FDA milestone for Biom’up
The surgical hemostasis specialist company announces the submission of an application to the FDA and the renewal of supply agreement
Two products in Biom’up’s hemostatic devices have had milestones. Hemoblast Bellows and Hemosnow.
The Lyon-based company renewed the human-derived thrombin supply agreement for its hemostatic product Hemoblast Bellows, the flagship product of the line, for the next seven years. The product will be used to control bleeding in a broad range of surgical procedures.
Hemosnow, another hemostatic product in the range, however, doesn’t contain human pooled plasma thrombin. A component that is only available from limited providers. The absence of this ingredient in Hemosnow means the product is effective at a lesser degree of bleeding but at a lower cost. An alternative to Hemoblast bellows that uses the same application systems so would be immediately ready for use.
Hemosnow has applied for an Investigational Device Exemption (IDE). The plans are now to prepare for the launch of clinical studies required for approval in the US in 2020.
Etienne Binant, Biom’up CEO, commented: “We have an ongoing capacity to deliver our flagship product, Hemoblast Bellows, and expand our portfolio of hemostatic products”.