UNITED STATES

 

SECURITIES AND EXCHANGE COMMISSION

 

WASHINGTON, D.C.

 

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): June 16, 2020

 

 

BIOMERICA, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

001-37863

95-2645573

(State or Other Jurisdiction of Incorporation)

(Commission File Number)

(IRS Employer Identification Number)

 

 

17571 Von Karman Ave.

Irvine, California 92614

(Address of Principal Executive Offices

Including Zip Code)

 

 

949-645-2111

(Registrant’s Telephone Number,

Including Area Code)

 

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))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, par value $0.08

BMRA

NASDAQ Capital Market

 

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      ¨

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.      ¨

 

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Item 7.01 Regulation FD Disclosures.

 

On June 16, 2020, Biomerica, Inc. (“Biomerica”) issued a press release announcing that it has filed for FDA Emergency Use Authorization of its unique laboratory antibody test for COVID-19.  The Company also announced that it has filed a provisional patent on technology to allow simplified blood collection of samples. A copy of Biomerica’s press release is furnished hereto as Exhibit 99.1 to this Current Report on Form 8-K and incorporated in this Item 7.01 in its entirety.

 

The information contained in Item 7.01 of this Current Report on Form 8-K, including the exhibit attached hereto, is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of, or otherwise regarded as filed under, the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into 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 filing.

 

Item 8.01 Other Events.

 

On June 14, 2020, the Company filed for FDA Emergency Use Authorization (EUA) for an ELISA lab-based serology blood test for the detection of antibodies that identify if a person has been infected with the novel Coronavirus (COVID-19).

 

On April 21, 2020, the Company filed a provisional patent on technology to allow simplified blood collection of samples.

 

Item 9.01        Financial Statements and Exhibits

 

(d)       Exhibits.

 

 Number

  

Description

 

 

 

99.1

 

Press Release issued June 16, 2020.

 

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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.

 

 

Dated:  June 17, 2020

Biomerica, Inc.

 

 

 

By:

/s/ Zackary S. Irani

Zackary S. Irani

Chief Executive Officer

 

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Exhibit 99.1

 

Biomerica files for FDA Emergency Use Authorization (EUA) of its Unique Laboratory Antibody Test for COVID-19

 

-     This high-volume laboratory test will allow for collection of blood samples using a simplified proprietary blood collection device once cleared by the FDA.

 

-     This test adds to the previously announced Biomerica 10-minute finger prick antibody tests already being sold outside of the US.

 

-     Biomerica has filed a provisional patent on technology to allow simplified blood collection.

 

IRVINE, CA - (June 16, 2020) - Biomerica Inc. (NASDAQ: BMRA) announced today they have submitted to the FDA an EUA application for an ELISA lab-based serology blood test for the detection of antibodies that identify if a person has been infected with the novel Coronavirus (COVID-19). Antibody testing can be an important next step in opening the economy to tell people if they have been previously infected. This is the third COVID- 19 antibody test introduced by the Company. The other two, which are finger-prick rapid tests, are actively being sold outside of the US and have been well received. The Company also intends to obtain a CE mark to market and sell this ELISA laboratory test outside the US.

 

Biomerica performed testing both internally and at two external labs located in California. The data from this testing that was submitted to the FDA under the EUA application showed 100 percent specificity and zero percent cross reactivity with many common disease states. This test, which uses the ELISA microplate format, can be run on existing open system equipment found in most hospitals and clinical laboratories in the US and outside the US and uses a modified, trimeric spike protein from the SARS-CoV-2 virus. This spike protein is known to be the target of neutralizing antibodies, which can help prevent the virus from entering the cells.1 Persons who are no longer infectious and have tested positive for the antibodies, can possibly be cleared to return to work as they may have a lower likelihood of reinfection and/or spreading the virus. Antibody tests will also help in better understanding the virus including how long antibodies stay in the body and if they help in immunity as well as how many people have been infected in the population as a whole. Further, this type of testing could be particularly important for the immune surveillance of health care workers, first responders, government workers, and others whose infection risks could be heightened by working with COVID-19 infected individuals.

 

This ELISA laboratory test was developed by Biomerica and will be manufactured exclusively at Biomerica’s manufacturing facility located in Irvine, California, using existing high-throughput, automated equipment. Biomerica has extensive experience manufacturing similar serology ELISA tests for other diseases.

 

"We are working to provide significant, high specificity and meaningful diagnostic solutions for the novel Coronavirus," said Zack Irani-Cohen, CEO and Chairman of Biomerica. "Our ELISA test will be unique in the market place by simplifying the blood sample collection process in a proprietary way. We have been working with the FDA, who has been very responsive, and we’re looking forward to a quick review for this submission. I’m very proud of our team members who are working around the clock to develop, validate and attain regulatory clearance on these COVID-19 diagnostic solutions that benefit patients, healthcare workers and society”.

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About Serology Tests

Serology tests look for the presence of antibodies, which are specific proteins made in response to infections. The antibodies detected by serology tests indicate that a person has had an immune response to the novel Coronavirus (SARS-CoV-2), whether symptoms developed from infection or the infection was asymptomatic. Antibody test results are important in detecting infections with few or no symptoms.2

 

1.  medRxiv preprint doi: https://doi.org/10.1101/2020.03.30.20047365. Accessed 15Jun20

2.  Emerging Microbes & Infections 2020, VOL. 9 Molecular and serological investigation of 2019-nCoV infected patients.

 

About Biomerica (NASDAQ: BMRA)

Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment 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 focus is on Gastrointestinal and inflammatory Diseases where the Company has multiple diagnostic and therapeutic products in development.

 

About InFoods®

The Biomerica InFoods®IBS product is designed to allow physicians to identify patient specific foods(e.g.eggs, broccoli, wheat, potatoes, corn, etc.), that when removed from the diet, may alleviate or improve an individual's IBS symptoms including, but not limited to, constipation, diarrhea, bloating, pain and indigestion. This patented, 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 already 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. An estimated 45 million people in America currently suffer from IBS making it a leading cause for patient doctor visits.

 

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 written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the efficacy of the Company’s COVID-19 test, FDA clearance, EUA clearance, the rapidity of testing results, uniqueness of a product, pricing of the Company’s test kits,demand for international orders, availability of the Company’s COVID-19 test kits, and patent protection on the test technology. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the efficacy of the Company’s COVID-19 test; regulatory approvals necessary prior to commercialization of theCompany’sCOVID-19 test; availability of the Company’s COVID-19 test kits; capacity, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our COVID-19 test; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; regulations and the Company’s ability to obtain patent protection on any aspects of its rapid test technology. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business mode land 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 INFORMATION

 

Company Spokesperson

949-645-2111

http://www.biomerica.com

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