologists, and mathematicians,” says Professor ter Haar, Head of the Foundation’s Center of Excellence at the Institute for Cancer Research.
Neuromodulation Research Prize Encourages Progress
The Focused Ultrasound Foundation will award a clinical neuromodulation research prize to the first investigator or team of investigators to elicit transient sensory symptoms or tremor suppression using non-thermal FUS neuromodulation during a patient treatment.
The cash prize for determining sonication parameters in humans will be $25,000 if achieved before August 15, 2016 (with a chance to present at the 2016 International Symposium on Focused Ultrasound) or $15,000 if achieved before January 1, 2017.
OCD/Depression Steering Committee Begins Clinical Study Protocol Design
Nir Lipsman, MD, PhD will lead a North American group of neurosurgical, psychiatric, and technology experts to advance the use of focused ultrasound for treating obsessive-compulsive disorder (OCD) and depression--two neuropsychiatric disorders that can be challenging to successfully treat with medication. In its first meeting this month, the committee initiated work on its mandate to 1) develop evidence-driven clinical study protocols, and 2) generate hypotheses for further clinical and translational research via workshops and collaborative projects.
Researchers at UCLA have begun a clinical trial using low intensity focused ultrasound pulsation (LIFUP) to modulate activity in the temporal lobe of patients with epilepsy. This safety study is the first step to assess if this approach could treat epilepsy disorders. The study is being conducted using a brain system with a single-element transducer developed by Brain Sonix and is funded through a grant from the Dorothy and Gerald R. Friedman Foundation.
Meeting Report: Society of Interventional Radiology
Interventional radiologists gathered this month in Vancouver for the Society of Interventional Radiology 2016 Annual Meeting. Pejman Ghanouni, MD, PhD, participated in an Expert Panel on the Future of Ablation Techniques and Technology. His presentation, entitled “Magnetic Resonance Guided Focused Ultrasound: Transcranial Applications,” was discussed with other emerging interventional technologies.
raise tumor temperature to evoke an immune response
serve as an adjunct therapy to chemotherapy and radiation for rectal cancer
provide prostate hyperthermia
treat pancreatic cancer
deliver drugs, including antibiotics
In one of the concluding sessions, panelists debated whether FUS or EM phased array was better for treating large tumors.
Dr. Liu’s group in Taiwan has developed a new method for real-time monitoring of BBB opening. Their paper is published in Physics in Medicine and Biology.
A phase correction technique to improve breast treatment with focused ultrasound has been published by the University of Utah group. Read the paper in Medical Physics.
JTU Now Indexed in Scopus
The Journal of Therapeutic Ultrasound has been accepted for indexing in Scopus, a bibliographic database of academic journals. Inclusion in Scopus (by August 2016) will improve the journal’s visibility, discoverability, and enable us to better track citations to the JTU, as well as other journals. The Foundation helped found the JTU in 2013 in partnership with BioMed Central and the International Society for Therapeutic Ultrasound.
JTU Article of the Month – Palliation of Head and Neck Cancer
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EDAP Applies for FDA Clearance of Focal One
EDAP-TMS has submitted a 510(k) application to the US FDA for the clearance of Focal One, its focused ultrasound, robot-assisted prostate tumorectomy device. If approved, Focal One will join Ablatherm, which gained clearance in November 2015 for the ablation of prostate tissue. In announcing the application, EDAP CEO Marc Oczachowski commented that "…There is a clear, growing demand from the worldwide urology community for non-invasive options for the ablation of prostatic tissue, and we are well positioned to address this market with our complementary Ablatherm and Focal One devices."
"The 33 Sonablate systems we have sold since FDA clearance is a remarkable testament to the pent up demand for alternatives to the traditional ways of targeting prostate tissue." – Mark Carol
Sonablate Systems Selling Well
Since obtaining FDA clearance last October, SonaCare Medical has sold 28 Sonablate Systems in the US and 33 overall. Mark Carol, MD, the company’s CEO also announced that they are partnering with four leading image-guided fusion companies and continuing to develop additional probes for use with their Sonasource console. “The 33 Sonablate systems we have sold since FDA clearance is a remarkable testament to the pent up demand for alternatives to the traditional ways of targeting prostate tissue, such as radiation therapy and surgery,” said Carol.
HealthCare Business News Publishes FUS Update
The Foundation’s Chief Scientific Officer, Jessica Foley, PhD, has updated the healthcare business community on recent progress made in focused ultrasound in her recent article “A Technology That Has Reached the Tipping Point,” published in DOTmed’s Healthcare Business News. The 3-page spread describes the growing US market, the opening of the blood-brain barrier, her predictions for 2016, and the awareness generated by John Grisham’s book.
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