BMRA

Biomerica, Inc. Common Stock NASDAQ Capital Market
$4.01
Open: $3.92 High: $5.05 Low: $3.85 Close: $4
Range: 2021-06-23 - 2021-06-24
Volume: 319,620
Market: Open
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BMRA
Biomerica, Inc. Common Stock 17571 Von Karman Avenue Irvine CA, 92614 http://www.biomerica.com
Biomerica Inc develops, manufactures, and markets medical diagnostic products designed for the early detection and monitoring of chronic diseases and medical conditions.
  • CEO: Zackary S. Irani
  • Employees: 52
  • Sector: Healthcare
  • Industry: Medical Instruments & Equipment
BMRA News
Latest news about the BMRA
  • Biomerica Signs Exclusive Distribution Agreement in Canada for its New and Proprietary Helicobacter Pylori (H. pylori) Test, hp+detect™

    Prevalence of H. pylori infection in the United States is approximately 35% to 40% of the population IRVINE, Calif., June 24, 2021 (GLOBE NEWSWIRE) -- Biomerica Inc. (NASDAQ: BMRA) today announced that it has signed an exclusive five-year distribution agreement with a Canadian partner for the distribution and marketing of Biomerica’s new and proprietary Helicobacter pylori test, called hp+detect™. The hp+detect™ product has been developed for the identification and monitoring of H. pylori infect

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  • 50+ Companies to Present at the Access to Giving Virtual Investor Conference - July 13th - 15th, 2021

    RALEIGH, NC / ACCESSWIRE / June 23, 2021 / Access to Giving - an investor conference themed around investor education and advocacy is set for July 13-15, 2021. There will be 50+ companies conducting virtual presentations as well as private meetings with qualified investors throughout the three-day event.

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  • Biomerica Receives Notice of Allowance from Mexican Patent Office for Irritable Bowel Syndrome Food Sensitivity Testing & Treatment

    IBS is one of the most important gastrointestinal disorders in Mexico, with a prevalence of around 16% [1] (approximately 20 million patients)Broadens InFoods® global patent coverage with recently allowed patents in Korea and Japan IRVINE, Calif., June 15, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA) today announced that the Mexican Patent Office has issued a notice of allowance for Biomerica’s patent application pertaining to the Company’s InFoods® technology platform that offers a r

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  • Biomerica, Inc.'s (NASDAQ:BMRA) Path To Profitability

    We feel now is a pretty good time to analyse Biomerica, Inc.'s ( NASDAQ:BMRA ) business as it appears the company may...

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  • Biomerica to Participate in Upcoming Investor Conferences

    IRVINE, Calif., June 04, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced that it will be participating in two upcoming investor conferences: the Truist Life Sciences Series and LD Micro Invitational XI event. Zack Irani, Chief Executive Officer of Biomerica will be presenting virtually at the LD Micro Invitational XI event on Tuesday, June 8th at 2:30 PM ET. Register to access the LD Micro Invitational XI here. Biomerica wi

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  • 35 of the Best Ideas Companies to Present at the Summer Solstice - Best Ideas from the Buy-Side Virtual Investor Conference on June 1-4, 2021

    RALEIGH, NC / ACCESSWIRE / May 27, 2021 / The Summer Solstice - Best Ideas from the Buy-Side will take place on June 1-4, 2021, where 35 SmallCap, MicroCap and NanoCap public companies will be presenting via virtual webcast to a global investor audience.The Summer Solstice - Best Ideas from the Buy Side: VIRTUAL begins on Tuesday, June 1, 2021, with company presentations beginning at 9am Eastern Time.

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  • Thinking about buying stock in Minerva Neurosciences, Fubotv, Lucira Health, Biomerica, or Comstock Mining?

    InvestorsObserver issues critical PriceWatch Alerts for NERV, FUBO, LHDX, BMRA, and LODE.

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  • MedTech Round Up: Update On Products By Biomerica, 908 Devices, Ekso Bionics, Hologic

    Biomerica Inc (NASDAQ: BMRA) has announced that its new COVID-19 Antigen Rapid Test can now be performed with a simple, less invasive nasal swab. The test is highly portable, cost-effective, and provides results in 15 minutes versus lab-run PCR tests, taking up to three days for results. Price Action: BMRA shares closed 17.3% lower at $3.41 on Tuesday. 908 Devices Inc (NASDAQ: MASS) has announced updates to its MX908 handheld mass spec device, including an aerosol module to detect and identify aerosolized chemical threats. The new capabilities also include added targets that allow responders to recognize additional priority drug substances and activate a Bluetooth capability to export reports and device history to Android devices. Price Action: MASS shares closed 5.8% lower at $44.44 on Tuesday. Ekso Bionics Holdings Inc (NASDAQ: EKSO) has expanded its partnership with Kindred Healthcare LLC bringing EksoNR to four of Kindred's Long-Term Acute Care Hospitals in the U.S. The multi-unit order follows a successful pilot program of the EksoNR last year. EksoNR is a robotic exoskeleton device that empowers patients recovering from acquired brain injury, stroke, and spinal cord injury. Price Action: EKSO shares closed 7.59% higher at $5.53 on Tuesday. Hologic Inc's (NASDAQ: HOLX) subsidiary Biotheranostics Inc has received broader Medicare coverage for its Breast Cancer Index test under an expanded Medicare Local Coverage Determination effective today. Under the new criteria, the Breast Cancer Index test is now covered for post-menopausal women diagnosed with early-stage node-positive, non-relapsed, estrogen receptor or progesterone receptor-positive, HER2 negative breast cancer. Previously, Medicare covered the test only for patients with node-negative, non-relapsed, ER or PR positive, HER2 negative breast cancer. Price Action: HOLX closed 0.95% lower at $64.47 on Tuesday. See more from BenzingaClick here for options trades from BenzingaHologic Shares Drop On Q2 Earnings Miss; Q3 Guidance Trail Consensus© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Biomerica’s Fast 15-Minute Easy to Use COVID-19 Antigen Test Now Available With Simple Nasal Swab

    Less invasive nasal swab taken from front opening of the nose is more comfortable for patientsTest can be performed by doctors, school and company nurses, and medical assistants, in any location without specialized equipment IRVINE, Calif., May 11, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, announced that its new COVID-19 Antigen Rapid Test can now be performed with a simple less invasive nasal swab. This simple nasal swab, which takes the sample from the front opening of the nose, is less invasive and more comfortable for patients than the deep anterior nasal swab which is typically used. The test is highly portable, cost effective and provides visual results negating the need for any equipment to perform or read the test. The test also provides results in 15 minutes versus lab-run PCR tests which can take up to three days for results, thereby potentially expediting the process of identifying infectious people and preventing further spread of the virus. Zack Irani, CEO at Biomerica, commented, “COVID-19 testing will be with us well past the pandemic, and ensuring that health care professionals have a simple, reliable testing solution is imperative. Our nasal swab test is simple to use, accurate and portable.” Mr. Irani continued, “It is important to note that while we continue to utilize and apply our diagnostic know-how to COVID-19 tests, our primary focus remains the validation and commercialization of our InFoods® diagnostic platform. We believe that InFoods® is a revolutionary approach to the diagnosis and treatment of Irritable Bowel Syndrome and other gastrointestinal diseases and we continue to work tirelessly to bring these products to market.” About the Biomerica COVID-19 Rapid Antigen Test: The Biomerica COVID-19 Rapid Antigen Test is intended to identify people who are currently infected and who should quarantine to help prevent the spread of the disease. No lab equipment is necessary to process the test or read the tests results. This test uses lateral flow technology, making it a reliable and familiar format for mass testing by healthcare providers. In independent testing at clinics in three different countries outside of the U.S., the Biomerica COVID-19 Rapid Antigen Test demonstrated an overall performance of 92.5% positive agreement (sensitivity) and 100.0% negative agreement (specificity) as compared to lab-based molecular PCR tests. The Biomerica COVID-19 Rapid Antigen Test was engineered for near-patient, point-of-care settings. A simple nasal swab is used to collect specimens from people suspected of having an active infection. Patient samples should be tested immediately and should not be diluted or used with viral transport media or frozen specimens. The test Is CE marked and targeted for use outside the United States. 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 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, pork, 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 IBS outcomes. A point-of-care version of the 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 is expected to 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® 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 tests, FDA clearance of the Company’s products, EUA clearance, the rapidity of testing results, uniqueness of the Company’s products, test result accuracy of products, pricing of the Company’s test kits, demand for domestic or international orders, potential revenues from the sale of current or future products, availability of the Company’s COVID-19 test kits, and patent protection on any of the Company’s products or technologies. 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 tests, InFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; availability of the Company’s COVID-19 test kits and other products; 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 various COVID-19 tests and other products; 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 technologies. 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. 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

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  • BMRA: COVID-19 Test Contributes to More Than Doubling Of Revenue in 3Q FY21

    By M. Marin NASDAQ:BMRA READ THE FULL BMRA RESEARCH REPORT COVID-19 Test Contributes to More Than Doubling Of Revenue in 3Q FY21 Biomerica (NASDAQ:BMRA) recently reported Q3 fiscal 2021 results. BMRA’s focus in 2020-21 has included extending its expertise and technology to develop and commercialize COVID-19 diagnostics. Revenue in 3Q FY 2021 more than doubled to $3.62 million, largely the result

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  • Biomerica Reports 208% Increase In Q3 Fiscal 2021 Sales, Over Q3 Fiscal 2020

    Sales increase driven by first sales of COVID-19 Antigen Rapid Test in Europe after January 2021 CE Mark approval Awarded two new patents for InFoods® diagnostic guided therapy technology, including the first Japanese patent InFoods® IBS diagnostic-guided therapy clinical trial expecting top line trial results by the third calendar quarter of 2021 IRVINE, Calif., April 15, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced its fiscal third quarter 2021 financial results for the three months ended February 28, 2021. The Company reported consolidated sales of $3.62 million for the fiscal third quarter of 2021, compared to $1.18 million for the same period in fiscal 2020, an increase of 208%. The increase in revenues during the quarter was primarily due to sales of the Company’s 15-minute COVID-19 Antigen Rapid Test in Europe, after its January 2021 CE Mark approval, as well as increased sales for several of the Company’s other diagnostic products. For the nine months ended February 28, 2021, consolidated net sales for Biomerica increased 55% to $6.14 million compared to $3.97 million for the same period in fiscal 2020. The Company’s cost of sales for fiscal third quarter 2021, included an exceptionally large inventory reserve of approximately $1.43 million. Gross margin excluding this exceptionally large inventory reserve would have been 38%. During the quarter the company increased its investment in research and development which is largely focused on several COVID-19 tests and ongoing development of the InFoods® IBS product. The Company incurred higher general and administrative expenses, mainly due to higher reserves, and increased legal, personnel and consulting costs related to the Company preparing for anticipated growth related to the InFoods® Technology, and possible commercialization of other products in the pipeline. Net loss for the fiscal third quarter 2021 was $1.84 million compared to a net loss of $0.86 million for the same period in fiscal 2020. During the fiscal third quarter, the Company recorded a receivables reserve of $0.29 million and recorded a non-cash charge of $0.24 million for stock-based compensation related to the annual equity (stock option) awards granted to its Board of Directors and senior managers. Excluding the exceptionally large inventory and receivables reserves, and the non-cash annual compensation charge, the Company would have reported a profit for the quarter. Cash and cash equivalents were $5.27 million, and current assets were $10.78 million, on February 28, 2021. Zack Irani, Chairman and Chief Executive Officer of Biomerica, commented, “This was a strong quarter for the Company. First and foremost, we’ve made great progress enrolling patients for our InFoods® IBS endpoint clinical trial in a tough pandemic environment, with some of the most respected healthcare institutions in the world, including Mayo Clinic, Beth Israel Deaconess Medical Center, Inc., a Harvard Medical School teaching Hospital, Houston Methodist, University of Texas Health Science Center at Houston, and the University of Michigan. While COVID-19 has delayed this clinical trial, we still expect to have top line analysis from this clinical trial by the end of the third calendar quarter of 2021. “InFoods® IBS is a patented product addressing the $30 billion Irritable Bowel Syndrome market where surprisingly little relief is currently available for patients. Our product is a disruptive technology redefining how patients with gastrointestinal diseases can be treated. InFoods® goes beyond simply treating symptoms of disease, it also is designed to help identify one of the underlying causes. If cleared, InFoods® IBS will be the first FDA-regulated diagnostic therapy identifying both the problematic foods of IBS patients, as well as alleviating the symptoms, offering broad appeal to patients, physicians and insurers. We are also excited to announce we now have six issued patents related to our InFoods® IBS product and platform technology, with many more in active prosecution and review. These patents should provide us strong protection from competition as we plan to launch these products into the market. “Alongside the progress we are making with InFoods®, the Biomerica team is working with leading institutions to quickly launch accurate COVID-19 tests while maintaining our commitment to providing these tests at a low cost,” Mr. Irani continued. “We have applied our technology and expertise to bring to market COVID-19 tests that drove significant revenue growth in the quarter, and we are encouraged by the traction we saw in Europe and look forward to expanding into other markets to bring our solution to more patients around the world. At the same time, the FDA continues to review our EUA submission for our products in the U.S. market. “While we are proud to be helping with the current global pandemic and believe that there are considerable revenue opportunities for testing around the world, it is important to note that our primary long-term focus continues to be on validation and commercialization of products based on our patented InFoods® technology platform. Our improved financial results in the quarter demonstrate the earnings leverage in our business model given our low-cost structure and focus on high ROI products. We continue to believe our InFoods® products could revolutionize the way people are treated for a variety of gastrointestinal diseases, while offering Biomerica sizable revenue opportunities,” Mr. Irani concluded. 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 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 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 is expected to 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 tests, FDA clearance, EUA clearance, the rapidity of testing results, uniqueness of a product, accuracy of products, 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 tests; regulatory approvals necessary prior to commercialization of the Company’s COVID-19 tests; 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 various COVID-19 tests; 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 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. The Company is under no obligation to update any forward-looking statements after the date of this release. 1. medRxiv preprint doi: https://doi.org/10.1101/2020.03.30.20047365. Accessed 15Jun20 Corporate Contact: John Nesbett /Jennifer BelodeauIMS Investor Relations203.972.9200jnesbett@institutionalms.com

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  • Biomerica, Inc. (NASDAQ:BMRA) Shares Could Be 25% Below Their Intrinsic Value Estimate

    Does the April share price for Biomerica, Inc. ( NASDAQ:BMRA ) reflect what it's really worth? Today, we will estimate...

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  • We Think Biomerica (NASDAQ:BMRA) Can Afford To Drive Business Growth

    There's no doubt that money can be made by owning shares of unprofitable businesses. Indeed, Biomerica ( NASDAQ:BMRA...

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  • Biomerica Reports Fiscal 2021 Second Quarter Financial Results and Provides Business Update

    * Biomerica expects completion of enrollment of its Irritable Bowel Syndrome Diagnostic-Guided Therapy clinical trial by end of April, 2021   * FDA actively reviewing Company’s EUA submission for its first of its kind “at-home” Blood Collection kit used with the Biomerica COVID-19 IgG ELISA Lab Test system   * Simple to use 15-minute COVID-19 Antigen Rapid Test, which now has CE Mark, receives first large ordersIRVINE, Calif., Jan. 15, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced financial results for its second quarter of fiscal year 2021, which ended November 30, 2020.The Company reported second quarter worldwide revenue of $1.373 million as compared to $1.596 million for the same period in the previous year. The decrease in sales during the quarter was primarily due lower sales in Asia. However, sales in Asia have substantially increased in the first half of the third fiscal quarter. Net loss was $1.485 million for the second fiscal quarter compared to a net loss of $0.485 million for the same period in the previous fiscal year. The increase in net loss was primarily due to higher research and development expense, largely related to the development of several COVID-19 tests, and higher general and administrative expenses, mainly due to increases in legal fees, reserves and personnel/consulting costs. Cash and cash equivalents were $5.684 million, and current assets were $11.947 million, at the end of the second fiscal quarter.The Company announced that the U.S. Food and Drug Administration (“FDA”) is now actively reviewing the Company’s Emergency Use Authorization (“EUA”) application for its COVID-19 IgG ELISA Test along with the Company’s professional use and at-home Whole Blood Collection Card system. If EUA clearance is granted, it would be the first for an in-home blood sample collection system combined with an ELISA test kit. This collection system offers the simplicity of a finger-prick blood sample which can be easily collected in multiple settings such as homes, schools, workplace, community care and healthcare settings, and have these samples sent back to a lab to be run on the Company’s highly accurate ELISA test. In clinical studies, the finger-prick blood collected samples demonstrated 100% specificity for detecting IgG antibodies to the spike protein of SARS-CoV-2 and 0% cross-reactivity with many common diseases. The Company’s COVID-19 IgG ELISA test uses modified trimeric spike protein from the SARS-CoV-2 virus, which is known to be the target of neutralizing antibodies that prevent the virus from entering cells.1 The Company also recently announced that it has received a CE mark for its new antigen rapid test. The Company has already received its first large European orders and plans to ship the first part of these orders in the coming weeks. The Company will now begin marketing this product broadly in Europe and other regions outside of the U.S. Biomerica’s new COVID-19 Antigen Rapid Test is highly portable, affordable and provides results in approximately 15 minutes with no equipment required to perform or read the test. This test can be performed by doctors, nurses, school nurses, medical assistants, and trained medical specialists. In independent testing at clinics in three different countries outside of the U.S., the Biomerica COVID-19 Rapid Antigen Test demonstrated an overall performance of 94.7% positive agreement (sensitivity) and 99.7% negative agreement (specificity) as compared to lab-based molecular PCR tests. A simple nasal swab is used to collect specimens from people suspected of having an active infection. Patient samples should be tested immediately and should not be diluted or used with viral transport media or frozen specimens.Also, as previously announced, the Company is nearing completion of patient enrollment in the endpoint clinical trial for its InFoods® Irritable Bowel Syndrome (“IBS”) diagnostic-guided therapy (“DGT”). This double-blinded, randomized, controlled clinical trial is validating the Biomerica InFoods® IBS test to manage the debilitating pain and suffering of patients diagnosed with IBS. Utilizing an antibody guided blood test, the InFoods® IBS product identifies patient-specific foods that may alleviate IBS symptoms when eliminated from the patient’s diet. Mayo Clinic, Beth Israel Deaconess Medical Center, Inc., a Harvard Medical School Teaching Hospital, Houston Methodist, University of Texas Health Science Center at Houston, and the University of Michigan are participating in this study. Biomerica expects to complete patient enrollment at these centers by the end of April, 2021, and to have summary analysis results from the clinical trial by the end of July, 2021.“We have worked to differentiate our COVID-19 products from the competition by focusing on proprietary methods of sample collection. For example, by using our simple finger-prick blood collection device we can enable a simple collection of a blood sample virtually anywhere (at home, at the office, or virtually any other location). At the same time, we are now launching our point of care 15-minute antigen test. Most importantly, we are very excited about nearing completion of patient enrollment in our endpoint clinical trial for its InFoods® IBS diagnostic-guided therapy. While we are proud to be helping with the current global pandemic, it is important to note that our primary long-term focus continues to be on validation and commercialization of products based on our patented InFoods® technology platform. We continue to believe our InFoods products could revolutionize the way people are diagnosed and treated for a variety of gastrointestinal diseases, while offering Biomerica sizable revenue opportunities,” stated Zackary Irani, CEO of Biomerica.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 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 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 is expected to 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 tests, FDA clearance, EUA clearance, the rapidity of testing results, uniqueness of a product, accuracy of products, 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 tests; regulatory approvals necessary prior to commercialization of the Company’s COVID-19 tests; 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 various COVID-19 tests; 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 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. The Company is under no obligation to update any forward-looking statements after the date of this release.1\. medRxiv preprint doi: https://doi.org/10.1101/2020.03.30.20047365. Accessed 15Jun20Corporate Contact: Company Spokeperson 949-645-2111

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  • Company News for Jan 13, 2021

    Companies in the news are: ACI, GM, BMRA, LMNL

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  • Biomerica’s Fast 15-Minute Simple to Use Covid-19 Antigen Rapid Test Receives CE Mark

    * Biomerica receives first orders and plans to ship tests in coming weeks   * Clinical studies demonstrated an overall performance of 94.7% positive agreement (sensitivity) and 99.7% negative agreement (specificity) as compared to lab-based molecular PCR testsIRVINE, Calif., Jan. 12, 2021 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced it has received CE Mark for its new COVID-19 Rapid Antigen Test for detection of COVID-19 infection. The Company has already received its first European orders and plans to ship the first part of these orders in the coming weeks. The Company will now begin marketing this product broadly in Europe and other regions outside of the US.Biomerica’s new COVID-19 Antigen Rapid Test is highly portable, affordable, and provides results in 15 minutes with no equipment required to perform or read the test. Because this test can be performed by doctors, nurses, school nurses, and medical assistants, the Biomerica COVID-19 Rapid Antigen Test can be performed at the point of care, outside of medical labs, taking pressure off of labs performing COVID-19 testing. The test also provides results in 15 minutes versus lab-run PCR tests which can take up to three days for results, thereby potentially expediting the process of identifying infectious people so they don't spread the disease to others.About the Biomerica COVID-19 Rapid Antigen Test: The Biomerica COVID-19 Rapid Antigen Test is intended to identify people who are currently infected and who should quarantine to help prevent the spread of the disease. No lab equipment is necessary to process the test or read the tests results. This test uses lateral flow technology, making it a reliable and familiar format for mass testing by healthcare providers. In independent testing at clinics in three different countries outside of the US, the Biomerica COVID-19 Rapid Antigen Test demonstrated an overall performance of 94.7% positive agreement (sensitivity) and 99.7% negative agreement (specificity) as compared to lab-based molecular PCR tests. The Biomerica COVID-19 Rapid Antigen Test was engineered for near-patient, point-of-care settings. A simple nasal swab is used to collect specimens from people suspected of having an active infection. Patient samples should be tested immediately and should not be diluted or used with viral transport media or frozen specimens.“We are pleased to launch the Biomerica COVID-19 Rapid Antigen Test to help combat this ongoing global pandemic and which may help people become more confident about their own health,” said Zack Irani, CEO at Biomerica. “While we are proud to be contributing to the management of the current global pandemic and help bring more normalcy into our lives, our primary focus remains the validation and commercialization of products that are based on our patented InFoods® technology platform. We continue to believe our InFoods® products could revolutionize the way people are diagnosed and treated for a variety of common diseases including Irritable Bowel Syndrome (IBS). As such, we see a large potential for helping the millions of patients suffering with IBS,” he concluded.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 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 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 is expected to 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 tests, FDA clearance, EUA clearance, the rapidity of testing results, uniqueness of a product, accuracy of products, 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 tests; regulatory approvals necessary prior to commercialization of the Company’s COVID-19 tests; 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 various COVID-19 tests; 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 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. The Company is under no obligation to update any forward-looking statements after the date of this release.Corporate Contact: Company Spokeperson 949-645-2111

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  • Imagine Holding Biomerica (NASDAQ:BMRA) Shares While The Price Zoomed 302% Higher

    Some Biomerica, Inc. ( NASDAQ:BMRA ) shareholders are probably rather concerned to see the share price fall 32% over...

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  • BMRA: InFoods Clinical Trial Advances, Further Step Towards Potential FDA Clearance

    By M. Marin NASDAQ:BMRA READ THE FULL BMRA RESEARCH REPORT Last week, Biomerica (NASDAQ:BMRA) announced that it is nearing completion of patient enrollment in the InFoods® IBS endpoint clinical trial. As a diagnostic-guided therapy (not a drug), InFoods does not have the side effects drugs often have and can be used alone and/or as part of a drug therapy program. Patient enrollments are expected

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  • Biomerica's InFoods® Irritable Bowel Syndrome Diagnostic-Guided Therapy Clinical Trial Nears Completion of Enrollment

    * Patient enrollment completion anticipated by the end of April 2021 * InFoods® Diagnostic-Guided Therapy is designed to address the $30 billion market for IBS treatment * Therapy seeks to identify patient-specific foods that trigger IBS symptoms and suffering * Approximately 45 million Americans suffer from IBS1IRVINE, Calif., Dec. 09, 2020 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today announced it is nearing completion of patient enrollment in the endpoint clinical trial for its InFoods® Irritable Bowel Syndrome (“IBS”) diagnostic-guided therapy (“DGT”). This double-blinded, randomized, controlled clinical trial is validating the Biomerica InFoods® IBS test to manage the debilitating pain and suffering of patients diagnosed with IBS. Utilizing an antibody guided blood test, the InFoods® IBS product identifies patient-specific foods that may alleviate IBS symptoms when eliminated from the diet."I am pleased our clinical endpoint trial for InFoods® IBS remains on track to complete enrollment despite the challenges imposed by this pandemic," stated Zack Irani, CEO of Biomerica. "There is clearly a large unmet need in IBS patients who seek relief but are limited to trial-and-error for foods or drugs that treat symptoms but not the cause. Importantly, the InFoods® IBS therapy can be used in isolation or as part of the pharmacological drug therapy a patient would often receive, but without adding to the side-effect burden."Mr. Irani concluded, "The endpoint trial results should open potential partnering opportunities with global health sciences, pharmaceutical and medical device companies, and is expected to pave the way to a final pivotal trial and ultimately lead to FDA clearance. InFoods® IBS, provides a novel therapy for patients suffering from IBS without the drug side-effects. We look forward to providing updates on our continued progress in the coming months as we move closer to completing this endpoint trial."As previously indicated, Mayo Clinic joined Beth Israel Deaconess Medical Center, Inc., a Harvard Medical School Teaching Hospital, Houston Methodist, University of Texas Health Science Center at Houston and the University of Michigan as enrollment centers for this study. Biomerica expects to complete patient enrollment at these centers by the end of April 2021.The clinical endpoint trial's objective is to validate key elements and provide the selection of a proper endpoint of a proposed larger and final FDA pivotal trial. The design of the InFoods® IBS product clinical endpoint study has already received a non-significant risk determination from the FDA. The Company will not be required to submit an investigational device exemption (“IDE”) for the InFoods® IBS product study.Biomerica will commence the final pivotal trial following the completion of the clinical endpoint trial.About IBS It is estimated that over 45 million Americans suffer from IBS.1 IBS is a common condition that can significantly impair the physical and mental well-being and a person's ability to function at home and in the workplace. The symptoms of IBS are often triggered by the consumption of specific foods, which differ for every individual. The total cost of IBS has been estimated at $30 billion annually in just the United States.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 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 focuses 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, severe pain and indigestion. This patented, diagnostic-guided therapy is designed to allow for a patient-specific, guided dietary regimen to improve IBS outcomes. A 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 is expected to 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, written statements and other press release issued, made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the timing of the completion of clinical studies and clinical trials, the final clinical results from clinical trials, potential partnering opportunities, the efficacy of the Company's COVID-19 test and other tests and products developed by the Company, FDA clearance, EUA clearance, receipt of CE Mark, the rapidity of testing results, uniqueness of a product, pricing of the Company's various test kits, demand for domestic and international orders for the Company's COVID-19 tests and other Company products, availability of the Company's COVID-19 tests, and patent protection on the Company's products and technologies. 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 tests, InFoods tests and other Company products; regulatory approvals necessary prior to commercialization of the Company's COVID-19 tests and other Company products; capacity, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; competition from products similar to those developed or sold by the Company and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that could 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 tests and technologies. 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 competes, 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.1Canavan et al. The epidemiology of irritable bowel syndrome Clin Epidemiol. 2014; 6: 71–80. doi: 10.2147/CLEP.S40245 Corporate Contact: Company Spokesperson 949-645-2111

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  • Biomerica Reports Fiscal 2021 1st Quarter Financial Results

    IRVINE, Calif., Oct. 16, 2020 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical products, today reported financial results for the fiscal quarter ended August 31, 2020. Net sales for the three months ended August 31, 2020 were $1.14 million compared to net sales of $1.19 million for the same period of 2019. Net loss was $1.6 million for the three months ended August 31, 2020 compared to a net loss of $0.5 million for the same period in the previous year. Research and Development (R&D) expense was $0.7 million for the three months ended August 31, 2020 compared to $0.4 million the same period in the previous year, an increase of over 80%. The increase in R&D investment expense was primarily due to the development of several COVID-19 tests, including a new antigen test for COVID-19. The Company is working to complete the validation testing of this product, which if successful, will enable the launch of the new antigen test in several weeks, pending international regulatory clearances. The Company also expects R&D investment to decrease as it prepares to move its remaining COVID-19 test products out of development and into manufacturing and sales. Selling, general and administrative expenses for the three months ended August 31, 2020 were $1.2 million, compared to $0.5 million, for the same period in the previous year. This increase was due to an increase in reserves for aged receivables, an increase in legal fees and to a lesser extent, higher salaries due to several new employees hired to help manage the company’s projected growth.Cash and cash equivalents were $7.0 million, and current assets were $13.1 million on August 31, 2020."By leveraging our technology and expertise, we were able to develop tests to detect COVID-19 antibodies quickly. While we wait for the FDA to issue an Emergency Use Authorization (EUA) for our COVID-19 antibody ELISA lab-based serology blood test, we are completing work on our COVID test line. As part of these efforts, we are planning to launch an antigen test, preparing to launch the ELISA product outside of the US under a CE mark, and filing for other point of care applications for certain products. We believe that the introduction of an antigen test will enable us to offer a more complete line of point of care products for COVID-19 testing. In addition, we have also worked diligently to differentiate our products from the competition by focusing on a simple finger-prick blood collection device, which enables blood samples to be collected virtually anywhere (corporation, university or other organization) by a trained professional. This device is used in conjunction with our ELISA lab-based serology test," said Zackary Irani, CEO of Biomerica.“International demand for our disposable point-of-care antibody test decreased during the quarter. I believe this decrease was due in part from a lower daily infection rate during the summer months in the international markets in which we operate, as well as an increase in customer focus on virus testing (PCR and antigen tests). Importantly, as we enter the fall and winter months, the daily rate of new infections is rising, and the number of persons who have been infected by COVID-19 continues to increase, we are seeing increases in demand for both antigen and antibody tests. In addition, I am encouraged to see revenues of our non-COVID related products, which have been negatively affected by the pandemic, now starting to recover,” concluded Mr. Irani.About Biomerica (NASDAQ:) 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 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 is expected to 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 tests, FDA clearance, EUA clearance, the rapidity of testing results, uniqueness of a product, pricing of the Company’s test kits, increase in demand, 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 tests; regulatory approvals necessary prior to commercialization of the Company’s COVID-19 tests; availability of the Company’s COVID-19 test kits; capacity, resource and other constraints on our suppliers; completion of validation testing; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various COVID-19 tests; 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 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. The Company is under no obligation to update any forward-looking statements after the date of this release.Corporate Contact: Company Spokesperson 949-645-2111

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