-----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, S3lDCL+FPtmoq8yshqhA279edtU8flZHne8mysuNVU66BWe0dNMm/6FoGdZyBnEG nMKkDi5gt5Wf2sXaxRr3HA== 0001299933-08-003987.txt : 20080820 0001299933-08-003987.hdr.sgml : 20080820 20080820163128 ACCESSION NUMBER: 0001299933-08-003987 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080820 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080820 DATE AS OF CHANGE: 20080820 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HOME DIAGNOSTICS INC CENTRAL INDEX KEY: 0000884909 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 222594392 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33027 FILM NUMBER: 081030320 BUSINESS ADDRESS: STREET 1: 2400 NW 55TH COURT CITY: FORT LAUDERDALE STATE: FL ZIP: 33309 BUSINESS PHONE: 9546779201 MAIL ADDRESS: STREET 1: 2400 NW 55TH COURT CITY: FORT LAUDERDALE STATE: FL ZIP: 33309 8-K 1 htm_28622.htm LIVE FILING Home Diagnostics, Inc. (Form: 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):   August 20, 2008

Home Diagnostics, Inc.
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 001-33027 22-2594392
_____________________
(State or other jurisdiction
_____________
(Commission
______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
2400 NW 55th Court, Fort Lauderdale, Florida   33309
_________________________________
(Address of principal executive offices)
  ___________
(Zip Code)
     
Registrant’s telephone number, including area code:   954-677-9201

Not Applicable
______________________________________________
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:

[  ]  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 August 20, 2008, Home Diagnostics, Inc. issued a press release announcing that it had received 510(k) clearance from the U.S. Food and Drug Administration for its TRUE2go™ and TRUEresult™ no-coding blood glucose monitoring systems. A copy of this press release is attached hereto as Exhibit 99.1 and the information contained therein is incorporated herein by reference. The information in this Form 8-K (including the exhibit attached hereto) is being furnished under Item 8.01 and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liability of such section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.





Item 9.01 Financial Statements and Exhibits.

(c) Exhibits. The following material is filed as an exhibit to this Current Report on Form 8-K:

Exhibit No. Description
99.1 Press release dated August 20, 2008.






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.

         
    Home Diagnostics, Inc.
          
August 20, 2008   By:   /s/ Ronald L. Rubin
       
        Name: Ronald L. Rubin
        Title: Sr. Vice President and Chief Financial Officer


Exhibit Index


     
Exhibit No.   Description

 
99.1
  Press release dated August 20, 2008
EX-99.1 2 exhibit1.htm EX-99.1 EX-99.1

PRESS RELEASE

Contacts:

     
Home Diagnostics
Sabrina Rios
Corporate Communications Manager
(954) 332-2141
srios@hdidiabetes.com
  Schwartz Communications, Inc. for Home
Diagnostics

Courtney Smith or Jennifer Barlow
(781) 684-0770
homediagnostics@schwartz-pr.com

Home Diagnostics Receives FDA Clearance for
TRUE2go, TRUEresult No-Coding Blood Glucose Monitoring Systems

TRUE2go ™ is World’s Smallest Blood Glucose Meter,
Designed to Help Patients Better Manage Their Diabetes On-the-Go

FORT LAUDERDALE, Fla. – August 20, 2008 – Home Diagnostics, Inc. (NASDAQ: HDIX), a leading manufacturer and marketer of diabetes testing supplies, announced today that it received 510(k) clearance from the U.S. Food and Drug Administration for the world’s smallest blood glucose meter, TRUE2go™, and for TRUEresult™, the company’s latest advanced performance, no-coding meter for at-home testing.

Small enough to twist and attach to the top of a vial of test strips, TRUE2go offers patients the convenience of anywhere, on-the-go testing to help them better manage their diabetes. TRUEresult, the latest state-of-the-art, high performance meter, offers patients advanced monitoring capabilities at an affordable price. In clinical testing, both systems achieved a high degree of accuracy and repeatability, and were considered to be easy to use by people with diabetes.

Both new meters are compatible with the company’s new TRUEtest platform of blood glucose test strips featuring the company’s patent-pending, state-of-the-art GoldSensor™ laser accuracy and TRUEfill™ beveled tip. These advanced features ensure highly accurate test results and first test success by allowing for greater sampling precision and consistency.

The new TRUE systems feature no-coding technology that simplifies blood glucose testing by eliminating the need for users to code the meter with each new box of test strips. Both TRUE2go and TRUEresult deliver precise results in as fast as four seconds using only 0.5 microliters of blood. This advanced no-coding technology combined with a small sample size also makes it more convenient and cost–effective for diabetics to test their blood glucose levels more often, allowing for greater control of their glucose levels.

“Over the past three years we made capital investments in excess of $15 million in order to bring the TRUE2go and TRUEresult to market and are pleased to have FDA clearance for the new products,” said J. Richard Damron, Jr., President and Chief Executive Officer of Home Diagnostics. “Our new product platform is designed to fit people’s needs whether they are testing at home or on-the-go, making it easier for them to test accurately and quickly.”

TRUE2go and TRUEresult will be available in the fourth quarter of this year.

About Home Diagnostics, Inc.
Based in Fort Lauderdale, Florida, Home Diagnostics, Inc. (NASDAQ: HDIX) is a leading developer, manufacturer and marketer of diabetes management solutions. Home Diagnostics, Inc. offers a portfolio of high-quality blood glucose monitoring systems that spans the spectrum of features and benefits to help every person with diabetes better monitor and manage their disease. The Home Diagnostics, Inc. product line includes TRUE2go™, TRUEresult™, TRUEtrack™, Sidekick®, TRUEread™ and Prestige Smart System® blood glucose monitoring systems. The products are available in more than 45,000 pharmacies throughout the U.S. Home Diagnostics is the exclusive co-brand supplier of blood glucose monitoring supplies for leading pharmacies including CVS, Rite Aid and Walgreens as well as national distributors such as AmerisourceBergen, Cardinal Health and McKesson. For more information please visit www.homediagnostics.com.

TRUE2go, TRUEresult, TRUEtest, TRUEtrack, Sidekick, TRUEread and Prestige Smart System are trademarks of Home Diagnostics, Inc. All other trademarks are property of their respective owners.

[HDIX-F]

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