BiO2 Medical said today it won FDA 510(k) clearance for its Angel Catheter designed for pulmonary embolism protection by trapping clinically significant pulmonary emboli.
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 in a press release.
The device is designed as an alternative to inferior vena cava filters and are designed for bedside placement without fluoroscopic guidance and safe retrieval, BiO2 said. The company said the device is now commercially available in the U.S.
“The approval for clinical use by the FDA for this device will significantly impact trauma care. The majority of pulmonary emboli occur in the first three to four days after injury. Being able to protect our patients from pulmonary embolism during this time period, which is also the time period where traditional chemoprophylaxis is frequently contraindicated, will be extremely beneficial. In addition, this device also obviates the significant long-term complications of the currently available indwelling vena cava filters which include migration, fracture, erosion and caval thrombosis, where the current removal rate is dismal,” Dr. John Myers of San Antonio’s University of Texas Health Science Center said in prepared remarks.
In January, Oxford Finance said it closed an $8 million secured term loan with BiO2 Medical, with funds slated to support FDA clearance and an anticipated commercial launch of the catheter in mid-2016.
This makes the 2nd influx of money to BiO2 Medical this month. Earlier in January, the company said it raised a $9 million Series D round for its Angel catheter, after concluding its pivotal clinical trial a year ahead of schedule.
BiO2 said it also arranged $5 million in venture debt financing from Oxford Finance, with another $3 million due upon winning 510(k) clearance from the FDA for the Angel device. That could happen as soon as the 2nd quarter, BiO2 has said.