UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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FORM
CURRENT REPORT
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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:
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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| Press Release of Biomerica, Inc., issued February 8, 2022. |
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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.
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BIOMERICA, INC. |
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Date: February 10, 2022 |
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/s/ Zackary S. Irani |
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Zackary S. Irani |
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