-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, R079DBluYWgf6f/jNtDJoNXGN9XzKOBzbQDEN0kBymLwtoBniReSLckv1NH1NViU uXnabjmbv+rmY/c3dLCxPA== 0000914317-06-000973.txt : 20060403 0000914317-06-000973.hdr.sgml : 20060403 20060403151751 ACCESSION NUMBER: 0000914317-06-000973 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060330 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060403 DATE AS OF CHANGE: 20060403 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDISCIENCE TECHNOLOGY CORP CENTRAL INDEX KEY: 0000064647 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 221937826 STATE OF INCORPORATION: NJ FISCAL YEAR END: 0228 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-07405 FILM NUMBER: 06733132 BUSINESS ADDRESS: STREET 1: 1235 FOLKESTONE WY CITY: CHERRY HILL STATE: NJ ZIP: 08034 BUSINESS PHONE: 6094287952 MAIL ADDRESS: STREET 1: 1235 FOLKESTONE WAY CITY: CHERRY HILL STATE: NJ ZIP: 08034 FORMER COMPANY: FORMER CONFORMED NAME: CARDIAC TECHNIQUES INC DATE OF NAME CHANGE: 19730920 8-K 1 form8k-75738_mdsc.txt UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) March 30, 2006 MEDISCIENCE TECHNOLOGY CORP. - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) NEW JERSEY 0-7405 22-1937826 - -------------------------------------------------------------------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) 1235 Folkestone Way, P.O. Box 598, Cherry Hill, New Jersey 08034 - -------------------------------------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (215) 485 0362 (Former name or former address, if changed since last report.) Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2- below): [ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) [ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17CFR240.14a-12) [ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) [ ] Pre-commencement communications pursuant to Rule 13 e-4(c) under the Exchange Act (17 CFR 240.13 e-4(c)) Item 8.01. Other Events. On April 3, 2006 Mediscience Technology, Corp. (OTCBB:MDSC.OB) announced The Food and Drug Administration on March 29, 2006 approved as a "Non-significant risk device study the Company's multi-center pilot study to establish the safety and parameters of efficacy of its proprietary Optical Biopsy Device (CD-R) for cancer detection of the cervix preliminary to a pivotal study" expected to bring this molecular algorithmic specific technology to market. 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. Item 9.01. Financial Statements and Exhibits. (c) Exhibits 99.1 Press Release of Mediscience Technology Corp. dated April 3, 2006 SIGNATURES Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized on April 3, 2006 MEDICSCIENCE TECHNOLOGY CORPORATION By: Peter Katevatis ------------------------------ Name: Peter Katevatis Title: Chairman of the Board and Chief Executive Officer 2 Exhibit Index Exhibit No. Description - ----------- ------------------------------------------------------------------ 99.1 Press Release of Mediscience Technology Corp. dated April 3, 2006 3 EX-99.1 2 ex99-1.txt Exhibit 99.1 FDA Approves Mediscience Optical Biopsy Device multi-center pilot study for molecular cancer detection of the cervix CHERRY HILL, N.J.--(BUSINESS WIRE)--April 3, 2006 Mediscience Technology, Corp. (OTCBB:MDSC.OB) announced today: The Food and Drug Administration on March 29, 2006 approved as a "Non-significant risk device study the Company's multi-center pilot study to establish the safety and parameters of efficacy of its proprietary Optical Biopsy Device (CD-R) for cancer detection of the cervix preliminary to a pivotal study" expected to bring this molecular algorithmic specific technology to market. Dr Robert Schiff of Schiff & Company/ Regulatory Affairs advised "The FDA has notified Mediscience that the device (CD-R) is a non-significant risk device. We can therefore commence the Pilot study at any time observing the regulations governing patient consent and institutional IRB approval. The FDA has also given us comments and suggestions which will assist Mediscience in its clinical studies." Peter Katevatis Chairman/ CEO "The main objectives of this pilot study are to determine efficacy; the clinical sensitivity and clinical specificity (ability for the device to distinguish between tissues that are normal, benign, precancerous low grade, precancerous high grade, CIS and cancer) by comparing the device real-time results to the PAP test and biopsy; and assess any adverse events based on Good Clinical Practices. Frequency, type and intensity of clinical adverse events will also be evaluated. Assuming the results of this initial efficacy and safety study are satisfactory, in the detection of cervical cancer precursors i.e. (pre-cancerous cells), indications of possible cancer development the Company will continue into its pivotal study where the principal endpoint will be proof of effectiveness in a statistically significant sample of subjects. Dr. Robert Alfano (pioneer in optical biopsy, co-founder and advisor to Mediscience Technology and President of Alfanix LTD) " This FDA approval advances Mediscience to the next level towards commercialization and is a major step in advancing diagnostic medicine using fluorescence light. Alfanix plans to help Mediscience with it's CD-R platform technology in the medical cancer areas and possibly expanding the market into Latin America." Mediscience Technology Corporation is engaged in the design and development of fluorescence-based optical biopsy platform system that uses the properties of light and its molecular interaction with tissue to aid in the diagnosis of physiological change and cancer. The Mediscience IP technology platform is based on imaging native fluorescence from the surface of an optically excited tissue and offers paradigm shift potential as a noninvasive, in-vivo cancer diagnostic because of the unique ability to detect/distinguish abnormalities in molecular tissue composition and/or structure. Further, the development of a Mediscience cost effective, high resolution commercial imaging system for real-time 4 in-vivo diagnostics has the potential to vastly improve upon current standards of diagnostic sensitivity and specificity. (e.g. Cervical cancer a highly preventable cancer with early detection and removal of pre-cancerous cervical lesions) About Mediscience Technology Mediscience Technology Corporation and its New York subsidiary, Medi-photonics Development Company LLC, are 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, Pre-cancerous 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. www.infotonics.org/ResearchProjects/CompactPhotonicExplorers.asp www.cunyphotonics.com www.MEDISCIENCETECH.com Mediscience 8-K filing dated April 4, 2006 New England Journal of Medicine 7-29-04 (capsule endoscopic technology) CITIGROUP/Smith Barney Analyst Report 10-1-2004 by Peter Bye. Page 20 (Mediscience/Infotonics) Alfanix LTD Dr. Robert Alfano 917 969 2209 web: info@alfanix.com INVESTOR NOTICE 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 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. CONTACT: Mediscience ---Peter Katevatis Chairman/CEO 215 485 0362 or metpk@aol.com Dr. Robert Alfano 917 969 2209 web: info@alfanix.com 5 -----END PRIVACY-ENHANCED MESSAGE-----