01/12 08:17 Biocontrol Subsidiary, IDT, Receives FDA Marketing Clearance For |
Biocontrol Subsidiary, IDT, Receives FDA Marketing Clearance
For ThermoChem-HT System(TM)
PITTSBURGH, Jan. 12 /PRNewswire/ -- Biocontrol Technology, Inc. (OTC Bulletin Board: BICO) subsidiary, IDT, Inc., in conjunction with HemoCleanse, Inc., announced today that they have received FDA clearance to market the ThermoChem-HT System(TM) and related disposables.
The ThermoChem-HT System and disposables will now be available to hospitals and doctors nationwide to help standardize a revolutionary cancer treatment. This treatment has been developed clinically at Wake Forest University Baptist Medical Center since 1991 by Dr. Brian Loggie, a surgical oncologist, with correlative laboratory studies performed by Ronald Fleming, Pharm. D., an adjunct professor. It now is offered at the Medical Center as standard-of-care for the treatment of ovarian, gastrointestinal, and other tumors that have spread to the lining surface (peritoneum) of the abdomen and pelvis (peritoneal carcinomatosis, peritoneal mesothelioma, pseudomyxoma peritoneum).
"We are very pleased with the clinical results that have been achieved using the combination of surgery, Intraperitoneal Hyperthermia, and chemotherapy," said Dr. Loggie.
The intended use of the ThermoChem-HT System is to raise the core temperature of the peritoneum to the desired targeted temperature in the 41 degree Celsius (105.8 degrees Fahrenheit) to 42 degrees Celsius (107.6 degrees Fahrenheit) range by continuously lavaging the peritoneum with circulating sterile solution. Heating of the peritoneum can make the area more receptive to adjunct therapies physicians might choose, such as chemotherapy or natural biological agents.
Glenn Keeling, CEO of IDT, stated, "The FDA clearance is a significant step. It reinforces our belief that by standardizing the IPH with the ThermoChem-HT System, this cancer treatment will be available to more patients." IDT is pursuing a strategic partnership as part of its overall marketing plan and continues to develop additional cancer treatment protocols to be submitted to the FDA.
In addition, IDT is in the process of submitting clinical and technical data to a European Notified Body. This process will lead to the awarding of the CE Mark, which signifies that the device meets the requirements for distribution into the European community.
In an agreement with IDT, Biocontrol Technology, Inc., which is an FDA approved manufacturer and an ISO 9000 manufacturing facility, is manufacturing the ThermoChem-HT System at its Indiana, PA facility.
Biocontrol Technology has its corporate offices in Pittsburgh, PA and is involved in the development and manufacture of biomedical devices and environmental products. IDT, Inc., a subsidiary of Biocontrol also located in Pittsburgh, PA, holds exclusive worldwide marketing rights to the ThermoChem- HT System and related disposables for regional hyperthermia and the ThermoChem System and related disposables for whole body hyperthermia.
Investor Relations Newsline Number: 1-800-357-6204.
This press release contains statements of a forward looking nature. Shareholders and potential investors are cautioned that such statements are predictions and actual events or results may vary significantly. SOURCE Biocontrol Technology, Inc.
/CONTACT: Investors, Diane McQuaide, 412-429-0673, or fax, 412-279-9690, or Media, Susan Taylor, 412-429-0673, or fax, 412-279-5041, both of Biocontrol Technology/
/Web site: bico.com / -- PHW011 -- 9874 01/12/2000 08:01 EST prnewswire.com Copyright PR Newswire 1998. All rights reserved.