According to the American Cancer Society 220,000 men and women in the U.S. develop lung and bronchial cancer every year and 147,000 die of the disease. Of lung cancer patients, 85% present with non-small-cell lung cancer and 16.7% of these will present with localized disease. Note that lung cancer is very difficult to treat. The five year survival for localized disease is 52%, the five year survival for more advanced disease is less than 24%. At present, brachytherapy devices used for lung cancer treatment consist of metal I-125 or Cs-131 seeds, originally designed for prostate cancer, sewn to a bio-absorbable vicryl mesh. The device is not optimal for treating lung cancer. The device emits radiation in all directions and delivers radiation to otherwise healthy tissue. It is cumbersome to handle and difficult to shape to the patient?s anatomy. Lung tumors are often located near critical structures sensitive to radiation exposure. Approximately 20% of patients who otherwise could be treated with lung brachytherapy are either not treated or prescribed alternative treatments due to the risk of radiation exposure to the arteries, nerves, the heart, the chest wall, the skin, and in female patients, the breasts. Those patients who are treated with the existing device are exposed to unnecessary radiation dose. CivaTech developed, with partial support from a Phase I SBIR contract from the National Cancer Institute, a prototype brachytherapy device specifically designed for lung cancer treatment that directions radiation therapy to diseased tissue only. This device, called the CivaSheet, is planar, uni-directional and partially bio-absorbable. CivaTech is seeking Phase II support to develop the prototype into a clinic ready device.
