Saint-Priest, France, January 7, 2019, 8:00 am (CET) – Biom’up (the “Company”), a specialist in surgical hemostasis, today announces an IDE (Investigational Device Exemption) application submitted to the FDA for HEMOSNOW, a hemostatic dry powder made from porcine collagen and bovine-derived chondroitin sulfate for managing minimal and mild levels of bleeding during surgical procedures. The Company now plans to prepare the launch of the clinical studies required to obtain approval in the United States in 2020.
HEMOSNOW will complement its flagship product, HEMOBLAST Bellows. HEMOSNOW contains the same components as HEMOBLAST Bellows, but without human pooled plasma thrombin and is therefore effective against lesser degrees of bleeding at lower cost. The applicator systems are exactly the same as for HEMOBLAST Bellows permitting HEMOSNOW to be immediately ready for use and highly versatile with the ability to stop bleeding at focal bleeding sites as well as large area bleeding up to 50 square centimeters.
This submission to the FDA is a major step to the approval of a second hemostatic device with substantial development potential to complement HEMOBLAST Bellows already on the market. Biom’up is thereby strengthening its position in the sector of hemostasis and will thus be able to fulfill the expectations of surgeons providing them with a wider range of ready-to-use hemostatic products. This portfolio of devices will be capable of managing minimal to moderate levels of bleeding and assuring a safer surgical procedure for the patient at rationalized costs.
In addition, the Company announces the renewal, for the next seven years, of its supply agreement for human-derived thrombin, a key component of HEMOBLAST Bellows, only available from a limited number of suppliers. With this new agreement, the Company ensures an adequate supply of its key component to meet its goals.
Etienne Binant, Chief Executive Officer of Biom’up, commented: “The achievement of these two major milestones ensures that we have an ongoing capacity to deliver our flagship product, HEMOBLAST Bellows, and expand our portfolio of hemostatic products towards a diversified hold in this sector. It illustrates our determination to meet our strategic goals.“
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