510(k) Submitted to FDA on Product to be Marketed By Biocontrol Subsidiary, IDT
PITTSBURGH, July 23 /PRNewswire/ -- Biocontrol Technology, Inc. (Nasdaq:BICO) announced today that a 510(k) Notification has been submitted to the Food and Drug Administration (FDA) by HemoCleanse, Inc., which works in conjunction with BICO subsidiary, IDT, Inc. The 510(k) requests market clearance for the ThermoChem HT(TM) System (ThermoChem) for use in Intraperitoneal Hyperthermic Chemotherapy (IPHC).
HemoCleanse, Inc., of West Lafayette, IN, manufactures the ThermoChem while IDT holds exclusive worldwide marketing rights to the ThermoChem and related disposables.
The ThermoChem HT System was formerly known as the BioLogic-HTA(TM), a part of the BioLogic-HT System(TM), currently being tested by IDT, Inc., in conjunction with HemoCleanse, Inc., for whole-body extracorporeal hyperthermia treatment of cancer and HIV/AIDS. The product name was changed to provide clear product identification in the intended market.
The ThermoChem HT System heats and/or cools fluids, such as chemotherapy agents in solution, and recirculates these fluids into the peritoneal (abdominal) cavity, thus providing a hyperthermic condition for combined cancer therapy.
ThermoChem and related disposables are intended to be used in a hospital operating room and in ambulatory settings for patients with gastrointestinal and other cancers within the peritoneal cavity.
Biocontrol Technology, Inc. has its corporate offices in Pittsburgh, PA, and is involved in the development and manufacture of biomedical devices and environmental products. IDT, Inc., a wholly owned subsidiary of Biocontrol also located in Pittsburgh, PA, holds exclusive worldwide marketing rights to the ThermoChem HT System, which is manufactured by HemoCleanse, Inc.
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SOURCE: Biocontrol Technology, Inc.
Contact: Diane McQuaide, Investors, 412-429-0673, or fax, 412-279-9690, or Susan Taylor, Media, 412-279-9455, or fax, 412-279-9447, both of Biocontrol Technology |
