Next Generation Synthetic Bioactive Bone Graft Substitute Strengthens Biomaterials Offering Within Spine Portfolio
RAYNHAM, Mass. – May 9, 2018 – DePuy Synthes*, part of the Johnson & Johnson Medical Devices Companies**, today announced an exclusive agreement in the U.S. between DePuy Synthes Sales, Inc. and Prosidyan to promote the FIBERGRAFT® Family of Products, a line of synthetic bone graft materials which are ultra-porous, designed for ease of use, and have been engineered for optimal resorption in clinical use during spine fusion surgery. By adding FIBERGRAFT to its offerings, DePuy Synthes will further enhance the company’s biomaterials portfolio for spine, which currently includes cellular allograft, demineralized bone matrix and first generation synthetic solutions. Surgeons will now have a broad range of handling options based on the needs of each patient and surgical case.
Approximately 400,000 patients in the U.S. undergo spinal fusion surgery annually to help reduce pain and nerve root inflammation.1 Surgeons will often use a biomaterial to facilitate bone growth and fusion. Each case is unique, and providing a broad portfolio of offerings allows surgeons the opportunity to select the right consistency.
“Our exclusive agreement with Prosidyan allows us to complete our biomaterials offering through a next generation synthetic solution and provide our customers with a variety of options based on handling preference and needs of their patients,” said Juan-José Gonzalez, President, DePuy Synthes U.S. “This offering allows us to provide a more complete solution for our customers.”
Prosidyan was founded in 2009 to develop a family of synthetic bioactive bone graft substitutes based on microsized fibers of bioactive glass. Prosidyan’s first product, FIBERGRAFT BG Morsels, a synthetic bone graft substitute, received FDA clearance in March 2014, and the first surgery utilizing this innovative bone substitute was performed in May 2014. The firm’s second product in the line, FIBERGRAFT BG Putty, received FDA clearance in March 2015, and comprises FIBERGRAFT BG Morsels delivered through Prosidyan’s proprietary bioactive carrier, OSSIGLIDE. Prosidyan’s third and flagship product FIBERGRAFT BG Matrix, received FDA clearance in October of 2017 and comprised FIBERGRAFT BG Morsels combined with Prosidyan’s proprietary type I collagen based bioactive carrier.
To date, FIBERGRAFT products have been provided for more than 10,000 patients across the U.S.
DePuy Synthes is expected to begin promoting FIBERGRAFT in Q2 2018.
About the Johnson & Johnson Medical Devices Companies
The Johnson & Johnson Medical Devices Companies’ purpose is to reach more patients and restore more lives. Having advanced patient care for more than a century, these companies represent an unparalleled breadth of products, services, programs and research and development capabilities in surgical technology, orthopaedics, and interventional solutions with an offering directed at delivering clinical and economic value to health care systems worldwide.
About DePuy Synthes
DePuy Synthes, part of the Johnson & Johnson Medical Devices Companies, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit: www.depuysynthes.com.
*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional businesses within Johnson & Johnson's Medical Devices segment.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding an agreement with Prosidyan to exclusively promote the FIBERGRAFT Family of Products. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither DePuy Synthes, the Johnson & Johnson Medical Devices Companies, nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
The third party trademarks used herein are the trademarks of their respective owners.
©DePuy Synthes 2018. All rights reserved.
- Rajaee, Ss et al. Spinal fusion in the United States: analysis of trends from 1998 to 2008. Spine. 2012 Jan 1;37(1):67-76.