DEPUY SYNTHES COMPANIES INTRODUCES VIVIGEN™ CELLULAR BONE MATRIX,
NEW CELLULAR ALLOGRAFT FOR SPINAL FUSION
SAN FRANCISCO – Nov. 12, 2014 – DePuy Synthes Companies of Johnson & Johnson, in collaboration with LifeNet Health®, today announced the introduction of ViviGen™ Cellular Bone Matrix*, a differentiated cellular allograft for the repair or reconstruction of musculoskeletal defects. The announcement was made by DePuy Synthes Spine at the North American Spine Society (NASS) annual meeting.
Spine surgeon Dr. Robert Masson** of the NeuroSpine Institute in Orlando, Florida, was the first to implant ViviGen earlier this year. "ViviGen is a unique addition to the cellular allograft market and represents a promising step forward in the field of bone regeneration," said Dr. Masson.
ViviGen is a HCT/P (Human Cells, Tissues, and Cellular and Tissue-based Product) comprised of cryopreserved live, viable cells within a cortical cancellous bone matrix and demineralized bone, delivering all of the properties required for bone formation. Over the past four years, LifeNet Health has conducted extensive research to enable the processing of ViviGen to maintain cell viability, resulting in an acceptable alternative to autograft1. ViviGen has been utilized in a variety of spinal fusion surgeries since its initial availability.
"The science behind ViviGen, combined with the intraoperative flexibility it provides, drove me to try it initially," said Dr. Kennedy Yalamanchili, MD, of Christiana Care Hospital in Newark, Delaware, which is one of several sites that has recently used ViviGen. "My experience early on has shown that ViviGen has desirable handling characteristics and is an appropriate alternative to taking the patient’s own bone for many of my spinal procedures."
DePuy Synthes Spine and DePuy Synthes Biomaterials, divisions of DePuy Orthopaedics, Inc., have an exclusive worldwide agreement to market and promote ViviGen, which was developed by LifeNet Health, a world leader in allograft bio-implants and cellular therapies.
"Cellular allografts represent an exciting and fast growing new category within the bone graft substitute market," said Max Reinhardt, President, DePuy Synthes Spine. "We are pleased to expand the category with ViviGen, an innovative product, that together with our existing portfolio, provides a total procedural solution."
ViviGen will be fully released in the U.S. in January 2015.
Also Launching at the NASS Meeting
DePuy Synthes Spine is also launching for the SYNAPSE™ System, SYNAPSE Advanced enhancements, a collection of new implants and instruments for the SYNAPSE Platform, which is used for posterior stabilization of the upper spine. These enhancements are designed to provide more surgical options and enhance usability during posterior stabilization of the upper spine.
DePuy Synthes Spine also reports that it has received clearance from the U.S. Food and Drug Administration (FDA) to market SYNAPSE System and EXPEDIUM® Spine System together for the first time through the use of Titanium Dual Diameter Rods. This clearance will provide surgeons with many more options for treating disease spanning from the cervical region of the spine into the thoracic and lumbar regions. The two systems are global market leaders in the treatment of both cervical and thoracolumbar spinal conditions.
About DePuy Synthes Companies of Johnson & Johnson
DePuy Synthes Companies of Johnson & Johnson is the largest provider of orthopaedic and neurological solutions in the world. Together the companies offer an unparalleled breadth of products, services, programs and research and development capabilities that are designed to advance patient care and deliver clinical and economic value to health care systems throughout the world. DePuy Synthes Companies of Johnson & Johnson include eight businesses that focus on joint reconstruction, trauma, neurological, cranio-maxillofacial, spinal surgery and sports medicine.
*ViviGen is regulated as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product; pursuant to 21 CFR 1271.
**Consultant to DePuy Synthes Spine
©DePuy Synthes Companies 2014. All rights reserved.
ViviGen is a registered Trademark of LifeNet Health
1Data on File LifeNet Health
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding a new product. 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 Orthopaedics, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; and uncertainty of commercial success. A further list and description 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 29, 2013, including in Exhibit 99 thereto, and the company’s subsequent 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 Orthopaedics, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments).