BiO2 Medical has won FDA 510(k) clearance for its Angel Catheter designed for pulmonary embolism protection by trapping clinically significant pulmonary embolisms.
The Golden, Colo.-based company said the clearance includes a 1st ever prophylactic indication to protect critically ill patients at high risk for pulmonary embolism and are contraindicated for anticoagulation.
“We are excited to enter into this new commercial phase and to have the opportunity to fulfill our company’s mission to improve patient outcomes by offering our life-saving product to the American public. The transition to a successful and profitable company is fully underway with the hiring and training of a national direct sales team, led by Jeffrey Hutchison, our new Vice President of U.S. Sales. The achievement of U.S. FDA 510(k) clearance represents the successful culmination of a significant undertaking for Bio2 Medical, and we could not have done it without the faith, trust and support of our entire team, our Board of Directors and our investors who have tirelessly supported our dream and made this day possible,” CEO Christopher Banas said.