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Who We Are

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Improving patient care, saving lives, and providing tools that make the job easier for medical professionals are the driving forces behind our company.

We have the team, the facilities, the experience, and the commitment necessary to elevate patient care and create devices that save lives.

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The company was established in 2006, and features a state-of-the-art research and development facility in Golden, CO.

Bio2 Medical® is currently dedicated to the design, development, manufacture, and commercialization of the Angel® Catheter, a revolutionary new medical device.

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The Angel® Catheter provides a novel approach to Pulmonary Embolism (PE) protection, a currently underserved clinical need for a variety of critically ill patients.

The device provides IVC filtration and central venous access in critically ill patients; is designed for bedside placement (without the need for fluoroscopic guidance); and can be safely retrieved in all cases once no longer indicated.

Angel® Catheter

  • 510(k) cleared
  • First Inferior Vena Cava (IVC) filter to receive FDA clearance for a prophylactic use indication in critically ill patients
  • Facilitates hour zero placement following hospital admission, providing rapid and acute PE protection at the bedside
  • IVC filter permanently attached to the CVC eliminates the need for securement hooks/barbs, and guarantees retrieval
  • Self-centering IVC filter provides efficient filtration
  • Nitinol filter conforms to the inferior vena caval wall
  • Robust closed cell structure combined with short dwell time minimizes the risk of filter fracture, caval penetration, and other risks associated with traditional filters

Value Proposition

Clinical
Economic
Quality

PE Prophylaxis

70% of Pulmonary Embolisms (PE) develop in the ICU. Critically ill patients face much greater risk of PE related mortality due to longer length-of-stays, elevated thrombosis risks, and extended periods of immobility. Routine screening is often difficult to perform and can be less reliable in critically ill patients.

The Angel® Catheter addresses these issues by providing PE prophylaxis for high-risk patients. The device can be placed at bedside upon admission, providing immediate defense against hospital acquired PE.

Simple Retrieval

66% of "retrievable" Inferior Vena Cava (IVC) filters are never removed, resulting in long term complications. The majority of traditional IVC filters are used prophylactically, however these devices are currently only approved for protection against recurrent PE. Most complications (93%) caused by IVC filters occur after 30 days, beyond the Angel® Catheter's usage window.

The permanent attachment of the IVC filter to the central venous catheter provides short-term PE protection with guaranteed retrieval, greatly reducing preventable complications associated with traditional filters.

Bedside Placement

Traditional IVC filters are effective in preventing PE, but leave room for improvement in terms of usage and the mitigation of avoidable complications. They are not typically placed until several days after a patient is admitted to the ICU due to logistical complications associated with transporting critically ill patients to and from the IR suite.

This means most IVC filters do not cover the time period when critically ill patients are at highest of PE. The Angel® Catheter is optimally designed to provide the patient with essential preventative care immediately.

Clinical Need

Current standards of care are not suitable for providing PE protection in all high risk patients. Anticoagulation medications are effective in providing PE protection. However, anticoagulation therapy is contraindicated for a variety of patients at high risk of bleeding. Traditional IVC filters are also effective at preventing PE, but require transport to and from the IR suite for placement. This logistical complication typically delays placement and PE protection until several days after ICU admission, leaving patients unprotected directly following admission when the risk for PE is highest.

References:
  1. HCUP National Inpatient Sample (NIS), 2013, Agency for Healthcare Research and Quality (AHRQ)
  2. Arterioscler Thromb Vasc Biol. 2008 March ; 28(3): 370–372.
  3. The American Journal of Surgery (2011) 201, 209–215

View Our Clinical Evidence

Bio2 Medical® is a clinically-minded organization focused on providing innovative medical devices in response to unmet clinical needs. Tracking ongoing clinical evidence and industry trends are paramount to the success of the Angel® Catheter.

Please visit the following section for the clinical evidence compiled on the Angel® Catheter to-date.

Clinical Evidence

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Investor Relations

Bio2 Medical® has spent more than a decade leading vascular innovation to improve the current Standards of Care (SoC). The Company’s product development engine, commercial sales channel, experienced regulatory team, and talented management personnel have a proven track record of success.

To learn more about Bio2 Medical’s unique and defining characteristics, visit our Investors page.

Become an Investor

News

First Commercial Placements of the Angel® Catheter in the United States

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Bio2 Medical® Announces 510(k) Clearance from the FDA for the Angel® Catheter, the First Ever Prophylactic Use Indication for a Medical Device for Pulmonary Embolism

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