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Bio2 Medical® is a leading developer and manufacturer of innovative vascular devices that protect critically ill patients at high risk of pulmonary embolism (PE). The Company’s primary product, the Angel® Catheter, was developed to address the unmet need for adequate protection against pulmonary embolism, which occurs when clot segments within the deep venous system detach, travel to the lungs, and lodge within the pulmonary arteries.

With expertise in bringing innovative medical products to market, Bio2 Medical provides novel, cost-effective vascular solutions to address significant unmet clinical needs. Investing with Bio2 Medical® presents an opportunity to not only see a positive return, but to affect positive change in the healthcare industry.

Investment Highlights

Investing with Bio2 Medical® presents an opportunity to not only generate a positive return, but to also affect positive change in the healthcare industry.

  • Focused product portfolio
  • Positive clinical outcomes from FDA pivotal study – 11% averted PE rate in patients with a cavogram
  • Secure regulatory pathway
  • First mechanical PE protection device with a prophylactic indication
  • Focused on the vast underserved patient population in critical care and trauma
  • Compelling health economic, quality metric, clinical need and risk mitigation model for the healthcare system
  • Addresses an significant opportunity in the US market
  • Exceptional management team with a track record of successful commercialization’s and high-value company exits
  • Strategic commercialization and market development plans

Market Opportunity

According to independent market analysis performed by the Millennium Research Group (“MG”), there are approximately 5.6 million ICU admissions annually across US hospitals. While the majority of these hospitalized patients are at risk for VTE, approximately 20% of these admissions (over 1 million patients) are untreated and at risk of PE, relying on standards of care that do not provide adequate protection from PE.

Data from literature and Bio2 Medical’s clinical trial both identify the types of critically ill patients who can benefit from the Angel® Catheter. These patients include high-risk, critically ill patients who are contraindicated for anticoagulation therapy (either upon initial admission to the hospital or for the full duration of their hospital stay). The patient populations identified from primary research are spinal cord injury, multiple extremity fractures, head injuries, intracranial hemorrhage, multiple trauma, traumatic brain injury, abdominal surgeries, and subdural hematomas. Research has identified multiple other patient groups that can benefit from the Angel Catheter. However, the Company has chosen to initially focus on trauma, critical care, and neurosurgery.

This high risk, unprotected patient population benefits from the use of early thrombophrophylaxis during the time frame in which these patients (i) are most critical, (ii) have the highest risk of bleeding, and (iii) are contraindicated to anticoagulation. Overall, the total addressable U.S. opportunity in the trauma segment is estimated to be over one million patients, which indicates an opportunity in excess of $2 billion for the Angel Catheter.

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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.

 

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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.

 

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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 issues in the US and two foreign registered trademarks.

Funding To Date

Bio2 Medical, Inc. is a commercial stage medical device company that has raised over $53.1 million of capital from a combination of Angel investor funding, venture capital funds, and debt capital. The lead investor in Bio2 Medical® is Remeditex Ventures, LLC. Additionally Incyte Ventures Targeted Technology Fund is a contributing investor in Bio2 Medical. Incyte Ventures focuses on investing in and accelerating the development of promising early stage life science companies.