Biomerica Reports Real-World Data: Nearly 60% of IBS Patients Achieved Clinically Meaningful Pain Reduction and 68% Achieved Bloating Reduction with the inFoods® IBS Therapy

Rhea-AI Summary

Biomerica (Nasdaq: BMRA) reported real-world responder results for inFoods® IBS: 59.4% of 69 patients had ≥30% abdominal pain reduction and 68.1% had ≥30% bloating reduction using the FDA-recognized responder endpoint.

Mean pain scores fell 34.6% and bloating 41.7% at 8 weeks. Commercial milestones include a $300 national Medicare rate (effective Jan 1, 2026), a dedicated CPT PLA code (effective Oct 1, 2025), and a Henry Schein marketing services agreement.

Positive

• Pain responder 59.4% (41 of 69 patients met ≥30% reduction)
• Bloating responder 68.1% (47 of 69 patients met ≥30% reduction)
• Mean pain -34.6% from 3.24 to 2.12 at 8 weeks (P = 0.0002)
• Mean bloating -41.7% from 4.35 to 2.54 at 8 weeks (P < 0.0001)
• $300 CMS rate established nationally, effective Jan 1, 2026
• CPT PLA code approved effective Oct 1, 2025, simplifying billing
• Henry Schein agreement provides access to 400+ sales representatives

Negative

• Small real-world sample size: n=69, limiting statistical generalizability
• Real-world study lacked a randomized control arm, constraining causal inference

Key Figures

Pain responders: 59.4% Bloating responders: 68.1% Study completers: 69 patients +5 more

8 metrics

Pain responders 59.4% Patients achieving ≥30% abdominal pain reduction in 8-week real-world study (41 of 69)

Bloating responders 68.1% Patients achieving ≥30% bloating reduction in 8-week real-world study (47 of 69)

Study completers 69 patients Patients completing full 8-week protocol with baseline and endpoint assessments

Pain score change 34.6% decrease Mean abdominal pain score fell from 3.24 to 2.12 at 8 weeks (IgG-positive subgroup)

Bloating score change 41.7% decrease Mean bloating score declined from 4.35 to 2.54 at 8 weeks (IgG-positive subgroup)

Pain p-value P = 0.0002 Statistical significance for abdominal pain reduction in IgG-positive subgroup

Bloating p-value P < 0.0001 Statistical significance for bloating reduction in IgG-positive subgroup

CMS Medicare rate $300 National Medicare payment rate for inFoods IBS test effective January 1, 2026

Market Reality Check

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Peers on Argus

BMRA’s 2.86% gain came as peers showed mixed moves: RSLS +29.8%, LFWD +18.27%, P...

1 Up 2 Down

BMRA’s 2.86% gain came as peers showed mixed moves: RSLS +29.8%, LFWD +18.27%, PAVM +4.85%, HSCS -0.36%, SSKN flat. Multiple peers advancing suggests some sector tailwind alongside company-specific news.

Historical Context

5 past events · Latest: Feb 18 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 18	Intl. approval	Positive	+0.0%	Vietnam approved EZ Detect for nationwide colorectal cancer screening distribution.
Jan 14	Earnings results	Negative	-0.6%	Reported lower revenue, ongoing losses, and going concern language for FY2026 Q2.
Dec 23	Reimbursement win	Positive	+10.6%	CMS set a <b>$300</b> national Medicare payment rate for inFoods IBS testing.
Dec 11	Regulatory authorization	Positive	+3.2%	Egyptian Drug Authority authorized Biomerica’s full rapid screening test portfolio.
Nov 25	Clinical profile	Positive	+4.4%	InFoods IBS trial data featured, showing strong responder rates vs. control in IBS patients.

Pattern Detected

Recent positive commercial and clinical milestones have usually aligned with upward price reactions, with one notable instance of no move on good news.

Recent Company History

Over the past six months, Biomerica has advanced both international distribution and its inFoods IBS platform. Authorizations in Egypt and Vietnam expanded access to its screening portfolio and EZ Detect test, while inFoods IBS gained visibility through a feature in Biotherapeutics Quarterly and a CMS decision setting a $300 Medicare rate effective January 1, 2026. Earnings updates highlighted weaker sales and going-concern risks but also a strategic pivot toward diagnostic-guided therapy, making today’s real-world IBS data a continuation of that commercialization focus.

Market Pulse Summary

This announcement reinforces inFoods IBS with real-world evidence, showing 59.4% of patients achievi...

Analysis

This announcement reinforces inFoods IBS with real-world evidence, showing 59.4% of patients achieving clinically meaningful pain reductions and 68.1% achieving bloating reductions using FDA-recognized endpoints. The data build on prior randomized controlled trial results and tie into a CMS Medicare payment rate of $300 starting in 2026. Investors may watch how these outcomes support physician adoption, reimbursement uptake, and revenue trends against the backdrop of recent going-concern disclosures.

Key Terms

randomized controlled trial, clinical laboratory fee schedule

2 terms

randomized controlled trial medical

"the Company’s peer-reviewed randomized controlled trial (RCT) published in Gastroenterology."

A randomized controlled trial is a research method that tests the effects of a new idea or treatment by randomly dividing participants into two groups: one that receives the treatment and one that does not. This approach helps ensure that the results are fair and unbiased, providing clear evidence about whether the treatment actually works. Investors value such trials because they offer reliable information that can influence decision-making and reduce uncertainty.

clinical laboratory fee schedule regulatory

"under the Clinical Laboratory Fee Schedule, effective January 1, 2026."

A clinical laboratory fee schedule is a set list of prices that a payer—such as a government program or insurance company—will reimburse for specific lab tests and services. Think of it as a menu of allowed payments that determines how much labs can charge and get paid; changes to those prices directly affect a lab’s revenue, profit margins and investment prospects because lower rates squeeze earnings while higher rates improve cash flow.

AI-generated analysis. Not financial advice.

Physician Interview Now Available

Key Highlights

• Responder Analysis: 59.4% of patients achieved ≥30% reduction in abdominal pain; 68.1% achieved ≥30% reduction in bloating—using the FDA-recognized responder endpoint consistent with the Company’s peer-reviewed randomized controlled trial.
• CMS Payment Rate: $300 national Medicare payment rate established, effective January 1, 2026.
• Physician Perspective: New interview with Gastroenterologist Dr. Dak Patel about inFoods IBS in clinical use now available at https://investors.biomerica.com/events-and-presentations/default.aspx
  

IRVINE, Calif., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), an innovator in diagnostic-guided therapy, today announced responder analysis results from its ongoing real-world study of inFoods® IBS. The data demonstrates that a majority of patients achieved clinically meaningful reductions in both abdominal pain and bloating—the two most debilitating symptoms of Irritable Bowel Syndrome (IBS).

Responder Analysis

The analysis was conducted on 69 patients who completed the full 8-week study protocol with both baseline and endpoint assessments. The FDA-recognized responder definition of ≥30% improvement in weekly average symptom scores was applied—the same endpoint used in the Company’s peer-reviewed randomized controlled trial (RCT) published in Gastroenterology:

• Abdominal Pain: 59.4% of patients (41 of 69) met the responder threshold.
• Bloating: 68.1% of patients (47 of 69) met the responder threshold.

Among the 69 patients, 62 patients tested positive for one or more food sensitivities on the IBS-specific IgG assay:

• Mean abdominal pain scores decreased 34.6%, from 3.24 at baseline to 2.12 at 8 weeks (P = 0.0002).
• Mean bloating scores declined 41.7%, from 4.35 to 2.54 at 8 weeks (P < 0.0001).

These results validate the inFoods® IBS test in a real-world clinical setting using the same rigorous endpoints the FDA applies to clinical trials for IBS drug therapies, demonstrating clinical utility beyond controlled trial conditions.

Consistency with Peer-Reviewed Controlled Trial

These real-world findings build on a peer-reviewed, randomized controlled clinical trial of inFoods® IBS which is published in Gastroenterology. That study was conducted across five major academic centers, including Mayo Clinic, Cleveland Clinic, Beth Israel Deaconess Medical Center (Harvard Medical School), the University of Michigan, and Houston Methodist Hospital. That pivotal study demonstrated significantly greater abdominal pain relief in the treatment arm versus the sham diet arm (59.6% vs. 42.1%, p = 0.02 using the FDA responder endpoint).

The 59.4% real-world pain responder rate from the use of inFoods® IBS closely mirrors the 59.6% result from the controlled trial—offering an unusual degree of consistency between controlled and real-world settings that strengthens confidence in the product’s clinical utility.

Commercial Milestones

• CMS Medicare Payment Rate: In December 2025, CMS established a national Medicare payment rate of $300 for the inFoods® IBS test under the Clinical Laboratory Fee Schedule, effective January 1, 2026. The Company is working with Medicare Administrative Contractors to begin coverage and will also use the CMS pricing as a benchmark for negotiations with private commercial insurers.
• Henry Schein Marketing Agreement: In late 2025, the Company entered into a marketing services agreement with Henry Schein, Inc. (Nasdaq: HSIC), providing access to more than 400 medical field sales and tele-sales representatives targeting primary care and gastroenterology practices nationwide.
• Dedicated CPT® Code: The American Medical Association approved a unique CPT® PLA code for inFoods® IBS, effective October 1, 2025, simplifying billing for physicians and laboratories.
  

Physician Interview

A new interview with Dr. Dak Patel—discussing his first-hand clinical experience prescribing inFoods® IBS—is now available on the Company’s investor relations website at https://investors.biomerica.com/events-and-presentations/default.aspx. The interview offers investors, prospective physician partners, and other stakeholders insight into how the product is being integrated into clinical practice and the patient outcomes observed in a real-world setting.

“This responder analysis represents another significant data set for inFoods® IBS,” said Zack Irani, CEO of Biomerica. “Nearly 60% of patients saw clinically meaningful pain relief and more than two-thirds experienced significant improvement in bloating—using the FDA’s own standard for clinical response. These outcomes, combined with the $300 CMS Medicare rate, and our Henry Schein partnership, are building an increasingly compelling case for physicians, patients, payers, and potential partners.”

Market Opportunity

IBS affects an estimated 30 to 45 million adults in the United States, representing 10%–15% of the adult population. The condition leads to decreased quality of life, lost productivity, and reliance on medications with adverse side effects. Current IBS drugs address symptoms without targeting the underlying dietary triggers specific to each patient.

inFoods® IBS takes a fundamentally different approach—a precision diagnostic that identifies individual food triggers via a simple finger-stick blood test, enabling targeted, patient-specific dietary recommendations. This non-pharmacologic, personalized solution addresses a significant unmet clinical need within an estimated $30 billion total addressable market.

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.

About inFoods® IBS

inFoods® IBS is a diagnostic-guided therapy that identifies patient-specific food triggers responsible for symptoms such as abdominal pain, bloating, diarrhea, and constipation. Using a simple finger-stick blood sample, the test enables physicians to recommend targeted dietary changes tailored to the patient’s immune response—offering a non-pharmaceutical, precision-based approach to symptom relief.

A multicenter, double-blinded clinical study on the inFoods® IBS test was published in the June issue of Gastroenterology, the top peer-reviewed GI journal. As the largest study of its kind, it demonstrated statistically significant outcomes:

• 59.6% of patients in the treatment group (who eliminated identified trigger foods) achieved the FDA’s endpoint for abdominal pain reduction, compared to 42.2% in the control group.
• Among IBS-C patients, 67.1% of patients in the treatment group vs. 35.8% in the control group.
• Among IBS-M patients, 66% of patients in the treatment group vs. 29.5% in the control group.
  

These results highlight inFoods® IBS as the only targeted therapy to demonstrate efficacy specifically in IBS-M patients, a subgroup historically underserved by existing treatments. The study was conducted at leading U.S. institutions including Cleveland Clinic, Mayo Clinic, University of Michigan, and Beth Israel Deaconess Medical Center.

For more information about inFoods® IBS, visit www.inFoodsibs.com.

inFoods® IBS is Laboratory Developed Test (LDT) used within a single laboratory that is certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high-complexity testing.

Forward-Looking Statements

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.

Investor Contact: Zack Irani | 949-645-2111 | investors@biomerica.com
Source: Biomerica, Inc.

FAQ

What were Biomerica (BMRA) inFoods® IBS real-world pain responder results on Feb 26, 2026?

About 59.4% of patients achieved ≥30% abdominal pain reduction in the real-world study. According to the company, this rate came from 41 of 69 patients completing an 8-week protocol using the FDA-recognized responder endpoint.

How many patients showed bloating improvement with BMRA inFoods® IBS in the February 2026 data?

Approximately 68.1% of patients met the ≥30% bloating reduction threshold. According to the company, that equals 47 of 69 patients with mean bloating scores falling from 4.35 to 2.54 at 8 weeks (P < 0.0001).

What Medicare payment rate did Biomerica (BMRA) secure for inFoods® IBS and when is it effective?

Biomerica secured a national Medicare payment rate of $300, effective January 1, 2026. According to the company, CMS established the $300 rate under the Clinical Laboratory Fee Schedule in December 2025.

Does inFoods® IBS have a CPT code for billing and when did it take effect for BMRA?

Yes. A dedicated CPT PLA code for inFoods® IBS became effective October 1, 2025. According to the company, the AMA approval simplifies billing for physicians and laboratories.

What commercial distribution support did Biomerica (BMRA) announce for inFoods® IBS in late 2025?

Biomerica announced a marketing services agreement with Henry Schein giving access to 400+ field and tele-sales representatives. According to the company, this targets primary care and gastroenterology practices nationwide.

How robust is the Feb 26, 2026 BMRA real-world study evidence for inFoods® IBS clinical utility?

The data show promising symptom reductions but are limited by a small n=69 and lack of randomized control. According to the company, results mirror prior RCT findings, enhancing confidence while noting real-world constraints.