TriVascular announced on 4 June 2012 a US$60 million series D Preferred Stock equity financing commitment; the initial tranche of which closed on 1 June. New investor Kaiser Permanente Ventures, in partnership with the Redmile Group, led the round joining existing investors New Enterprise Associates, Delphi Ventures, MPM Capital, Kearny Venture Partners and Pinnacle Ventures. Sam Brasch, director at Kaiser Permanente Ventures, will join TriVascular’s Board of Directors.
Proceeds from the financing will be used to pursue US PMA approval of the Ovation Abdominal Stent Graft System, drive further sales expansion internationally, fuel product development efforts and initiate US commercial activity.
“We are grateful for the strong partnership with our investors,” said Christopher G Chavez, chairman and CEO of TriVascular. “We welcome Kaiser Permanente Ventures and the Redmile Group to the TriVascular Team and are thankful for the continued support from our existing syndicate. We believe a financing of this magnitude, in this economic environment, is a strong endorsement of our technology, team and opportunity. We are honored by the support and remain resolute in our mission: To partner with clinicians to improve the lives of patients suffering from aortic disease.”
In the US alone, there is an estimated prevalence of nearly 2 million people with abdominal aortic aneurysms. Many of these potential patients do not have access to minimally invasive endovascular aortic repair (EVAR) given the limitations of approved devices. With an ultra low-profile (14F OD) and innovative, unique sealing technology, the Ovation system is designed to expand the patient population suitable for EVAR by addressing a wider range of diseased anatomy. In November 2011, the US FDA granted Ovation the first ever humanitarian device exemption (HDE) approval in EVAR. Ovation received CE mark approval in August 2010. To date, over 900 patients worldwide have been treated with Ovation.
TriVascular recently submitted the fifth, and final, PMA module to the FDA. The primary content of module five is the global clinical trial data. The one-year results from the pivotal study were first presented earlier this year at the CX Symposium in London, UK. The Ovation Abdominal Stent Graft System is currently available for sale in the US, for a narrow subset of patients, under an HDE designation.