BiO2 Medical Announces First in Man Clinical Study
SAN ANTONIO, March 27, 2012 /PRNewswire/ — BiO2 Medical, Inc., a Texas based medical device manufacturer with manufacturing operations in Golden, Colorado, is proud to announce the first in man clinical study for the Angel(TM) Catheter. The clinical study is being conducted under IRB approval at two medical centers in Medellin, Colombia, Clinica Las Americas, and Hospital Pablo Tobon Uribe. As of today, eight critically ill patients have been enrolled in the study.
Dr. Cadavid and Dr. Gil, the principal investigators in the first in man clinical study, commented on the ease of bedside insertion of the Angel(TM) Catheter in a procedure that resembles a routine central venous catheter placement. Both principal investigators feel that the Angel (TM) Catheter fills an important clinical need for an Inferior Vena Cava filter designed for use in critically ill patients at high risk of pulmonary embolism (PE).
Dr. John A. Kaufman from the Dotter Interventional Institute and a member of BiO2 Medical’s clinical advisory board said, “This marks an important advance in the management of critically ill patients everywhere. The ability to protect from pulmonary embolism and resuscitate with one device is unique.”
This important milestone for the company will provide vital data regarding the safety of the Angel(TM) Catheter in a clinical setting, which will be instrumental in facilitating clinical adoption of the device. BiO2 Medical has been working closely with Pharmaceutical Product Development, Inc. (PPD), a contract research organization (CRO) that provides expertise in clinical development, management, and post approval services, in the design and execution of this first in man clinical study.
BiO2 Medical’s Chairman and Chief Executive Officer, Christopher E. Banas, commented on the initiation of the clinical study, “We are proud to be providing a lifesaving technology for critically ill patients at risk of PE, and this study demonstrates that this device is safe for use.” For more information regarding BiO2 Medical, and the Angel(TM) Catheter please visit www.bio2medical.com.
SOURCE BiO2 Medical, Inc.