Message #5 From:
Stock News Bot Date: July 26, 2005 01:48:00 AM
MDSC News Mediscience Technology Corp. Sets Meeting Date with FDA to Review Pre-IDE Submission Regarding Cancer Detection Device; Mediscience to Meet with FDA on August 18, 2005 to Discuss Its CD-Ratiometer Device
CHERRY HILL, N.J.--(BUSINESS WIRE)--July 26, 2005--Mediscience Technology Corp. (OTC:MDSC) announced that its wholly owned New York subsidiary, Medi-Photonics Development LLC, has been granted a date for a formal meeting with the FDA to discuss the possible commencement of a pivotal study by the FDA of its optical biopsy device, the CD-Ratiometer. The proposed indication for the use of the CD-Ratiometer is as a device that serves as an adjunct to diagnosis for cancer detection of the cervix and for other abnormalities.
The meeting is expected to expand upon the submission of the Pre-IDE document that was compiled by Schiff & Company, a firm specializing in international regulatory affairs, compliance and clinical research. Management expects to discuss aspects relating to clinical trials, fiber-optic probe details and the proposed indication of use of the CD-Ratiometer.
"The meeting with the FDA on August 18th will address the factors that can put Mediscience on the path to obtaining a submission for the IDE (Investigational Device Exemptions). We are eagerly looking forward to the in person opportunity to discuss the clinical protocol and determine the clearest path towards clinical efficacy for the CD-Ratiometer," said President and Chief Operating Officer, Michael Engelhart.
About Mediscience Technology
Mediscience Technology Corporation is engaged in the design, development and commercialization of medical devices that detect cancer and physiological change using frequencies of light that are emitted, scattered and absorbed to distinguish malignant, precancerous, or benign tissues from normal tissues. Mediscience's exclusive protected noninvasive technology combines the advantages of real-time results with enhanced diagnostic sensitivity and specificity compared with other methods of cancer detection.
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, the availability of financing, the parties/company's ability to implement its long-range business plan for the joint or independent development of various applications of its technology/IP; the company's ability to enter into future agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary US regulatory i.e. FDA clearances applicable to applications of the company's technology; and management of growth and other risks 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.
