Biom’up announced that it has received CE Marking for its Hemoblast Bellows active hemostatic powder and delivery system. Hemoblast Bellows is indicated in open surgical procedures as an adjunct to hemostasis when controlling of bleeding by conventional techniques is ineffective or impractical. Hemoblast Bellows is indicated in the following surgical specialties: cardiac, vascular, abdominal, urology, gynecology, orthopedic, spine, ear nose and throat (ENT) and head and neck.
As a new innovative solution, Hemoblast Bellows launches into a market worth $2B. While indicated for open and laparoscopic procedures, a laparoscopic applicator for Hemoblast Bellows is currently under development. Over the coming months, the company will start to market Hemoblast Bellows in target surgical procedures in Europe, specifically cardiac, hepatic and spine surgery.
The company is currently enrolling patients into a prospective, randomized, controlled, multicenter, pivotal, clinical investigation evaluating the safety and efficacy of Hemoblast Bellows in cardiothoracic, abdominal, and orthopedic lower extremity surgeries with the aim to reach post-market approval by the FDA in 2018.
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