HemoCleanse announces FDA approval for cancer study and preliminary results of HIV clinical trial.WEST LAFAYETTE, Ind.--(BW HealthWire)--Feb. 10, 1997-- HemoCleanse Inc., in conjunction with IDT Inc., announced that its BioLogic-HT System(TM) has been approved by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for use in a feasibility study "A Feasibility Study" is an episode of the original The Outer Limits television show. It first aired on 13 April, 1964, during the first season. It was remade in 1997 as part of the revived The Outer Limits series with a minor title change. under an IDE for extracorporeal whole-body hyperthermia (WBH) treatment of metastatic non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. . WBH involves elevating body temperature to control or destroy viruses and other heat sensitive organisms. The study, to be conducted at the University of Texas Medical Branch "UTMB" redirects here. For other system schools, see University of Texas System. The University of Texas Medical Branch (UTMB) is a component of the University of Texas System located in Galveston, Texas, about 50 miles (80 km) southeast of downtown Houston. at Galveston, is the first of its kind approved by the FDA. Non-small cell lung cancer is a major cause of cancer deaths in the United States. Current therapies including radiation therapy, chemotherapy, and surgery are only partially successful in the treatment of cancer and extending survival rates beyond about fifteen months. The companies also announced that the BioLogic-HT System is currently being used in FDA approved studies of whole-body hyperthermia in the treatment of HIV. Preliminary results of these studies suggest WBH, in patients in whom multi-drug therapies have been ineffective, may be helpful in extending the therapeutic effectiveness of drug therapies. HemoCleanse designs and manufactures the BioLogic-HT System which consists of the BioLogic-HT, the BioLogic-HTA(TM) and a single use disposable kit. Use of the system has made whole-body hyperthermia safe as the body's chemistries are balanced on a real-time basis. IDT Inc., a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Biocontrol Technology Inc. of Pittsburgh, has sponsored the hyperthermia hyperthermia /hy·per·ther·mia/ (-ther´me-ah) hyperpyrexia; greatly increased body temperature.hyperther´malhyperther´mic malignant hyperthermia treatment trials and holds exclusive worldwide marketing rights to the BioLogic-HT System and related disposables. HemoCleanse Inc., located in West Lafayette, develops and markets products that treat blood outside the body to remove toxins and balance blood chemistries. The BioLogic-DT(R) System is in use in liver transplant centers worldwide for the treatment of acute hepatic coma. Clinical trials are underway or planned for the company's other devices for the treatment of sepsis, cancers, HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome and autoimmune disorders. CONTACT: HemoCleanse Inc., West Lafayette Robert B. Truitt or Thomas J. Frosheiser, 800/264-4366 |
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