DePuy Mitek

RAYNHAM, MA - DePuy Mitek, Inc. announced a critical milestone in its multi-center randomized pilot study evaluating the safety and performance of its Cartilage Autograft Implantation System (CAIS), with 29 patients enrolled in the study in the United States since March 2006.Donec lobortis.

This investigational device and method is designed as a primary surgical treatment of damaged knee cartilage using the patient’s own healthy cartilage in a single operation. This study, comparing CAIS to microfracture in patients with lesions of the articular knee cartilage, is the first prospective, randomized multi-center clinical trial for a cell-based therapy product intended for cartilage repair in the United States.

“I am excited about the positive study results for this potential advance in cartilage repair. By combining intraoperative cartilage processing and a unique scaffold, this procedure could eliminate the need for a second operation and the expense of cell culturing,” said Jack Farr, MD a clinical investigator and orthopedic surgeon at OrthoIndy in Indianapolis, where the first patients were implanted. “This comparative investigation highlights the continuing developments in the field of cartilage restoration.”

The control group received a microfracture, a common procedure that has been performed for many years for cartilage repair. In the procedure, several tiny holes, or microfractures, are made in the bone beneath the defect causing bone marrow cells and blood to clot and cover the damaged area to promote healing and tissue repair. Published studies indicate that microfracture only produces softer fibrous cartilage and may require a subsequent operation.

“This technique under investigation would eliminate the need for a second procedure as required by other cell-based technologies, and also could eliminate the need for tedious suturing or the use of expensive donor cartilage potentially associated with the small risk of disease transmission" says Brian Cole, head of the Rush Cartilage Restoration Center, Chicago. "The large animal studies performed at Rush showed hyaline-like cartilage is produced with this system and this study is building on that.”

CAIS is a joint development effort between DePuy Mitek and Johnson & Johnson Regenerative Therapeutics, LLC, a regenerative medicine research and development organization. In CAIS, healthy cartilage cells are harvested, placed on to a bioabsorbable scaffold and implanted all in the same surgical procedure. DePuy Mitek scientists were the first to recognize and confirm the breakthrough that chondrocytes when processed/treated appropriately can be re-implanted immediately into the patient.

It is widely reported that those who have an untreated traumatic cartilage injury at a younger age are at risk of developing osteoarthritis later in life.

Other surgeons and centers involved in the U.S. pilot were: John Richmond at New England Baptist Hospital in Boston, MA , Bert Mandelbaum at Santa Monica Orthopedics Group in California, Timothy Hosea at St. Peter’s University Hospital and CARES Facility in New Brunswick, NJ, and Ralph Gambardella at Kerlan-Jobe Clinic in Los Angeles.

A similar pilot study is currently underway in Europe, designed to enroll approximately 30 subjects at six sites: Prof. Fredrik Almqvist, University of Gent in Belgium; Prof. Stefan Nehrer, Danube University, Krems, Austria; Dr. Mats Brittberg, Kungsbacka Hospital, Sweden; Tim Spalding, University of Warwick, Coventry, United Kingdom; Prof. Andreas Imhoff, Technische Universität, München Germany; Dr.Claudio Zorzi, Ospedale S. Cuore, Verona.

Information from both the U.S. and European pilot studies will be collected upon which to base the design of a larger, pivotal study in the U.S. Commercialization of the Cartilage Autograft Implantation System in Europe is planned in 2008.

About DePuy Mitek, Inc.

DePuy Mitek, Inc., a Johnson & Johnson company, is a leader in sports medicine and arthroscopy with a range of solutions that “Restore the Anatomy”™. DePuy Mitek also offers ORTHOVISC (High Molecular Weight Hyaluronan) visco-supplementation, a non-surgical treatment for mild-moderate osteoarthritis knee pain. For more information, go to http://www.depuymitek.com and http://managingosteoarthritis.com.

ORTHOVISC® is a registered trademark of Anika Therapeutics. Manufactured by Anika Therapeutics. Anika Therapeutics, Inc. Woburn, MA 01801 USA

This campaign features Mike “Coach K” Krzyzewski, a DePuy hip patient and coach of the 2008 U.S. Olympic Team of Men's Basketball and Duke University Basketball. Coach K is a hands-on leader. Not one to sit on the sidelines, he likes to get on the court with his team. But when he developed severe hip arthritis, he just couldn’t. As his condition worsened, the pain became so severe that he had to coach from a chair. That’s when his orthopaedic surgeon recommended a hip replacement from DePuy Orthopaedics.

“My life’s all about movement. So when arthritis pain nearly ended my career nine years ago, I had to do something about it. I want other patients to see that I have gone from coaching from a chair to coaching the 2008 U.S. Olympic Team of Men’s Basketball and think about what they can accomplish!” said Coach K.

The goal of the Never Stop Moving campaign is to motivate osteoarthritis sufferers to learn more about hip and knee replacement and seek the care of an orthopaedic surgeon. Many of these patients are waiting too long or failing to seek help. We believe awareness and education can make a difference for these patients.

This campaign, which will begin airing during the Olympics, will invite patients to visit www.depuyusa.com to learn more about available treatment options, including joint replacement.

DePuy’s Product Solutions

Pinnacle® Hip Solutions, developed since Coach K's hip replacement, were designed to help provide a more fluid range of natural motion. Only Pinnacle Hip Solutions feature TrueGlide™ technology, allowing the body to create a thin film of lubrication between surfaces. The result is a more fluid range of natural motion that more closely matches the feel and movement of a natural hip.

Sigma® Rotating Platform Knees from DePuy Orthopaedics, Inc. are unique because they are designed to bend and rotate. Unlike a hinge, the surfaces of the knee joint roll and glide against each other when the knee bends. In other words, the knee naturally rotates as it bends. The Sigma Rotating Platform Knee provides flexibility for patients who want their knee replacement to accommodate normal movement, while minimizing implant wear, when compared to traditional knee replacements.¹

As with any medical treatment, individual results may vary. Only an orthopaedic surgeon can determine whether an orthopaedic implant is an appropriate course of treatment. There are potential risks, and recovery takes time. The performance of the new joint depends on weight, activity level, age and other factors.

About DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc., a Johnson & Johnson company, is advancing the standard of orthopaedic patient care, with a focused commitment to help surgeons achieve excellence in surgical practice. The company designs, manufactures and distributes orthopaedic devices and supplies including hip, knee, extremity, trauma, cement, orthobiologics, and operating room products. As a global leader in joint replacement products, DePuy Orthopaedics is committed to Restoring the Joy of Motion® for patients whose mobility is restricted by severe osteoarthritis or other debilitating injury.

¹ Data on file at DePuy Orthopaedics, Inc., 2007.

Raynham, MA, July 11, 2007 DePuy Mitek, Inc., a leading manufacturer of surgical sports medicine devices, announced today the launch of the VAPR® S50 Radiofrequency Electrode, the company’s first small diameter suction electrode with a 12 percent smaller profile than the leading competitor’s electrode¹.

The VAPR S50 uses radiofrequency energy to smooth tissue and eliminate jagged edges resulting from the surgical removal of soft tissue in the knee or shoulder. It is designed to vaporize soft tissue (ablation) and remove debris, fluid and heat (suction), as well as seal blood vessels (coagulation) while minimizing damage to surrounding tissue and increasing visualization during arthroscopic surgery.

With its small diameter and anatomic bend, it offers surgeons optimal access to the tight anatomy of the knee or shoulder.

“The VAPR S50 does an excellent job of accessing tight anatomy and provides tremendous versatility for both controlled tissue sculpting, as well as rapid tissue removal when necessary,” said Brian Busconi, MD, Chief of Sports Medicine for the University of Massachusetts Memorial Medical Center.

At its default setting, the VAPR system provides sufficient power for controlled ablation including meniscal sculpting. Surgeons can adjust the wattage for aggressive tissue removal including ACL debridement, notchplasty or general tissue ablation. At its highest setting, the VAPR S50 is more powerful than the leading competitor, offering 53 percent faster tissue ablation².

The VAPR S50 also features a “Seamless Fault Safety Feature” that shuts off the electrode when it approaches metal and automatically reactivates when safely away. The VAPR S50 includes an integrated hand piece that benefits surgeons by reducing the number of required connections in the OR.

About DePuy Mitek, Inc.

DePuy Mitek, Inc., a Johnson & Johnson company, is the leading developer and manufacturer of innovative surgical sports medicine and soft tissue repair devices. The company offers a vast array of surgical solutions to assist in addressing the challenges of soft tissue repair. Through the on-going process of improving upon and creating new, technologically advanced materials, instruments and techniques, DePuy Mitek looks for continued growth in developing the means to advance procedural solutions in the field of sports medicine. For more information, visit www.depuymitek.com.

¹ Measurement Report. D Archila, March 2007. Data on File.
² Effectiveness of Various RF Electrodes for Knee Applications. F. Kummer, March 2007. Data on File.

Source: DePuy Mitek, Inc.