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inFoods® IBS Test Now Validated for Use with Simple Finger Stick Whole Blood Collection Technology

Biomerica, Inc.
·7 min read
Biomerica, Inc.
Biomerica, Inc.

  • Gastro Health, a leading gastroenterology group, plans to utilize this simplified blood collection method when recommending the inFoods® IBS to their patients

  • Biomerica also announced that inFoods® IBS clinical trial data was presented at the DDW conference May 8th.The data showed that the inFoods® IBS treatment diet significantly improved several key IBS symptoms including Abdominal Pain Intensity (API)

  • inFoods IBS showed improvement in API similar to, and in some cases better than, current IBS drugs in the market

NEWPORT BEACH, Calif., May 18, 2023 (GLOBE NEWSWIRE) -- Biomerica Inc. (NASDAQ: BMRA), a global biomedical company leading the way in innovative gastroenterology solutions, announced a significant advance in the management of irritable bowel syndrome (IBS). The inFoods® IBS diagnostic test has now been validated for use with finger stick (capillary) patient whole blood samples simplifying sample collection and facilitating wider access to the test.  With this new finger stick blood collection option, any trained medical professional in the doctor’s office can collect the patient’s blood sample during their office visit and forward the sample to the Lab for processing. This workflow enhancement greatly simplifies the process for healthcare providers to order the inFoods IBS test and is much easier for patients.  The InFoods IBS test will continue to be available using blood collected from a patient’s arm (venipuncture) by a trained phlebotomist.

The inFoods® IBS test is the first of its kind to identify specific foods that may trigger or provoke an IBS symptom, providing personalized dietary recommendations to help manage this often-debilitating condition. The test is offered as a laboratory developed test (LDT) performed in a CAP accredited, CLIA-certified high-complexity laboratory.

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It is estimated that over 40 million Americans suffer from IBS, with symptoms often triggered by consumption of specific foods (which are unique to each patient). The total direct and indirect cost of IBS has been estimated at $30 billion annually in the United States alone.

"This is a significant step forward for patients, healthcare providers, and the broader medical community," said Zackary Irani, CEO of Biomerica. "By enabling the use of finger stick whole blood samples, we're making our personalized IBS therapy more convenient and easier than ever. This process reduces patient discomfort, and facilitates wider access to the inFoods IBS test, allowing healthcare providers in a variety of settings to efficiently use inFoods IBS and initiate appropriate treatment plans."

Mr. Robert Carlson, Biomerica’s Chief Commercial Officer stated, "This advancement reflects our continued commitment to innovation and significantly expands the number of physician offices that can use the inFoods IBS system to create treatment protocols for their IBS patients". "Our goal is to make living with IBS easier by providing a personalized and accessible test that empowers patients to understand potential food triggers and help control their condition."

The inFoods IBS clinical study was performed at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. - a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan. In data presented May 8th at the 2023 Digestive Disease Week (DDW) annual meeting, clinical results for improvement in the Abdominal Pain Intensity (API) responder endpoint of >30%, for IBS patients in the treatment diet arm had a statistically significant improvement over patients in the placebo diet arm (p-value of 0.0246). The improvement for patients in the treatment arm versus the placebo arm is considered clinically significant and is similar and, in some cases, better than the current drugs in the market.

About InFoods IBS:
The InFoods IBS test involves a simple blood collection procedure and is designed to assess a patient’s above normal immunoreactivity to specific foods. Instead of difficult to manage broad dietary restrictions, physicians can now use the InFoods IBS information to make targeted, patient-specific recommendations about specific foods that, when removed from the diet, may alleviate IBS symptoms such as pain, bloating, diarrhea and constipation. Further information about Biomerica’s patented InFoods® Technology Platform can be found at: https://biomerica.com/inFoods/our-technology/

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.

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 Company’s InFoods® IBS test and other tests, FDA clearance or possible future clearance of the Company’s InFoods® IBS test and other products, timing of the commercial launch of the InFoods® IBS test, the efficacy of the InFoods product, possible future revenues from the sale of the InFoods® IBS test, growth in future revenues from the sale of the InFoods® IBS test, acceptance of the InFoods® IBS test by physicians and their patients, international regulatory approval and sales of the InFoods® IBS test, accuracy, efficacy and clinical trial results of the InFoods® IBS test, the rapidity of testing results, negotiations with clinical labs who would offer the InFoods® IBS test, the ability of a CLIA-certified, high-complexity lab to offer the InFoods® IBS test as a laboratory developed test (LDT), discussions with physicians and physician groups who could or would offer the InFoods Test to their patients, efficacy of the InFoods IBS test to improve IBS symptoms in patients, the company’s ability to manufacture the InFoods® IBS test as a commercial product and to increase manufacturing capacity to meet future product demands, any future FDA marketing authorization, the uniqueness of the Company’s InFoods® IBS test and other products, pricing of the Company’s InFoods® IBS test, future possible insurer reimbursement for the InFoods® IBS test, patent protection on the InFoods® IBS and the underlying technology of the test, or on any of the Company’s other products or technologies, and current or future competition for the InFoods® IBS test from other medical manufacturers or distributors. 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 tests and products; regulatory approvals necessary prior to commercialization any of the Company’s products; availability of the Company’s 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 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; the Company’s ability to comply with current and future regulations in the countries where our products are made and sold 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:

Zack Irani-Cohen
949-645-2111
investors@biomerica.com

Source: Biomerica, Inc.