BiO2 Medical is pleased to announce that The Angel catheter clinical trial, the pivotal investigation of the Angel® Catheter, has successfully achieved its target of 150 evaluable patients as of December 02, 2015.
The pivotal study has exceeded original forecasts and concluded one year earlier than anticipated. The early completion of The Angel Catheter Clinical Trial speaks to encouraging physician acceptance of the device and is a major accomplishment for BiO2 Medical.
The lead primary investigator of the trial provided the following comment:
"We are very excited about completing this pivotal U.S. trial. We have found that physicians are very enthusiastic about an IVC filter that can be placed at the bedside in patients at very high risk for acute DVT / PE, or those with VTE who temporarily cannot be anticoagulated.
This novel device may not only protect patients from death from acute PE but also could dramatically reduce the number of patients who are sent home with an IVC filter. We look forward to further analyzing the data."
BiO2 Medical is working diligently to ensure preparedness for the anticipated launch of the Angel® Catheter in the US. Assuming a 90 day 510(k) clearance cycle through the FDA, commercialization of the Angel® Catheter is estimated between Q2 and Q3 2016, which is approximately 18 months ahead of schedule.
BiO2 Medical aims to continue this positive trend and ultimately provide an innovative approach to Pulmonary Embolism (PE) protection, a currently underserved clinical need for a variety of critically ill patients.
To further support the targeted launch of the Angel® Catheter in the U.S., BiO2 Medical will be hosting a booth (# 20) at the 29th annual meeting of the Eastern Association for the Surgery of Trauma (EAST) on January 12 -16, 2016, in San Antonio, Texas.