HemaSure regulatory update

HMSR halted development of its SteriPath Blood Inactivation System after the FDA said the company could not proceed with trials under an IDE the company filed in December. SteriPath uses the hydroxymethylglycinate (HMG) to inactivate viruses that may exist in donated blood before it is transfused.

HMSR said the agency voiced concerns in February about HMG's mutagenicity and genotoxicity and the risk/benefit ratio related to whether the compound can be adequately washed from donated blood. The company determined that the cost of answering the FDA's questions, as well as a low probability of success, were too great to continue with development. ...