©DePuy Synthes Companies 2014. Results in other cases may vary. The product information included here may not be appropriate for use outside the United States, and the information from other sites you visit may not be appropriate for use in the United States. All Rights Reserved. *ViviGen is regulated as an HCT/P (Human Cells, Tissues, and Cellular and Tissue-Based Product; pursuant to 21 CFR 1271. ViviGen provides the following bone-forming components: Scaffold – ViviGen retains the natural scaffold, or support structure, for new bone to grown on and through5. 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. Osteogenic Potential of the ViviGen CellularComponent Results from In Vitro Studies. 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. Data on File LifeNet HealthDHF 12-008, DHF 15-001 Also Launching at the NASS Meeting
ViviGen is a registered trademark of LifeNet Health.The third party trademarks used herein are the trademarks of their respective owners.
"We are pleased to expand the category with ViviGen, an innovative product, that together with our existing portfolio, provides a total procedural solution.". Spine surgeon Dr. Robert Masson** of the NeuroSpine Institute in Orlando, Florida, was the first to implant ViviGen earlier this year. ViviGen is a cellular allograft intended for repair or reconstruction of musculoskeletal defects. ViviGen contains the elements necessary for bone formation¹ ViviGen is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) comprised of cryopreserved viable, lineage committed bone cells within a corticocancellous bone matrix and demineralized bone delivering all of the properties necessary for bone formation. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies. The fibers interconnectto achieve the formable handling favored in open void cases such as posterolateral fusion, a common type of spinal fusion surgery.This unique handling helps surgeons mold the allograft into a defined shape, allowing ViviGen Formable to conform to the surgical site. All Rights Reserved. ViviGen is a HCT/P (Human Cells, Tissues, and Cellular and Tissue-based Product) comprised of cryopreserved, live, viable bone cells within a corticocancellous bone matrix and demineralized bone. All contents © Medical Device Business Services, Inc. 2020. 68-20-210: K. Apostle, “Surgical Repair of Open FemurFracture with Bone Loss Using ViviGen® Cellular BoneMatrix”, 2018. Ovine coritical osteoblasts outperformbone marrow cells in an ectopic bone assy. Signals – For bone formation to occur, specific signals are necessary to direct the process. Throughout a 17-year collaboration, DePuy Synthes Companiesand lifenet health have provided safe, high quality bio-implants to surgeons and patients. delivers all three properties required for bone formation. "Cellular allografts represent an exciting and fast growing new category within the bone graft substitute market," said Max Reinhardt, President, DePuy Synthes Spine. 68-20-237: W. Giessler, “Surgical Repair of a Delayed Union to the Radius Diaphysis Using ViviGen, 68-20-238: W. Giessler, “Salvage of Failed Wrist Arthroplasty Using ViviGen. ViviGen and ViviGen Formable are trademarks of LifeNet Health
These enhancements are designed to provide more surgical options and enhance usability during posterior stabilization of the upper spine. 1.
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. As we celebrate 125 years of innovation, our commitment is to keep people moving. Providing a New Cellular Allograft with Alternative Consistency for Spinal Fusion SurgeryBone graft substitute comprised of viable, lineage committed bone cells ViviGen Formable augments the DePuy Synthes biomaterials portfolio and joins the first generation, ViviGen® Cellular Bone Matrix, which launched in late 2014. 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. **Consultant to DePuy Synthes Spine Osteoconductive ( Corticocancellous Chips)Provide a natural scaffold for cell attachment, migrationand proliferation.1, 3.
68-20-227: A. Kaz, “Surgical Repair of a Nonunion Fracture at the Fifth Metatarsal Using ViviGen CellularBone Matrix”, 2019.
(This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding a new product. "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. Reichert et al. For more information, visitwww.depuysynthes.com. Osteogenic ( Lineage Committed Bone Cells)The processing of ViviGen removes bone marrowcomponents including Mesenchymal Stem Cells whileretaining the desirable bone cells (osteoblasts,osteocytes and bone lining cells).1, 2. DEPUY SYNTHES COMPANIES INTRODUCES VIVIGEN™ CELLULAR BONE MATRIX, Sachs, Chen. ViviGen is a comprehensive bone graft developed to mimic your own bone.
DePuy Synthes Companies of Johnson & Johnson is the largest provider of orthopaedic and neurological solutions in the world. About DePuy Synthes Companies DSUS/MOC/0117/0662(1) 2/17 EX-17-008, All contents © Medical Device Business Services, Inc. 2020. Contains viable, lineage committed bone cells that areable to proliferate in vitro post cryopreservation and thaw4, Contains corticocancellous chips that provide a naturalscaffold for cell attachment, cell migration and cellproliferation1, Demineralization of the cortical bone exposes thenatural growth factors within the matrix1, Every lot is aseptically processed and tested for sterilityusing USP <71>1, The rapid heat transfer not only allows for all sizes tothaw in less than 5 minutes, but is also vital for cellviability5, ViviGen reaches cryopreservation within 72 hours maximizing cell viability 24 hours sooner than competitive products1, The processing of ViviGen is focused on protecting viable, lineage committed bone cells from recovery to implantation1, ViviGen and ViviGen Formable provide a comprehensive solution to meet surgeons’ clinical needs, ViviGen®/ViviGen Formable® Sell Sheet- TRAUMA. 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.
Over the past several years, LifeNet Health has conducted extensive research to enable the processing of these products to maintain cell viability, resulting in an acceptable alternative to autograft1.
The product information included here may not be appropriate for use outside the United States, and the information from other sites you visit may not be appropriate for use in the United States. Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson. By clicking to continue, you will be taken to a web site governed by their own Legal and Privacy Policies. The development of tissue-engineeredbone of different origin through endochondral andintramembranous ossification following the implantationof mesenchymal stem cells and osteoblasts in a murinemodel.
Advantage of ViviGen Packaging Results from InVitro Studies. You are about to leave jnjmedicaldevices.com. 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. 1,2,3 "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. The newest addition to our biomaterials portfolio is the introduction of Vivigen™cellular Bone matrix. The announcement was made by DePuy Synthes Spine at the North American Spine Society (NASS) annual meeting. ViviGen is being utilized in fusion, non-union, and mal-union for foot/ankle or long bone trauma in patients with compromised biology. © DePuy Synthes 2020. You are about to leave jnjmedicaldevices.com. 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.
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