References in periodicals archive
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The BioLogic-HT System with its special sorbent suspension system for delivering extracorporeal whole-body hyperthermia is the only system that has received Food and Drug Administration (FDA) approval under two separate Investigational Device Exemptions (IDEs) for studies on HIV and cancer and offers several advantages over existing methods of perfusion, minimizing the physiological and biological changes associated with extracorporeal heating of the blood.
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.
These add-on modules are the BioLogic-PF System, which is designed to remove intermediate and protein-bound toxins; the BioLogic-PFC System, which is designed to provide the synthetic function of the liver utilizing a bioreactor filled with porcine hepatocytes; and the BioLogic-HT System, which is designed to simultaneously balance blood chemistries while achieving a controlled elevation of blood temperature.
Cancer is the second indication for which the FDA has given approval to conduct studies utilizing the BioLogic-HT System.
of Pittsburgh, in the clinical trials of HemoCleanse's BioLogic-HT system in the whole body hyperthermia treatment (WBHT) of AIDS patients.
Previous FDA-approved studies on WBHT have yielded very encouraging results in the ability of the BioLogic-HT System to maintain the safety of the patient during the procedure and in the effects of the WBHT on the HIV virus.
In this expanded Phase II clinical trial, IDT plans to further substantiate the safety of the BioLogic-HT System and the efficacy of the WBHT.
Nasdaq: BICO), announced today that it has received its first order for the BioLogic-HT System which is used for hyperthermia treatment of patients who have AIDS.
IDT also reported that the BioLogic-HT System, used in the procedure and crucial to the safety of the patient, functioned above expectation to monitor and regulate the body chemistries.
Biocontrol develops and manufactures biomedical and environmental products while IDT develops the hyperthermia treatment procedure and will market worldwide the BioLogic-HT System and related disposables used in that treatment.
Both studies involve the use of the BioLogic-HT System, manufactured by HemoCleanse, which significantly increases the safety of the procedure.
The BioLogic-HT System is designed to induce a high artificial fever, while controlling critical blood chemistries, thereby diminishing the risks to the patient.
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