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Home Page > News > MAY 12, 2016

MAY 12, 2016

Today Biom'Up announced it has received FDA clearance for the HEMOBLASTTM Bellows IDE pivotal clinical trial design.

The prospective, randomized, controlled, multi-center clinical investigation evaluates the safety and efficacy of HEMOBLASTTM Bellows, the company’s novel hemostat, in cardiothoracic, abdominal, and orthopedic lower extremity surgeries.

The study meets the FDA requirement for reliability by establishing the eligibility of the target bleeding site and achievement of hemostasis based on the SPOT GRADETM, a validated Surface Bleeding Severity Scale (SBSS), that is a proprietary creation of Biom’Up. (...)

» Biom'up press release