-----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, AZqBARsscGlvt3V0CCHnv4lUhLKkNHkSuwNX4oBxijSZWeRL2JrGjtRS6V3YjNHH Z70YZfons9Er8Y+IQDXhJg== 0000739944-05-000002.txt : 20050218 0000739944-05-000002.hdr.sgml : 20050218 20050218091953 ACCESSION NUMBER: 0000739944-05-000002 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050217 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050218 DATE AS OF CHANGE: 20050218 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDTOX SCIENTIFIC INC CENTRAL INDEX KEY: 0000739944 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 953863205 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11394 FILM NUMBER: 05625866 BUSINESS ADDRESS: STREET 1: 402 WEST COUNTY ROAD D CITY: ST PAUL STATE: MN ZIP: 55112 BUSINESS PHONE: 6126367466 MAIL ADDRESS: STREET 1: 402 WEST COUNTY ROAD D CITY: ST PAUL STATE: MN ZIP: 55112 FORMER COMPANY: FORMER CONFORMED NAME: EDITEK INC DATE OF NAME CHANGE: 19940902 FORMER COMPANY: FORMER CONFORMED NAME: ENVIRONMENTAL DIAGNOSTICS INC DATE OF NAME CHANGE: 19920703 8-K 1 form8-k021705.htm 8-K 8-K

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): February 17, 2005


MEDTOX SCIENTIFIC, INC.
(Exact name of registrant as specified in its charter)



Delaware 1-11394 95-3863205
(State or other jurisdiction (Commission File Number) (IRS Employer
of incorporation)   Identification No.)



402 West County Road D, St. Paul, Minnesota 55112
(Address of principal executive offices) (Zip Code)



Registrant’s telephone number, including area code: (651) 636-7466


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:

|_| 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 (17 CFR 240.14a-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 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 8.01.    Other Events

On February 17, 2005, MEDTOX Scientific, Inc. announced that it has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance to market its Sure-Screen® drugs-of-abuse point-of-collection test (POCT) device, as described in the press release attached as Exhibit 99.1.

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Item 9.01.    Financial Statements and Exhibits.


(a) Financial statements of businesses acquired.
Not applicable.

(b) Proforma financial information.
Not applicable.

(c) Exhibits.

        The following exhibit is filed as part of this report:


Exhibit No. Description
99.1 MEDTOX Scientific, Inc. Press Release, dated February 17, 2005.

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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.


  MEDTOX Scientific, Inc.  
     
     
     
Date:   February 17, 2005 By:          /s/ Richard J. Braun  
  Name:     Richard J. Braun
  Title:       Chief Executive Officer

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INDEX TO EXHIBITS


Exhibit No. Description
99.1 MEDTOX Scientific, Inc. Press Release, dated February 17, 2005.

5


EX-99 2 ex99-1021705.htm EXHIBIT 99.1 Exhibit 99.1

Exhibit 99.1

February 17, 2005

FOR:
MEDTOX Scientific, Inc.
402 West County Road D
St. Paul, MN 55112
Contact: Paula Perry (877) 715-7236

FOR IMMEDIATE RELEASE

MEDTOX SCIENTIFIC FILES 510(K) APPLICATION WITH FDA FOR ITS NEW
SURE-SCREEN® DEVICE

ST. PAUL, February 17, 2005 – MEDTOX Scientific, Inc. (AMEX-TOX), announced today that it has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for clearance to market its Sure-Screen® drugs-of-abuse point-of-collection test (POCT) device.

Sure-Screen® is a POCT device intended to provide significantly lower detection levels for eight commonly abused drugs. Current tests provide detection levels that have been established by the Substance Abuse and Mental Health and Services Administration (SAMHSA), a Federal agency that regulates workplace drug testing required under Federal law. Those detection levels have generally been adopted by both laboratories and device makers for all drug screening. The SAMHSA established detection levels are generally intended to deter drug abuse and minimize litigation related to employment drug screening, but not necessarily to detect all usage.

The Company believes there is a demand for lower detection levels in certain markets. Specific markets to which Sure-Screen® will be targeted are probation, parole, rehabilitation, hospital emergency departments and corporate clients interested in lower detection levels for pre-employment testing. In all of these markets there is value added in reducing the detection level for abused drugs, and therefore increasing the number of those detected abusing drugs.

Clinical data supports that Sure-Screen® will provide lower detection levels on eight drugs (marijuana, opiates, cocaine, amphetamines, methadone, benzodiazepines, methamphetamines, and MDMA-Ecstasy) by an average of approximately 50% each.


MEDTOX Scientific, Inc.
February 17, 2005
Page 2

The Company is currently unaware of any existing FDA cleared POCT devices with this broad panel and low detection levels. MEDTOX Scientifics’ unique structure in owning an ISO certified POCT device manufacturer and a federally certified drug screening laboratory creates additional competitive advantages in two ways. First, Sure-Screen® is a preliminary on-site screen that may require further laboratory confirmation. MEDTOX’s laboratory can provide that confirmation in a seamless manner. Second, there are a limited number of laboratories that are either willing or capable of confirming the low drug levels that will be detected by Sure-Screen®.

MEDTOX Scientific, Inc., headquartered in St. Paul, Minn., is a provider of high quality specialized laboratory and on-site/point-of-collection (POC) devices. The Company also supports customers with complete logistics, data and program management services. MEDTOX develops and manufactures diagnostic devices for quick and economical on-site/point-of-collection analysis for drugs-of-abuse, therapeutic drugs and biological and agricultural toxins and provides employment drug screening and occupational health testing. MEDTOX is a leader in providing esoteric laboratory testing services to hospitals and laboratories nationwide. This includes both central laboratory and bio-analytical testing for pharmaceutical clinical trials. For more information see www.medtox.com.


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