The special focus of this month's newsletter is reimbursement, an important factor in ensuring the widespread adoption of MR-guided focused ultrasound therapies. First up is an interview with German radiologist Matthais Matzko, MD. He has not only created the most successful and busiest FUS center in Europe, but also convinced leading insurers to provide reimbursement for the uterine fibroid treatments he performs.
Next, is an interview with the Foundation's own Susan Klees. As Director of Patient Access, she has become immersed in the reimbursement conversation here in the U.S. In what may come as a surprise, she believes that the research community can play an important role in ensuring the success of the reimbursement process.
Finally, we provide a brief profile of Stephanie Small, the young and extremely gracious uterine fibroid patient who allowed CBS Evening News to tape her procedure last December. Denied coverage by her medical insurer, she downloaded the Reimbursement Resource Toolkit from the Foundation's Fibroid Relief website. Ultimately, Small decided to participate in a clinical trial rather than appeal her insurance company's decision. Now fully recovered, she has become an advocate for patients, especially young women like herself.
We will revisit the topic of reimbursement as the field of MR-guided focused ultrasound evolves. In the meantime, summer is upon us, and we hope your holidays are safe and enjoyable.
German radiologist leads the way in surmounting FUS reimbursement barriers
Matthias Matzko, MDhas emerged as a leading European advocate for MR-guided focused ultrasound. In his native Germany, he has also played a key role in eliminating one of the most challenging barriers to widespread adoption of the promising medical technology: reimbursement.
Head of Interventional and Diagnostic Radiology at the 450-bed Amper Kliniken AG in Dachau, Matzko learned about focused ultrasound in 2008 from a colleague. He admits to becoming "kind of infected" with enthusiasm for the technology after visiting Wladyslaw Gedroyc, MD, at St. Mary's Hospital in London.
From the start, Matzko and his colleagues were convinced that careful patient selection was essential to achieving good results with focused ultrasound. They offered the treatment to only to those who met stringent selection criteria - about 30% of the center's uterine fibroid patients. "When you want to have reimbursement for such a new method, you have to produce good results, and that's why you have to select patients very carefully," he says.
FUS researchers can set the stage for reimbursement
Special interview: Susan Klees, FUSF Director of Patient Access
The scientific community has a critical role to play in gaining optimal insurance reimbursement for MR-guided focused ultrasound. As Susan Klees, Director of Patient Access for the Focused Ultrasound Surgery Foundation, reports, "Evidence is the key driver for reimbursement, and it all begins with the way studies are designed. Research priorities must be grounded in sound science as well as the realities of the marketplace."
Designing studies that address marketplace realities requires an understanding of what is valued by different groups. "We know that physicians are seeking cutting-edge treatment modalities to solve medical challenges, patients want to avoid complex surgery and lengthy recovery times and medical payers expect enhanced outcomes and efficiencies in treatment," she explains.
FUSF is valuable resource for patient featured in CBS Evening News report
Patient profile: Stephanie Small, Pennsylvania, USA
Stephanie Small and her UVA physician, Alan Matsumoto, MD, were panelists at a Fibroid Relief at Last event.
On June 12, 2011, CBS Evening News broadcast Stephanie Small's gripping story. Suffering from a large uterine fibroid, the 27 year-old was convinced that MR-guided focused ultrasound was her best treatment option. She was ready to undergo the procedure at a medical center near home, when her insurance company denied coverage. Rather than back away, she pressed on and ultimately enrolled in a clinical trial at the University of Virginia in Charlottesville.
Small's journey unfolded over many months, from the time she received her diagnosis and was advised to have a myomectomy. Fearful of the risks associated with that treatment, she began searching for other possibilities. Surfing the web for information, she discovered the websites for the FUS Foundation and our patient support organization,Fibroid Relief. What she learned there proved to be invaluable.
Click here to watch CBS Evening News report, "Ultrasound replaces scalpel for some tumor ops."
FUS Foundation hosts "Medicine's Best Kept Secret" event
Foundation Chairman Neal Kassell, MD, chatted with Beatrix Ost (far left) during the "Medicine's Best Kept Secret" event on May 25. Standing nearby (left to right) were Mary Lou Seilheimer and Arlette de Barros. In the background were the Foundation's Brain Program Technical Director John Snell and his wife, Julie.
The FUS Foundation hosted an awareness-building event on May 25 that was attended by 150 friends, neighbors and supporters in the Charlottesville area.
Sponsored by JP Morgan, the evening featured an update presentation by Foundation Chairman Neal Kassell, MD. He discussed exciting recent advances in MR-guided focused ultrasound.
"Right now, evidence generated by medical research is the most important factor in advancing the field of MR-guided focused ultrasound," Kassell said. "That's why the foundation invests most of our funds in research that will lead to new, reimbursable applications."
Regarding development activities, Kassell reported that the foundation has raised a total of $32.5 million since being established in 2006 and that more than $4.5 million in contributions has been committed since January 2011. He said the foundation's goal is to raise $40 million during the next four years.
The event's other speakers included FUS Foundation board member Daniel Jordan, PhD, and Charles Seilheimer, Jr., co-chairman of the Foundation Council, a special advisory group that builds goodwill and increases awareness of the foundation's work.
Clinicians and researchers from the Focused Ultrasound Center of Excellence at the University of Virginia were on hand for informal discussions about recent developments. Neurosurgeon W. Jeffery Elias, MD, fielded questions from guests about the world's first clinical trial evaluating MR-guided focused ultrasound as a treatment for essential tremor. As principal investigator of that foundation-funded trial, Elias has treated four patients so far and plans to treat 11 more in the next several months.
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
Profound Medical Inc. (PMI) has closed 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.
Financing was provided by a syndicate of Canadian investors led by Genesys Capital Partners and the Business Development Bank of Canada. Health Technology Exchange (HTX) provided substantial support through its Business Investment Program.
PMI will use the funds to hire 15 new employees and to initiate human clinical trials in the US, Europe and Canada. As previously reported in this newsletter, two yet-to-be-named hospitals will participate in the company's US clinical trial which is expected to start later this year. A pilot study, it will evaluate the safety of PMI's device, treating as many as 30 patients with early stage prostate cancer.
"Our device is a blend of two of the leading techniques for imaging and treatment," explains the company's CEO Paul Chipperton. "We use MRI as the best imaging modality to see the target organ. We marry that in a unique way with thermal ultrasound which is a well known and well understood treatment modality. Chipperton says the device has the ability to treat patients three to six times faster with greater accuracy and fewer side effects than existing options.
Related information: Click here to view PMI treatment animation. Click here for FUS Foundation print and video interview with Paul Chipperton, PMI CEO.
The special symposium will provide day-long programs dedicated to education, therapy and diagnoses. Scheduled for August 2, the session on therapy is being organized by Christian Diederich, PhD, Director of the Thermal Therapy Research Group at the University of California San Francisco. His collaborator is Stanley Benedict, PhD, Associate Professor and Director of Radiological Physics at the University of Virginia.