-----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, WhT9QbR/r4UDzcqAjt7fHdPl0CEnj6HrxXu/Ziti8t8BU7xhlf3XjuzyhRRnbFmU nU+DrtiDBUYFXNgWlFDjpw== 0000950134-01-000628.txt : 20010205 0000950134-01-000628.hdr.sgml : 20010205 ACCESSION NUMBER: 0000950134-01-000628 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20010131 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20010131 FILER: COMPANY DATA: COMPANY CONFORMED NAME: COLORADO MEDTECH INC CENTRAL INDEX KEY: 0000720013 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 840731006 STATE OF INCORPORATION: CO FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-12471 FILM NUMBER: 1520804 BUSINESS ADDRESS: STREET 1: 6175 LONGBOW DR CITY: BOULDER STATE: CO ZIP: 80301 BUSINESS PHONE: 3035302660 MAIL ADDRESS: STREET 1: 6175 LONGBOW DRIVE CITY: BOULDER STATE: CO ZIP: 80301 FORMER COMPANY: FORMER CONFORMED NAME: CYBERMEDIC INC DATE OF NAME CHANGE: 19920703 8-K 1 d83733e8-k.txt FORM 8-K DATED 1/31/01 1 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: JANUARY 31, 2001 COLORADO MEDTECH, INC. ---------------------- (Exact name of registrant as specified in its charter) COLORADO 000-12471 84-0731006 -------- --------- ---------- (State or other jurisdiction (Commission File (I.R.S. Employer of incorporation) Number) Identification No.) 6175 LONGBOW DRIVE BOULDER, COLORADO 80301 ----------------------- (Address, including zip code, of principal executive offices) (303) 530-2660 -------------- (Registrant's telephone number, including area code) 2 ITEM 5. OTHER EVENTS. Colorado MEDtech, Inc. issued a press release regarding a letter from the FDA. The text of the press release is attached hereto as Exhibit 99.1. ITEM 7. FINANCIAL STATEMENT AND EXHIBITS. (c) Exhibits. No. Description 99.1 Press release dated January 31, 2001 -2- 3 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. DATED, this 31st day of January, 2001. COLORADO MEDTECH, INC. By: /s/ PETER J. JENSEN ------------------------------------- Peter J. Jensen Vice President 4 EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION - ------- ----------- 99.1 Press release dated January 31, 2001
EX-99.1 2 d83733ex99-1.txt PRESS RELEASE DATED JANUARY 31, 2001 1 EXHIBIT 99.1 FOR IMMEDIATE RELEASE: NEWS - ---------------------- January 31, 2001 NASDAQ-CMED COLORADO MEDTECH, INC. ANNOUNCES RECEIPT OF FDA LETTER BOULDER, Colorado -- Colorado MEDtech, Inc. (NASDAQ -- CMED), a Boulder, Colorado-based medical products and outsourcing services company, today announced that it has received a warning letter from the United States Food and Drug Administration (FDA). The FDA's letter states that there are certain areas in which the company's Longmont, Colorado contract medical device manufacturing facility is not in compliance with the FDA's Quality System Regulation (QSR). The company has been working aggressively to improve its QSR compliance and is working with the FDA to address and resolve all issues that have been raised. The company has already taken several significant steps to improve its quality system. In particular, the company o presented to the FDA a comprehensive corrective action plan and a detailed response, o retained highly-respected industry consultants to ensure that its quality system meets or exceeds all requirements, o has begun to implement new procedures and training, and o is working with its vendors to ensure that their components meet the company's elevated quality system. "Our new management team recognized that actions were needed prior to this letter and had already begun to strengthen our quality systems," said Stephen K. Onody, President and Chief Executive Officer of the company. "We pledged to the FDA that we would be proactive in doing independent external audits, and the first independent external audit is complete. Its results indicate that we are on track with the plan we presented to the FDA to resolve the deficiencies. By this spring we expect to have addressed all of the deficiencies and to have made improvements to our entire quality system to meet customer and business needs for the future." Colorado MEDtech, Inc., through its wholly-owned subsidiaries and operating divisions, is a leading full-service provider of advanced medical products, critical components, and comprehensive outsourcing services. FORWARD-LOOKING STATEMENTS The statements in this news release and in the conference call that are not historical facts are forward-looking statements that represent management's beliefs and assumptions based on currently available information. Forward-looking statements can be identified by the use of words such as "believes," "intends," "may," "will," "should," "anticipated," "expected" or comparable terminology or by discussions of strategy. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it cannot assure that these expectations will prove to be correct. Such statements involve risks and uncertainties including, but not limited to, the risk that the Company's existing level of orders may not be indicative of the level or trend of future orders, the risk that the 2 Company may not successfully complete the work encompassed by current or future orders, the risk that unforeseen technical or production difficulties may adversely impact project timing and financial performance, the risk that the management changes will not produce the desired results, the risk of potential litigation, the risks associated with regulation by the Federal Food and Drug Administration including compliance with the Quality System Regulation, the risk that acquired companies cannot be successfully integrated with the Company's existing operations and the risk that a downturn in general economic conditions or customer budgets may adversely affect research and development and capital expenditure budgets of potential customers upon which the Company is dependent. Should one or more of these risks materialize (or the consequences of such a development worsen), or should the underlying assumptions prove incorrect, actual results could differ materially from those forecasted or expected. These factors are more fully described in the Company's documents filed from time to time with the Securities and Exchange Commission. The Company disclaims any intention or obligation to update publicly or revise such statements whether as a result of new information, future events or otherwise. ### CONTACTS: Colorado MEDtech, Inc. Stephen K. Onody, President and CEO Telephone: 303.530.2660 Gregory A. Gould, CFO Fax: 303.581.1010 Email: cmedinfo@cmed.com Website: www.cmed.com
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