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 1, 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.   ¨

 

1


 

 

Item 7.01 Regulation FD Disclosures.

 

On June 1, 2020, Biomerica, Inc. (“Biomerica”) issued a press release announcing that it had signed agreements with Mayo Clinic to join its clinical trial for its InFoods product. It also announced that it had received a patent in Japan pertaining to its Infoods product.  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 March 26, 2020, the Japanese Patent Office issued Biomerica’s first Japanese patent pertaining to the Company’s InFoods® family of products that allow for a revolutionary new treatment option for patients suffering from IBS and several other disease states.   Specifically, this patent  (JP,6681907,B) contains numerous claims that broadly cover a product that enables physicians to identify patient-specific foods (e.g. pork, milk, shrimp, broccoli, chickpeas, 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. It is estimated that about 19 million people in Japan suffer from IBS.

 

On May 28, 2020, the Company signed definitive agreements with Mayo Clinic to join the clinical trial for Biomerica’s new InFoods® diagnostic-guided therapy (DGT), designed to alleviate Irritable Bowel Syndrome (IBS) symptoms.   Mayo Clinic can now begin enrollment of patients in this trial.

 

 

Item 9.01        Financial Statements and Exhibits

 

(d)       Exhibits.

 

 Number

  

Description

 

 

 

99.1

 

Press Release issued June 1, 2020.

 

2


 

 

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 2, 2020

Biomerica, Inc.

 

 

 

 

 

 

By:

/s/ Zackary S. Irani

Zackary S. Irani

Chief Executive Officer

 

 

3

 

Exhibit 99.1

 

Mayo Clinic joins Biomerica’s InFoods® Irritable Bowel Syndrome ("IBS") Diagnostic-Guided Therapy clinical trial. 

 

-         Biomerica also announces its first Japanese patent has been granted for its InFoods® IBS Diagnostic Guided Therapy technology 

 

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

 

-         Approximately 45 million Americans suffer from IBS1

 

IRVINE, CA--(June 1, 2020) - Biomerica Inc. (NASDAQ: BMRA) today announced they have signed definitive agreements with Mayo Clinic to join the clinical trial for Biomerica’s new InFoods® diagnostic-guided therapy (DGT), designed to alleviate Irritable Bowel Syndrome (IBS) symptoms.   Mayo Clinic is joining Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, Houston Methodist and the University of Michigan as primary enrollment centers for this study. Mayo Clinic can now begin enrollment of patients in this trial.

 

Biomerica has added several new, large medical centers and groups to assist with accelerating completion of the endpoint trial and to participate in the subsequent pivotal trial needed for final FDA clearance.  Biomerica continues to add leading gastrointestinal ("GI") physicians operating in world-renowned centers to the InFoods® IBS clinical study, who are potential users and advocates for this product once cleared by the FDA.

 

Biomerica also announced today that the Japanese Patent Office has issued Biomerica’ s first Japanese patent pertaining to the Company’s InFoods® family of products that allow for a revolutionary new treatment option for patients suffering from IBS and several other disease states.   Specifically, this patent  (JP,6681907,B) contains numerous claims that broadly cover a product that enables physicians to identify patient-specific foods (e.g. pork, milk, shrimp, broccoli, chickpeas, 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. It is estimated that about 19 million people in Japan suffer from IBS.

 

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 person’s ability to function both at home and in the workplace.

 

1


 

 

A clinical lab version of the product is being used in this clinical trial.  However, the Company is also developing InFoods® IBS DGT as a point-of-care product that allows physicians to perform the test in-office using a finger stick blood sample.  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 seventy percent (70%) of physicians surveyed would utilize the InFoods® DGT without reimbursement and over 90% would utilize it with reimbursement. 

 

Importantly, the InFoods® DGT can be used without or in conjunction with current 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 clinical trials are randomized, double-blinded, and placebo-controlled. Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, has completed its enrollment of patients for this endpoint study but will continue to participate in the final pivotal trial once that commences.

 

This clinical endpoint 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).   There is currently no FDA cleared therapy for IBS-Mixed.  The study design has already received a non-significant risk determination from FDA.

 

Zackary Irani, Chief Executive Officer of Biomerica, commented: “We are excited to have Mayo Clinic join the InFoods® IBS trial.   IBS patients who desperately seek symptom relief will be the beneficiaries of this revolutionary disruptive technology.  Also, we are pleased to have additional countries issue patents with broad claims that acknowledge the novel and innovative attributes of this technology platform that can be used to help patients that suffer from IBS and many other diseases.”  

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.

2


 

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 tests, the rapidity of testing results, pricing of the Company’s test kits, commencement of FDA clinical trials, completion of clinical trials, favorable outlook pertaining to clinical trial outcomes, the FDA’s acceptance of clinical trials data, clearance from the FDA for the Company’s products to be sold in the US, receipt of regulatory approvals for the Company’s products to be sold outside of the US, demand for international orders, availability of the Company’s 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 test; regulatory approvals necessary prior to commercialization of the Company’s test and or therapy; availability of the Company’s 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 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 Company’s 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 Company’s 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.

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

 

3