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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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.
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
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.
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.
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:
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.
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.
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.
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).
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.
The 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.
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.
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.
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.
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.
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.
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.
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.
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.
Last August, the Foundation newsletter reported that the University of California San Francisco had received a $1,368,750 grant from the National Institutes of Health to install a MR-guided focused ultrasound system.
Principal investigator for the project - Fergus Coakley, M.D., Professor of Radiology, Abdominal Imaging Section Chief, and Vice Chair of Clinical Service - said that the equipment would be used to explore new applications of MR-guided focused ultrasound such as treatments for painful bone metastases and prostate cancer. "We're looking to push the envelope and do what we can to advance this exciting field," he said.
Since installing an ExAblate 2100 system in May 2010, Alessandro Napoli, M.D., Ph.D.and his colleagues at Sapienza University of Rome have wasted no time in making their mark on the field of MR-guided focused ultrasound.
InSightec, a leading producer of MR-guided focused ultrasound equipment, has posted a special report summarizing the FUS Foundation's highly successful 2nd International Symposium. InSightec was among the corporate sponsors that supported the symposium, which was held October 17-20, 2010 in Chantilly, Virginia, USA.
Click here to download the summary.
The Foundation’s Focused Ultrasound-mediated Targeted Drug Delivery Program (FUS-TDD) has announced the formation of a Core Stakeholders Group that includes many of today’s leading researchers and experts:
CE Mark certification expanded to include adenomyosis
Until late last month, women suffering from adenomyosis – a benign gynecologic condition that causes heavy menstrual bleeding, pain and diffuse uterine enlargement – had two treatment options: have a hysterectomy and lose the ability to conceive; or, take medication for temporary symptom relief.
The Foundation congratulates Toronto-based Profound Medical, Inc., winner of the prestigious, 2010 Ontario Premier’s Catalyst Award for “Start-up Company with the Best Innovation.” The Ontario government will also invest C$ 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.
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.
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
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
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.
The Advanced Medical Technology Association (AdvaMed) recently issued the following call-to-action: Thank Congress for repealing the medical device excise tax. It would be a powerful message if all two million medtech employees in the US reached out to Congress to thank them.
The United States Small Business Administration (SBA) offers programs that may be of interest to US-based focused ultrasound companies. Working directly with state governors, the SBA is providing targeted, low-interest loans to small businesses and non-profits in states that have been severely impacted by the 2019 Novel Coronavirus (COVID-19).
SonALAsense was recently named as one of 15 winners in a pool of 124 applicants in the Center for Advancing Innovation’s “Brain Race,” an open innovation contest to advance high-impact inventions and solutions to defeat brain tumors.
The 14th annual meeting of the European Association of Neuro-Oncology (EANO) was held in Lyon, France, September 19-22, 2019. More than 800 participants from over 50 countries convened with the goal to improve the treatment of patients with various neurological malignancies.
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