
Clinical Need
Despite being the most preventable cause of hospital death, PE claims 100,000 lives every year, and it is estimated that 300,000 individuals per year are diagnosed with PE. This life-threatening occurrence is exceptionally difficult to diagnose and is often missed; in fact, for every PE that is identified, two can be missed.
Clinical studies show that an effective treatment in PE prophylaxis in these high-risk patients is the inferior vena cava (IVC) filter; however, up to 66% of filters are not retrieved, causing long-term complications such as migration, perforation, and fracture of the filter.

Economic Viability
In the US, costs to treat PE average $31,000 more than patients with the same admission diagnosis without PE. Critically ill patients at risk for Pulmonary Embolism have increased morbidity and mortality rates. The Angel® Catheter can decrease length of stay by 4.9 days.
Cases of preventable PE place an economic burden on the global health care economy. They increase treatment costs, length of stay, and risk of mortality. Utilizing this new technology will reduce hospital costs compared to off-label prophylactic use of traditional IVC filters due to its immediate bedside placement, and it will minimize the costs associated with removal and long-term filter complications.

IP Portfolio
Bio2 Medical® has received CE Mark approval for two variations of the Angel® Catheter product family; a 5-lumen design and a 3-lumen design. The Company has demonstrated safety and clinical utility through several key clinical studies, including an eight patient OUS first-in-man clinical study, an FDA-approved five patient Early Feasibility Pilot Study, 60 patient European Registry; and the Angel® Catheter Pivotal Study.
Bio2 Medical has 24 issued US patents, 18 issued foreign patents, and 44 pending US and foreign patent applications, which support both the existing Angel® Catheter designs and the future development of new products. Bio2 Medical also has four registered trademarks issued in the US and two foreign registered trademarks.