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 29, 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:

o         Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o         Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

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o         Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o         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   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

 

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Item 7.01 Regulation FD Disclosures

 

On June 29, 2020, Biomerica, Inc. (“Biomerica”) issued a press release announcing that it has signed a definitive agreement with the University of Texas Health Science Center at Houston to join the clinical trial for Biomerica’s new InFoods® diagnostic-guided therapy, designed to alleviate Irritable Bowel Syndrome (IBS) symptoms.

 

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 25, 2020, Biomerica, Inc. signed a definitive agreement with the University of Texas Health Science Center at Houston to join the clinical trial for Biomerica’s new InFoods® diagnostic-guided therapy designed to alleviate Irritable Bowel Syndrome (IBS) symptoms.

 

Item 9.01        Financial Statements and Exhibits

 

(d)  Exhibits

 

 

Number           Description

 

99.1                 Press Release issued June 29, 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 30, 2020

Biomerica, Inc.

By:

/s/ Zackary S. Irani

Zackary S. Irani

Chief Executive Officer

 

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Exhibit 99.1

 


The University of Texas Health Science Center at Houston joins Biomericas InFoods® Irritable Bowel Syndrome ("IBS") Diagnostic-Guided Therapy (DGT) clinical trial.  


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InFoods® Diagnostic-Guided Therapy is designed to identify patient-specific foods that, when removed from the diet, may alleviate an individual's IBS symptoms


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Approximately 45 million Americans suffer from IBS1


IRVINE, CA--(June 29, 2020) - Biomerica Inc. (NASDAQ: BMRA) today announced it has signed a definitive agreement with the University of Texas Health Science Center at Houston (UTH) to join the clinical trial for Biomericas new InFoods® diagnostic-guided therapy, designed to alleviate Irritable Bowel Syndrome (IBS) symptoms. The University of Texas Health Science Center at Houston is the fifth large medical center to be part of the InFoods® clinical trial which includes:  Mayo Clinic, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, Houston Methodist and the University of Michigan as primary enrollment centers. UTH can now begin enrollment of patients in this trial.


It is estimated that over 45 million Americans suffer from IBS and the symptoms are often triggered by consumption of specific foods (which are unique in each sufferer).  The total cost (direct + indirect) of IBS has been estimated at $30 billion annually in the United States. IBS is a common condition that can substantially impair physical and mental well-being of a patient and a persons ability to function both at home and in the workplace.


A clinical lab version of the InFoods® IBS DGT product is being used in this clinical trial. However, the Company is also working to develop a point-of-care version of the InFoods® IBS DGT product that would potentially allow physicians to perform the test in-office using a finger stick blood sample. The point of care version would allow physicians to be reimbursed for administering the test.  A billable CPT code that can be used by both clinical labs and physicians' offices is already available for the InFoods® IBS products. Market research conducted by a leading, independent, pharmaceutical, marketing research firm, determined that over 70% of physicians surveyed would utilize the InFoods® DGT to treat their IBS patients without reimbursement and over 90% would utilize it with reimbursement.  


Importantly, the InFoods® DGT can be used without or in conjunction with current IBS pharmaceuticals to potentially improve patient outcomes. Since the InFoods® product is a diagnostic-guided therapy and not a drug, it has no drug-type side effects.    


The current endpoint clinical trial is expected to be completed in approximately 6 months. However, due to the novel coronavirus impact on the U.S.s healthcare system, it may take longer. If all goes as expected,




Biomerica plans to commence the final pivotal trial several months thereafter, which is needed for submission to the FDA for final clearance.  The endpoint trial stratifies enrollment by the three main IBS subclasses (IBS-Constipation, IBS-Diarrhea and IBS-Mixed). The clinical study design has already received a non-significant risk determination from the FDA.

Dr. Brooks D. Cash, Chief of Gastroenterology, Hepatology, and Nutrition at the University of Texas Health Science Center at the Texas Medical Center, stated, We are excited about the potential impact this can make for IBS patients and excited to be part of the clinical trial group for InFoods® IBS. The product is novel in that it is addressing a root cause of IBS with a non-pharmaceutical therapy, yet can be combined with current pharmaceutical therapies to improve outcomes.

Zackary Irani, Chief Executive Officer of Biomerica, commented: IBS remains a major burden for up to 45 million people in the United States who desperately seek some form of medical advancement providing relief.  We believe our approach, supported by a Scientific Advisory Board comprised of the leading minds in the IBS medical community, is differentiated by focusing on one possible root cause of IBS compared to simply treating symptoms.  

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.

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 Companys tests, the rapidity of testing results, pricing of the Companys test kits, commencement of FDA clinical trials, completion of clinical trials, favorable outlook pertaining to clinical trial outcomes, the FDAs acceptance of clinical trials data, clearance from the FDA for the Companys products to be sold in the US, receipt of regulatory approvals for the Companys products to be sold outside of the US, demand for domestic US and international orders, availability of the Companys 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 Companys test; regulatory approvals necessary prior to commercialization of the Companys test and or therapy; availability of the Companys test kits; capacity, resource and other constraints on our suppliers; the Companys ability to effectively manufacture the test kit once approve for sale; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our tests or therapy; competition 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 Companys ability to obtain patent protection on any aspects of its 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 other things; 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 competes and will be competing, the impact of the coronavirus on the Companys operations, revenues and the completion of the clinical trials, the and the Company's dependence on partners and strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.

We are susceptible to a widespread outbreak of an illness or other health issue, such as the recent 2019 CoV-19 Coronavirus (Covid-19 Virus) outbreak first reported in Wuhan, Hubei Province, China in December 2019 and




subsequently spreading throughout the world resulting in hundreds of thousands of confirmed cases worldwide and many deaths. The outbreak of the Covid-19 Virus has caused the various governments, including the U.S., to implement quarantines, various restrictions on travel causing airlines to suspend international and certain domestic flights, shelter in place orders. Governments have also implemented work restrictions that prohibit many employees from going to work, and for businesses that are allowed to remain open, many employees are electing to remain at home to avoid spread of the disease. As a result of this Covid-19 Virus outbreak and potential future pandemic outbreaks, the Company faces significant risks including, but not limited to; a) supply chain disruptions making it difficult for the Company to order and receive materials needed for production of its products, and needed to ship finished products to our end customers, b) loss of contract and customers from the financial strains or other disruptions they are experiencing as a result of the pandemic, c) financial risks pertaining to receivables due from customers that may fall into insolvency or otherwise be unable to pay their bills, d)government responses including orders that make it difficult to remain open for business, restrict imports of raw materials or exports of finished goods, refuse to allow the Companys product to be licensed for sale in their countries, and other seen and unforeseen actions taken by government agencies, e) absenteeism or loss of employees at our Company, or at our partners companies, due to health reasons or government restrictions, that are needed to develop, validate, manufacture and perform other necessary functions for our operations, f) equipment failures, loss of utilities and other disruptions that could impact our operations or render them inoperable, g) litigation or government actions against the Company pertaining to existing products new products sold by the Company that are directed at limiting or treating the spread of the pandemic outbreak, h) a local or global recession or depression that could harm the international banking system, limit demand for all products including those made by the Company, and many other seen and unforeseen events and circumstances, all of which could negatively impact the Company.


CONTACT INFORMATION

Company Spokesperson
949-645-2111
www.biomerica.com

1 The epidemiology of irritable bowel syndrome. Clin Epidemiol. 2014; 6: 71–80. . doi:  10.2147/CLEP.S40245 Caroline CanavanJoe West, and Timothy Card


i The epidemiology of irritable bowel syndrome. Clin Epidemiol. 2014; 6: 7180. . doi:  10.2147/CLEP.S4024