0001513162-22-000014.txt : 20220210 0001513162-22-000014.hdr.sgml : 20220210 20220210160417 ACCESSION NUMBER: 0001513162-22-000014 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20220208 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20220210 DATE AS OF CHANGE: 20220210 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOMERICA INC CENTRAL INDEX KEY: 0000073290 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 952645573 STATE OF INCORPORATION: DE FISCAL YEAR END: 0531 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-37863 FILM NUMBER: 22613856 BUSINESS ADDRESS: STREET 1: 17571 VON KARMAN AVENUE CITY: IRVINE STATE: CA ZIP: 92614 BUSINESS PHONE: 9496452111 MAIL ADDRESS: STREET 1: 17571 VON KARMAN AVENUE CITY: IRVINE STATE: CA ZIP: 92614 FORMER COMPANY: FORMER CONFORMED NAME: NMS PHARMACEUTICALS INC DATE OF NAME CHANGE: 19871130 FORMER COMPANY: FORMER CONFORMED NAME: NUCLEAR MEDICAL SYSTEMS INC DATE OF NAME CHANGE: 19830216 FORMER COMPANY: FORMER CONFORMED NAME: NUCLEAR INSTRUMENTS INC DATE OF NAME CHANGE: 19720508 8-K 1 bmra-20220208.htm FORM 8-K Form 8-K

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):  February 8, 2022

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 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))

 

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

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which registered

Common Stock, par value $0.08

 

BMRA

 

The Nasdaq Stock Market LLC

 

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 Disclosure.

 

On February 8, 2022, Biomerica, Inc. (the “Company”) issued a press release regarding the results from the endpoint clinical trial of its InFoods® IBS Treatment for patients with Irritable Bowel Syndrome.  The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information provided under this Item 7.01, including Exhibit 99.1 attached hereto, is being furnished 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 liabilities of that section. Such information shall not be deemed incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise expressly set forth by specific reference in such filing.

 

Item 8.01              Other Events.

 

On February 8, 2022, the Company issued a press release regarding the results from the endpoint clinical trial of its InFoods® IBS Treatment for patients with Irritable Bowel Syndrome. 

 

The InFoods® IBS endpoint trial was run at several medical institutions including Mayo Clinic, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, Houston Methodist Hospital and the University of Michigan. Multiple endpoints demonstrated statistically significant improvements, indicating that the elimination of specific foods may meaningfully reduce the symptoms of IBS in all subtypes (the clinical study included patients with IBS-Constipation, IBS-Diarrhea & IBS-Mixed).  The greatest clinical improvements were seen in patients diagnosed with IBS-Mixed and IBS-Constipation.  The Company plans to meet with the FDA to review these results and finalize a pivotal trial for FDA clearance. Highlights of select topline results from the InFoods® IBS endpoint trial were:
 

  • P-value of 0.007 for improvement in the Subject Global Assessment of Relief (SGA) endpoint for all patient subtypes as a group (baseline vs 8 weeks)
  • P-value of 0.040 for improvement in the Global Improvement Scale (GIS) endpoint for all patient subtypes as a group (baseline vs 8 weeks)
  • P-value of 0.012 for improvement in the Abdominal Pain Intensity (IBS-API) endpoint for IBS-Mixed & IBS-Constipation patients as a group (baseline vs 8 weeks)
  • P-value of 0.022 for improvement in the Bloating endpoint for IBS-Mixed & IBS-Constipation patients as a group (baseline vs 8 weeks)

 

Item 9.01              Financial Statements and Exhibits.

(d)   Exhibits.

 Number

  

Description

 

 

 

99.1

 

Press Release of Biomerica, Inc., issued February 8, 2022.

 

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.

 

 

BIOMERICA, INC.

 

 

 

Date:  February 10, 2022

By:

/s/ Zackary S. Irani

 

 

Zackary S. Irani
Chief Executive Officer

 

3

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EX-101.SCH 2 bmra-20220208.xsd XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 000 - Document - Document And Entity Information link:presentationLink link:definitionLink link:calculationLink EX-101.DEF 3 bmra-20220208_def.xml XBRL TAXONOMY EXTENSION DEFINITION LINKBASE DOCUMENT EX-101.LAB 4 bmra-20220208_lab.xml XBRL TAXONOMY EXTENSION LABELS LINKBASE DOCUMENT EX-101.PRE 5 bmra-20220208_pre.xml XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT EX-99.1 6 exhibit99_1.htm EXHIBIT 99.1 Exhibit 99.1

Biomerica Announces Positive Topline Results from the Endpoint Clinical Trial of its InFoods® IBS Treatment for Patients with Irritable Bowel Syndrome

 

  • InFoods® IBS Diagnostic-Guided Therapy is the first therapy of its kind using science, diet and technology to identify patient specific foods, which when eliminated, help reduce the symptoms of IBS without the use of drugs
  • Multiple endpoints demonstrated statistically significant improvements, indicating that the elimination of specific foods may meaningfully reduce the symptoms of IBS in all subtypes (clinical study included patients with IBS-Constipation, IBS-Diarrhea & IBS-Mixed)
  • Greatest clinical improvements, including but not limited to pain and bloating, were seen in patients diagnosed with IBS-Mixed and IBS-Constipation
  • The InFoods® IBS trial was run at leading medical institutions including Mayo Clinic, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, Houston Methodist Hospital and the University of Michigan 
  • InFoods® IBS is expected to address all IBS types that make up an approximate $30 billion market; up to 40 million Americans suffer from IBS

·     Biomerica plans to meet with the FDA to review these results and finalize a pivotal trial for FDA clearance

 

Irvine, California – February 08, 2022 -- Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) today announced positive topline results from the endpoint clinical trial of its InFoods® IBS diagnostic-guided therapy (DGT), with the trial showing statistically significant improvements in multiple endpoints in the Intent-to-Treat population. The InFoods® DGT is the first of its kind therapy for Irritable Bowel Syndrome (IBS) that uses a simple blood test designed to identify patient-specific foods that when removed from the diet may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. The InFoods® IBS DGT works by identifying above normal immunoreactivity to specific foods in patients.  A food identified as positive is simply removed from the diet for the patient to feel better.  

The clinical trial was conducted by Mayo Clinic, Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, Houston Methodist Hospital and the University of Michigan among others.   It was a double-blinded, randomized, placebo controlled clinical trial using the InFoods® IBS therapy and was designed to select the optimal primary endpoint to be used in a pivotal trial to obtain FDA clearance.  Based on this data showing statistically significant improvements in multiple endpoints, the Company will meet with the FDA to develop a final pivotal clinical trial which if positive would enable FDA clearance of its InFoods® IBS DGT. 

 

While multiple endpoints demonstrated statistically significant improvements in all patient subtypes in the study which included patients with IBS-Constipation, IBS-Diarrhea & IBS-Mixed, the top line data showed patients diagnosed with IBS-Mixed and IBS-Constipation benefitted the most from the InFoods® IBS Therapy. Biomerica finds this data very promising because there is currently no FDA cleared therapy for IBS-Mixed which accounts for roughly 33% of the approximate 40 million IBS sufferers in the United States.

 

1

Highlights of Topline Results from the InFoods® IBS Endpoint Trial

 

·         P-value of 0.007 for improvement in the Subject Global Assessment of Relief (SGA) endpoint for all patient subtypes as a group (baseline vs 8 weeks)

·         P-value of 0.040 for improvement in the Global Improvement Scale (GIS) endpoint for all patient subtypes as a group (baseline vs 8 weeks)

·         P-value of 0.012 for improvement in the Pain endpoint for IBS-Mixed & IBS-Constipation patients as a group (baseline vs 8 weeks)

·         P-value of 0.022 for improvement in the Bloating endpoint for IBS-Mixed & IBS-Constipation patients as a group (baseline vs 8 weeks)

 

Biomerica’s Chairman and Chief Executive Officer Zack Irani stated, “We are extremely excited about these results. IBS is a pervasive condition impacting the lives of well over 100 million patients worldwide. We are thrilled that this endpoint trial of InFoods® IBS demonstrates a significant improvement in symptoms for IBS patients.  Further, our platform can play a key role identifying the unique foods that may trigger or worsen symptoms in IBS patients, paving the way for a more effective therapy to alleviate patient suffering. We are now excited to embark on the final trial before submitting for FDA clearance. We’re sincerely thankful for the key investigators at some of the most prestigious medical centers in the US, who helped us conduct the study and reach this milestone in the progression of the InFoods® IBS program.”

 

Dr. Doug Drossman, President Emeritus of the Rome Foundation, Professor Emeritus in Medicine and Psychiatry at University of North Carolina, and Chairman of Biomerica’s Scientific Advisory Board stated, “We are encouraged and excited by these positive clinical trial results and look forward to assisting in the final pivotal trial phase.  We believe the innovative InFoods® IBS platform could provide physicians with a new way to treat patients and the data also suggests that this could be a key therapy for IBS-Mixed patients.” 

 

Dr. Brian Lacy, professor of medicine at Mayo Clinic and former co-Editor in Chief of the American Journal of Gastroenterology stated, “We are excited about this trial and the results. This therapy would be a significant and important tool for physicians treating IBS patients especially those with mixed symptoms.  In addition, this therapy can be used without or in conjunction with current pharmaceuticals, to potentially improve patient outcomes and revolutionize the way IBS is treated.”

 

Next Steps

With the positive outcome from this endpoint trial, Biomerica plans to meet and work with the FDA to design a final pivotal trial focused on the endpoint(s) that show the greatest improvement. The pivotal trial protocol is expected to be substantially similar to the completed endpoint trial, with a larger number of patients participating. At the same time Biomerica is in discussions about opportunities to commercialize the InFoods® IBS DGT prior to FDA clearance as a Laboratory Developed Test service offered through a CLIA laboratory, and as a CE Marked product in Europe or other countries. 

 

The InFoods® IBS study design has already received a non-significant risk determination from FDA, which should expedite the final approval process. Since the InFoods® IBS product is a diagnostic-guided therapy, and not a drug, it has no drug type side effects which benefits patients.     

 

Biomerica plans to hold an R&D day to discuss the full results in the next several months including the input and insights from key opinion leaders that were involved in the conduct of this trial. This will be part of a separate announcement.


2

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’s primary 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 Company’s InFoods IBS DGT, clinical trial designs, meetings with the FDA, FDA clearance of the Company’s InFoods IBS DGT product and commercialization of the Company’s InFoods IBS DGT product. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of a final review the endpoint trial’s data, the Company’s ability to design and enroll patients in a pivotal trial for InFoods IBS DGT, delays in the anticipated timing of clinical trials, meeting with FDA, risks that the costs of a pivotal trial will exceed expectations, risks that a pivotal trial will not replicate the results of the Company’s endpoint clinical trial, risks associated with the unpredictability of the regulatory approval process and the Company’s ability to find a strategic partner to help commercialize its In Foods IBS DGT product. 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 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, and such other risks described in the Company’s Annual Report on Form 10-K and other reports the Company files with the Securities and Exchange Commission from time to time. The Company is under no obligation to update any forward-looking statements after the date of this release.

 

 Corporate Contact:

John Nesbett /Jennifer Belodeau

IMS Investor Relations

203.972.9200

jnesbett@institutionalms.com

 

1 Canavan et al. The epidemiology of irritable bowel syndrome Clin Epidemiol. 2014; 6: 71–80. doi: 10.2147/CLEP.S40245


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Document And Entity Information
Feb. 08, 2022
Document Information Line Items  
Entity Registrant Name BIOMERICA, INC.
Trading Symbol BMRA
Document Type 8-K
Amendment Flag false
Entity Central Index Key 0000073290
Document Period End Date Feb. 08, 2022
Entity Emerging Growth Company false
Entity Incorporation, State or Country Code DE
Entity File Number 001-37863
Entity Tax Identification Number 95-2645573
Entity Address, Address Line One 17571 Von Karman Ave
Entity Address, City or Town Irvine
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92614
City Area Code 949
Local Phone Number 645-2111
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.08
Security Exchange Name NASDAQ
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