Los Alamos National Laboratory

Gary Kliewer, (505) 665-2085 / [email protected]
Gene Hedin, Thermosurgery Technologies, (602) 780-9089

LOS ALAMOS TECHNOLOGY USED TO TREAT SKIN DISEASES

LOS ALAMOS, N.M., July 16, 1997 -- An electronic instrument that will help physicians treat a range of disfiguring skin diseases soon will be available world-wide. The instrument can be used to treat numerous benign skin conditions and certain tumors. And it offers a long-awaited cure for 12 million people in 88 countries who suffer from an endemic tropical disease that causes persistent skin lesions.

The device, carried down the long road from lab bench to doctor's office by a small Arizona company called Thermosurgery Technologies Inc, is based on technology developed decades ago by Los Alamos National Laboratory.

"I am pleased to see technology we transferred so long ago now doing wonderful things we did not even imagine," said Los Alamos engineer James Doss.

The radio frequency device delivers precisely controlled, localized heat to a small area of tissue. Malignant cells are typically more sensitive to slightly elevated temperatures. Application of heat close to the range of a very high fever destroys malignant cells, but allows healthy surrounding cells to regenerate. The technology provides an effective way to apply heat only to diseased tissues and precisely control the temperature in the treated areas.

Los Alamos researchers patented a technique for radio frequency heating of tumor tissue in 1977. Doss created computer software that modeled electric and thermal fields in tissue. With his colleagues Bill McCabe, Tom Boyd and Joe Albillar, Doss designed electrodes to deliver the radio frequency current. The team collaborated with several veterinary and medical schools for research on applications of the localized current fields for general cancer therapy. In the process, they treated tumors in a variety of animals, including cats, dogs and even a zoo elephant.

The animal research led to the first commercial application of the Los Alamos technology in the late 1970s -- a veterinary treatment of tumors of the eye and eyelid in cattle. Cancer-eye is a common disease of cattle, especially the Hereford breed, that sharply reduces the commercial value of the animals. A battery-operated field unit with dual electrodes became a viable tool for veterinarians and ranchers.

One entrepreneur who manufactured the device for cancer-eye treatment was Gene Hedin. But Hedin recognized the broader potential of the technology. Now, after 15 years of clinical trials, venture capital appeals, collaborations with Los Alamos and product development, Hedin's company, Thermosurgery Technologies Inc., is introducing the refined technology to the medical market.

The ThermoTech instrument directs a radio frequency current to a dual- electrode tip. A physician places the electrodes in contact with the tissue. Due to resistance to current flow, the tissue between the probes is heated. The technology does not simply transfer heat from the instrument, but generates heat within the tissue itself.

The effective temperature for treatment, called hyperthermia, does not burn the tissue. Treatment is effective at about 111 degrees Fahrenheit (44 degrees Celsius).

One of the electrodes contains a thermocouple device that continuously monitors the temperature of the treatment site and controls the electrical circuitry that generates the radio frequency field. Many conditions can be treated with a single application of 30 to 60 seconds. Compared to traditional treatments, skin heals rapidly, with reduced recurrence and diminished side effects and scarring.

Hedin financed a research contract with Los Alamos for technical assistance. Doss provided ThermoTech with computer models to estimate the distribution of temperatures in tissues under treatment. And the Los Alamos team also designed electrodes for specific applications.

"The development of our product would not have been possible without the support and help of Doss and his team and our contract with Los Alamos," Hedin said.

ThermoTech will initially market one instrument model with eight exchangeable tips for treating various skin conditions. According to the company, the FDA has issued market release approvals for treatment of 16 benign diseases. Hedin said patients will begin seeing the device in doctors' offices within the year.

But the most potent impact of the ThermoTech instrument on world health at this time will be the easy and effective treatment of a tropical skin disease called cutaneous leishmaniasis.

Leishmaniasis is caused by a microscopic protozoan parasite transmitted by the bite of a small blood-feeding sand fly. Untreated leishmanial skin lesions, from small papules to large disfiguring ulcers, last nine months or more, with some lesions persisting for years.

Major outbreaks of leishmaniasis occur in Africa, the Arab countries, India, Mexico and Central and South America. Based on estimates by experts in tropical diseases, more than 12 million people suffer from the disease. Antibiotics generally prescribed against bacterial infections are useless against leishmaniasis. Drugs currently used to combat the disease are toxic, slow acting, expensive and often not available in many countries.

Now, however, doctors treating leishmaniasis victims with the localized current field instrument in southern Mexico report a 95 percent cure-rate, despite the rugged field conditions. A few instruments are also in use in Peru.

According to Bryce Walton, parasitic disease specialist and former secretary of the steering committee on leishmaniasis for the World Health Organization, the Pan American Health Organization -- regional office of WHO for the Americas -- has adopted the device as the treatment of choice for leishmaniasis.

"I spent years looking for an alternate treatment for cutaneous leishmaniasis -- and this is it," said Walton.

The localized current field technology born at Los Alamos is seen as an attractive alternative treatment for many skin diseases traditionally requiring laser or conventional surgery, freezing, radiation therapy or drugs. The commercial product is compact, portable, and rugged.

Los Alamos National Laboratory is operated by the University of California for the U.S. Department of Energy.

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