Healthcare Industry News: Radiometer
News Release - January 5, 2006
Mediscience Inc. Files Investigational Device Exemption (IDE) Application with the Center for Devices and Radiological Health of the FDACHERRY HILL, N.J.--(HSMN NewsFeed)--Jan. 5, 2006--MEDISCIENCE TECHNOLOGY CORP. -- Mediscience (MTC) (OTCBB:MDSC ) reported that it has filed an Investigational Device Exemption (IDE) application with the Center for Devices and Radiological Health of the FDA. The filing is subject to evaluation by the FDA to determine when a proposed human clinical pilot study of the Company's Cervical Cancer Detection Radiometer (CD-R) may begin.
Mediscience Chairman Peter Katevatis Esq. stated, "This anticipated pilot study for the initiation of MTC adjunct clinical trials brings the Company one step closer to commercialization of its broad patented Optical Biopsy technology platform applications. We further believe that any and all acquired FDA/MTC approvals will add significant synergistic and applicable value to our Joint effort with INFOTONICS RESEARCH CORP. in the development of the 'Compact Photonic Explorer' (CPE), or 'pill camera,' an ingestible photonic pill that would enable physicians to detect early stage cancer of the complete auto-digestive tract with our embedded patented Optical Biopsy technology platform."
The clinical objectives are to demonstrate the device's ability to distinguish between tissues that are normal, benign, precancerous low grade, precancerous high grade, and cancerous. The device results will be compared to the PAP test and tissue biopsy and will be evaluated for clinical adverse events.
The pilot study will enroll 400 patients in a multi-center study of sensitivity and specificity of MDSC's precancer/cancer detection ratiometer (CDR) device. Two groups of 50-75 patients each will be tested to define the spectral characteristics of the normal and cancerous cervix (histology). The remaining population will be tested to define intermediary states between normal and various stages of cancer.
Mediscience and its New York subsidiary, Medi-photonics Development Company LLC, is engaged in the design, development and commercialization of medical devices that aid in the molecular diagnosis of cancer and physiological change using frequencies of light that are emitted, scattered and absorbed to distinguish malignant, precancerous, or benign tissues from normal tissues. The Company's exclusive protected IP non-invasive technology combines the advantages of real-time results with enhanced diagnostic sensitivity and specificity compared with other methods of cancer detection and offers a paradigm shift unique ability to detect molecular abnormalities in tissue composition and/or structure with out patient health hazard.
The Infotonics Technology Center Inc. (Infotonics) operates New York State's Center of Excellence in Photonics and Microsystems. Infotonics is structured as a consortium whose founding participants include Corning, Inc., Eastman Kodak Company, and Xerox Corporation. The Rochester Regional Photonics Cluster is an industrial partner, and academic participants include some 20 New York State colleges and universities. Infotonics' goal is to establish a unique, world-class research and development facility to enable rapid commercialization of new products. This initiative will provide major benefits to the region, including creation of jobs and attraction of new companies and investment revenue. Infotonics is a present and significant shareholder of MTC.
See Web sites:
See Mediscience 8-K filing dated Sept 8 2005 (MTC and INFOTONICS to jointly develop the "Compact Photonic Explorer" (CPE), or "pill camera")
See New England Journal of Medicine 7-29-04 (general results of developing capsule endoscopic technology)
Certain of the matters discussed in this announcement contain forward-looking statements that involve material risks to and uncertainties in the parties/company's business that may cause actual results to differ materially from those anticipated by the statements made herein. Such risks and uncertainties include among other things, FDA approvals, the availability of financing, the parties/company's ability to implement its long-range business plan for various applications of its technology; the company's ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary US regulatory clearances, including but not limited to FDA, applicable to various applications/submissions of the company' technology; and management of growth and other risked and uncertainties that may be detailed from time to time in the parties/company's reports filed with the Securities and Exchange Commission. This disclosure is intended to satisfy: SEC Section 6, 6.01 Regulation FD, disclosure and Section 7 and 7.0 as well as all applicable and presently effective Sarbanes-Oxley disclosure requirements under Regulation G.
Source: Mediscience Technology
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