PMA Approved Superion® Demonstrating Early Commercial Success
CARLSBAD, Calif.–(BUSINESS WIRE)–#Superion–Vertiflex, Inc., a leading innovator of advanced, minimally
invasive interventions for spinal stenosis, today announced
completion of a $40M financing round. New investors, Endeavour Vision
and H.I.G. BioHealth Partners led the financing alongside existing
investors, New Enterprise Associates; Thomas, McNerney & Partners; and
Alta Partners. Proceeds from the financing will primarily be used to
fund U.S. commercial expansion of the company’s Superion® Indirect
Decompression System, a minimally invasive spinal implant designed to
treat moderate lumbar spinal stenosis, a painful and often debilitating
condition that affects an estimated 500,000 new patients every year in
the United States.
“Vertiflex has seen tremendous early success in the commercialization of
the Superion System,” said Earl Fender, President and CEO of Vertiflex.
“With favorable long-term clinical outcomes, a new Category I AMA CPT
code and broad reimbursement in place, adoption of Superion has
continued at a rapid and steady pace, driven by significant interest
from both patients and treating physicians.”
Once implanted, Superion is intended to reduce pressure on the affected
nerves and allow patients to return to a more active lifestyle.
Following completion of a successful 391 patient randomized controlled
trial, the Superion System received Premarket Approval (PMA) from the
U.S. Food and Drug Administration (FDA), and starting January 2017 the
system is described by a new American Medical Association (AMA) Current
Procedural Terminology (CPT) Category I code.
“I’m also excited to see continued momentum with our current investors
who have steadfastly supported the company to date, and look forward to
working closely with our new investors to realize the potential for the
Superion System, as we further invest in the commercial expansion of an
important treatment option for physicians and patients,” Fender added.
To accommodate its accelerating growth, Vertiflex recently relocated its
corporate headquarters from San Clemente, CA, to a larger facility in
Carlsbad, CA. The new location includes expanded distribution
capability, and a state-of-the-art physician education center, as part
of the company’s commitment to supporting physicians by providing
didactic as well as hands-on cadaver training with Superion.
Nick Shamie, M.D., Chief of Orthopedic Spine Surgery and Professor of
Orthopedic Surgery and Neurosurgery at UCLA School of Medicine, stated,
“The Superion System offers patients a minimally invasive solution to
treat leg pain associated with spinal stenosis. The implant, placed
through a small tube the size of a dime, does not deconstruct any of the
anatomical elements and provides immediate relief. I incorporated this
treatment into my practice after seeing the clinical data from the FDA
IDE clinical trial. The safety, efficacy, and five-year durability that
the data presented made it a procedure I can stand behind.”
About Vertiflex, Inc.
Vertiflex is a privately held medical device company dedicated to the
advancement of minimally invasive solutions for the treatment of lumbar
spinal stenosis, which is the leading cause of spinal surgery in the
elderly. Founded in 2005 and headquartered in Carlsbad, CA, Vertiflex
has developed proprietary, minimally invasive technologies for
performing both indirect and direct decompressions of the lumbar spine.
These procedures fill the gap in the stenosis treatment continuum
between conservative care and traditional spine surgery. To date,
Vertiflex has compiled the largest, most rigorous body of device
clinical evidence related to lumbar spinal stenosis. For more
information, visit www.vertiflexspine.com.
About New Enterprise Associates
As one of the world’s largest and most active venture capital firms, NEA
has developed deep domain expertise and insight into multiple
industries. The NEA team channels that knowledge into every technology
and healthcare investment they make – at any stage, in any location,
around the globe. Visit www.nea.com.
About Endeavour Vision SA
Endeavour Vision is a growth investor in exceptional private medtech
companies, and an ideal partner for medtech entrepreneurs. Headquartered
in Geneva, Switzerland, with a presence in the United States, the
Endeavour Vision team comprises experienced investors, seasoned
entrepreneurs, and medtech specialists, all committed to helping
entrepreneurs grow and develop thriving businesses. Endeavour’s latest
$275 million fund is fully dedicated to investing in European and U.S.
medtech companies that seek worldwide growth and aim to improve the
quality and cost of care for patients across the globe.
About H.I.G. BioHealth Partners
H.I.G. BioHealth Partners is the dedicated life-science investment
affiliate of H.I.G. Capital. H.I.G. BioHealth Partners invests in a
broad range of healthcare opportunities across sectors and stages,
principally in companies developing therapeutic drugs, medical devices,
and diagnostics for significant unmet medical needs. With approximately
$400 million in committed capital, H.I.G. BioHealth Partners invests $5
million to $40 million per company over the life of an investment. Visit www.higbio.com.
Kathryn Larson, (442) 325 5900