This important milestone has allowed the company to complete Design Verification Testing in support of CE Mark submission, initiate a first in human clinical study in Medellin, Colombia, and conduct a Pre-IDE Meeting with FDA.
As stated by Christopher E. Banas, BiO2 Medical's Chairman and Chief Executive Officer, "This Series B funding has been instrumental to the recent successes of BiO2 Medical, and specifically the Angel Catheter program. With CE Mark approval anticipated in Q1/2 2012, the first in human clinical study underway, and a clear regulatory pathway defined in the US, BiO2 Medical is well on its way to commercializing the Angel Catheter worldwide which will help protect critically ill patients from hospital acquired PE."
BiO2 Medical's Angel Catheter, named after its inventor and BiO2 Medical's Chief Medical Officer, Dr. Luis F. Angel, is a central venous catheter and Inferior Vena Cava (IVC) filter combination device, intended to protect against potentially fatal Pulmonary Embolism (PE) in critically ill patients. The Angel Catheter will include a first of its kind prophylactic indication for IVC filter use. For more information regarding BiO2 Medical and the Angel Catheter, please visit www.bio2medical.com.
SOURCE BiO2 Medical, Inc.