SAN DIEGO, June 12, 2018 /PRNewswire/
-- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine
technology innovation, focused on transforming spine surgery with
minimally disruptive, procedurally-integrated solutions, today
announced the U.S. launch of AttraX® Scaffold, an absorbent
ceramic-collagen bone graft with an optimized surface that has been
validated in preclinical testing to drive increased bone formation
and faster fusion than traditional ceramic bone
grafts.1
Unlike traditional ceramic materials that do not by themselves
generate bone formation when implanted in an intramuscular site,
AttraX Scaffold has unique microstructure and microporosity that
are optimized for bone formation in this environment. The AttraX
surface technology, through its carefully defined and tightly
controlled features at the submicron scale, drives the
differentiation of mesenchymal stem cells into bone-forming
osteoblasts without added growth factors.2
"AttraX Scaffold was easy to use and maintained excellent
handling characteristics throughout the procedures," said Dr. J.
Kenneth Burkus of the Hughston
Clinic in Columbus, Ga., after
performing the first clinical cases with the NuVasive biologic.
"The material was highly absorbent of bone marrow aspirate and
easily cut or molded to the desired shape. After experiencing
AttraX Scaffold firsthand, I am very pleased to offer this
scientifically advanced ceramic bone graft to my spinal fusion
patients."
Available in strips, blocks and morsels, AttraX Scaffold can be
used in the posterolateral spine to promote fusion. AttraX Scaffold
complements the currently marketed AttraX Putty product line to
offer spine surgeons a suite of surface-optimized ceramic graft
materials to meet surgical needs. During preclinical testing in
posterolateral fusion (PLF) models, AttraX fusion rates were
equivalent to or better than autograft, and faster than traditional
ceramic grafts.1,3-5 In addition, spinal segments fused
with AttraX had greater biomechanical strength than segments
treated with ACTIFUSE ABX or Vitoss BA in a rabbit PLF
model.6
"With AttraX Scaffold we have enhanced the NuVasive Biologics
portoflio to better serve our surgeons," said Matt Link, executive vice president, strategy,
technology and corporate development for NuVasive. "We are
delivering the only ceramic-collagen scaffold for spine surgery
that achieves desirable handling characteristics, elicits an
osteogenic response from the body's cells and performs with
remarkable fusion rates. Surface optimization represents the next
leap forward in ceramic bone grafting technology and has the
potential to deliver outstanding clinical outcomes for surgeons and
their patients."
The addition of AttraX Scaffold strengthens the NuVasive
biologics portfolio by providing differentiated clinical options in
each of the major biologics categories: Osteocel® in the cellular
allograft category, Propel™ in the DBM category and AttraX in the
synthetic category.
About NuVasive
NuVasive, Inc. (NASDAQ:
NUVA) is the leader in spine technology innovation, focused on
transforming spine surgery and beyond with minimally disruptive,
procedurally-integrated solutions designed to deliver reproducible
and clinically-proven surgical outcomes. The Company's portfolio
includes access instruments, implantable hardware, biologics,
software systems for surgical planning, navigation and imaging
solutions, magnetically adjustable implant systems for spine and
orthopedics, and intraoperative monitoring service offerings. With
over $1 billion in revenues, NuVasive
has an approximate 2,400 person workforce in more than 40 countries
serving surgeons, hospitals and patients. For more information,
please visit www.nuvasive.com.
Forward-Looking Statements
NuVasive cautions
you that statements included in this news release that are not a
description of historical facts are forward-looking statements that
involve risks, uncertainties, assumptions and other factors which,
if they do not materialize or prove correct, could cause NuVasive's
results to differ materially from historical results or those
expressed or implied by such forward-looking statements. The
potential risks and uncertainties which contribute to the uncertain
nature of these statements include, among others, risks associated
with acceptance of the Company's surgical products and procedures
by spine surgeons, development and acceptance of new products or
product enhancements, clinical and statistical verification of the
benefits achieved via the use of NuVasive's products (including the
iGA® platform), the Company's ability to effectually manage
inventory as it continues to release new products, its ability to
recruit and retain management and key personnel, and the other
risks and uncertainties described in NuVasive's news releases and
periodic filings with the Securities and Exchange Commission.
NuVasive's public filings with the Securities and Exchange
Commission are available at www.sec.gov. NuVasive assumes no
obligation to update any forward-looking statement to reflect
events or circumstances arising after the date on which it was
made.
1 Walsh, WR, Oliver
RA, Pelletier MH, et al. Efficacy of a novel microstructured
calcium phosphate-collagen bone graft in a rabbit posterolateral
spine fusion model. International Society for the Advancement of
Spine Surgery 2018 Annual Conference. Toronto, Canada.
2 Yuan H, Fernandes H, Habibovic P, et al.
Osteoinductive ceramics as a synthetic alternative to autologous
bone grafting. Proc Natl Acad Sci 2010;107:13614-9.
3 Vizesi F, Cunningham B, Hu N, et al. Nanostructured
TCP in the sheep posterolateral fusion model. 9th World
Biomaterials Congress 2012. Chengdu,
China.
4 Ismailoglu AS, Vizesi F, Cunningham B, et al.
Fibrillar collagen/TCP scaffold in the sheep posterolateral fusion
model. Society for Biomaterials Annual Meeting 2012. New Orleans, LA, USA.
5 Fredericks DC, Smucker JD, Peterson EB, et al. Novel
TCP compares favorably to autograft in posterolateral fusion:
evaluation in rabbit and sheep models. International Society for
the Advancement of Spine Surgery 2013 Annual Conference.
Vancouver, BC, Canada.
6 Walsh WR, Degroot F, Bertollo N, et al. Nanostructured
TCP in rabbit posterolateral fusion compared to commercial
osteobiologics. American Academy of Orthopaedic Surgeons 2011
Annual Meeting. San Diego, CA,
USA.
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SOURCE NuVasive, Inc.