Biomerica, Inc. reported that its inFoods® IBS diagnostic‑guided therapy achieved a 59.4% responder rate for abdominal pain and a 68.1% responder rate for bloating in a real‑world study of 69 patients who completed an eight‑week protocol. The analysis used the FDA‑recognized ≥30% improvement endpoint, the same criterion applied in the company’s pivotal randomized trial.
The real‑world responder rates mirror the 59.6% pain relief observed in the controlled trial, demonstrating that the diagnostic‑guided approach translates effectively into everyday clinical practice. Sixty‑two of the 69 participants tested positive for one or more food sensitivities on the inFoods® IgG assay, underscoring the test’s role in identifying actionable triggers.
The study’s timing coincides with two key commercial milestones: a $300 CMS Medicare payment rate that became effective on January 1, 2026, and a marketing partnership with Henry Schein that was entered into in late 2025. Together, the reimbursement and distribution agreements lower barriers for physicians and laboratories, accelerating adoption of the test in routine care.
IBS affects an estimated 30–45 million adults in the United States, creating a sizable addressable market. The diagnostic‑guided therapy offers a non‑pharmaceutical, precision‑based option that can generate recurring revenue streams as patients continue to use the test to manage symptoms over time.
CEO Zack Irani said, “This responder analysis represents another significant data set for inFoods® IBS. 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.”
Investors are monitoring these developments against the backdrop of recent going‑concern disclosures, weighing the positive clinical and commercial signals against the company’s broader financial position.
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