• CMS is the single largest payer for healthcare in the United States, with Medicare responsible for approximately 21% of total healthcare expenditure.
  • The $300 rate will apply to claims approved and paid by Medicare with dates of service on or after January 1, 2026.
  • Adults of Medicare age comprise over 20% of US adults and a substantial portion of patients with IBS symptoms, making Medicare a critical payer for inFoods® IBS.

IRVINE, Calif., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, today announced that the Centers for Medicare & Medicaid Services (CMS) has issued its final pricing determination for the company's inFoods® IBS test, establishing a national Medicare payment rate of $300 under the Clinical Laboratory Fee Schedule (CLFS). The pricing will apply to claims for InFoods IBS tests that Medicare approves and pays with dates of service on or after January 1, 2026.

This milestone follows the American Medical Association's (AMA) approval of a unique CPT® Proprietary Laboratory Analyses (PLA) code for inFoods® IBS, which became effective October 1, 2025. The CMS pricing determination establishes a clear national payment rate for the test and this pricing clarity should expand patient access.

Significant Commercial Milestone

The $300 CLFS payment rate provides a foundation for negotiations with private insurers. CMS is the single largest payer for healthcare in the United States, with Medicare responsible for approximately 21% of total healthcare expenditure.

"The CMS pricing determination is a major milestone for Biomerica and for patients suffering from IBS," said Zack Irani, CEO of Biomerica. " With both a dedicated PLA code and established Medicare pricing, we are well-positioned for continued commercial growth in 2026 and beyond."

Addressing a Significant Unmet Need

Irritable bowel syndrome affects approximately 10% to 15% of adults in the United States, representing over 30 million potential patients. The condition significantly reduces quality of life and work productivity, with patients experiencing chronic symptoms including abdominal pain, bloating, diarrhea, and constipation. Current treatment options often provide inconsistent relief and may involve side effects or compliance challenges that many patients find difficult to sustain. In addition, there no FDA-approved drugs for IBS-M (mixed constipation and diarrhea), IBS subtype which is represents approximately 1/3 of the IBS market.

The inFoods® IBS test addresses this unmet need through a personalized diagnostic approach that identifies patient-specific food triggers contributing to IBS symptoms. By measuring immune responses to IBS trigger foods, the test enables physicians to provide targeted dietary recommendations that address underlying causes rather than merely managing symptoms.

Clinical Validation and Evidence

The clinical efficacy of inFoods® IBS was demonstrated in a rigorous randomized, multicenter (Mayo Clinic, Harvard Beth Israel Deaconess, University of Michigan, etc.), double-blind, placebo-controlled trial published in Gastroenterology , a leading medical journal in the field. The study found that 59.6% of patients who eliminated trigger foods identified by the inFoods IBS test, met the FDA-standard target for abdominal pain reduction, compared to 42.2% in the control group.

The benefits were particularly notable in difficult-to-treat patient populations: 67.1% of IBS-C (constipation) patients in the treatment group met the FDA target for pain reduction versus 35.8% in the control group, while 66% of IBS-M (mixed constipation and diarrhea) patients experienced FDA-target pain reduction compared to 29.5% in the control group.

"The convergence of Level 1 clinical evidence, a dedicated PLA code, and a national CLFS price represents an important inflection point for InFoods IBS," said Scott Madel, Chief Commercial Officer of Biomerica.

Commercial Strategy and Market Access

With the CMS payment rate now established, the Company and its lab partner will work with Medicare Administrative Contractors to attain Medicare coverage for the inFoods® IBS test. Biomerica will also work to use the CMS pricing as a benchmark to begin negotiations with private commercial insurers such as Aetna, United Healthcare, Blue Cross and others. The Company will also continue working to expand relationships with gastroenterology practices and leverage clinical trial relationships with institutions including Mayo Clinic, Harvard, University of Michigan, and University of Texas Medical Center. Biomerica will seek to expand distribution of the test in the US with partners similar-to the previously announced distribution relationship with Henry Schein.

Key Value Propositions

The CMS pricing announcement strengthens several aspects of Biomerica's market opportunity:

Differentiated Offering : inFoods IBS is the only IBS specific diagnostic guided dietary intervention supported by the largest of its kind randomized, multi-center clinical trial published in a leading peer-reviewed journal

Large Patient Population : Substantial market opportunity with over 30 million IBS patients in the US

Personalized Medicine Approach : Aligns with growing demand for non-pharmaceutical treatment alternatives

Platform Potential : inFoods® technology applicable to, and holds patents for, additional gastrointestinal conditions

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 primarily focuses 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 current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company’s products and tests including the inFoods IBS Test, FDA, CMS, Medicaid and/or international regulatory authorization for the Company’s products to be marketed and sold, including the inFoods IBS Test, and the Company’s other current and future products, the possible current or future payment coverage by CMS, Medicare or other government agencies in the US and in other markets for the inFoods IBS test or other Company tests provided to patients, the possible future payment coverage or reimbursement of the inFoods IBS test by private medical insurance companies, expansion in to other markets, uniqueness of the Company’s products, accuracy of the Company’s tests and products, pricing of the Company’s test kits, domestic and/or international market adoption and acceptance and demand for the Company’s products including the inFoods IBS Test, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company’s inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; availability of the Company’s test kits and other products; capacity, shipping logistics, 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; regulatory compliance and oversite, and the Company’s ability to obtain patent protection on any aspects of its diagnostic or therapeutic 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 | CEO
p. 949.645.2111
www.biomerica.com

Source: Biomerica