Hyperthermia (also called thermal therapy or thermotherapy) is a type of cancer treatment in which body tissue is exposed to high temperatures (up to 113°F). Research has shown that high temperatures can damage and kill cancer cells, usually with minimal injury to normal tissues. By killing cancer cells and damaging proteins and structures within cells, hyperthermia may shrink tumors.
The BSD-2000 is especially useful for cervical cancer patients that are unable to withstand chemotherapy, or are ineligible for other reasons. They can be treated with radiation and heat alone. The BSD-2000 allows the physician to apply local heating to a solid tumor using a radio frequency, somewhat like a microwave principal.
The purpose of the HDE is to allow these small number of patients use of the device before as quickly as possible. HDE's are granted where the disease affects fewer than 4000 people per year.
According to Harold Wolcott, CEO of BSD Medical, "We are excited to reach this significant milestone in BSD's history and obtain marketing approval for the BSD-2000 Hyperthermia System.
This HDE approval provides physicians a new clinical tool for cervical cancer patients who are candidates for radiation therapy but ineligible for chemotherapy, a patient group that has few, if any, therapeutic options. The HDE approval provides a new marketing opportunity for BSD."
Estimates show more than 12,000 women in the US alone, diagnosed with cervical cancer in 2010, with around a third of that number dying of the disease. Nearly one and a half billion dollars a year are spent on cervical cancer research, which is the fifth most common cancer in women worldwide and remains one of the leading causes of cancer death in developing countries.
Research suggests that developing countries could face a 75% increase in cervical cancer cases over the next twenty years, as their populations have increasing numbers of elderly people.
The BSD-2000 is a highly dynamic delivery device that allows the energy to be focused and targeted according to shape, size and position of the tumor. Adjusting the frequency, phase, and amplitude of the radiowaves, combined with different applicators and adjusting the patients positioning, allows a doctor to optimize the delivery of energy into the tumor.
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy delivered using focused radiofrequency (RF) and microwave energy. BSD's product lines include both hyperthermia and ablation treatment systems. Their devices have been use in the United States for several years and are used to treat certain cancers. They also have a microwave device used to ablate and destroy soft tissue.
