WARSAW, Ind., Dec. 13, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of PrimaGen Advanced Allograft, an autograft substitute containing the same bone healing elements as autograft, but without the risks associated with donor site morbidity or harvest site complications. Allograft is human tissue transplanted from a donor to a patient, while autograft tissue is transferred from one part of a patient’s body to another. PrimaGen Advanced Allograft offers a combination of demineralized cortical bone fibers with verified osteoinductivity and cancellous bone, providing a trabecular structure for natural bony in-growth with optimal handling and delivery characteristics.
Dr. Donald Kucharzyk*, Orthopaedic Surgeon at The Orthopaedic, Pediatric and Spine Institute in Crown Point, Ind., was one of the first surgeons to use PrimaGen Advanced Allograft. “The syringe allows for easy preparation and replication of the graft consistency prior to each use,” noted Dr. Kucharzyk, who was pleased with the new delivery system, as well as the handling, moldability and stability under irrigation.
PrimaGen Advanced Allograft is designed to provide all three components essential for bone growth and healing: osteoconductivity, osteoinductivity and osteogenicity. Advanced testing of each donor tissue verifies the following:
- Cells in cancellous bone, which provides an interconnected trabecular structure, remain viable post-thaw;
- The graft contains at least 750,000 cells per cubic centimeter (cc) of cancellous tissue with at least 70 percent cell viability; and
- The cells present are able to differentiate into mature osteoblasts, which is critical for new bone formation.
“PrimaGen Advanced Allograft was developed to overcome the limitations of other bone graft substitutes and designed to offer a real alternative to autograft,” said Adam Johnson, Zimmer Biomet’s Group President of Spine, Dental, CMF and Thoracic. “We are pleased to include within our Spine portfolio a graft that not only has desirable handling characteristics, but is simple and convenient to use. PrimaGen Advanced Allograft recreates the Gold Standard, while reducing the co-morbidities tied to graft harvest.”
PrimaGen Advanced Allograft is indicated for use as an allogeneic bone graft substitute containing viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient’s tissue in musculoskeletal defects. These defects may be surgically created defects or defects created from traumatic injury to bone.
About Zimmer Biomet
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.
We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.
We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.
*Dr. Kucharzyk is a paid consultant of Zimmer Biomet Spine.
Cautionary Statement Regarding Forward-Looking Statements
This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Accordingly, such forward-looking statements speak only as of the date made. Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this news release.
SOURCE Zimmer Biomet Holdings, Inc.