Industry News

  • Meeting Report: AAPM 2017

    AAPM 2017 Logo Square Final 01The 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.”

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  • Raising Awareness about Essential Tremor among Consumers

    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.

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  • Advancing Focused Ultrasound for Movement Disorders

    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.

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  • Company Profile: Mirabilis Medical

    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. 

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  • Mirabilis Medical Awarded CE Mark for Uterine Fibroids

    Mirabilis Medical has been granted European CE Mark approval to begin marketing their robotically assisted non-invasive focused ultrasound system to treat uterine fibroids. This milestone was accomplished 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.

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  • NaviFUS Executives Visit Foundation

    NaviFUS logo 180Executives from NaviFUS, a new focused ultrasound company in Taiwan, visited the Foundation to share information on the status of their company and their plans to begin clinical trials. Company Chairman, Chiu S. Lin, PhD, and CEO, Ming-Che Wang, PhD, were joined by Neurosurgeon Kuo-Chen Wei, MD, and Professor Hao-Li Liu for meetings at the Foundation and the University of Virginia. 

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  • Verasonics Develops Flexible, High Tech Ultrasound for Research

    Seattle Area-based Verasonics designs and develops a programmable research ultrasound platform that optimally combines energy application and image monitoring all in one for focused ultrasound (FUS) research, development, and commercialization. In addition to therapy, Verasonics’ research ultrasound systems are used for investigation in novel imaging techniques, physics, materials testing, education, and other applications.

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  • Medicare Establishes Payment Level for Treatment of Tremor

    The Centers for Medicare and Medicaid Services (CMS) has set the institutional payment for focused ultrasound treatment for essential tremor at approximately $10,000. After two years CMS will reevaluate the payment level based on the actual costs of treatments performed during that interval.

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  • EpiSonica Gains Regulatory Approval in Taiwan

    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.

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  • 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 the commercial sale in Europe and in other CE Mark jurisdictions.

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  • FUS Poised for Growth in Japan

    After nearly 20 years of activity in the country, focused ultrasound may now be positioned for commercial success in Japan.

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  • Translation and Commercialization Flourish at the University of Washington

    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.

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  • Profound Partners with Philips for Prostate

    As announced this summer by Philips and Toronto-based Profound Medical, the two companies will integrate Profound’s TULSA (Transurethral Ultrasound Ablation) technology onto Philips’ 3T MRI systems. TULSA is designed to provide minimally invasive, single session whole gland ablation for patients with prostate cancer.

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  • Canadian Government Agency Deems FUS as Cost-Effective, Least Invasive Treatment Option for Fibroids

    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.

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  • EDAP Changes U.S. Regulatory Strategy

    EDAP-TMS is changing their US regulatory strategy to pursue direct De Novo 510(k) approval for their Ablatherm systemto treat prostate cancer instead of continuing to pursue a Pre-Market Approval (PMA) application. The company made this decision based on discussions with the US Food and Drug Administration (FDA).

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  • Company Profile: Sonic Concepts

    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.

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  • Important Meetings for Your 2015 Calendar

    As we begin the new year, we encourage you to mark your calendars for these important meetings.

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  • EDAP Receives FDA Guidance for Ablatherm

    EDAP-TMS received a letter from the US Food and Drug Administration (FDA) indicating that, although their premarket application for the Ablatherm device to treat localized prostate cancer was not approvable in its current form, a path forward is possible.

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  • FUS Experts Believe Brain and Cancer Applications Have Most Potential to Improve QOL

    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.

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  • Elekta’s Executive Director Shares Insight, Praises the Role of the Focused Ultrasound Foundation

    Tomas Puusepp, Executive Director of the Board of Elekta and its former CEO, recently visited the Foundation and shared his experience in providing an emerging technology (the Gamma Knife) to the patients who need it. His thoughts on taking risks, competition, and overcoming barriers provide many valuable insights that apply to focused ultrasound.

    When Puusepp joined Elekta in 1988, it was a $5 million company with a staff of 22—today it has $1.5 billion in revenue and 4,000 employees. With a background in electrical engineering and physics, he advanced through the management ranks within Elekta to serve as President and CEO from 2005 through April 2014.

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  • Company Profile: Philips Healthcare

    This month, we highlight the company behind the new focused ultrasound Center of Excellence (COE) in London: Philips Healthcare. Thanks to Philips’ generous support and impressive scientific vision, the COE is established at the Institute for Cancer Research (ICR) at The Royal Marsden Hospital’s Sutton, Surrey site and will advance focused ultrasound treatment of cancer.

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  • The Institute of Cancer Research and The Royal Marsden Celebrate Opening of Focused Ultrasound Center of Excellence in London

    The first clinical trial has begun at the new Focused Ultrasound Foundation Center of Excellence (COE) at the Institute of Cancer Research, London. This center is a public-private collaboration between the Foundation, The Institute of Cancer Research (ICR), Philips Healthcare, and The Royal Marsden NHS Foundation Trust to create a state-of-the-art resource for clinicians and scientists to develop clinical evidence and establish best practices, treatment standards, and protocols for the use of focused ultrasound to treat cancer.

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  • Commentary: Putting the FDA Panel’s Feedback Into Perspective

    Last month, the FDA advisory panel made a highly unfortunate ruling that, based on data presented by EDAP, there is not reasonable assurance that the Ablatherm focused ultrasound device is safe and effective for the treatment of low risk localized prostate cancer. The device has been approved in Europe since 1999, and 40,000 patients around the world have been treated with the system to date.

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  • FDA Advisory Panel Votes Against Approval of Prostate Device

    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.

    Rocky Path

    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.

    Unclear Effectiveness

    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.

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  • Foundation’s Unique Partnership Showcased

    The Foundation’s chairman, Dr. Neal F. Kassell, delivered the keynote speech at the BIRD (United States-Israel Binational Industry Research & Development) Foundation’s Reception at the United States Chamber of Commerce on June 25. Addressing a room of decision makers from Washington and Israel, Kassell shared the story of focused ultrasound technology in neuroscience and next steps for essential tremor research.

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  • Company Profile: Theraclion

    Celebrating its 10th anniversary this year, Theraclion is a French focused ultrasound company that currently specializes in treating benign breast tumors and thyroid nodules. Their Echopulse system is approved in Europe and available to patients in France, Italy, and Germany. With the start of their first U.S. clinical trial and the recent news that the company has become publicly traded, we interviewed Chief Technology Officer Sylvain Yon, PhD, to discover more about the company’s accomplishments, status, and future direction. Sneak peak: Their ultimate goal is to noninvasively treat every kind of tumor. 

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  • Reimbursement Summit Attendees Create Action Plan for Fibroids and Bone Pain Palliation

    In an example of the power of collaboration, the Foundation hosted a Reimbursement Summit on May 13th in Charlottesville. The more than 20 attendees included professionals from Philips Healthcare, InSightec, EDAP-TMS, and reimbursement consulting firm ADVI. The group attained their primary objective to develop an integrated action plan to obtain U.S. reimbursement for focused ultrasound treatment of uterine fibroids and palliation of painful bone metastases.

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  • Company Profile: HistoSonics

    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.

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  • Washington-Russian Collaboration Sends Shock Waves Through Focused Ultrasound

    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.

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  • International Society for Therapeutic Ultrasound 14th Annual Symposium Highlights Latest Advances in Non-Invasive Focused Ultrasound Technology

    ISTU Release Photos mdApril 15, 2014 -- Charlottesville, VA – Presentations at the recent symposium of The International Society for Therapeutic Ultrasound (ISTU) demonstrate an increasing body of data supporting the potential of focused ultrasound to transform the treatment of a wide range of diseases. This early-stage, non-invasive technology could be a cost-effective alternative or adjunct to traditional surgery, radiation therapy, and drug delivery to treat conditions such as brain tumors, movement disorders, prostate cancer, and soft tissue tumors. Currently approved in the U.S. for the treatment of uterine fibroids and painful bone metastases, many healthcare experts consider focused ultrasound a disruptive technology to watch.

    “Focused ultrasound is increasingly being considered a game-changing technology,” said Kim Butts Pauly, Ph.D., ISTU 2014 Committee Chair and Professor of Radiology, Stanford University School of Medicine. “We are excited to host researchers from many disciplines around the world -- including medical physics, engineering, biomedical science, radiology, oncology, and neurosurgery -- to share significant pre-clinical and clinical progress being made with focused ultrasound.”

    Promising Data Expands the Frontiers of Focused Ultrasound

    The range and depth of scientific presentations at the 2014 ISTU meeting demonstrate the broad applicability of this platform technology to produce multiple biological mechanisms. Focused ultrasound can have therapeutic effect both directly by ablating unhealthy tissue or dissolving blood clots and indirectly, such as by opening up the blood-brain barrier to allow the delivery of therapeutic agents.

    “It is critical that the next phase of innovation in focused ultrasound optimizes the potential to treat the most urgent medical needs that will benefit the greatest number of patients,” said Neal F. Kassell, chairman of The Focused Ultrasound Foundation, a major sponsor of the conference. “One revolutionary approach involves using the technology to non-invasively treat problem areas deep in the brain, while bypassing healthy brain tissue and preserving normal functions. The successes in movement disorders point to a very promising future for this powerful tool.”

    Presentation Highlights

    Several new clinical studies were presented at the symposium, including the following highlights:

    Uterine Fibroids

    In-Office Rapid Volumetric Ablation of Uterine Fibroids Under Ultrasound Imaging Guidance: Preclinical And Early Clinical Experience With The Mirabilis Trans-Abdominal HIFU Treatment System

    Jessica Parsons, Ph.D., Clinical Science Manager at Mirabilis Medica, Inc. presented results of a single-arm pilot study of 37 women treated with their experimental focused ultrasound system prior to hysterectomy. The treatment was delivered using ultrasound imaging guidance with no skin burns or collateral tissue injury. No anesthesia or sedation was required in a large majority of patients. The average total treatment time was 4.9 minutes. This dramatically shorter treatment time was achieved using a shell ablation technique, which involves focusing the ultrasound energy on the outer surface of the target volume to allow thermal and ischemic effects to work in concert. The average non-perfused volume created in the study ranged between 0.6 and 51.3 cc, depending on the treatment parameters used.

    Clinical Application of High-Intensity Focused Ultrasound Ablation in Gynecology: Safety Analysis

    Lian Zhang, M.D., of Chongqing Medical University in China presented a seven-year study evaluating the safety of focused ultrasound treatment of more than 10,000 patients with uterine fibroids or adenomyosis at 10 centers in China. The treatments were very effective, with an average of 80% non-perfused fibroid volume achieved. The treatments were safe, with 13.15% of patients experiencing anticipated minor side effects immediately after the procedure (abnormal vaginal secretion, lower abdominal pain, transient leg or buttock pain, dysuria, vomiting, uterine bleeding, urinary retention or fever). Longer-term side effects (skin blisters, leg or buttock pain, and uterine bleeding) occurred in 0.12%. Major complications, which have previously led to substantial morbidity and disability, did not occur in this study.

    Soft Tissue Tumors

    Treatment of Extra-Abdominal Desmoid Tumors Using MR-Guided High Intensity Focused Ultrasound: Preliminary Results after Five Patients

    Pejman Ghanouni, M.D., Ph.D., Stanford University, shared his experience treating 5 patients with desmoid tumors, rare aggressive benign growths that affect young adults. Five patients with a median age of 17 years were treated. The average treatment time was 4 hours 39 minutes, and no serious adverse events occurred. Complications of the procedures included a small blister, muscle ablation, and acute biochemical pancreatitis that was asymptomatic and self-resolving. Focused ultrasound seems promising for achieving local control of tumor growth with an average of 63% of the tumors ablated after one or two treatments. The procedure was associated with few adverse events compared to surgery or radiation, and it can be repeated without toxicity to normal tissue.

    Bone Pain

    Osteoid Osteoma: Magnetic Resonance Guided High Intensity Focused Ultrasound for Entirely Non-Invasive Treatment. A Prospective Developmental Study.

    Alessandro Napoli, M.D., Sapienza University of Rome, presented results of a study treating 15 patients with osteoid osteoma, a rare benign tumor causing localized bone pain that affects young adults. The patients were treated with MR-guided focused ultrasound and followed up at 1, 6, and 12 months post-treatment. There were no treatment-related complications. A statistically significant difference was noted between the overall pre- and post-treatment visual analogue scores for pain (8.3 and .6 respectively).


    ABOUT FOCUSED ULTRASOUND
    Focused ultrasound is a revolutionary, early-stage therapeutic technology with the potential to transform the treatment of many serious medical disorders. This breakthrough technology uses ultrasonic energy guided by magnetic resonance or ultrasound imaging to treat tissue deep in the body without incisions or radiation. Multiple intersecting beams of ultrasound are directed and concentrated on a target as small as a grain of rice, much like a magnifying glass can focus multiple beams of light on a single point.
    Focused ultrasound is currently approved in the U.S. to treat uterine fibroids and painful bone metastases, and there are a growing number of clinical applications in various stages of research and development around the world, including Parkinson’s disease, essential tremor, neuropathic pain, breast and prostate cancer, and brain tumors.

    ABOUT THE INTERNATIONAL SOCIETY FOR THERAPEUTIC ULTRASOUND
    The International Society for Therapeutic Ultrasound (ISTU) is a non-profit organization founded in 2001 to increase and diffuse knowledge of therapeutic ultrasound to the scientific and medical communities, and to facilitate the translation of therapeutic ultrasound techniques into the clinical arena for the benefit of patients worldwide.

    ABOUT THE FOCUSED ULTRASOUND FOUNDATION
    The Focused Ultrasound Foundation was created to improve the lives of millions of people worldwide by accelerating the development and adoption of focused ultrasound therapies. The Foundation works to clear the path to global adoption by coordinating and funding research, fostering collaboration among stakeholders, and building awareness of the technology among patients and professionals. The Foundation is dedicated to ensuring that focused ultrasound finds its place as a mainstream therapy for a range of conditions within years, not decades. Since its establishment in 2006, the Foundation has become the largest non-governmental source of funding for focused ultrasound research. More information about the Charlottesville, Virginia-based Foundation can be found at www.fusfoundation.org.

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  • Focused Ultrasound Clinical Trial for Breast Fibroadenoma Gains FDA Approval

    Theraclion, a manufacturer of focused ultrasound equipment based in France, announced today that they have attained approval from the US Food and Drug Administration (FDA) for a feasibility study in the United States. Their device, EchoPulse, uses ultrasound-imaging to guide the treatment of breast fibroadenoma using focused ultrasound. Breast fibroadenoma are benign tumors of the breast, and it is estimated that 10% of women will experience them in their lifetime.  

    Theraclion will collaborate with the University of Virginia on this study, evaluating 20 patients to prove safety and efficacy of the treatment. This trial is considered first phase, and a multicenter pivotal study is planned upon the trial’s completion.

    Read the release. 

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  • Foundation Publishes Global Report on Focused Ultrasound – A Resource for all Stakeholders

    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.

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  • Focused Ultrasound Makes Cover of DOTmed HealthCare Business News

    Focused ultrasound secured a spot on the front page of the January 2014 issue of DOTmed HeathCare Business News.  The article, which asks “is focused ultrasound medicine’s best kept secret,” chronicles the conception of the technology and details the current state of development and adoption for some important conditions, including uterine fibroids, Essential Tremor, Parkinson’s disease, Obsessive Compulsive Disorder, and prostate cancer. It also covers next steps for the technology, including the arena of widespread reimbursement.

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  • Company Profile: Kona Medical

    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.

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  • InSightec Names New President, CCO

    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.

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  • Two Focused Ultrasound Companies Recognized for Innovation

    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.

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  • ISTU Meeting Gave Added Emphasis to Clinical Studies

    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.

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  • American Urologists Show Strong Interest in HIFU

    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.

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  • Canadian Study Assessing Thermal Ultrasound Treatment for Prostate Cancer

    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.

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  • Seattle Center To Be a Major Force in Focused Ultrasound Brain Studies

    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.

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  • Industry Trade Reports on Positive Essential Tremor Data Using Focused Ultrasound

    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.

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  • SonaCare’s Devices Treat Prostate Cancer, Other Urological Conditions

    In a March 14 press release, SonaCare announced that it would showcase a retooled version of the Sonablate 500 system  and display the Sonatherm for the first time ever during this month’s European Association of Urology Congress in Milan. The company also reported a 130% increase in global sales during 2012 and said that yearly sales had more than doubled since 2011. SonaCare Medical, LLC – the new name of focused ultrasound device-maker U.S. HIFU – is gearing up for growth. According to Chief Development Officer Mark Carol, MD, the company plans to add the world’s largest healthcare market – the U.S. – to the list of countries where its flagship Sonablate system is cleared to treat prostate cancer. The company is also gearing up to commercialize its Sonatherm system, a laparoscopic HIFU surgical ablation device that received 510(K) clearance from the U.S. Food and Drug Administration (FDA) in 2008 to treat organs other than the prostate.

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  • EDAP Leads the Charge in Commercializing FUS for Prostate Cancer

    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.

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  • EDAP Submits U.S. FDA Pre-Market Approval Application for Ablatherm(R)-HIFU for Treatment of Low Risk, 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.

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  • Clinical Trial is Evaluating Theraclion’s Ultrasound-Guided Device in Treating Bone Tumor Pain

    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.

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  • Theraclion's EchoPulse receives CE marking for treatment of breast fibroadenoma

    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.

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  • InSightec’s ExAblate Neuro System Awarded European CE Mark for Non-invasive Treatment of Neurological Disorders in the Brain

    ExAblate treatment indicated for use for essential tremor, tremor dominant Parkinson’s disease and neuropathic pain

    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.

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  • Vendor Profile: Alpinion Medical Systems Offers a Pre-clinical Focused Ultrasound System

    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.

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  • EDAP Concludes Follow-up Phase of its U.S. Prostate Cancer Study

    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

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  • New Report Provides Excellent Overview of Focused Ultrasound Foundation's History, Mission and Unique Approach to Venture Philanthropy

    “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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  • Philips and Celsion Receive FDA Go-ahead for Phase II Study of ThermoDox and MR-Guided HIFU in Bone Cancer

    ANDOVER, MA and LAWRENCEVILLE, NJ -- (Marketwire) -- 08/07/12 -- Royal Philips Electronics (NYSE: PHG) (AEX: PHI) and Celsion Corporation (NASDAQ: CLSN) today announced that the U.S. Food and Drug Administration (FDA) has provided clearance to initiate a clinical study supporting a joint development program for Celsion's ThermoDox® combined with Philips' Sonalleve MR-HIFU (MR-guided high intensity focused ultrasound) technology for the palliation of painful metastases to the bone caused by lung, prostate or breast cancers. The companies expect to initiate a Phase 2 study in this indication in the second half of 2012.

    READ FULL PRESS RELEASE

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  • PanAm HIFU Opens Prostate Cancer Treatment Center in Mexico

    Sarasota, Florida-based PanAm HIFU has opened a prostate cancer treatment site at Amerimed Hospital in Cancun, Mexico. The new site represents a partnership between PanAm and EDAP TMS SA, manufacturer of the Ablatherm-HIFU system, which is approved in Europe and generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment.

    The Cancun center is PanAm’s second offshore site; the first is in London, England. Medical Director Ronald E. Wheeler, MD, explained that PanAm’s new facility will satisfy increasing patient demand and serve as a HIFU technology training site for American physicians “in preparation for [Ablatherm’s] U.S. approval.” READ PRESS RELEASE

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  • UVA Focused Ultrasound Center Receives an Additional $1.5M in State Funding

    The Focused Ultrasound Foundation’s first designated Center of Excellence at the University of Virginia will be receiving an added $1.5 million for research over two years from the Commonwealth of Virginia. As a participant in the public-private partnership that created the UVA Center in 2009, the Commonwealth had previously provided $4 million in support.

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  • EDAP Realigns Executive Team to Focus on US Opportunities

    EDAP TMS SA of Lyon, France has relocated its Chief Executive Officer Marc Oczachowski to the US. "The U.S. market is critically important for EDAP," said Philippe Chauveau, Chairman of the company’s Board of Directors. "We see significant growth drivers in the US, both in the lithotripsy market and in continuing to drive our Ablatherm-HIFU program toward FDA submission, targeted for fourth quarter 2012."  

    The realignment impacted the accountabilities of the company’s Chief Financial Officer Eric Soyer and Japanese subsidiary CEO, Jean Francois Bachelard. NEWS RELEASE

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  • Kona Medical Raises $30M to Commercialize Focused Ultrasound Treatment for High Blood Pressure

    American medical device-maker Kona Medical, Inc. has raised $30 million in venture financing to advance development and commercialization of an ultrasound system to treat drug-resistant hypertension. The device is designed to noninvasively ablate renal nerves, which play a significant role in determining blood pressure. According to the company, recent clinical data have shown that renal nerve ablation can result in profound and lasting reduction in hypertension in patients whose blood pressure is not adequately controlled by medication. The privately-held Kona is based in Bellevue, Washington. READ REPORT

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  • St-Augustin Urology Clinic in France Using Focused Ultrasound to Treat Prostate Cancer

    EDAP TMS SA reports that patients with prostate cancer are being successfully treated at the St-Augustin Urology Clinic in Bordeaux, France utilizing the company’s Ablatherm High Intensity Focused Ultrasound system. Dr. Thierry Piechaud, partner and urology surgeon at the clinic, noted, "We are very enthusiastic about adding the Ablatherm-HIFU device to our therapeutic arsenal. We believe HIFU has developed a clear lead among other current technologies as a new approach and a modern concept of non-invasive treatment for early stage prostate cancer which preserves patient quality of life." EDAP reports that there are 278 Ablatherm installations worldwide.

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  • Sunnybrook Research Institute Receives $6.91M to Lead Project Involving 19 Industry Partners

    Accelerating the development and commercialization of innovative image-guided therapies for cancer and heart disease is the goal of a major initiative announced last month. Sunnybrook Research Institute (University of Toronto) will lead the project with $6.91 million in funding from the Canadian government. Project partners will include Western University (Ontario, Canada) and 19 industry partners, who were not identified. The goal of the project is to develop, test and license four new image-guided therapies: ultrasound surgery, magnetic resonance imaging intervention; an early feedback system for chemotherapy patients; and a hybrid optical/ultrasound catheter for imaging of coronary atherosclerosis. READ PRESS RELEASE

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  • ExAblate Named One of Israel's Top 64 Innovations

    In honor of Israel's 64th birthday, the online news magazine ISRAEL21c spotlighted the country's 64 top innovations, including InSightec's ExAblate MR-guided focused ultrasound system. Responding to the news, InSightec's President and Chief Executive Officer Kobi Vortman, PhD wrote to his collegues, "As part of the exceptional InSightec team, we are all pushing the state of the art with a vision that we will help millions of people that desperately need help. Innovation, hard work, dedication and perseverance by all of you made it happen. It is a great honor, that on Independence Day, we were selected to be one of the top all-time 64 innovations." Read news story.

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  • Celsion and Philips Plan Study of Patients with Prostate Cancer Metastasized to the Bone

    Celsion Corporation and Philips Healthcare have resubmitted an Investigational New Drug/ Investigational Device Exemption application with the U.S. Food and Drug Administration for a Phase II patient study. The trial will evaluate a combined therapy using Celsion's liposome encapsulated drug, ThermoDox, and the Philips Sonalleve MR-guided high intensity focused ultrasound system for the treatment of prostate cancer metastasizes to the bone. The study is set to launch following FDA acceptance of the proposed program. Read press release.

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  • Acublate: New Focused Ultrasound Company Formed

    Cancer Research Technology, the commercial arm of Cancer Research UK has spun off a private comapny called 'Acublate Limited' which will be developing a HIFU device used to treat various types of solid tumors.  Initially, the Acublate device will treat patients with bowel cancer that has spread to the liver.

    Dr Keith Blundy, CRT's CEO, said: "We're delighted to be able to take the research into this exciting technology that Cancer Research UK helped fund onto the next stage. The HIFU technology currently approved for clinical use in the UK specifically targets prostate cancer but we hope the Acublate device will be able to treat most solid tumour types."

    Read the press release here:

    http://www.cancertechnology.com/news/single/acublate/

     

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  • Major Developments Expected in 2012

    The positive energy surrounding the field of focused ultrasound has reached unprecedented levels. During the last 60 days, recognition inTIMEmagazine and viewership of the TEDMED video have caused “an explosion in public awareness of the promise and potential of this revolutionary technology,” according to FUS Foundation Chairman Neal F. Kassell, MD.  As a result, he says, demand for rapid development of focused ultrasound treatments is greater than ever before. 

    Kassell expects momentum to continue building in the year ahead. “The pace is definitely accelerating. We anticipate that 2012 will be a year of significant developments, especially in the clinical arena,” he notes.

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  • GE Healthcare CEO Blogs About FUS Therapy

    By Thomas Gentile, President and CEO of GE Healthcare

    The following article is reprinted with permission from GE Healthcare.

    When I was in India a few months ago, I first came across an exciting technology called Magnetic Resonance Guided Focused Ultrasound (MRgFUS).  A doctor there was doing investigational research with it to evaluate its use in ablations of tumors.

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  • Vendor Profile: Theraclion is Pioneering Focused Ultrasound Treatments for Breast Fibroadenoma and for Thyroid and Parathyroid Conditions

    Start-up French device maker, Theraclion, continues to break new clinical ground with its TH-One ultrasonic ablation system. Last month, the company announced early success in the noninvasive treatment of patients with breast fibroadenomas, which are benign tumors that affect about one in ten women and are especially problematic for those under 30 years old. 

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  • Site Update: Sunnybrook Opens Doors to New Biomedical Imaging Research Suite

    Leading-edge facility will advance work in image-guided therapeutics and technology development

    By Eleni Kanavas, Communications Coordinator, Sunnybrook Research Institute, Toronto, Canada

    Sunnybrook Research Institute (SRI) officially opened its biomedical imaging research suite on November 10, 2011. The event was part of SRI’s second annual research day for the Centre for Research in Image-Guided Therapeutics (CeRIGT).

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  • TIME Magazine Features Focused Ultrasound as One of This Year's 50 Best Inventions

    The visibility of focused ultrasound is skyrocketing. TIME Magazine has named it one of the 50 most inspired ideas, innovations and revolutions of 2011. In its coverage, TIME heralds MR-imaging and focused ultrasound "remarkable in their own right"and observes that "something life-changing" emerges when the two are combined.

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  • Medtech Insight Article on Image-guided Focused Ultrasound

    MedTechInsightFUSThe organization Medtech Insight just released a report with an overview of the field of image guided focused ultrasound and the Foundation has obtained the rights to make this article available to visitors of our website.

    It's an excellent overview of the field, the current and potential applications of focused ultrasound, and features an interview with the Chairman of the Foundation, Dr. Neal Kassell.

    To download this report please click here.

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  • Philips Launches New Sonalleve Platform at CIRSE

    By Neil Glossop, FUS Foundation Consultant

    Held in Munich, Germany from September 10 to 14, the 2011 meeting of the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) brought together researchers and clinicians in interventional applications from all over the world. The strength and commitment of this community was signified by the number of delegates in attendance – 6,164, a new record – and the number of abstracts submitted – 1,413.

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  • Site Update: Sapienza University of Rome

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  • InSightec Provides Update on its Prostate Cancer Clinical Trial

    In a press release last month, InSightec, Ltd. reported that pilot clinical trials at four sites have used its MR-guided focused ultrasound system to treat 23 patients with organ confined low risk prostate cancer and that results are promising.

    According to InSightec, five patients underwent near total gland ablation that preserved their urinary sphincter and neurovascular bundles, and 18 received focal treatments. None of the procedures (whole gland or focal) triggered Severe Adverse Events during or after treatment, and none required post-treatment intervention, demonstrating a good safety profile.

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  • Russian FUS Center Nearing 900-patient Mark in Treating Uterine Fibroids

    In the July 2011 issue of this newsletter, we reported thatCHA Bundang Medical Center in Seoul, South Korea had become the first MR-guided FUS site in the world to treat more than 500 uterine fibroid patients. An email fromPaul Wragg, MSc (MRI) European Applications Manager for InSightec, Ltd., informed us that another site had already passed this clinical milestone.

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  • Company That Pioneered Therapeutic Ultrasound is Collaborating with Siemens to Develop an MR-guided Treatment System

    Haifu operates its own 32-bed Clinical Center for Tumor Therapy at the 2nd Affiliated Hospital of Chongqing Medical University (CQMU). The center, which was the first to treat breast cancer and bone tumors with HIFU, draws patients from around the world. In 2004, the center added gynecological diseases to its clinical specialties and now treats patients with lichen sclerosis, squamous cell hyperplasia and chronic cervicitis.

    To build a global presence, Haifu has established relationships with leading academic research sites, including the University of Oxford (UK), University of Utah (USA), University of Chiba (Japan), Catholic University of Korea (South Korea) and University of Hong Kong (China). The company is also exploring new commercial opportunities, including a highly promising collaboration with Siemens Medical Solutions that is developing an MR-guided focused ultrasound system to treat uterine fibroids, osteosarcoma and other tumors.

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  • Profound Medical Secures $9.4 Million in Venture Capital

    Device maker set to hire staff and launch clinical trials of its new prostate cancer treatment

    The Focused Ultrasouns Surgery Foundation contgratulates Profound Medical Inc. (PMI) for closing Canada's largest, early-stage medical device venture capital financing in recent years. The Toronto-based company is using intellectual property and technology licensed from Sunnybrook Health Sciences Centre to develop an MRI-guided, trans-urethral treatment for localized prostate cancer.

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  • Celsion and Philips Plan Clinical Studies of Focal Drug Delivery Treatment for Metastatic Bone Cancer

    In a major development, Celsion Corporation and Philips Healthcare have requested FDA permission to launch U.S. clinical studies of a new focal drug delivery treatment for metastatic bone cancer. The method uses Celsion’s ThermoDox – a heat-sensitive liposomal encapsulation of the proven and widely used cancer drug, doxorubicin – and Philips’ MR-guided focused ultrasound technology.

    Celsion is developing the combination of ThermoDox and high intensity focused ultrasound (HIFU) through a joint research agreement with Philips Healthcare, a division of Royal Philips Electronics.

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  • More Sites and Patients Participating in Clinical Trial Assessing New MR-guided FUS System for Prostate Cancer

    Kobi Vortman, Ph.D., CEO of InSightec, reports that two new sites have joined the company's Phase 1 clinical trial assessing the ExAblate Prostate System and 14 patients with low-risk prostate cancer have now received treatment.

    The newly added sites are the University of Rome in La Sapienza, Italy and Jaslok Hospital in Mumbai, India. The other participating sites are the N.N. Petrov Research Institute of Oncology in Saint Petersburg, Russia and the National Cancer Centre at the Singapore General Hospital in Singapore. Click here to view video interview and read full report.

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  • Sunnybrook Plans Added Clinical Trials of its MR-guided Transurethral Ultrasound Device for Prostate Cancer

    Site Update: Laurence Klotz, M.D, Sunnybrook Health Sciences Centre, Canada

    Laurence Klotz, M.D., a urologic oncologist at the University of Toronto’s Sunnybrook Health Sciences Centre, says planning is underway for a second clinical trial using an investigational transurethral ultrasound device developed at Sunnybrook to ablate prostate cancer.

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  • Imaging Scientist Position Available at UCSF

    Last August, the Foundation newsletter reported that the University of California San Francisco had received a $1,368,750 grant from the National Institutes of Health to install a MR-guided focused ultrasound system.

    Principal investigator for the project - Fergus Coakley, M.D., Professor of Radiology, Abdominal Imaging Section Chief, and Vice Chair of Clinical Service - said that the equipment would be used to explore new applications of MR-guided focused ultrasound such as treatments for painful bone metastases and prostate cancer. "We're looking to push the envelope and do what we can to advance this exciting field," he said.

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  • Sapienza University of Rome is First to Treat Pancreatic Cancer Patients with FUS

    Since installing an ExAblate 2100 system in May 2010, Alessandro Napoli, M.D., Ph.D.and his colleagues at Sapienza University of Rome have wasted no time in making their mark on the field of MR-guided focused ultrasound.

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  • New Report from InSightec Summarizes 2nd International Symposium on MR-guided Focused Ultrasound

    InSightec, a leading producer of MR-guided focused ultrasound equipment, has posted a special report summarizing the FUS Foundation's highly successful 2nd International Symposium. InSightec was among the corporate sponsors that supported the symposium, which was held October 17-20, 2010 in Chantilly, Virginia, USA.

    Click here to download the summary.

     

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  • Leading Experts Join FUS-TDD Core Stakeholder’s Group

    The Foundation’s Focused Ultrasound-mediated Targeted Drug Delivery Program (FUS-TDD) has announced the formation of a Core Stakeholders Group that includes many of today’s leading researchers and experts:

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  • European Union Approves New Indication for MR-guided Focused Ultrasound

    CE Mark certification expanded to include adenomyosis

    Until late last month, women suffering from adenomyosis – a benign gynecologic condition that causes heavy menstrual bleeding, pain and diffuse uterine enlargement – had two treatment options: have a hysterectomy and lose the ability to conceive; or, take medication for temporary symptom relief.

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  • Province of Ontario Honors Profound Medical

    The Foundation congratulates Toronto-based Profound Medical, Inc., winner of the prestigious, 2010 Ontario Premier’s Catalyst Award for “Start-up Company with the Best Innovation.” The Ontario government will also invest C$ 200,000 in further developing the company’s investigational MR-guided focused ultrasound device for treating prostate cancer.

    The company is in the midst of securing financing to accelerate clinical trials in North America, Canada and the European Union.

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  • MR-guided FUS Spotlighted During 2010 Girl’s Day in Germany

    German Chancellor Angela Merkel learned about MR-guided focused ultrasound during Girl’s Day on April 21. (Photo courtesy of Quelle der Fotos: TK)

    To encourage school girls to pursue careers in science and technology, Germany celebrated its tenth annual Girl’s Day on April 21, and one of the newest developments featured was a MR-guided focused ultrasound system, Insightec’s ExAblate 2000.

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  • Industry Profile: Celsion

    The heat is on at Celsion

    Small biotech is making giant strides in heat-mediated targeted drug delivery

     

    Heat-sensitive nanotechnology is moving closer to dramatically changing cancer therapy. In the near future, this technology will be used to deposit chemotherapy directly onto tumors, minimizing toxic side effects and maximizing treatment efficacy. Though small in size (17 employees), Maryland-based Celsion Corporation is making a huge impact on this important and emerging area of medicine.

    Founded in 1982 as Cheung Laboratories, Inc., Celsion specializes in developing products for heat-based medical treatments. In its early years, the company produced devices. It turned its attention to drug making in the late 1990’s after licensing a heat-activated liposomal technology from Duke University. That technology serves as the platform for the company’s first investigational nanomedicine, ThermoDox, a liposome-encased form of a potent, widely used cancer drug, doxorubicin.

    In the future, Celsion expects to use its liposomal encapsulation technology for other therapeutics and indications.

     

    First investigational drug: ThermoDox

    One hundred nanometers in size, ThermoDox liposomes transport doxorubicin intact through a patient’s bloodstream to treatment sites (tumors) that have been heated to the level of mild hyperthermia (40-42 degrees Celsius; 104-107.6 degrees Fahrenheit). When activated by the heat, the liposomes restructure and create channels through which doxorubicin rapidly disperses into surrounding tissue, precisely where needed.

     

     

    Two clinical trials are now evaluating ThermoDox as a treatment for primary liver cancer (the global 600-patient Phase III HEAT Study) and for recurrent chest wall breast cancer (the stateside 100-patient Phase I/II DIGNITY Study). The HEAT study is using radiofrequency ablation to both activate ThermoDox and destroy liver tumors. Expected to be completed by June 2010, the DIGNITY trial is using a non-ablative mild heat energy to trigger the drug’s release. Celsion expects to file New Drug Applications after completion of each study.

     

    Later this year, the company will begin a randomized Phase II study to evaluate ThermoDox and radiofrequency ablation as a treatment for colorectal liver metastases. Montefiore Medical Center in New York City will be the lead site, and Celsion expects to add at least two other study locations in North America and in the Asia Pacific region. Launch of the new trial follows completion of a Phase I safety study involving 24 patients, 15 of whom had liver metastases from nine primary sites.


    Combining MR-guided FUS with ThermoDox

    Working in partnership with Royal Philips Electronics (parent company of Philips Healthcare), Celsion has also begun exploring the use of ThermoDox in combination with magnetic resonance-guided high intensity focused ultrasound (FUS) to treat various solid tumor cancers. Researchers at the U.S. National Cancer Institute, Sunnybrook Health Sciences Centre in Toronto and Université de Bordeaux in France have helped establish technical parameters for this combined therapy. Celsion is reported to be in discussions with the FDA regarding the launch of Phase I/II clinical trials to evaluate ThermoDox with MR-guided FUS in treating metastatic bone cancer and pancreatic cancer.

    In recent weeks, the Center for Translational Molecular Medicine, a public-private research consortium based in the Netherlands, awarded 6.4 million Euro (approximately $8.7 million U.S.) to Celsion and Philips to develop FUS-mediated ThermoDox therapies for liver tumors and secondary bone tumors. Set to begin in May 2010, the project will be led by the University Medical Center Utrecht in the Netherlands. Also participating are Technical University Eindhoven in the Netherlands and the National Institutes of Health's Clinical Center in the U.S. As a first step, the group will conduct pre-clinical studies to assess doxorubicin drug delivery and to optimize MR-guided FUS performance in this application. According to Celsion, an Investigational New Drug submission is planned for 2010, following successful completion of the pre-clinical studies.

    Written by Ellen C., McKenna

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  • 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.”

    Read the full press release here

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  • 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.

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