BMRA News & Events

Biomerica announced that the Medicare Administrative Contractor, MAC, responsible for processing inFoods IBS claims has confirmed to the Company's CLIA-certified laboratory partner, Ethos Laboratories, that the test is eligible for Medicare coverage on an individual, claim-by-claim basis. This confirmation is consistent with established CMS policy for other similar diagnostic tests, which provides that in the absence of a formal Medicare coverage policy, claims are reviewed individually by the MAC to determine whether all coverage requirements have been met. This development represents an important step toward scalable, near-term revenue for Biomerica.

Biomerica announced it has received its first commercial order for Hp Detect, its Helicobacter pylori diagnostic stool antigen test, from one of the largest clinical laboratory chains operating across Europe. The initial order is for the United Kingdom market, where Hp Detect received registration from the UK Medicines and Healthcare products Regulatory Agency, or MHRA in February. This commercial order represents a significant step in Biomerica's commercialization of Hp Detect throughout Europe. The customer's position as one of the leading clinical laboratory networks in Europe provides Biomerica with a high-profile account that the Company believes will support future distribution discussions across the broader EU market. H. pylori is one of the most prevalent bacterial infections worldwide, estimated to infect 45% of the population across Europe's five largest countries. It is the strongest known risk factor for gastric cancer and is designated by the WHO as a Class 1 carcinogen. The WHO also lists H. pylori among the 16 antibiotic-resistant bacteria posing the greatest threat to human health, increasing the urgency for accurate, timely diagnostics to guide appropriate treatment.

Biomerica announced that it has received official registration from the UK Medicines & Healthcare products Regulatory Agency, MHRA, for its hp+detect diagnostic test that detects Helicobacter pylori bacteria. This product will now be marketed to labs throughout the UK for the detection of H. pylori infection in patients. "Receiving MHRA registration for hp+detect is a meaningful commercial milestone that expands our international reach into the United Kingdom," said Zack Irani, CEO of Biomerica. "The UK represents an important addressable market given the high prevalence of H. pylori infection across Europe. This registration reflects our ongoing commitment to delivering innovative diagnostic solutions to patients and clinicians worldwide."

Biomerica 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. 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 greater than or equal to30% improvement in weekly average symptom scores was applied-the same endpoint used in the Company's peer-reviewed randomized controlled trial published in Gastroenterology: Abdominal Pain: 59.4% of patients met the responder threshold. Bloating: 68.1% of patients 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 Mean bloating scores declined 41.7%, from 4.35 to 2.54 at 8 weeks. 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. 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, 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. 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.