Biomerica Inc Stock Price, News & Analysis

Biomerica announced the publication of its pivotal clinical trial results for the inFoods® IBS test in Gastroenterology journal. The randomized, multicenter, double-blind study involving 238 patients across eight U.S. academic centers demonstrated significant symptom improvement in IBS patients following a personalized elimination diet. The treatment group showed 59.6% of patients achieving FDA-defined abdominal pain reduction versus 42.2% in the control group. Notably, IBS-M patients showed remarkable improvement with 66% meeting treatment targets compared to 29.5% in controls. The test, which identifies specific foods triggering immune responses in IBS patients, showed particular promise for IBS-M patients, who represent 33% of the IBS market and currently lack FDA-approved drug treatments.

Biomerica (NASDAQ: BMRA) reported significant real-world data for its inFoods® IBS diagnostic-guided therapy, showing remarkable symptom reduction in IBS patients. Data from over 360 patients demonstrated a 48.5% reduction in gastrointestinal pain and a 49.8% reduction in bloating over an 8-week period.

The company also launched a HIPAA-compliant real-time patient feedback system that enables physicians to track symptoms and adjust treatment plans accordingly. These results complement a peer-reviewed study published in Gastroenterology, which showed that patients on an inFoods® IBS-guided diet experienced significantly more abdominal pain relief compared to placebo (59.6% vs. 42.1%, p-value=0.02).

The solution targets a substantial market, as IBS affects 10-15% of U.S. adults, offering a personalized, non-drug approach to identify and eliminate specific food triggers causing IBS symptoms.

Biomerica (NASDAQ: BMRA) has submitted a Proprietary Laboratory Analysis (PLA) code application to the American Medical Association for its inFoods® IBS diagnostic test. This represents a crucial step toward obtaining insurance reimbursement and expanding patient access. The inFoods® IBS test is a non-invasive diagnostic tool that identifies patient-specific foods triggering IBS symptoms like bloating, abdominal pain, diarrhea, and constipation. A published clinical trial in Gastroenterology demonstrated significantly greater symptom relief in patients following personalized diets based on test results compared to placebo. The test addresses a significant market, as IBS affects 10-15% of U.S. adults and contributes to billions in healthcare costs annually. The test is currently available for direct-to-consumer ordering through www.inFoodsIBS.com.

Biomerica (Nasdaq: BMRA) has received approval from the UAE Ministry of Health and Prevention for its Fortel® Ulcer Test, a rapid diagnostic tool for detecting H. pylori infection. The test delivers results in 10 minutes and identifies the bacterium responsible for peptic ulcers, dyspepsia, and gastric cancer.

H. pylori affects approximately 35% of the U.S. population, 45% in major European countries, and over 50% in the UAE. The WHO has classified it as a Class 1 carcinogen, with 15-20% of infected individuals developing complications. Notably, about 80% of gastric cancer cases, the third most common cause of cancer-related death globally, are linked to H. pylori infection.

This approval strengthens Biomerica's presence in the Middle East, following previous launches of other diagnostic products. The company is working with UAE-based distributors to make the test available throughout the country.

Biomerica (NASDAQ: BMRA) has received approval from the UAE Ministry of Health and Prevention for its Fortel® Kidney Disease Test, enabling commercial expansion in the UAE market. The 10-minute urine test detects early signs of kidney damage by measuring microalbumin levels.

The approval addresses a significant healthcare need in the UAE, where over 12% of adults have diabetes and 29-35% have hypertension - major risk factors for chronic kidney disease (CKD). The test targets high-risk individuals, including those with diabetes, hypertension, obesity, and people over 65.

CKD is globally underrecognized, with more than 80% of at-risk patients undiagnosed. By 2040, it's projected to be the 5th highest cause of years of life lost globally. Early detection enables timely intervention to prevent progression to end-stage renal disease, potentially reducing healthcare costs and improving patient outcomes.

Biomerica (NASDAQ: BMRA) has announced a 1-for-8 reverse stock split effective April 21, 2025, aimed at regaining compliance with Nasdaq's minimum bid price requirement. The split will automatically convert every 8 pre-split shares into one new share, reducing outstanding shares from approximately 20.37 million to 2.55 million.

The company's common stock will continue trading on The Nasdaq Capital Market under the symbol 'BMRA' with a new CUSIP number (09061H406). The split was authorized at Biomerica's 2024 Annual Meeting on December 13, 2024. Fractional shares will be rounded up to the next whole share.

Proportionate adjustments will be made to equity awards, option exercise prices, and shares available under stock incentive plans. The par value remains unchanged. Stockholders holding shares electronically will receive transaction notices, while those holding through brokers will have positions automatically adjusted.

Biomerica (NASDAQ: BMRA) reported Q3 fiscal 2025 financial results with 10% year-over-year revenue growth to $1.10 million. The company achieved significant improvements in financial metrics, including a gross margin increase from -15% to +2% and a 37% reduction in operating expenses to $1.20 million.

Key developments include UAE regulatory approval for the Fortel® PSA Screening Test, publication of positive inFoods® IBS clinical trial results in Gastroenterology journal, and CE-IVDR certification for new food intolerance products targeting Ulcerative Colitis.

The company reached its cost savings target early, delivering $1.1 million in savings (16% of annual operating expenses) within the first nine months. Cash burn improved by over 55% to $800,000 quarterly, with cash and equivalents at $3.06 million as of February 28, 2025.

Biomerica (NASDAQ: BMRA) has secured IVDR certification in the European Union for its food intolerance diagnostic products targeting Crohn's Disease and Ulcerative Colitis. The certification validates compliance with the EU's new In Vitro Diagnostic Medical Devices Regulation (IVDR – 2017/746), demonstrating the products' safety, quality, and performance standards.

The company's proprietary technology helps identify specific foods that may trigger inflammation in patients with these inflammatory bowel diseases (IBD). This certification positions Biomerica to expand its presence in the European market and potentially facilitate access to other international markets that recognize EU IVDR certification.

The company is currently finalizing materials for product launch in the near future, focusing on providing non-invasive and personalized solutions for IBD management.

Biomerica (NASDAQ: BMRA) has published clinical trial results for its inFoods® IBS test in Gastroenterology journal. The test identifies specific foods triggering elevated IgG antibody responses in IBS patients. A randomized, double-blind trial with 238 patients across eight U.S. academic centers showed significant results:

The treatment group following personalized elimination diets showed 59.6% success rate in pain reduction compared to 42.2% in the control group. Results were particularly strong for IBS-C patients (67.1% vs 35.8%) and IBS-M patients (66% vs 29.5%).

The test enables patients to eliminate only 2-4 trigger foods on average, offering a more targeted approach compared to traditional restrictive diets. This advancement is particularly significant for IBS-M patients, for whom no FDA-approved medications currently exist.