VertiFlex announced completion of a US$14 million equity placement, with provision for an additional US$14 million investment within twelve months. A new investor, Thomas, McNerney & Partners, has joined current investors Aberdare Ventures, Alta Partners and New Enterprise Associates. The new capital will be used to complete enrolment in the Superion Interspinous Spacer (ISS) IDE trial before the end of 2011, and to advance global market development of the technology.
“We are very pleased with the continued confidence placed in us by our current investors, and welcome Thomas, McNerney & Partners,” said Earl R. Fender, president and CEO of VertiFlex. “Enrolment in the Superion IDE trial is ahead of plan and will be completed within 2011. We recently surpassed the 275 patient enrolment mark, and are highly encouraged by the clinical results to date, which are consistent with data from two independent studies of the Superion device outside the USA.”
James E. Thomas, co-founder and Partner of Thomas, McNerney & Partners, remarked, “We strongly believe in the role interspinous spacers play in the continuum of care for lumbar spinal stenosis. Because Superion is implanted percutaneously, interventional surgeons will greatly expand the market opportunity, as will traditional spine surgeons who seek an alternative to current offerings.” Thomas will become a member of the VertiFlex board.
The Superion IDE trial is a prospective, multicentre, randomised but unblinded clinical trial, studying the safety and efficacy of the Superion ISS compared to the X-STOP IPD from Medtronic, in patients with moderate lumbar spinal stenosis. This national trial is being conducted at 30 leading spine surgery and interventionalist spine sites throughout the USA.
The Superion ISS is a minimally invasive spinal implant, delivered fully percutaneously with virtually no disruption to a patient’s muscle or other soft tissue. Further, Superion can be implanted on an outpatient basis under local anesthesia. There are over 1.2 million Americans diagnosed each year with lumbar spinal stenosis – a number expected to rise as the population ages. A significant portion of these patients are living with the limited pain relief received from existing non-surgical treatments, and are candidates for a minimally invasive, outpatient surgical
The Superion ISS received CE mark in 2007 and has been implanted in over 1500 patients worldwide.