Legal
As originally announced back in June, this week the Supreme Court heard a Medtronic case involving a failed balloon catheter. The decision of the case could have broader implications for the FDA's authority and product liability. According to the Wall Street Journal, a majority of the justices appeared to support this view that Congress wanted the FDA to regulate medical devices without interference from state regulators or courts. An opinion is expected by July.
Product Introduction and Update
DePuy Orthopaedics, Inc., announced that Gription™ Porous Coating received 510(k) clearance for use on the Company's Pinnacle® Acetabular Cup System. According to the Company, the Gription Coating technology offers a high coefficient of friction and engineered pore form featuring 63% porosity and 300-micron average pore size that are intended to provide a secure, stable fit.
ReGen Biologics (OTC: RGBI) announced that its collagen meniscus implant device previously known as CMI® will be renamed Menaflex™ and be featured on a new website: www.menaflex.com. Gerald E. Bisbee, Jr., Ph.D., Chairman and Chief Executive Officer stated, "Now that we are marketing the product outside the United States, we will utilize a unique brand name that allows for improved recognition among patients and surgeons."
Smith & Nephew's Endoscopy Division launched a family of redesigned and expanded CLEAR-TRAC Disposable Cannulas, with a new, triple-seal system that aims to reduce fluid leakage and helps surgeons manage sutures during arthroscopic surgery. The Cannulas feature a flexible plastic shaft that provides surgeons with a better feel for changes in tissue density.
Clinical
Kinamed announced that in a recent issue of The Journal of Bone & Joint Surgery (JBJS) "unparalleled surgical outcomes" were reported when using Kinamed's FDA-cleared KineMatch® Patello-Femoral Replacement device. This device is custom made and replaces a single part of the knee unlike total knee replacements that replace all three compartments. The study describes the treatment of 25 KineMatch treated knees. After an average follow-up period of 73 months all 25 implants were in place and functioning well. There were 18 "Excellent" and 7 "Good" results using the Knee Society scoring method. There were no instances of additional surgery or component loosening.
M&A
Integra LifeSciences announced the acquisition of the Precise Dental family of companies for $10 million in cash. The Precise companies manufacture and distribute an array of products sold to endodontists. It will be integrated with Integra's Miltex subsidiary, which also sells dental equipment.
Appointments
David W. Petty was named President of Exactech and elected to the Board of Directors. Mr. Petty previously served the Company in various capacities in the areas of operations and sales and marketing since 1988. Mr. Petty is replacing his father, Dr. William Petty, as President. Dr. Petty will remain in his role as Chief Executive Officer and as Chairman of the Board of Directors, and will continue as leader of the Exactech management team.
TranS1 appointed Joseph P. Slattery to serve on its Board of Directors and to serve as the Chairman of the Company's Audit Committee. Mr. Slattery currently serves on the board of Micromet, Inc. and was previously Senior Vice President and Chief Financial Officer of Digene Corporation. The current Chairman of the Audit Committee, Jon Osgood, will remain on the Company's Board and as a member of the Audit Committee.
Miscellaneous
Novation, LLC announced that its trauma agreements have saved members >$17 million over the past year, and expects up to $51.5 million in total savings over the 3-year term of the agreements.
Stryker's board declared a year-end cash dividend of 33 cents, representing an increase of 50 percent over the 22 cents paid last year.
