Revolutionary GE MR Guided Focused Ultrasound Treatment Facility Opens at Jaslok Hospital, Offers India's first non-surgical treatment for uterine fibroids

MUMBAI, July 8, 2010: A new facility offering Indian women a major breakthrough treatment for uterine fibroids, a common gynaecological condition, is opening at Jaslok Hospital, Mumbai. The revolutionary new technology - GE Magnetic Resonance-guided Focused Ultrasound surgery (MRgFUS) treats uterine fibroids in women by using high intensity ultrasound waves to non-invasively destroy benign tumours of the uterus. Uterine fibroids affect large numbers of women, causing a variety of symptoms such as pelvic pain, incontinence and swelling of the abdomen. The most common treatment for fibroids is hysterectomy, a surgical procedure that involves a stay in hospital and up to six weeks of recovery time. MRgFUS which destroys fibroids without causing damage to surrounding tissues and could be used as a common alternative to removal of a uterus or hysterectomy. The treatment, which is carried out as an outpatient procedure has a short recovery time than hysterectomy and can help women to return much more quickly to normal daily activities.

The MRgFUS technology - the ExAblate® 2000, developed by Insightec Inc is the only US Food and Drug Administration (FDA) approved system for treatment of uterine fibroids and works exclusively with GE 1.5T and 3.0T Magnetic Resonance Imaging (MRI) systems. The technology is also CE approved for pain palliation treatment for bone metastases and clinical trials are under way to determine if the technology could be an alternative treatment for a number of cancers including breast, brain, liver cancer, and prostate. Business Week lists MRgFUS as "One of the 25 ideas for a changing world.

Col Manesh Masand, CEO of Jaslok Hospital and Research Centre said "Jaslok Hospital and Research came into force this day, 37 years back. We have been at the forefront of medical and technology advances since then. On the eve of our 37th anniversary, we are pleased to take India to the non-invasive surgery era with the First MR Guided Focused Ultrasound system in India and South Asia. With this, patients, especially women in India, neighboring countries, Middle-East and African countries can look forward to surgery without cutting the body or losing a drop of blood".

The ExAblate® 2000 system uses the breakthrough MRgFUS technology that combines MRI to visualize tissues in the body, plan the treatment and monitor, in real time, treatment outcome and high intensity focused ultrasound to heat or thermally ablate diseased tissue. MR thermal feedback, provided uniquely by the system, allows the physician to control and adjust the treatment in real time to ensure that the targeted tumor is fully treated without damaging the surrounding tissue.

"We are proud to be the first hospital in the world to introduce MR Guided Focused Ultrasound technology with complete available treatment capabilities such as treatment modules for uterine fibroids, bone metastases, breast, prostate and other cancers. said Dr Shrinivas Desai, Director, Imaging and Interventional Radiology, Jaslok Hospital, Mumbai. "This revolutionary technology can cut tumors and fibroids without cutting the body! It is the best thing that has happened to medicine since the scalpel. In this case, we are saving the patient from the difficulties associated with cutting the body, without losing a drop of blood, hospitalization and related costs. I believe this is just the first step and with more developments coming our way, I am sure we will usher in a non-surgical era of cancer treatment and other targeted therapies. I am fortunate to be part of this giant leap"

Dr Desai added: "We are proud to be part of expanding the usage of this miracle technology for usage in conditions like breast, liver and prostate cancers, etc. through research programs at Jaslok Hospital. While we advance the technology use, we will be able to help a number of those needy, poor patients with free treatment" said Dr Shrinivas Desai.

Fibroid cases on the rise

Globally, uterine leiomyomas (fibroids) affect approximately 25% of women of reproductive age (1). The association between fibroids and infertility has been documented when there is distortion of the endometrial cavity (2–5).

Uterine fibroids are the most common benign tumor found in women and a number of studies show that they affect an estimated 25-30% of Indian women. Experts and gynecologists believe this is a conservative estimate as a large number of them remain un-diagnosed. . Uterine fibroids are rare in women under the age of 20 and most common in women during the reproductive age groups. The symptoms of fibroids can become a major health problem for women making even routine tasks at the workplace and home very difficult. There have also been instances where formation of fibroids has hampered the proper formation and growth of a fetus in the womb. Upto 50% of women with uterine fibroids show no symptoms. However, if they do, it can involve heavy menstrual flow or period for a longer duration than normal, increased menstrual cramping, back ache, irregular or unpredictable bleeding, lower abdominal pressure, constipation, abdominal bloating, infertility and miscarriage. Fibroids are primary reason for surgical removal of uterus, accounting for 30-70% of all hysterectomies performed in India. Hysterectomy is a highly invasive procedure which can entail long hospital stay and longer recovery times.

For women who aren't comfortable with the removal of their re-productive organs, the extended recovery time, or simply do not want to undergo surgery, and would like to preserve fertility, MRgFUS can be a great solution. Patients treated with MRgFUS miss on average a total of 1.4 work days compared to an average of 18 days for hysterectomy patients.

Other women's health issues, such as breast cancer, are fast becoming acceptable topics of conversation. Uterine fibroids, however are just not discussed among women despite the fact that it is very common. More than 70% of women between age 25 and 52 are diagnosed with them at some point.

Today, patient options for uterine fibroids are based on the clinician's knowledge of existing treatments, and many are unaware of it as an available option.

Imagine taking the core of an apple, without cutting it open

MRgFUS uses high-intensity ultrasound beams to heat and destroy the fibroid tissue. MRI provides critical data such as high-resolution 3D imaging of the tumor and internal organs, and real-time temperature feedback that indicates the degree of tissue heating and coagulations.

MRgFUS provides a completely non-invasive and effective treatment for fibroids. MRgFUS can be performed as an outpatient procedure and does not require anesthesia. Normally the recovery period for invasive surgery is upto 6 weeks but with this breakthrough technology the treatment is almost immediate and symptom relief is generally felt quickly. The treatment is associated with minimal risks and complications, requires no overnight hospital stay and allows most patients to return to work and their normal activities in one to two days. A session lasts up to three hours. The cost of treatment can range from Rs. 60000/- to 100,000/-

"I was diagnosed with large uterine fibroids five years ago and surgery was not an option for me as I wanted to preserve my uterus. said Sandhya Dhure, one of the first women in India to undergo MRgFUS treatment at Jaslok Hospital. "I took medication for five long years till I came across this new, non-surgical option at Jaslok Hospital. It took just 2 hours for my treatment, no cuts, no scars, no pain, no anesthesia and I have even joined my duty immediately after the procedure! It is a month since the procedure, and I can see the results already - no excessive bleeding or pain and my stomach bloating is gone"

For doctors MRgFUS offers many clinical advantages. MR is the only imaging modality that allows temperature changes in the body to be monitored (MR Thermometry) MR images allow the physician to see the difference between treated and non-treated tissue, without ionizing radiation; MR images enable the physician to obtain a three dimensional image of the target and MR anatomical and thermal images are updated in real time throughout the treatment.

"It is like a magical tool". said Dr Irena Dey, a Gynecologist practicing in Hyderabad. "This is a treatment that has minimum risk with maximum gain. I am only 32 years old and I was diagnosed with adenoma in uterus. Since I wanted to have babies in the future, surgical removal of uterus was not an option I considered at all. I went through my first session of treatment and a second session in the next couple of months, since it was a very large one. It is keeping alive my hope of having babies in the future. I was back on my feet immediately and resumed my gynecology practice next day".

Commenting on the breakthrough technology, Dr Reshma Pai, Consulting Gynecologist, Jaslok Hospital said "Clinical evidence suggests that women have been able to conceive and successfully deliver children after undergoing MRgFUS treatment for their uterine fibroids. No treatment-related adverse events were reported. Women should discuss this option with their physicians and weigh the risks and benefits against other procedures." said Dr Reshma Pai, Consulting Gynecologist at Jaslok Hospital.

A GE Healthymagination Certified Technology:
GE's healthymagination represents the company's commitment to deliver product and services that allow physicians to deliver better care to more people at a lower cost. Announced in early 2009, healthymagination has been launched to address an industry challenged by rising costs, inequality of access and persistent quality issues. The aim of the initiative is to innovate smarter processes and technologies that help physicians and hospitals throughout the world provide a higher level of healthcare to more people – and save costs in the process. While all GE Healthcare products and services are in the spirit of healthymagination, only those products that pass a rigorous third-party assessment will carry the title of healthymagination verified.

"When we launched healthymagination one year ago, our vision was to provide better health for more people at lower cost through powerful technology, innovation and the talent of our people." said V Raja, President and CEO, GE Healthcare South Asia. We are tremendously proud of our initial achievements. To date, we have validated 24 healthymagination products, many of them from designed and developed in India to reduce costs, increase healthcare access and quality.

Healthymagination is a catalyst for change, an incubator for developing new ways to deliver healthcare. Today, we are proud to bring one of our top healthymagination certified products to India - MRgFUS offering breakthrough treatment for uterine fibroids that could reduce number of hysterectomies and surgeries for other tumors. With this, we are empowering consumers with a better and non-invasive option of treatment and heralding a new generation of diagnostic and treatment for patients".

Future of MRgFUS:

High-intensity, focused ultrasound waves are gaining more and more in popularity in modern medicine as a non-invasive form of treatment. GE Healthcare and Insightec Inc are currently conducting research to determine if MRgFUS could allow breast, brain and liver tumors to be removed without any blood being shed. Jaslok Hospital will be part of this global research effort and will conduct research and clinical trials for breast, liver and bone cancer.

"It is very exciting, anything we can see with MRI, can now be treated too. MRgFUS as a technology is shifting from a visualization to a treatment tool." said Dr Shrinivas Desai.

ABOUT GE HEALTHCARE:

GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Our broad expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, biopharmaceutical manufacturing technologies, performance improvement and performance solutions services help our customers to deliver better care to more people around the world at a lower cost. In addition, we partner with healthcare leaders, striving to leverage the global policy change necessary to implement a successful shift to sustainable healthcare systems.

Our "healthymagination" vision for the future invites the world to join us on our journey as we continuously develop innovations focused on reducing costs, increasing access and improving quality and efficiency around the world. Headquartered in the United Kingdom, GE Healthcare is a $16 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. For more information about GE Healthcare, visit our website at www.gehealthcare.com. For our latest news, please visit http://newsroom.gehealthcare.com

About ExAblate® 2000
ExAblate® 2000 received FDA approval for the treatment of symptomatic uterine fibroids in October 2004. ExAblate® 2000 has been recognized for its innovation and potential to serve mankind and has been awarded the 2004 European Union's Information Society Technologies Grand Prize, The Wall Street Journal's 2004 Technology Innovation Awards, Advanced Imaging's 2005 Solutions of the Year, and most recently, the Red Herring 100 Europe 2007 Award.

About InSightec

InSightec Ltd. is a privately-held company owned by Elbit Imaging, General Electric, MediTech Advisors, LLC and employees. It was founded in 1999 to develop the breakthrough MR guided Focused Ultrasound technology and transform it into the next generation operating room. Headquartered near Haifa, Israel, the company has over 160 employees and has invested more than $130 million in research, development, and clinical investigations. Its U.S. headquarters are located in Dallas, Texas. For more information, please go to: http://www.insightec.com/