TriVascular announced on 18 November 2013 the close of a US$40 million Series E Preferred Stock equity financing. Existing investors New Enterprise Associates, Delphi Ventures, MPM Capital, Kearny Venture Partners, Kaiser Permanente Ventures and the Redmile Group were joined by new investors Deerfield Management, Rock Springs Capital and Permal Asset Management in the transaction. Proceeds from the financing will be used to expand commercial efforts worldwide and to fuel product pipeline and clinical research activities.
“We are fortunate to have such strong financial support,” said Christopher G Chavez, chairman and CEO of TriVascular. “We welcome our new investors to the TriVascular family and are very grateful for the commitment of our existing investment syndicate. Our goal is to ensure that physicians and their patients gain access to minimally invasive endovascular aneurysm repair, which is enabled by the Ovation and Ovation Prime platforms. This financing further strengthens our ability to continue to invest in innovation and offer clinically compelling endovascular solutions.”
In the USA, the prevalence of abdominal aortic aneurysms is estimated at 2 million people. Many of these potential patients do not have access to minimally invasive, on-label endovascular aortic repair (EVAR) given the limitations of conventional wire-and-fabric technology. With an ultra low-profile (14F OD) delivery system and an innovative sealing technology, the Ovation and Ovation Prime platforms are designed to expand the on-label patient population suitable for EVAR. In October 2012, the US FDA granted PMA approval for the Ovation system. The Ovation system received CE mark clearance in August 2010.
In August 2013, the one-year results from the Ovation pivotal study were published online by the Journal of Vascular Surgery. In October 2013, Manish Mehta, director of Endovascular Services for the Vascular Group in Albany, USA, presented two-year data on the Ovation pivotal study at the annual Vascular InterVentional Advances (VIVA) meeting in Las Vegas. The study demonstrated 100% freedom from type I and III endoleaks, migration, rupture or conversion to open surgical repair at both the one-year and two-year marks. In addition, the pivotal trial cohort showed no aortic neck growth at either one or two years. Forty three per cent of the patients in the trial were treated via a percutaneous (PEVAR) vessel access method. Thirty nine per cent of the patients treated in the Ovation pivotal study would have been excluded from treatment in previous EVAR trials. The Ovation platform is approved for sale in over 30 countries. Approximately 2,700 patients have been treated with the Ovation and Ovation Prime systems to date.