Biom’up announced that the U.S. Food and Drug Administration (FDA) has granted marketing approval for its HEMOBLAST Bellows Laparoscopic Applicator for all minimally-invasive procedures. Biom’up submitted the premarket approval (PMA) supplement to the FDA in July, 2018. The FDA completed its response within the standard 180 days, for this type of supplement, applicable when no challenge is raised, demonstrating the quality of the Company’s regulatory work. FDA approval expands the indications of the HEMOBLAST Bellows device and enables U.S. surgeons to use the hemostatic powder for both traditional and laparoscopic surgeries with the same patient and surgeon benefits of efficacy, simplicity and rapid availability. The HEMOBLAST Bellows Laparoscopic Applicator offers a quick and simple delivery of the HEMOBLAST powder to bleeding sites in minimally invasive surgeries. The 35cm long polycarbonate applicator fits easily into the existing applicator and delivers HEMOBLAST powder to minimally invasive bleeding sites in under one minute. HEMOBLAST Bellows is the only surgical hemostatic agent approved by the FDA based on the validated Spot Grade™ Surface Bleeding Severity Scale (SBSS), which demonstrates its ability to control a range of bleeding from minimal (oozing), mild (pooling) and moderate (flowing) bleeding. HEMOBLAST Bellows is proven to control bleeding with flow rates up to 117 mL per minute. Uncontrolled bleeding is a major surgical complication associated with increased mortality, longer hospitalization, higher rates of transfusions, and reoperations. Controlling bleeding in minimally invasive surgery is especially challenging because surgeons have to utilize instruments and cameras through small port sites of 5mm to 10mm instead of a much larger field of operation in traditional surgery. The FDA approval allows Biom’up to expand its use of HEMOBLAST Bellows in a growing laparoscopy market that is estimated at nearly 443,000 surgeries per year1. Biom’up obtained a CE Mark for its HEMOBLAST Bellows Laparoscopic Applicator in July 2018 for use in the European market, valued at 500,000 laparoscopic procedures annually.