Christopher Busch, PhD, General Manager of Philips Radiation Oncology Solutions & MR Therapy, met with the Foundation in August to review their current focused ultrasound program, vision for the future, and some of the challenges and opportunities for an established global company in this emerging field. Busch explains that they are shifting their focus from technical development to evidence building and commercial success for a sustainable value proposition for focused ultrasound.
“We continue to support the commercialization of our Sonalleve systems for bone and fibroids,” says Busch. “When it comes to expanding to new applications, our preferred approach is to partner with organizations that have compelling proprietary technology and expertise within their segment and offer them an opportunity to accelerate required technology and clinical developments and to leverage our penetration in imaging suites around the world.”
“Philips plays an important role in the focused ultrasound ecosystem, and we are thrilled that they have the resources and the reach to partner with other companies to help pave the way for the success of other players in the field,” said Foundation Chairman Neal F. Kassell, MD.
Partnerships for Prostate Cancer
As part of this strategy, in July Philips and Profound Medical announced a joint development agreement to support Profound’s transurethral ultrasound ablation technology to treat patients with prostate cancer on Philips MRI systems. “This partnership will enable our customers to have access to a novel MR-guided focused ultrasound ablation therapy that has the potential to improve outcomes for prostate cancer with lower rates of side effects and high quality of life,” he adds.
This prostate collaboration is not exclusive, and through their company Invivo, Philips is supporting SonaCare to enhance their ultrasound-guided Sonablate prostate treatment system with fusion of preoperatively acquired MR data sets to the real time US images.
Building the Case for Fibroids Success
Philips continues to support their Sonalleve system for treating uterine fibroids. There have been some challenges with obtaining reimbursement, but progress is being made. “One thing that has hampered usage has been that the right patients were not being treated. Through the experience of our sites, we now better understand the profile of the fibroid patient that will have the optimal benefit of focused ultrasound treatment,” says Busch. “Armed with this information, some of our key sites are becoming more successful and are starting to gain reimbursement.” With treatment reimbursed in South Korea, the site in Busan is now treating four patients per week. In Germany, a number of hospitals have local arrangements with insurance companies and there are some encouraging signs towards a structural reimbursement also for outpatient treatments. The Marienhospital, in Stuttgart, Germany, has significantly increased the number of fibroid patients they serve by offering focused ultrasound as a non-invasive option within a comprehensive treatment portfolio, supported by the Philips sponsored patient website, fibroid-care.com.
In the US, they have had encouraging discussions with the FDA to modify their pivotal trial for fibroids, broadening the study criteria to speed recruitment and enable completion of the study. Philips is collaborating with Insightec and the Foundation to conduct RELIEF, a global comparative study of women treated with focused ultrasound and myomectomy for uterine fibroids, designed to generate evidence to facilitate widespread reimbursement.
Entering Chinese Market for Fibroids
Philips is making regulatory progress in new markets as well. The company will soon submit for approval to treat uterine fibroids with Sonalleve in China. Given a review timeline between 9-18 months, the approval could happen any time from the first half of 2016 through 2017. “The main benefit I see to entering the Chinese market is that there is HIFU competition and experience,” Busch remarks. “Physicians and patients are already aware of focused ultrasound as an established method to treat fibroids. There are some real shortcomings to the ultrasound guidance systems that are most prevalent. So we believe that patients may be attracted to MR guidance.”
Expanding Cancer Applications
With oncology as a core business, Philips is supporting focused ultrasound research for a range of cancers. The company already has regulatory approval in Europe to treat pain from bone metastases, and they are starting a pilot study in the US as well. They are supporting research at two sites in Europe using a system designed to treat breast tissue. Research is ongoing in the Netherlands on a system to treat the liver. They also support research on ultrasound-induced hyperthermia as an adjuvant to make cancers more susceptible to radiation and chemotherapy treatment.
Philips Focused Ultrasound Facts in BriefName of focused ultrasound system: Sonalleve MR-HIFU
Years in Development and Origins
Philips entered the field of focused ultrasound in 2005. The first generation system was introduced in Europe in 2010, followed by a second generation system in 2011. The business unit headed by Christopher Busch is headquartered in Helsinki, Finland. The unit currently employs about 120 people who work with customers around the world.
The Sonalleve MR-HIFU focused ultrasound system is designed to work with Philip’s MRI machines at 1.5T and 3.0T field strength: Ingenia, Achieva, and Multiva. Sonalleve’s table slides over Philips’ standard MR tables, making it easy to switch between diagnostic MR and focused ultrasound therapy. It is embedded with integrated imaging coils designed for pelvic and abdominal applications.
Philips also has a proprietary skin cooling technology called DISC (DIrect Skin Cooling) that keeps the patient’s skin at a constant temperature by providing a heat sink that is created by cooled, circulating water between two membranes forming the patient contact. To decrease treatment time, Sonalleve’s software suggests patient-specific cooling times between sonications.
A 3-step workflow procedure uses 3D MRI data sets on the Sonalleve console during the planning stage, applies the ultrasound energy to elevate target volume during the treatment stage, and then switches to contrast-enhanced MRI for the therapy-verification stage.
Number of Sonalleve Sites Worldwide and in the US
There are more than 50 systems installed around the world, with about 40% in the Americas, 40% in Europe and the Middle East, and 20% in Asia. In the US, the business is entirely comprised of research systems (clinical trials or preclinical work).
Key sites include: UMC Utrecht, the Netherlands; Institute for Cancer Research/The Royal Marsden, Sutton, UK; National Institutes of Health, Bethesda, MD; Children’s National Medical Center, Washington DC; Johns Hopkins University, Baltimore, MD; University of Chicago, Chicago, IL; University of Washington, Seattle, WA; University of Texas Southwestern, Dallas, TX; Samsung Medical Center, Seoul, Korea; Cologne University Hospital, Cologne, Germany.
Number of Treatments/Patients Treated Worldwide to Date
About 1,500 patients have been treated with Sonalleve, predominantly women with uterine fibroids.
The Sonalleve system is currently approved for commercial use in Canada (uterine fibroids), Europe (CE mark for bone metastases, uterine fibroids), India (uterine fibroids and bone), and Korea (uterine fibroids) and other jurisdictions accepting one of these approvals.
Several clinical studies are ongoing with the Sonalleve system, including:
- Uterine Fibroids: ongoing, now recruiting in the United States and Canada (SOFIA) and China.
- Bone Metastases: Recruiting in Korea, Netherlands, and the UK for pain palliation and another pain palliation study is also recruiting in the UK.
- Breast Cancer: Recruiting in the Netherlands.
- Pediatric Solid Tumors: Recruiting in the United States.
All studies can be found (including those that are completed) here.
Watch a Video of Philips executive Thomas Andreae talking about the company’s focused ultrasound program
Watch a Slide Presentation on the Philips website that reviews upcoming oncology applications for focused ultrasound
- Company Profile: Philips Healthcare
- Focused Ultrasound Foundation Establishes Pioneering Research Initiative in London Under International Center of Excellence Program