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News Release - January 6, 2006
Kyphon Announces Completion of Patient Enrollment in Landmark Randomized, Controlled Study of KyphoplastySUNNYVALE, Calif., Jan. 6 (HSMN NewsFeed) -- Kyphon Inc. (Nasdaq: KYPH ) today announced completion of patient enrollment in the FREE (Fracture Reduction Evaluation) Study, the world's first fully-enrolled, prospective, randomized, controlled multi-center trial designed to compare balloon kyphoplasty to non-surgical management in the treatment of painful, acute vertebral compression fractures.
A total of 300 patients in 21 international centers, primarily in the United Kingdom, Belgium, Germany, Sweden and other European locations, ultimately were randomized into the FREE Study. The first patient was enrolled in February 2002; the last in December 2005.
This landmark Study includes evaluations of adverse events, pain, quality of life, physical function, spinal deformity and subsequent fracture at 1, 3, 6, 12, and 24 months post-randomization. The clinical measurements are being performed using validated instruments including the Roland-Morris Disability Questionnaire, the Visual Analog Pain Scale (VAS), the EQ-5D, and the SF-36 Quality of Life Questionnaire. Radiographic evaluations will assess changes in vertebral body height and spinal angulation, as well as subsequent fractures, which will be performed by two independent radiologists. In addition, the Study contains an economic analysis that will evaluate and compare the cost of back-related care for the two groups. The Company anticipates that publication of the full two year follow-up results will be available in 2009.
"The FREE Study is a critical step in advancing the clinical evidence supporting the value of balloon kyphoplasty in treating osteoporotic spinal fractures," said Richard Mott, president and chief executive officer of Kyphon. "This study design is the most rigorous and clinically significant in the field of surgical treatment of osteoporotic vertebral compression fractures to date in the U.S. The information gained from this study will expand the knowledge base for treating these fractures with balloon kyphoplasty."
Spinal Fractures and Balloon Kyphoplasty
The majority of spinal fractures are caused by osteoporosis, a progressive disease that causes bones to become brittle, weak and susceptible to painful, debilitating fractures. According to the National Osteoporosis Foundation, over 700,000 spinal fractures occur annually in the U.S. One in two women and one in four men over the age of 50 in the U.S. will experience a spinal fracture, with two-thirds going undiagnosed. Cancer, including multiple myeloma and the metastasis of other tumors to bone, can also affect bone quality and lead to spinal fracture. In cases of multiple spinal fractures, a loss of height and stooped posture -- known as kyphosis -- can occur, which affects the ability to stand upright and walk, and can make simple tasks like lifting a bag of groceries or getting dressed difficult. Left untreated, each additional fracture increases future fracture risk, accelerating the effects of the spinal deformity. Increasing kyphosis is associated with decreased respiratory function, reduced ability to walk, decreased quality of life, and an increased risk of early mortality.
First performed in 1998, balloon kyphoplasty is a minimally invasive procedure which can treat the fracture, reduce pain, restore quality of life, and repair some or all of the associated deformity. To date, over 200,000 spinal fractures have been treated using the balloon kyphoplasty procedure worldwide.
About Kyphon Inc.
Kyphon develops and markets medical devices designed to restore spinal function using minimally invasive technologies. The company's KyphX line of products is used in balloon kyphoplasty, a minimally invasive procedure to treat spinal fractures caused by osteoporosis or cancer. More information about the company can be found at http://www.kyphon.com.
Kyphon and KyphX are registered trademarks of Kyphon Inc.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward looking statements include, but are not limited to, those that use words such as "believes," "expects," "anticipates," "targets," "intends," "plans," "projects," and words of similar effect, and specifically include the company's future financial projections and anticipated business direction and performance. Forward-looking statements are based on management's current preliminary expectations and are subject to risks, uncertainties and assumptions, which may cause the company's actual results to differ materially from the statements contained herein. Information on potential risk factors that could affect Kyphon, its business and its financial results are detailed in the company's periodic filings with the Securities and Exchange Commission (SEC), including, but not limited to, those risks and uncertainties listed in the section entitled "Management's Discussion and Analysis of Financial Condition and Results of Operations - Factors Affecting Future Operating Results," which can be found in Kyphon's quarterly report on Form 10-Q for the quarter ended September 30, 2005, filed with the SEC on November 2, 2005 and in Kyphon's annual report on Form 10-K for the year ended December 31, 2004 filed with the SEC on March 2, 2005. Kyphon undertakes no obligation to release publicly any revisions to any forward-looking statements contained herein to reflect events or circumstances after the date hereof.
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