Biomerica Reviews Fiscal 2021 Second Quarter Financial Final results and Gives Business Update

  • Biomerica expects completion of enrollment of its Irritable Bowel Syndrome Diagnostic-Guided Treatment medical demo by conclude of April, 2021
     
  • Fda actively reviewing Company’s EUA submission for its initially of its form “at-home” Blood Selection package utilized with the Biomerica COVID-19 IgG ELISA Lab Take a look at system
     
  • Straightforward to use 15-minute COVID-19 Antigen Fast Take a look at, which now has CE Mark, receives initial substantial orders

IRVINE, Calif., Jan. 15, 2021 (World NEWSWIRE) — Biomerica, Inc. (Nasdaq: BMRA), a world wide supplier of sophisticated health-related items, these days declared fiscal benefits for its second quarter of fiscal yr 2021, which ended November 30, 2020.

The Company noted 2nd quarter all over the world profits of $1.373 million as compared to $1.596 million for the exact same interval in the former 12 months. The reduce in profits during the quarter was generally thanks lower product sales in Asia. However, income in Asia have substantially elevated in the to start with half of the third fiscal quarter. Net loss was $1.485 million for the 2nd fiscal quarter when compared to a net loss of $.485 million for the very same period in the prior fiscal year. The improve in net loss was generally owing to increased research and growth cost, largely linked to the improvement of several COVID-19 tests, and larger general and administrative expenditures, predominantly because of to improves in authorized expenses, reserves and personnel/consulting expenses. Cash and money equivalents ended up $5.684 million, and latest belongings ended up $11.947 million, at the stop of the next fiscal quarter.

The Corporation declared that the U.S. Food and Drug Administration (“FDA”) is now actively reviewing the Company’s Unexpected emergency Use Authorization (“EUA”) application for its COVID-19 IgG ELISA Take a look at together with the Company’s professional use and at-property Total Blood Selection Card technique. If EUA clearance is granted, it would be the initial for an in-household blood sample selection method merged with an ELISA check kit. This selection technique delivers the simplicity of a finger-prick blood sample which can be conveniently collected in numerous options these kinds of as residences, faculties, workplace, community care and health care configurations, and have these samples sent back to a lab to be run on the Company’s very accurate ELISA examination. In clinical scientific studies, the finger-prick blood collected samples demonstrated 100{23996c8f5258275f450f40d5a867c22ad72c04895f28059581bc525cc6cb4bd0} specificity for detecting IgG antibodies to the spike protein of SARS-CoV-2 and {23996c8f5258275f450f40d5a867c22ad72c04895f28059581bc525cc6cb4bd0} cross-reactivity with quite a few typical illnesses. The Company’s COVID-19 IgG ELISA check makes use of modified trimeric spike protein from the SARS-CoV-2 virus, which is regarded to be the goal of neutralizing antibodies that stop the virus from coming into cells.1

The Enterprise also lately introduced that it has gained a CE mark for its new antigen quick exam. The Corporation has currently gained its very first significant European orders and ideas to ship the initially part of these orders in the coming weeks. The Enterprise will now begin advertising and marketing this products broadly in Europe and other locations outdoors of the U.S. Biomerica’s new COVID-19 Antigen Rapid Examination is hugely moveable, very affordable and offers success in somewhere around 15 minutes with no machines demanded to execute or browse the take a look at. This exam can be executed by medical doctors, nurses, school nurses, clinical assistants, and educated clinical specialists. In independent screening at clinics in three distinctive international locations outdoors of the U.S., the Biomerica COVID-19 Speedy Antigen Take a look at shown an overall performance of 94.7{23996c8f5258275f450f40d5a867c22ad72c04895f28059581bc525cc6cb4bd0} beneficial arrangement (sensitivity) and 99.7{23996c8f5258275f450f40d5a867c22ad72c04895f28059581bc525cc6cb4bd0} negative arrangement (specificity) as in contrast to lab-centered molecular PCR checks. A simple nasal swab is made use of to acquire specimens from people suspected of obtaining an active infection. Patient samples really should be analyzed right away and should really not be diluted or utilized with viral transportation media or frozen specimens.

Also, as formerly declared, the Enterprise is nearing completion of affected individual enrollment in the endpoint scientific demo for its InFoods® Irritable Bowel Syndrome (“IBS”) diagnostic-guided treatment (“DGT”). This double-blinded, randomized, controlled medical demo is validating the Biomerica InFoods® IBS test to take care of the debilitating agony and struggling of clients diagnosed with IBS. Making use of an antibody guided blood exam, the InFoods® IBS products identifies affected individual-precise foods that may perhaps relieve IBS signs and symptoms when removed from the patient’s diet program. Mayo Clinic, Beth Israel Deaconess Medical Center, Inc., a Harvard Clinical University Educating Hospital, Houston Methodist, University of Texas Well being Science Middle at Houston, and the College of Michigan are collaborating in this examine. Biomerica expects to total affected person enrollment at these facilities by the end of April, 2021, and to have summary investigation outcomes from the scientific demo by the close of July, 2021.

“We have worked to differentiate our COVID-19 solutions from the level of competition by focusing on proprietary procedures of sample assortment. For instance, by working with our straightforward finger-prick blood selection product we can allow a basic collection of a blood sample virtually everywhere (at house, at the place of work, or just about any other location). At the very same time, we are now launching our issue of care 15-moment antigen take a look at. Most importantly, we are incredibly psyched about nearing completion of affected person enrollment in our endpoint scientific trial for its InFoods® IBS diagnostic-guided treatment. Although we are very pleased to be encouraging with the current world wide pandemic, it is vital to be aware that our main extensive-term target continues to be on validation and commercialization of items based mostly on our patented InFoods® technological innovation platform. We continue on to believe that our InFoods solutions could revolutionize the way persons are diagnosed and dealt with for a selection of gastrointestinal conditions, when supplying Biomerica sizable profits opportunities,” stated Zackary Irani, CEO of Biomerica.

About Biomerica (NASDAQ: BMRA)
Biomerica, Inc. ( www.biomerica.com ) is a international biomedical know-how firm that develops, patents, manufactures and markets innovative diagnostic and therapeutic items made use of at the stage of care (in property and in physicians’ workplaces) and in hospital/clinical laboratories for detection and/or remedy of professional medical situations and conditions. The Company’s items are made to greatly enhance the well being and very well-currently being of folks, even though cutting down whole healthcare costs. Biomerica’s largely concentration is on gastrointestinal and inflammatory diseases exactly where the Enterprise has a number of diagnostic and therapeutic items in development.

About InFoods®
The Biomerica InFoods® IBS solution is created to permit doctors to recognize patient-precise foods (e.g., eggs, broccoli, wheat, potatoes, corn, etc.), that when eliminated from the diet plan, might reduce or make improvements to an individual’s IBS signs and symptoms such as, but not confined to, constipation, diarrhea, bloating, discomfort and indigestion. This patented, diagnostic-guided therapy is created to make it possible for for a patient-unique, guided dietary program to improve IBS outcomes. The level-of-care item is remaining made to allow for doctors to carry out the test in-office applying a finger stick blood sample though a medical lab variation of the product is expected to be the very first for which the Corporation will seek regulatory approval. A billable CPT code that can be utilised by both medical labs and physicians’ places of work is presently accessible for InFoods® diagnostic goods. Because the InFoods® product is a diagnostic-guided therapy, and not a drug, it has no drug variety aspect results. An estimated 45 million people in America at this time endure from IBS producing it a top result in for affected person health care provider visits.

The Private Securities Litigation Reform Act of 1995 gives a “safe harbor” for forward-looking statements. Particular details integrated in this push launch (as nicely as facts provided in oral statements or other published statements designed or to be created by Biomerica) includes statements that are ahead-wanting, these as statements relating to the efficacy of the Company’s COVID-19 exams, Fda clearance, EUA clearance, the rapidity of screening effects, uniqueness of a merchandise, precision of items, pricing of the Company’s check kits, demand for intercontinental orders, availability of the Company’s COVID-19 exam kits, and patent protection on the test technologies. These types of ahead-searching information and facts involves crucial challenges and uncertainties that could drastically impact expected effects in the future, which includes, with out limitation: success of experiments screening the efficacy of the Company’s COVID-19 checks regulatory approvals required prior to commercialization of the Company’s COVID-19 tests availability of the Company’s COVID-19 examination kits capacity, useful resource and other constraints on our suppliers dependence on our third celebration brands dependence on international shipping and delivery carriers governmental import/export restrictions demand from customers for our various COVID-19 tests opposition from other comparable items and from rivals that have substantially more economical and other assets obtainable to them governmental virus control rules that make it hard or not possible for the enterprise to manage current operations restrictions and the Company’s capacity to receive patent defense on any features of its quick test know-how. Appropriately, these success could vary materially from these expressed in any ahead-seeking statements manufactured by or on behalf of Biomerica. Moreover, probable threats and uncertainties consist of, amongst other people, fluctuations in the Company’s functioning effects because of to its business enterprise design and growth designs, downturns in global and or national economies, the Company’s capacity to elevate further funds, the competitive atmosphere in which the Organization will be competing, and the Company’s dependence on strategic associations. The Corporation is under no obligation to update any forward-hunting statements soon after the day of this release.

1. medRxiv preprint doi: https://doi.org/10.1101/2020.03.30.20047365. Accessed 15Jun20

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