Biom’Up announced that it has received FDA marketing approval for HEMOBLAST™ Bellows, its flagship product, 7 months ahead of schedule. This pre-marketing approval (PMA), which allows a Class III medical device to be marketed in the United States, is the most stringent pathway to approval by FDA for devices. The PMA application is based on scientific and clinical data demonstrating that the device is safe and effective for patients and users under usage prerequisites. HEMOBLAST™ Bellows, a best in class hemostatic product that aims to control bleeding during surgical procedures (heart surgery, general surgery, orthopedic surgery, etc.) is thus now accessible to American surgeons. This FDA approval is notably based on the results of a prospective, controlled, randomized clinical trial carried out among 412 patients undergoing either cardiothoracic, abdominal or orthopedic (lower limb) surgery. All primary and secondary endpoints of this study were met with very high statistical significance. In view of the exceptional nature of these interim results (93% efficacy at 6 minutes, versus 74% for the control arm), the members of an Independent Data Monitoring Committee (IDMC) unanimously recommended that the study be stopped prior to the initially-scheduled end of this trial and that the application be submitted faster. This approval follows an FDA inspection of the Biom’Up facility where HEMOBLAST™ Bellows is manufactured, which was concluded with no findings. This highly-positive outcome led the Company’s management to anticipate the recruitment of the sales & marketing teams for the US market to prepare the launch of HEMOBLAST™ Bellows.