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| Angel catheter--Courtesy of BiO2 Medical |
Golden, CO's BiO2 Medical has raised about $9 million in Series D financing and obtained an additional $5 million in debt following the completion of the FDA clinical trial of its CE-marked Angel Catheter.
The capital will be used to fund the U.S. product launch upon FDA clearance, and expand the U.S. and overseas sales force, conduct incremental R&D and develop additional infrastructure, according to the company release.
The triple-lumen central venous catheter is designed to prevent pulmonary embolisms (a blockage of an artery in the lung) in the hospital following treatment with anticoagulant therapy, which is known to increase the risk of uncontrolled bleeding. It is used to deploy a temporary inferior vena cava filter through the femoral vein.
Once the catheter is in place and the IVC filter is deployed, doctors have access to the central venous system, while the patient is protected from pulmonary embolisms. It remains in place for up to 30 days, after which the catheter and attached filter are retrieved and removed.
The funding indicates the company believes 510(k) clearance is likely following the conclusion of a 182-patient, single-arm trial measuring freedom from clinically significant or fatal pulmonary embolism during treatment with the device and up to 3 days post-catheter removal.
Devices going through the 510(k) pathway are not typically subjected to clinical trials, so the FDA must believe the device is more innovative and/or poses more potential risk to patients than most other devices in the pathway.
Following 510(k) clearance, BiO2 Medical is eligible for an additional $3 million in debt financing from Oxford Financing.
"With this equity and venture debt capital secured, we are on the path to commercializing the Angel Catheter in the US and providing pulmonary embolism prophylaxis to over one million patients who are at high risk of pulmonary embolism and are ineligible for existing venous thromboembolism prevention," company CEO Christopher Banas said in a statement.
- read the release