The desire to be thinner and more shapely can carry a heavy price tag: About $4 billion was spent in the United States in 2001 on liposuction surgical procedures. The price tag can sometimes be more than just financial. There are potential costs to one's health: Invasive surgery can pose several dangers. If the invention jointly created by Dr. Ami Glicksman, a plastic surgeon at Sheba Medical Center, Tel Hashomer, and Dr. Yoram Eshel, a physicist specializing in the use of high-power ultrasound to destroy blood clots without the need for invasive surgery, successfully passes the stage of experimentation on humans, the device developed by UltraShape could become an alternative to liposuction.
Glicksman, the company's founder and president says: "We decided to invent a machine that would melt down subcutaneous fat of any density and in a completely non-invasive manner. We aimed for a simple procedure that would be uncomplicated and painless and which would not involve the use of medications. We wanted a procedure where the only pain would be to the patient's wallet."
The system developed at the Atidim Industrial Park has been successfully tried out on pigs. Clinical trials on humans are scheduled for early August. If everything works out according to plan, UltraShape will begin marketing its product within a year and half, initially in Europe and later in the U.S.
The main concept behind the UltraShape device is the use of ultrasonic waves operating at a frequency of more than 20 kilohertz to destroy the membrane of fat cells. The procedure involves the employment of an integrated transducer that is applied directly to the area where the fat is to be melted and which is capable of diminishing up to 500 cubic centimeters of fat in one treatment session. The fat reduction is selective and is uniform in the designated area. The treatment lasts between 30 and 45 minutes and can target two to three areas in the body. Following the treatment, the patient must wait one month until the next treatment. The destroyed fat cells flow into the body's intercell cavity and, within 10 days, are eliminated from the body through its lymphatic and immune systems.
"We are using the same technique that, up until now, has been employed for viewing a human fetus in its mother's womb, for the identification of tumors and various problems in the abdominal cavity, and for the conducting of tests targeted on the patient's blood vessels," explains Eshel.
"The only difference is that the intensity we use is far greater than the level of power employed in imaging. The effect created in our treatment procedure is mechanical and thus there is no heating-up of human tissue. Furthermore, the process is selective and destroys only the skin of fat cells. The nerves and connecting tissues remain perfectly intact after the treatment procedure."
"Unlike dieting, which reduces fat in various parts of the body, we are offering a focused form of body shaping and sculpting," Glicksman points out. "Today, the only procedure for body sculpting is liposuction, which involves the use of a vacuum pump to draw fat out of the human body. This procedure requires total anesthesia, which, of course, poses certain potential dangers."
The UltraShape device enables the provision of imaging data on the state of the tissues before the initiation of the treatment. This data prevents the release of energy if the physician has not precisely targeted the device at the designated fat cells. A special software program enables the smooth continuation of the device's operation even if the patient moves, breathes or coughs. The system "remembers" the exact spot that has been selected and the destruction of the fat cells continues after the interruption, according to the procedure determined beforehand.
The developers of the UltraShape device believe that both the patient and the administrator of the UltraShape procedure will be motivated to use this non-invasive technique. The administrators will be particularly interested in reducing the costs involved in the utilization of operating rooms. UltraShape's technology and its prototype aroused considerable interest at the recent annual convention of the American Society for Aesthetic Plastic Surgery (ASAPS) that was held in May in Las Vegas. The organization's president, Dr. Franklin L. DiSpaltro, was very impressed by the UltraShape device and, in a letter to the company, requested further information so that he could include it in his lectures on developments in his field.
UltraShape, founded in 2000 and registered in Delaware with its R&D department headquartered in Israel, today has a staff of 13. The company has so far developed and manufactured the key components of its system. Some $2 million have already been invested in the system. Of this sum, $500,000 was invested as seed money, while the remaining $1.5 million was invested in January 2001. Glicksman and Eshel each own about 25 percent of the company's shares. The remaining portion of the shares are owned by private investors (about 35 percent) and the company's employees (about 15 percent).
The company looks forward to mobilizing additional funds - between $1 to $5 million - by the end of 2002. The price of each system is expected to be somewhere in the neighborhood of $120,000. UltraShape's owners estimate that, by the end of 2004, the scope of their device's use will reach the level of 350,000 procedures a year.
UltraShape, notes Glicksman, intends to conduct comprehensive tests on human subjects in Eastern Europe in August 2002 as part of the procedure needed for obtaining the European CE Standard. The next stage will be an application for approval from the Federal Drug Administration in the U.S.
Glicksman explains: "We opted for the European track as our first step because it is faster. If everything goes well, we will be able to have our first machines on the market within a year and a half."