Spectral Medical Inc. announced that it is now recruiting the last 46 patients into its pivotal Phase III EUPHRATES trial. Based on current enrolment rates, it is expected that the trial should be completed in the first half of 2016. To date, 400 patients have been enrolled into the trial, representing 90% of the total estimated sample size of 446 evaluable patients.

The composite mortality rate of approximately 50% for patients randomized since the April 10, 2014 protocol amendment remains consistent with the assumptions used for the recent sample size recalculation which was accepted by the US Food and Drug Administration (FDA). The company further announced that it is on track to submit the fourth and final Pre-Market Approval (PMA) module containing clinical data to the FDA for market approval of its Toraymyxin™ (PMX) medical device in the second half of 2016.