Enhanced MR-guided focused ultrasound guidelines demonstrate improved efficacy and durability

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GE and InSightec, a company that develops non-invasive therapy systems, developed the world's first magnetic resonance (MR) image guided focused ultrasound system. InSightec's ExAblate 2000 system, approved by the Food and Drug Administration (FDA) in October 2004, works exclusively in combination with GE's Signa MR system to non-invasively treat symptomatic uterine fibroids.

"These findings further underscore the utility of MRgFUS as a long-lasting, non-invasive option for the millions of women suffering from uterine fibroids," said Dr. Gee. "With these expanded treatment guidelines, we are able to successfully treat more of the tumor and virtually eliminate the need for future hysterectomies." Additional data presented at ACOG this week by David Lee, Ph.D., Senior Director, Health Economics and Outcomes Research, GE Healthcare, showed that clinically significant uterine fibroids are common among women in their prime working years and are associated with several debilitating co-morbid conditions. The research also showed that uterine fibroid treatments impose substantial direct and indirect costs on employers, and that nearly one in three women treated surgically for uterine fibroids experiences an adverse event.

"These new data suggest that uterine fibroids impose a substantial clinical burden on women, and a tremendous economic burden on employers. MRgFUS holds the promise of lessening this burden by offering women a non-invasive treatment option for this debilitating condition," said Dr. Lee.

UTERINE FIBROIDS - A NON-INVASIVE TREATMENT WITH DURABLE RESULTS

According to NIH, uterine fibroids are the most common, non-cancerous tumors in women of childbearing age and the second most common reason reproductive women undergo surgery. Uterine fibroids, the cause of more than 200,000 hysterectomies every year, have no known cause and only a few treatment options, also according to NIH.

According to a report by RAND Corporation, an international non-profit research organization, direct costs associated with treating uterine fibroids are more than $1 billion annually. Traditionally, treatment options for uterine fibroids have included invasive and minimally invasive procedures such as hysterectomy, myomectomy or uterine artery embolization (UAE). Hormonal therapy, the only non-invasive treatment available, offers only temporary relief of symptoms, and fibroids frequently grow back once therapy is terminated.

Summary of Data

*Dr. Gee's Poster: "Enhanced MR guided Focused Ultrasound Surgery (MRgFUS) Guidelines Demonstrates Improved Efficacy and Durability for the Treatment of Uterine Myoma"

* Patients treated under expanded and commercial treatment guidelines achieved greater nonperfused myoma volumes and greater symptom relief than those treated under the pivotal study guidelines. The symptom severity score (SSS) was used to quantify the results.

o 86% of patients treated with commercial treatment guidelines sustained a 10-point or greater improvement in SSS by 12 months compared with 84% of patients treated with expanded treatment guidelines and 71% of patients treated with pivotal guidelines.

o Expanded and commercial treatment guidelines resulted in greater reduction in symptom severity score at three, six, 12 and 24 months. Durable and sustained symptom relief lasted up to 36 months.

Dr. Lee's posters: "Incidence, Prevalence, and Treatment of Uterine Fibroids in Insured Women", "Surgical Treatment for Uterine Fibroids: Adverse Events and One-Year Re-Treatment Rates", and "What Does Surgical Treatment for Uterine Fibroids Really Cost?"

* 1 in 100 (~450,000) women with employer-provided insurance have clinically significant uterine fibroids
o These women have a high comorbidity burden
o Nearly one-half were treated with hysterectomy

* Nearly one in three women treated surgically for uterine fibroids had an adverse event
o Approximately 7% of women treated surgically for uterine fibroids were re-treated within a year. Treatment failures were most common for endometrial ablation.

* Total (direct and indirect) short-term treatment costs were highest for hysterectomy ($17,373), followed by myomectomy, ($16,460), UAE ($14,064), and endometrial ablation ($6,825)
o Lost work and disability accounted for 18.0% of total costs for UAE, compared to 28.7% for endometrial ablation, 40.5% for hysterectomy, and 42.1% for myomectomy

GE Healthcare