Biomet, Inc., a global leader in the manufacture of orthopedic and biotechnology products, announced today that its subsidiary, Biomet Biologics, LLC, has completed the required 230 subject enrollment for its Recover® Kit clinical trial. This clinical trial studies the use of the Recover® Kit device, which produces autologous platelet-rich plasma (PRP) to treat chronic tennis elbow (lateral epicondylitis). This multicenter, prospective, randomized, controlled, double-blind clinical trial will be completed when the last subject enrolled reaches 24 weeks follow-up in mid-2011. Enrollment was completed by twelve investigational sites in the United States.
The clinical trial is being performed under a U.S. Food and Drug Administration (FDA)‐approved Investigational Device Exemption (IDE) to evaluate the safety and efficacy of the Company’s Recover® Kit to treat chronic tennis elbow. Study subjects received either the investigational PRP treatment or an active control (bupivacaine). Adverse event profiles and clinical assessments of pain and function will be compared in the two treatment groups. The clinical data from this pivotal study will support a submission to the FDA requesting approval to market the Recover® Kit to treat chronic tennis elbow.
“We are excited to complete the required enrollment for this study, as it addresses a very problematic issue for the patient and surgeon alike,” said Stuart Kleopfer, President of Biomet Biologics. “We believe this is an important step forward in advancing the use of autologous, point-of-care therapies to treat chronic tendinopathies.”
Chronic tennis elbow is the most commonly diagnosed condition of the elbow. It is painful and typically afflicts patients between the ages of 35 and 50 years whose activities require strong gripping or repetitive wrist movements. Along with pain, this condition can result in disability and considerable time lost from work.
Biomet, Inc. and its subsidiaries design, manufacture and market products used primarily by musculoskeletal medical specialists in both surgical and non‐surgical therapy. Biomet’s product portfolio encompasses reconstructive products, including orthopedic joint replacement devices, bone cements and accessories, autologous therapies and dental reconstructive implants; fixation products, including electrical bone growth stimulators, internal and external orthopedic fixation devices, craniomaxillofacial implants and bone substitute materials; spinal products, including spinal stimulation devices, spinal hardware and orthobiologics; and other products, such as arthroscopy products and soft goods and bracing products. Headquartered in Warsaw, Indiana, Biomet and its subsidiaries currently distribute products in approximately 90 countries.
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. Those statements are often indicated by the use of words such as “will,” “intend,” “anticipate,” “estimate,” “expect,” “plan” and similar expressions. Forward-looking statements involve certain risks and uncertainties. Actual results may differ materially from those contemplated by the forward looking statements due to, among others, the following factors: the success of the Company’s principal product lines; the results of ongoing investigations by the United States Department of Justice and the United States Securities and Exchange Commission; the ability to successfully implement new technologies; the Company’s ability to sustain sales and earnings growth; the Company’s success in achieving timely approval or clearance of its products with domestic and foreign regulatory entities; the impact to the business as a result of compliance with federal, state and foreign governmental regulations and with the Corporate Integrity Agreement; the impact to the business as a result of the economic downturn in both foreign and domestic markets; the impact of federal health care reform; the impact of anticipated changes in the musculoskeletal industry and the ability of the Company to react to and capitalize on those changes; the ability of the Company to successfully implement its desired organizational changes and cost-saving initiatives; the impact to the business as a result of the Company’s significant international operations, including, among others, with respect to foreign currency fluctuations and the success of the Company’s transition of certain manufacturing operations to China; the impact of the Company’s managerial changes; the ability of the Company’s customers to receive adequate levels of reimbursement from third-party payors; the Company’s ability to maintain its existing intellectual property rights and obtain future intellectual property rights; the impact to the business as a result of cost containment efforts of group purchasing organizations; the Company’s ability to retain existing independent sales agents for its products; and other factors set forth in the Company’s filings with the SEC, including the Company’s most recent annual report on Form 10-K and quarterly reports on Form 10-Q. Although the Company believes that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or non-occurrence of future events. There can be no assurance as to the accuracy of forward-looking statements contained in this press release. The inclusion of a forward-looking statement herein should not be regarded as a representation by the Company that the Company’s objectives will be achieved. The Company undertakes no obligation to update publicly or revise any forward-looking statements, whether as a result of new information, future events or otherwise. Accordingly, the reader is cautioned not to place undue reliance on forward-looking statements which speak only as of the date on which they were made.
Bill Kolter, 574-372-1535
Corporate Vice‐President, Government Affairs,
Public Affairs and Corporate Communication