NuVasive Launches AttraX Scaffold Biologic And Reports First Clinical Use

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.

¹Walsh, 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.