ORTHOFIX INTERNATIONAL N V

Transcription

1 ORTHOFIX INTERNATIONAL N V FORM 8-K (Current report filing) Filed 04/16/09 for the Period Ending 04/15/09 CIK Symbol OFIX SIC Code Surgical and Medical Instruments and Apparatus Industry Medical Equipment & Supplies Sector Healthcare Fiscal Year 12/31 Copyright 2009, EDGAR Online, Inc. All Rights Reserved. Distribution and use of this document restricted under EDGAR Online, Inc. Terms of Use.

2 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 15, 2009 Orthofix International N.V. (Exact name of Registrant as specified in its charter) Netherlands Antilles N/A (State or other jurisdiction of incorporation) (Commission File Number) (IRS Employer Identification No.) 7 Abraham de Veerstraat Curacao Netherlands Antilles (Address of principal executive offices) N/A (Zip Code) Registrant s telephone number, including area code: Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions ( see General Instruction A.2. below): Written communications pursuant to Rule 425 under the Securities Act (17 CFR ) Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR a-12) Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR d-2(b)) Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR e-4(c))

3 Item Regulation FD Disclosure. On April 15, 2009, Orthofix International N.V. (the Company ) issued a press release regarding a qui tam complaint filed against the Company and other manufacturers of bone growth stimulators in the U.S. A copy of the press release is furnished herewith as Exhibit Item Financial Statements and Exhibits. (d) Exhibits 99.1 Press release, dated April 15, 2009

4 SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Orthofix International N.V. By: /s/ Raymond C. Kolls Raymond C. Kolls Senior Vice President, General Counsel and Corporate Secretary Date: April 15, 2009

5 EXHIBIT INDEX Exhibit No. Description 99.1 Press release, dated April 15, 2009

6 Exhibit 99.1 Investor Contact : Dan Yarbrough, Vice President of Investor Relations danyarbrough@orthofix.com (617) Orthofix International Reports Unsealing of Previously Filed False Claims Act Complaint Against Manufacturers of Bone Growth Stimulators BOSTON, Apr 15, 2009 Orthofix International N.V. (NASDAQ: OFIX) (the Company) today announced that a federal False Claims Act, or qui tam, complaint filed on March 23, 2005 against the primary manufacturers of bone growth stimulators in the U.S., including the Company, has been unsealed by the United States District Court for the District of Massachusetts. The civil complaint against these manufacturers of bone growth stimulators appears to focus on alleged reimbursement-related false claims associated with the sale versus the rental of those devices. The unsealing of the civil qui tam action is routine procedure and allows the individual plaintiff involved to pursue civil claims in federal court. The Company indicated that this week it also received what it believes is a related subpoena from the Department of Justice (DOJ) requesting documentation for a period from 1995 to The Company believes the DOJ is requesting information primarily related to claims for reimbursement for the sale of stimulation devices. Orthofix announced earlier this month that its subsidiary, Orthofix Inc., was approved for accreditation by the Accreditation Commission for Health Care, Inc., (ACHC) for the provision of Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) services. Obtaining accreditation is currently a voluntary activity where healthcare organizations submit their internal policies, processes and patient care delivery systems for peer review against national standards. Meeting and maintaining such accreditation status indicates the Company s compliance with ACHC s standards and its commitment to quality in the provision of DMEPOS services. About Orthofix Orthofix International, N.V., a global medical device company, offers a broad line of minimally invasive surgical, and non-surgical, products for the spine, orthopedic, and sports medicine market sectors that address the lifelong bone-and-joint health needs of patients of all ages-- helping them achieve a more active and mobile lifestyle. Orthofix's products are widely distributed around the world to orthopedic surgeons and patients via Orthofix's sales representatives and its subsidiaries, including BREG, Inc. and Blackstone Medical, Inc., and via partnerships with other leading orthopedic product companies. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Orthopedic Research and Education Foundation, Rutgers University, the Musculoskeletal Transplant Foundation, Texas Scottish Rite Hospital for Children and National Osteoporosis Institute. For more information about Orthofix, please visit