SAN CLEMENTE, Calif.--()--VertiFlex®, Inc., a leading innovator of percutaneous and motion preserving spinal surgery technologies, today announced completion of a $14M equity placement, with provision for an additional $14M investment within twelve months. Current investors Aberdare Ventures, Alta Partners and New Enterprise Associates were joined in the financing by new investor Thomas, McNerney & Partners.
“Enrollment in the Superion IDE trial is ahead of plan and will be completed within 2011. We recently surpassed the 275 patient enrollment 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 U.S.”
The new capital will be used to complete enrollment 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 & Chief Executive Officer of VertiFlex. “Enrollment in the Superion IDE trial is ahead of plan and will be completed within 2011. We recently surpassed the 275 patient enrollment 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 U.S.”
Justin Klein, VertiFlex Board member and Principal at New Enterprise Associates, stated, “NEA is proud to continue its investment in VertiFlex. The company has executed extremely well on all objectives associated with the Superion IDE trial. Very fast enrollment, coupled with compelling clinical data, is building significant value. This financing will take VertiFlex beyond the trial enrollment phase, to milestones associated with having long term data on a very high number of patients, and preparing for submission of a PMA.”
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.” Mr. Thomas will become a member of the VertiFlex Board.
The Superion IDE trial is a prospective, multi-center, randomized 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 U.S. 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 option.
About VertiFlex, Inc.
VertiFlex is a privately held medical device company dedicated to the advancement of percutaneous and motion preserving technologies for disorders of the spine. Founded in 2005 and headquartered in San Clemente, CA, VertiFlex has developed the Superion Interspinous Spacer System. The Superion ISS is the most advanced, least invasive interspinous spacer available, and has been implanted in over 1500 patients worldwide, receiving CE mark in 2007. Superion is currently enrolling patients in a pivotal IDE clinical trial in the U.S. The company’s goal is to establish Superion as the standard of care for percutaneous treatment of lumbar spinal stenosis.