News | May 7, 2010

Life-Saving Filter Technology Attracts $7.5M From Local Investors

San Antonio based BiO2 Medical, Inc. has created a medical device that the company's executives believe could save hundreds of thousands of lives per year. The company recently closed on a $7.5M Series B round, which includes about $6.5M of new capital that will be used to seek a CE Mark (Europe's equivalent to FDA Approval) for its lead product, the Angel™ Vena Cava Filter Catheter. The device aims to prevent the occurrence of a pulmonary embolism (PE) in critically ill patients.

A pulmonary embolism is usually the result of a blood clot which forms in the leg (deep vein thrombosis) and breaks free, traveling up through the veins to the lungs, where it blocks blood flow, leading to death or serious illness. Incidents of pulmonary embolism are on the rise, increasing by double digits, and cause approximately 300,000 deaths annually in the US, and 450,000 deaths per year in Europe.

Although anticoagulation therapy (blood thinners) is the preventive treatment of choice, in many patients that therapy is contraindicated and therefore those patients cannot receive anticoagulation. As a result, physicians are increasingly using temporary inferior vena cava (IVC) filters as a preventive measure, particularly in patients with a high risk of bleeding due to trauma, major surgery or critical illness.

Despite physicians' use of retrievable temporary vena cava filters as a preventative measure, the vast majority of these temporary filters are not retrieved. As a result, prolonged use of temporary filters has been associated with a number of complications, including migration of the filter to the heart, vena cava thrombosis, and perforation of the vena cava. To overcome these challenges, BiO2 Medical has developed the Angel™ Vena Cava Filter Catheter which has a NITINOL vena cava filter permanently attached to multilumen central venous access catheter and thus is able to be safely removed when no longer needed.

The Angel™ Vena Cava Filter Catheter is a combination device that incorporates two functions into a single device: a temporary/removable vena cava filter and a central venous access catheter. This device functions as a normal central venous catheter ("central line") by the use of a multilumen catheter, that provides access to the central venous system for the administration of medications, fluids and blood products in addition to blood sampling and central venous pressure monitoring, but it also includes a permanently attached NITINOL vena cava filter to the central line catheter. Like other central lines, this combination device is designed for bedside placement upon admission.

This new device could mean the difference between life and death for hundreds of thousands of patients world-wide, especially critically ill patients with venous thromboembolism or others who are at high risk of pulmonary embolism but cannot receive anticoagulation therapy.

"Incorporating a low profile, vena cava filter onto a fully functional central line catheter required sophisticated engineering to develop, but the result is elegantly simple, thanks to our talented team of engineers," says Chairman and CEO, Christopher E. Banas. "This Team is essentially the same team that successfully developed a variety of medical devices in the past then sold the resulting turnkey operations to major medical device companies, such as Johnson and Johnson, Genzyme and Volcano Corporation." BiO2 Medical was founded by Banas, Dr. Paul Castella (President and CFO) and Dr. Luis Angel, the Director of Lung Transplantation and Interventional Pulmonology at the University of Texas Health Science Center at San Antonio (UTHSC/SA) and the company's Chief Medical Officer and inventor of the Angel™ Vena Cava Filter Catheter.

Banas and Castella have a long and impressive history of product development and commercializing medical devices. In 2003, Banas and his partner in Advanced Bio Prosthetic Surfaces, Dr. Julio Palmaz ( inventor of the balloon expandable stent), licensed a unique NITINOL stent technologies to Cordis, a division of Johnson & Johnson. Xenotope Diagnostics' co-founder and CEO, Castella, licensed worldwide manufacturing and sales rights for a unique rapid-test technology developed by Xenetope to Genzyme Corporation in 2004. Then in 2005, Banas and Castella co-founded CardioSpectra, another medical device company, which they sold to Volcano Corporation in late 2007. "When we saw Dr. Luis Angel's concept for the Angel™ Vena Cava Filter Catheter, we knew it had the potential to become the new standard of care and save millions of lives," Banas recalls. "It is an elegant solution to a complex problem".

Funding for BiO2 Medical came from the San Antonio-based Targeted Technology Fund I, LP, led by Alan H. Dean the CEO of Incyte Venture Partners, LLC, and from local San Antonio investors. Karutz Flavin Wells Investment Bankers was the firm's exclusive representative in this financing. BiO2 Medical also previously received $1.0M from Governor Rick Perry's Texas Emerging Technology Fund (ETF), with which the founders have a successful track record.

The Angel™ Vena Cava Filter Catheter could be on the market in Europe next year where it will compete with other central lines and vena cava filters such as those made by C. R. Bard, Edwards Lifesciences, Terumo and Cordis, a division of Johnson and Johnson.

SOURCE: BiO2 Medical, Inc.