Gastric cancer is the third most common cause of cancer related death in the world and over 80% of gastric cancers are attributed to H. pylori bacterial infection
H. pylori infection is also a major cause of peptic ulcers
IRVINE, Calif., April 26, 2022 (GLOBE NEWSWIRE) — Biomerica, Inc. (NASDAQ:BMRA), (the “Company”) a global provider of advanced medical diagnostic and therapeutic products, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for hp+detect™, a new product that detects the presence of the H. pylori bacteria, which infects approximately 35% of the U.S. population.
Under the current FDA 510(k) Premarket Notification Process, the FDA’s goal is to provide a decision within 90 days to the submitting company, unless further information is requested.
Biomerica is also preparing to submit a CE Mark filing, which will enable the product to be sold in most EU countries and other regions around the world.
Biomerica’s Chairman and Chief Executive Officer Zack Irani stated, “This FDA submission is a milestone in our commitment to bringing a diagnostic solution for the over 115 million people suffering from H. pylori infection across the U.S. today. We’re particularly excited about this product as it has shown to be highly accurate as compared to other products in the market. We’ve also created an efficient, low-cost manufacturing process that should enable high gross margins on this product.”
About hp+detect™