FDA Cleared Synthetic Bone Graft With Novel Surface Structure That Promotes Bone Formation
SAN DIEGO, CA -- (Marketwired) -- 05/23/16 --
NuVasive, Inc.(NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the U.S. launch of the newest solution in its biologics portfolio, AttraX® Putty.
AttraX Putty is a next generation, synthetic bone graft product indicated for use as an autograft extender in posterolateral spine surgery. The unique biotextured™ surface features of AttraX Putty helps drive regeneration of bone at the implanted site.1
"We are excited to officially launch AttraX Putty for surgical use in the U.S. and expect it to be a cornerstone of our expanding biologics portfolio," Pat Miles, NuVasive's President and Chief Operating Officer, commented. "AttraX Putty has helped improve outcomes for more than 20,000 spine patients worldwide, and we are pleased to now bring this biologic to market in the United States. Today's launch is another example of NuVasive's continued commitment to invest in industry-leading innovation that delivers the best possible patient outcomes."
NuVasive has invested substantially in AttraX Putty pre-clinical studies, demonstrating improved performance when compared to top competitive synthetic bone graft options in challenging posterolateral animal spinal fusion models. AttraX Putty showed increased bone formation and mechanically stronger fusions when compared to Vitoss® BA and Actifuse® ABX in these studies.1
"AttraX Putty has shown promising results in pre-clinical models, highlighted by increased bone formation when compared to traditional osteoconductive synthetic scaffolds. The significant clinical experience with AttraX Putty outside the United States and extensive scientific pre-clinical study is an exciting and promising combination. I am looking forward to having access to this unique technology in my practice, for the benefit of my patients," said Robert Eastlack M.D., Orthopedic Surgeon at Scripps Clinic, La Jolla, CA.
AttraX Putty Advantage
AttraX Putty is a synthetic, osteoconductive bone void filler for the repair of bone defects. A proprietary manufacturing process generates the AttraX Putty surface structure, which provides an instructive environment for mesenchymal stem cells (MSCs) to differentiate into bone-forming osteoblasts without added growth factors. Its unique bioresorbable material composition is designed to support an appropriate cell-mediated resorption rate. AttraX granules are combined with Alkylene Oxide Copolymer (AOC®), a polymeric blend, which provides intraoperative flexibility allowing the clinician to mold the biologic into specific shapes as desired. When placed next to viable host bone, new bone will be deposited on the surface of the implant. The implant will be resorbed and replaced by bone during the natural process of bone remodeling.
NuVasive received 510(k) FDA clearance for AttraX Putty in the U.S. in October 2015, and has been used globally since 2011.
NuVasive, Inc.(NASDAQ: NUVA) is a world leader in minimally invasive, procedurally integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive's highly differentiated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $811 million in revenues (2015), NuVasive has an approximate 1,600 person workforce in more than 40 countries around the world. For more information, please visit nuvasive.com.
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 Data on File
Source: NuVasive, Inc.