Category: Uncategorized
April 5, 2004

News Release: Kyphon Receives FDA Clearance to Market KyphX HV-R Bone Cement for Use in Kyphoplasty; Kyphon to Promote Clinical Outcomes of Kyphoplasty to the Medical Community

Kyphon Inc. (Nasdaq:KYPH) announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market KyphX(R) HV-R(TM) Bone Cement for the fixation of osteoporosis-related pathological fractures of the vertebral body during kyphoplasty. The finding of substantial equivalence was based on clinical data supporting certain short and long term outcomes of kyphoplasty.

'This clearance is a significant event in the evolution of balloon kyphoplasty as a treatment option for patients with spinal fractures related to osteoporosis,'commented Richard Mott, President and Chief Executive Officer of Kyphon. 'By launching our KyphX HV-R Bone Cement in the United States, we will be able to provide and promote a complete procedural solution for surgeons who treat patients with these fractures. In addition, we can now train spine specialists on appropriate techniques for delivering bone cement during balloon kyphoplasty. Further, we believe clearance to promote the cleared clinical outcomes of kyphoplasty to the referring physician community and among patients and caregivers will enhance our ability to penetrate our core market over the long term.'

Kyphon's proprietary KyphX HV-R (High Viscosity -- Radiopaque) polymethylmethacrylate (PMMA) Bone Cement is designed to have the desired handling and visualization characteristics for minimally invasive surgery in the spine. The cleared indication for use is for the treatment of pathological fractures of the vertebral body due to osteoporosis using a kyphoplasty procedure. The Company is initiating launch activities in preparation of an anticipated second quarter full U.S. market release.

'Our KyphX HV-R Bone Cement is the first material specifically indicated for the treatment of osteoporotic fractures, and will further Kyphon's position as a leading innovator in minimally invasive spinal fracture therapies,'concluded Mott.

Balloon kyphoplasty is a minimally invasive spinal surgery that has been demonstrated to achieve sustained vertebral body height restoration and angular deformity correction in patients with vertebral body compression fractures caused by osteoporosis. Substantial equivalence was determined based on clinical data provided in the 510(k) demonstrating that the procedure is associated with significant and maintained reduction in back pain, improvement in quality of life, and increase in ability to perform activities of daily living and patient mobility. As with most surgical procedures, there are risks associated with kyphoplasty, including serious complications, although the complication rate with kyphoplasty has been demonstrated to be low.

Kyphon intends to discuss further the impact on its business of the clearance of KyphX HV-R during the Company's first quarter earnings conference call.

About Kyphon Inc.

Kyphon develops and markets medical devices designed to restore spinal function using minimally invasive technology. The Company's initial products are used in balloon kyphoplasty, a minimally invasive procedure to treat spinal fractures caused by osteoporosis. For more information, visit the company's web site at

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,''hopes,' '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 and uncertainties, which may cause the Company's actual results to differ materially from the statements contained herein. Further 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, 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,'commencing on page 32 of Kyphon's quarterly report on Form 10-K for the year ended December 31, 2003, filed with the Securities and Exchange Commission on March 10, 2004. 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 or to reflect the occurrence of unanticipated events.

Kyphon and KyphX are registered trademarks of Kyphon Inc.

SOURCE: Kyphon Inc.

Kyphon Inc. David M. Schummers, 408-548-6500 This email address is being protected from spambots. You need JavaScript enabled to view it.

WEBSITE This email address is being protected from spambots. You need JavaScript enabled to view it.

Videos / Webinars

View all videos