OCTOBER 16, 2018 Warsaw, IN – Johnson & Johnson Medical Devices Companies* today announced that DePuy Synthes Sales, Inc. has entered into an exclusive agreement with Ortho Development® Corporation to co-promote in the U.S. its KASM® Knee Articulating Spacer Mold. This is a sterile, disposable cement spacer mold for patients who develop an infection after primary knee replacement. This new offering builds upon DePuy Synthes’** commitment to innovative knee solutions focused on helping patients along the care continuum.
Of the five percent of patients who require total knee revision surgery1, prosthetic joint infections are among the leading cause2, with the majority occurring within the first two years after surgery3. Treating this type of infection requires a two-stage process. The primary knee implant is removed and replaced with a temporary antibiotic knee spacer. When the infection has cleared, the patient then undergoes a second surgery to replace the knee, known as a revision procedure.
Knee spacers are typically either static or articulating. Static spacers require patients to keep the infected knee immobilized for up to six months until the infection has cleared. Articulating spacers allow patients to weight bear with the use of crutches or a walker and possibly maintain motion during their recovery. KASM is designed to help preserve range of motion, joint space and soft tissue tension. Additional KASM features include:
- Smooth articulating surface for both femur and tibial sides
- Open mold design that allows surgeons to customize the fill of each component to accommodate for existing bony defects and other patient-specific conditions
- Three sizes to account for a variety of patient anatomies
“KASM provides us with the unique opportunity to help surgeons whose patients have developed an infection to maintain some mobility and freedom they might not otherwise have had throughout the healing process,” said Juan-José Gonzalez, President, DePuy Synthes U.S. “This exclusive agreement with Ortho Development adds to our existing knee portfolio that spans treatment from early intervention to surgical replacement, with the goal of helping people return to living active and fulfilling lives.”
Ortho Development Corporation designs, develops, manufactures, and markets devices for knee and hip joint reconstruction, spine treatment, and trauma. KASM is one of Ortho Development’s products and received FDA clearance in 2014. This product has also been on the market in Japan for several years.
DePuy Synthes will begin to promote KASM in the latter part of 2018.
About Johnson & Johnson Medical Devices Companies
As the world’s most comprehensive medical devices business, we are building on a century of experience, merging science and technology, to shape the future of health and benefit even more people around the world. With our unparalleled breadth, depth and reach across surgery, orthopaedics and interventional solutions, we’re working to profoundly change the way care is delivered. We are in this for life. For more information, visit www.jnjmedicaldevices.com.
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.
*The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and interventional solutions businesses within the Johnson & Johnson’s Medical Devices segment.
**DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
1 M. Khan, K. Osman, G. Green, F. S. Haddah (2016). The epidemiology of failure in total knee arthroplasty. The Bone & Joint Journal, 98-B (1 Suppl A), 105-12.
2 Current epidemiology of revision total knee arthroplasty in the United States. Delanois R, Mistry J, Gwam C, Mohamed N, Choksi U, Mont M. J Arthroplasty. 2017 Mar; 32:2663-2668.
3 Prosthetic joint infection. Tande A, Patel R. Clinical Microbiology Reviews. 2014; 27(2)302-345.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the agreement with Ortho Development to exclusively promote KASM. 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: the potential that the expected benefits and opportunities related to the collaboration may not be realized or may take longer to realize than expected; 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,” in the company’s most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and in 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 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.