Biomerica enrolled the first patient in a clinical trial for its InFoods diagnostic-guided therapy to alleviate irritable bowel syndrome symptoms.
Here's what you should know:
1. Researchers are launching a randomized, double-blind, placebo-controlled clinical trial to test the effectiveness of Biomerica's IBS therapy.
2. The InFoods IBS product allows physicians to identify specific foods that impact a patient's IBD. If approved, physicians will be able to take a finger stick blood sample to find foods that impact IBS.
3. The study is being conducted at Boston-based Beth Israel Deaconess Medical Center and Ann Arbor-based University of Michigan.
4. The trial will include 180 patients and last up to 14 months.
5. The study results will be used in a FDA 510(k) application seeking FDA approval for the therapy.