Biom’Up provided a regulatory update regarding the United States Food and Drug Administration’s (FDA) review of the company’s Premarket Approval (PMA) application for its HEMOBLASTTM Bellows. The FDA conducted a PMA pre-approval inspection at the Biom’up Saint Priest, France, manufacturing facility. The four-day Premarket Approval inspection focused on the firm’s HEMOBLASTTM Bellows product line and did not result in any FDA-483, Inspectional Observations. This inspection was part of the medical device approval process to market HEMOBLASTTM Bellows within the United States of America. Following the inspection, the FDA will provide the company with an inspection report and continue its review of the PMA. HEMOBLASTTM Bellows is currently CE Marked. HEMOBLAST™ Bellows is an investigational device in the United States and is under review pending PMA approval by the FDA.