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Precision Acoustics, Ltd. (PA) is a United Kingdom—based original equipment manufacturing company that designs and manufactures the tools that measure the ultrasonic pressure, intensity, and range of focused ultrasound systems.
With the encouraging completion of a first-in-human feasibility study, French manufacturer Cardiawave presented results from the first 10 patients at large cardiovascular meetings. This innovative start-up’s current clinical trial uses their Valvosoft platform and a completely noninvasive focused ultrasound technique to address aortic heart valve stenosis (narrowing) caused by calcification of the valve leaflets.
Bracco is one of the world’s leaders in diagnostic imaging. The Bracco Suisse Research Centre was founded in 1989 in Geneva from the spin-off of a research team of The Battelle Institute. Since 2010, the Centre has been devoting its efforts with an efficient process-oriented approach and has achieved a track record of innovations in the ultrasound field. The Bracco Geneva site, which houses both the R&D and Manufacturing Units, represents a key asset for the Bracco Group and a reference point at international level.
Thierry Bettinger, PhD, Bracco Research Center Geneva Director at Bracco Suisse SA, Switzerland. We recently spoke with Dr. Bettinger about this innovative company.
On June 20, the US Department of Health and Human Services (HHS) hosted a public hearing in Washington, DC, to seek input from a variety of stakeholders on their "ReImagine HHS: Accelerate Clinical Innovation" initiative.
In a June 10 announcement, EDAP-TMS shared positive news with regard to the billing and reimbursement of their Focal One high-intensity focused ultrasound (HIFU) treatment for prostate cancer. After submitting an application to the American Medical Association (AMA) CPT® Editorial Panel and gaining the support of both the American Urological Association and the American Association of Clinical Urologists, the company has been notified that the AMA established a new Category 1 CPT code* for HIFU ablation of malignant prostate tissue with their Focal One device. The code, which will be described as "ablation of malignant prostate tissue, transrectal, with high intensity focused ultrasound (HIFU) including ultrasound guidance," goes into effect on January 1, 2021.
The joint meeting of the International Society for Therapeutic Ultrasound (ISTU) and the European Focused Ultrasound Charitable Society (EUFUS) was held in Barcelona from June 13-15, 2019. The Foundation supported the meeting, which was ISTU’s 19th Annual International Symposium for Therapeutic Ultrasound and the 5th European Symposium of EUFUS. The meeting drew over 480 international participants from 33 counties with an interest in therapeutic focused ultrasound applications. Several representatives from the Focused Ultrasound Foundation participated in the program, met with industry representatives, and formed numerous collaborations. Foundation Chairman Neal F. Kassell, MD, spoke during the Horizon/Jolesz Lecture, and Director of Clinical Relationships, Suzanne LeBlang, MD, participated in a panel.
More than 85 neuroradiologists, neurosurgeons, neurologists, oncologists, and scientific researchers attended the 2nd meeting of the Society for Image-guided Neurointerventions (SIGN) held June 10-11 in Baltimore, Maryland. Co-sponsored by the Children's Brain Tumour Drug Delivery Consortium, the conference included daily live webinars covering clinical perspectives on drug delivery to the brain and technological advances along with its general sessions.
ESHO, the European Society for Hyperthermic Oncology, held their annual meeting in Warsaw, Poland, from May 22-24, 2019. The conference is centered on clinical hyperthermia, which is commonly achieved with deep regional radiofrequency (RF) heating and either local sensor-based temperature monitoring, or, more recently, noninvasive MRI-based temperature monitoring. In this context, hyperthermia means heating tumor tissue to a temperature range of 41 to 43 degrees C to sensitize the tissue to both radiation and chemotherapy and make these treatments more effective. Alternatively, hyperthermia could be used to trigger local drug release from temperature-sensitive drug carriers, such as liposomes.
Mirabilis Medical, Inc., the developer of a noninvasive therapeutic ultrasound system with an initial application for the treatment of uterine fibroids, appointed Wayne Poll, MD, as their new CEO.
With new clinical trial results published and a follow-up study now underway, CarThera is making strides in treating patients with serious brain tumors. We interviewed their Scientific Director, Michael Canney, PhD, to learn more about this dynamic company.
The Foundation has signed a Research Funding Agreement with two well-known companies in the focused ultrasound industry to develop a turnkey ultrasound-guided preclinical research system. Verasonics, a leader in research ultrasound, and Sonic Concepts, Inc., an innovator of high-performance transducers, will work to expand the HIFUPlex Portfolio into systems that can treat both large and small animals. The new devices will offer 3D positioning, planning, and therapy delivery as well as therapy monitoring. The Foundation will advise the two companies on device usability and software applications.
Leading the project from the Foundation’s team will be John Snell, PhD, Technical Director of the Brain Program, and Frederic Padilla, PhD, our current Richard Merkin Scholar and associate professor at the Laboratory of Therapeutic Applications of Ultrasound in Lyon, France. “Introducing a turnkey preclinical system can transform early focused ultrasound research,” said Snell. “To date, much of the preclinical research in the field has been using custom devices created by engineers at each site. This type of device can enable clinicians who are interested in preclinical research to create labs quickly without the hurdle of creating their own system. I also hope it will help standardize research so that we can easily compare data from multiple sites knowing that the same device was used.”“Ultrasound-guided focused ultrasound has become an exciting tool to treat or manage different medical conditions for improved outcomes,” said Jessica L. Foley, PhD, the Foundation’s Chief Scientific Officer. “We are looking forward to teaming up with Verasonics and Sonic Concepts on this compelling and important research project.”Read the Press Release from Verasonics and Sonic Concepts >
Related NewsCompany Profile – Sonic Concepts June 2018Focused Ultrasound Featured at CES – The World’s Largest Showcase of Technology and Innovation January 2018Seattle Collaboration Creates HIFUPlex, a New Research SystemJune 2017Company Profile – Verasonics Develops Flexible, High Tech Ultrasound for Research November 2016Company Profile – Sonic Concepts January 2015
EDAP TMS is a French company specialized in focused ultrasound treatment of the prostate. In 2015, the US Food and Drug Administration approved their Ablatherm® Robotic HIFU device, and their Focal One® device earned approval earlier this year. We recently interviewed three members of the company’s leadership: Emmanuel Blanc, Director of Research & Development; Vincent Mortureux, HIFU Product Manager; and Maude Pavageau, Communications Manager.
The American Association of Physicists in Medicine (AAPM) held their annual meeting from July 30 through August 2 in Denver. The focused ultrasound presentations covered topics ranging from the history of cancer immunotherapy and the role FUS can play in immunomodulation; clinical case studies in the use of FUS for the treatment of bone tumors and movement disorders; and the development of new FUS devices for brain treatments. “Many of the clinicians who attended this meeting share our views on open science and collaboration,” said the Foundation’s Director of Extramural Research, Matt Eames, PhD, after attending the sessions. “I was pleased to hear how the principles that are permeating our work at the Foundation (and other medical not-for-profit organizations) are also being advocated in the medical physicist community.”
The Foundation recently spoke with Rick Schallhorn, Vice President of Neurosurgery, and Xen Mendelsohn Aderka, Vice President of Marketing, for Israel-based Insightec, the company behind focused ultrasound technology for essential tremor (ET). They share their efforts to increase awareness for the focused ultrasound treatment for ET.
Insightec’s Exablate Neuro is approved in the US, Canada, Europe, Israel, Korea, Japan, and Russia for the treatment of essential tremor. It is also "CE marked" (a manufacturer’s indication that a product conforms with relevant legislation applicable to their product and therefore is permitted for use) to treat Parkinsonian tremor and neuropathic pain. Researchers around the world are working to assess the system in the treatment of several other related movement disorders.
Taiwan-based EpiSonica has secured Taiwan Food & Drug Administration (TFDA) clearance of its ArcBlate MR-guided focused ultrasound system for soft tumor ablation of uterine fibroids, adenomyosis, and palliative pain care. ArcBlate can be used in any commercial MRI system.
Eight years ago, focused ultrasound pioneer Larry Crum, PhD, transitioned away from directing the department that houses the focused ultrasound efforts at the University of Washington (UW), but under the leadership of Tom Matula, PhD, it has continued to grow into a powerhouse for researching and commercializing focused ultrasound technologies.
The Ontario Health Technology Advisory Committee (OHTAC) has recommended focused ultrasound (FUS) as a possible “cost-effective strategy” and a “safe and effective, noninvasive, uterine-preserving” option for women seeking treatment for uterine fibroids.
During the recent visit from Sonic Concepts’ Founder and President, George Keilman, we asked about the creation, technological advancements, and new applications of the company.
The Foundation conducted a survey of 150 members of the focused ultrasound community on the state of the field prior to the October 2014 Symposium. Respondents were asked to identify which clinical indications were most likely to improve patients’ quality of life. Neurological and oncological indications are tied for the most votes, with brain tumors, essential tremor, and pancreatic cancer being rated as the top three individual indications. Similarly, respondents were asked to rank the top three bioeffects that are most likely to have long-term therapeutic value. Thermal ablation is ranked first, followed by drug delivery and neuromodulation.
The following article appeared on Medscape.com. View the original story here.
A US Food and Drug Administration (FDA) advisory panel voted yesterday not to recommend approval of a high-focus ultrasound technology to treat low-risk prostate cancer with less erectile dysfunction.
The technology, Ablatherm Integrated Imaging High Intensity Focused Ultrasound (HIFU), has been used in other countries in 40,000 patients for 15 years. It would be the first device of its kind to be approved in the United States.
But members of the Gastroenterology and Urology Panel of the FDA's Medical Devices Advisory Committee voiced a range of concerns about lack of data available from the technology sponsor's research results that were presented as part of its US premarket approval (PMA) application. HIFU is marketed in Europe by EDAP TMS, a French company operating in the United States as EDAP Technology.
The company is seeking premarket approval for HIFU as indicated for primary treatment of individuals with low-risk, localized prostate cancer.
In the end, a majority of panel members voted no to the question regarding a reasonable assurance that the treatment is safe. Panel members voted unanimously against reasonable assurance that it is effective.
HIFU is a robotic technology that consists of a treatment module that connects a control console to an endorectal probe device. After a patient is anesthetized, aurologist robotically controls the probe for insertion into the rectum, and the device delivers ultrasonic energy to a focused portion of the prostate.
High-intensity waves from an ultrasound imaging transducer in the probe generates intensive heat (85° - 95° C) and causes ablation of cancerous tissue while preserving the apex, sphincter, and rectum, with a lower rate of erectile dysfunction.
A rocky regulatory path developed almost from the start, however, for HIFU in the United States. A nonrandomized trial intended to be a pivotal study that began in 2006 to test HIFU against cryotherapy terminated in 2010 because of the company's inability to enroll enough patients, particularly for cryotherapy.EDAP then conducted a meta-analysis of HIFU and cryotherapy results in the medical literature, plus a review of comparisons of a European HIFU registry with surgery in the US Veterans Administration study Prostate Cancer Intervention vs Observation Trial (PIVOT).
EDAP presenters at the hearing said the "body of evidence" supports the approval of HIFU in the United States. They said that the benefits of a noninvasive, localized therapy with precise energy delivery outweigh the risks for urinary obstructive morbidity and that side effects from HIFU treatment are "not dissimilar" to those of other prostate cancer treatments, including radiation therapy.
FDA presenters, however, went through EDAP's submission documents point by point, citing deficiencies, such as lack of information and potential safety concerns, including a 28% cumulative positive biopsy rate 2 years after HIFU treatment among individuals in the nonrandomized trial.
Regarding the lack of information, Johathon P. Jarow, MD, of the FDA's Office of Hematology and Oncology Products, said, "Absence of evidence is not the same as evidence of absence," and that it was not clear whether HIFU treatment is better than doing nothing for the low-risk patients.
The treatment does have its supporters, though. In the public hearing portion of the meeting, Pascal Rischmann, MD, professor and chair of urology, andrology, and renal transplant at Université Paul Sabatier in Toulouse, France, said that the treatment is safe and effective, that it preserves erectile function in more than 90% of patients through nerve sparing, and that it is cost- effective. He said he has used HIFU in more than 350 patients between 2006 and 2014.
Prostate cancer survivors also recommended approval during the public hearing.
Inderbir Gill, MD, chair of the University of Southern California, Los Angeles, Institute of Urology, and a monitor of the HIFU trial, told panel members that HIFU is certaintly not perfect but that all ablation technologies have similar biopsy rates.
"It's about patient choice," he said. He pointed out that HIFU has a track record of 40,000 patients during a 15-year period and that it has never been suspended or taken off the market.
But the FDA officials maintained that the benefit of HIFU is unclear and that the risk is substantial, although they acknowledged that EDAP's efforts had been constrained by practical difficulties associated with conducting trials for prostate cancer.
Stephen R. Kraus, MD, of the University of Texas Health Science Center in San Antonio and a temporary voting member, said he was concerned about the "murkiness" of the data, or "trying to use other trials to make up for the lack of recruitment. Murkiness is the absolute reason we need a controlled trial."
Consumer representative Mildred D. Fennal, PhD, RN, of the International Nurses Education Consortium in Tallahassee, Florida, said, "If anything, it sounds like they're trying to save all the work that's been done" and that maybe they should have reorganized early on and tried something else.
The advisory committee members have disclosed no relevant financial relationships.
View EDAP's official press release. Documents provided at the meeting will soon be available as well on their website.
View more coverage from Bloomberg.
HistoSonics, Inc. is a Michigan-based company that is using the non-thermal histotripsy mechanism of focused ultrasound to treat benign prostatic hyperplasia (BPH). Although BPH causes an enlarged prostate, it does not lead to cancer-the unwanted cells need to be removed when they cause irritation or obstruction. VortxRX is the company's investigational, image-guided, system for treating BPH. A pilot clinical trial is currently underway in North America to test the system’s safety and initial effectiveness.Q&A With HistoSonics Chairman & CEO Tom Davison, PhD
Q. How did you get involved in starting HistoSonics? I was introduced to the University of Michigan (UM) Department of Tech Transfer in late 2007. UM asked me to help evaluate several medical device technologies in their patent portfolio, including histotripsy. Because of my experience in therapeutic ultrasound businesses (UltraCision and Sontra), UM asked me to review the histotripsy program to determine whether it should be licensed or had the potential to support a stand-alone business. At the completion of the consulting assignment, I acquired an option to license the histotripsy technology and intellectual property. After several years of planning, HistoSonics was founded in December 2009.
An alternative method of tissue fractionation--boiling histotripsy--has been developed in a unique collaboration between and the University of Washington (UW) in Seattle and Moscow State University (MSU) in Russia. Drs. Vera A. Khokhlova, Lawrence A. Crum, and the growing UW/MSU teams have developed the method that uses longer (millisecond instead of microsecond) duration focused ultrasound pulses to generate a millimeter-sized boiling bubble (instead of a cavitation cloud) through tissue heating by shocks. Two papers that detailed their groundbreaking work were published in Ultrasound in Medicine and Biology and the Journal of the Acoustical Society of America.
The Focused Ultrasound Foundation has published its January 2014 Focused Ultrasound Global Perspective report, a comprehensive overview of the state of the technology, including facts and figures on approved indications, manufacturers, research centers, and treatment sites. This report will serve as a trusted resource for academia, government, industry, and investors, enabling them to monitor progress in the field and guide decision making.The report is now available on our website. An update will be produced every six months, identifying significant research and commercialization trends for the technology.
Kona Medical, Inc. is pioneering the use of focused ultrasound (FUS) to noninvasively treat hypertension through ablation of the renal nerves. Renal nerves are located near the renal arteries supplying blood to the kidneys and can play a significant role in regulating blood pressure. Recent clinical data have shown that ablation of renal nerves can result in profound and lasting reduction in hypertension in patients whose blood pressure is not adequately controlled by medication.
InSightec Ltd, a leader in MRI guided Focused Ultrasound therapy, has announced that Robert Sigal, MD, PhD, has taken over the role of President and Chief Commercial Officer. He will be responsible for all the commercial aspects of InSightec, reporting to Dr. Kobi Vortman, CEO and Founder of InSightec Ltd.
As a true testament to the potential of focused ultrasound to change medicine, TWO out of 15 companies selected by Fierce Medical for their top 15 innovators of the year are focused ultrasound companies: InSightec and Kona Medical.
Held in Shanghai, China from May 12-15, the 2013 meeting of the International Society of Therapeutic Ultrasound (ISTU) drew about 200 attendees and devoted an entire day to clinical presentations, indicating the society’s increasing emphasis on patient applications of therapeutic ultrasound.
Feng Wu, MD, PhD received the 2013 Fry Award, which is given annually to an individual who has made outstanding contributions to therapeutic ultrasound. Wu is a HIFU Consultant and Senior Clinical Scientist at Oxford University in the United Kingdom.
From the level of traffic at its booth to the “Best Poster” honors bestowed on two abstracts featuring its HIFU treatment for prostate cancer, focused ultrasound device maker EDAP TMS reported a “heightened level of interest and enthusiasm” among physicians and others attending the 2013 meeting of the American Urological Association (AUA) in May. Now in use in 29 countries, EDAP’s prostate cancer treatment device – the Ablatherm – is awaiting regulatory approval in the U.S.
Patients with localized prostate cancer are receiving treatment in a new clinical study assessing the safety of a transurethral ultrasound ablation system developed by Toronto-based Profound Medical Inc. The system, which uses a specially designed wand to deliver thermal ablative therapy, operates under MR guidance. It works on a variety of MRI platforms, can be moved from scanner to scanner and treats the whole prostate gland in one session.
First patient trial at Swedish Medical Center will be for essential tremor
One of the most prestigious neuroscience centers in the world is gearing up to become a major clinical force in MR-guided focused ultrasound brain research. Swedish Neuroscience Institute (SNI) at the Cherry Hill campus of Swedish Medical Center in Seattle, Washington, USA will soon treat patients with essential tremor as part of an upcoming Phase III multicenter randomized trial and is considering studies for epilepsy, Parkinsonian tremor, metastatic tumors and intracerebral hemorrhage.
The Gray Sheet, a cornerstone medical device publication for the healthcare industry, touts promising data on FUS for essential tremor and recognizes the Foundation's unique model in supporting research.
The year 2013 has gotten off to a solid start for device maker EDAP TMS with a steady stream of positive business and research news. The company has introduced its new Focal.One device for prostate cancer and is progressing in its quest for U.S. regulatory approval of its Ablatherm-HIFUsystem for localized prostate cancer.
LYON, France, Feb 01, 2013 (GLOBE NEWSWIRE via COMTEX) -- EDAP TMS SA EDAP, the global leader in therapeutic ultrasound, announced today the submission of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) on January 31, 2013 for the Company's Ablatherm-HIFU (High Intensity Focused Ultrasound) for treatment of low risk, localized prostate cancer. EDAP's PMA submission includes data from the ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the Company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.
The Focused Ultrasound Surgery Foundation has awarded a $232,808 research award to Wladyslaw M. Gedroyc, M.D. of St. Mary’s Hospital in London for a two-year randomized clinical trial comparing MR-guided focused ultrasound with radiofrequency ablation in the treatment of back pain caused by facet joint disease.
Theraclion receives CE marking approval for its ultrasonic device EchoPulse, in the non-invasive treatment of breast fibroadenomas;
Fibroadenoma is the most widely spread breast benign tumor;
EchoPulse has already been validated in European clinical trials.
"The CE marking widens the use of our technology in the major area of breast fibroadenoma. Our technology can now be offered to all women suffering from this pathology in Europe. They can benefit from a non-invasive outpatient treatment without general anesthesia which puts an end to the embarrassment and anxiety triggered by this kind of tumor.Non-invasive focused ultrasound surgery guided by real-time ultrasound imaging is consistent with the logic of developing lesser invasive treatments and a reduction of health costs. This market authorization in Europe will allow us to grow by creating non-invasive surgery centers based on our resulting echotherapy solution within leading hospitals and clinics. Other tumors beside breast fibroadenomas will be treated in a non-invasive manner in the near future,” says Jean-Yves Burel, CEO of Theraclion.
Tirat Carmel (December 4, 2012). InSightec Ltd. announced that its transcranial focused ultrasound system, ExAblate Neuro, has been awarded the European CE mark for the treatment of neurological disorders in the brain including essential tremor, Parkinson’s disease and neuropathic pain.
Based in Seoul, Korea, Alpinion Medical Systems has been offering ultrasound devices since 2007. Half of its 185 employees are R&D engineers, indicating the company’s strong focus on product development and innovation.
Alpinion has three core technologies: diagnostic ultrasound; ultrasound transducer technology and therapeutic ultrasound. It entered the therapeutic ultrasound market in 2011 with the introduction of its first high intensity focused ultrasound product, the VIFU 2000. A year earlier, the company opened an office in Seattle, Washington to focus on R&D for the VIFU 2000 and to expand sales in North America. Alpinion also has sales offices in Germany and China.
French focused ultrasound device maker, EDAP TMS SA, reports that the two-year follow-up phase has concluded for its multi-center U.S. Phase II/III clinical trial for the indication of low risk, localized prostate cancer. Data analysis is now underway, and the company is preparing a comprehensive Premarket Approval (PMA) submission, which is the next step in the FDA approval process.
Read press release
“Ultrasound foundation speeds medical advances” is title of an interview with Dr. Neal Kassell in today’s issue of C-ville Weekly. The article provides an excellent overview of the Focused Ultrasound Foundation’s history, mission and unique approach to venture philanthropy. READ ARTICLE
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