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Form 8-K BIOMERICA INC For: Dec 01

March 8, 2018 6:26 AM EST


UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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):  December 1, 2017

BIOMERICA, INC.

(Exact name of registrant as specified in its charter)

Delaware

0-8765

95-2645573

(State or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)



17571 Von Karman Ave. Irvine, California

92614


(Address of Principal Executive Offices)

(Zip Code)

Registrant's telephone number, including area code:  (949) 645-2111

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))


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).   Emerging growth company o      

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o  





 

Item 8.01 Other:

Approval by Mexicos COFEPRIS and entry into distribution agreement


The Company announced that it had received approval by Mexicos COFEPRIS for its colorectal screening test and had appointed DNA Biopharma (DNA) as its exclusive distributor for its EZ Detect product in Mexico.  See the attached Press Release in the Exhibit Index.






 

SIGNATURE

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.







BIOMERICA, INC.





Date:  March 8, 2018

By:


/s/ Zackary S. Irani




Zackary S. Irani
Chief Executive Officer







 

EXHIBIT INDEX

Biomerica Press Release Dated March 8, 2018





                                 NEWS - For Immediate Release


                                               

Mexicos COFEPRIS (Mexicos equivalent of the FDA) approves Biomerica colorectal screening test to help identify the early warning signs of colorectal cancer.

-Biomerica ships first order to Mexico-


Irvine, California March 8, 2018 -- Biomerica, Inc. (Nasdaq: BMRA) announced the Mexicos COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios - Mexicos equivalent of the U.S. Food & Drug Administration) approval of the EZ Detect colorectal screening test designed to help identify the early warning signs of colorectal cancer.   

Biomerica also announced it has appointed DNA Biopharma (DNA) as its exclusive distributor for its EZ Detect product in Mexico and has shipped the first order of EZ Detect to the company.  DNA has 25 years of expertise in marketing pharmaceutical and medical devices in Latin America.  Oscar H. del Cid, CEO of DNA, stated, We are excited about the prospects of colorectal cancer screening in Mexico.  The EZ Detect product is unique in that it offers the opportunity of cost savings for the healthcare system while saving lives.  

The EZ Detect colorectal screening test is the simplest at home test to detect fecal occult (hidden) blood, an early warning sign of colorectal cancer. The test does not require handling of stool or dietary restrictions.  The EZ Detect pad is tossed into the toilet after a bowel movement.  A change in the pads color to blue/green, which would appear within two minutes, indicates the presence of blood in the stool.  The pad is then simply flushed.  

Zackary Irani, CEO of Biomerica, stated, We are excited to work with Oscar and DNA to help enable colorectal screening in Mexico.

About Biomerica (NASDAQ: BMRA)

Biomerica, Inc. (www.biomerica.com) is a global biomedical company that develops, manufactures and markets advanced diagnostic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for the early detection of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on products for Gastrointestinal Disease, Diabetes and esoteric testing.

The Biomerica InFoods® IBS product identifies patient specific foods that when removed may alleviate an individual's IBS symptoms. This patent-pending, diagnostic-guided therapy is designed to allow for a patient specific, guided dietary regimen to improve Irritable Bowel Syndrome (IBS) outcomes. The point-of-care product is being developed to allow physicians to perform the test in-office using a finger stick blood sample while a clinical lab version of the product will be the first for which the company will seek regulatory approval. A billable CPT code that can be used by both clinical labs and physicians' offices is available for InFoods® diagnostic products. Since the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects.

The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other




                                 NEWS - For Immediate Release


written statements made or to be made by Biomerica) contains statements that are forward-looking; such as statements relating to intended launch dates, sales potential, significant benefits, market size, prospects, new products, favorable outlook, new distributors, expansion, increases in productivity and margins, expected orders, leading market positions, anticipated future sales or production volume of the Company, the launch or success of product and new product offerings. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, and accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. The potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.

 

Contact: Zackary Irani

949-645-2111


 





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