-----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, PXiHE38iGhFYKDkx8s/7wS0662K2fZIoncHhfFu1lSYxw1ccEgPJoc7n31XD6ccA SCSFxTwaJXToWM1mpOqJDA== 0000914317-06-001666.txt : 20060526 0000914317-06-001666.hdr.sgml : 20060526 20060526084733 ACCESSION NUMBER: 0000914317-06-001666 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20060526 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060526 DATE AS OF CHANGE: 20060526 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: 06868758 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-77093_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) May 26, 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)) Section 8 Other events Item 8.01. Other Events. On May. 26, 2006 Registrant reports FDA approval March 29, 2006 of registrants proposed clinical investigation as a nonsignificant risk (NSR) device study. Registrant submitted protocol for a pilot study for the C-D Ratiometer entitled "A Multicenter Pilot study to establish the Safety and Parameters of Efficacy of an Optical Biopsy Device (CDR) for Cancer Detection of Cervix Preliminary to a Pivotal Study." (see report exhibit 99.2) 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 FDA letter dated March 31, 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 May 26, 2006 MEDICSCIENCE TECHNOLOGY CORPORATION By: Peter Katevatis --------------- Name: Peter Katevatis Title: Chairman of the Board and Chief Executive Officer Exhibit Index Exhibit No. Description - -------------------------------------------------------------------------------- 99.1 FDA letter dated March 31, 2006 EX-99.1 2 ex99-1.txt DEPARTMENT OF HEALTH &. HUMAN SERVICES Public Health Service [LOGO] Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 3 I 2C06 Mediscience Technology Corporation c/o Robert Schiff, Ph.D. RAC President Schiff & Company 1129 Bloomfield Avenue WEST CALDWELL NJ 07006 Re: I040553/S003 and S004 Dated: January 4 and 17, 2006 Received: January 5 and 19, 2006 Q060019 Feasibility Study of Optical Biopsy Device for Cervical Cancer Detection Request for Determination about Significant Risk Investigation Dear Dr. Schiff: The Food and Drug Administration (FDA) has reviewed your submission, dated January 4, 2006, proposing a protocol for a pilot study for the C-D Ratiometer entitled "A Multicenter Pilot study to establish the Safety and Parameters of Efficacy of an Optical Biopsy Device (CDR) for Cancer Detection of Cervix Preliminary to a Pivotal Study."FDA has determined that your proposed clinical investigation is a nonsignificant risk (NSR) device study because it does not meet the definition of a significant risk (SR) device under ss. 812.3(m) of the investigational device exemptions (IDE) regulation (21 CFR 812, enclosed). However, this decision is based on a specific worst case scenario for UV exposure at a single measurement at 380 and 340 run and two exposures each at 300 and 289 run. If you anticipateexceeding this worst case scenario by delivering multiple exposures at 380 nm or any other wavelength, a new worst case scenario should be identified and submitted with a revised safety analysis. An IDE application is not required to be submitted to, or approved by, FDA for a NSR study. A NSR study is, however, subject to the abbreviated requirements described in ss. 812.2(b) of the IDE regulation. The abbreviated requirements stipulate that the sponsor of the investigation must label the device in accordance with ss. 812.5; obtain institutional review board approval of the investigation as a NSR study; ensure that each investigator obtains informed consent from each subject under the investigator's care; comply with the monitoring requirements of ss. 812.46; maintain records required under ss. 812.140(b)(4) and (5) and file the reports required under ss. 812.150(b)(1) through (3) and (5) through (10); and ensure that participating investigators maintain the records required by ss. 812.140(a)(3)(i) and file the reports required under ss. 812.150(a)(1), (2), (5) and (7). Under the abbreviated IDE requirements, a sponsor must also comply with the prohibitions against promotion and other practices as identified in ss. B 12.7. According to this section of the regulation, the sponsor of a NSR study, investigator, or any person acting for or on behalf of the sponsor or investigator is prohibited from promoting or test marketing the investigational device until after FDA has approved the device for commerciai distribution; commercializing the device by charging a price greater than that necessary to recover the cost of manufacture, research, development, and handling; unduly prolonging the investigation; and representing the investigational device as being safe or effective for the purposes for which it is being investigated. If you have any questions regarding our NSR detennination or the abbreviated IDE requirements, please contact Mridulika Virmani, Ph.D. at (301) 594-1180. Sincerely yours, /s/ Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure IDE Regulation (21 CFR, Part 812) -----END PRIVACY-ENHANCED MESSAGE-----