Ellipse completes enrollment for initial study of MAGEC Technology in at-risk early onset scoliosis patients

Ellipse Technologies, Inc.Jul 15 2010

Ellipse Technologies, Inc. ("Ellipse") announced it had completed the initial clinical study enrollment for its MAGEC^TM (MAGnetic Expansion Control) Technology in "At Risk Early Onset Scoliosis Patients."

This study has enrolled a total of 25 patients in six hospital centers located in three countries. Each of these patients has received either one or two of the MAGEC implants as prescribed by the participating clinical investigator. The majority of patient procedures have been conducted using a minimally invasive surgical procedure. During the ensuing months following the implant procedure, a series of non-invasive dynamic expansion procedures of the MAGEC distracting rod are completed to lengthen the implant to help straighten the spines of these growing children. In these patients, dynamic expansion of the implant has been completed with the MAGEC External Remote Controller ("ERC") in a totally non-invasive, outpatient procedure. Ellipse will continue to follow the patients in this study as these non-invasive adjustments continue over the next several months and years.

MAGEC TECHNOLOGY

Ellipse has developed the MAGEC Technology for minimally invasive, and ultimately non-invasive, orthopedic deformity prevention and management. Ellipse has filed numerous patent applications for use of the MAGEC Technology for a broad range of clinical applications. The Company is currently concentrating on deformity and trauma applications in the orthopedic and spinal markets. MAGEC Technology is a breakthrough medical device technology capable of non-invasively adjusting (expandable and reversible) implants within the human body from outside the body via remote control. The first application for this technology is for the treatment of spinal scoliosis in children.

Currently, growing children with severe spinal scoliosis have few medical options. The standard treatment requires a series of five to ten highly invasive surgical operations each with large surgical incisions and long recovery times performed over a number of years - a process so undesirable that some of these young patients and their families are being evaluated for Post Traumatic Stress Disorder.

With the MAGEC Technology, a single minimally invasive surgical procedure is completed. Then, during a series of routine outpatient visits, the physician will dynamically adjust the MAGEC Technology from outside the body via the MAGEC ERC System, thus eliminating the need for multiple highly invasive surgical procedures. The MAGEC Technology is being developed to provide multiple clinical advantages such as spinal motion preservation, no long term permanent implant, minimal trauma and scarring, and short hospitalization times.

Commenting on this study, Ellipse Chairman Michael Henson said, "The enrollment in this study has proceeded quite rapidly. Many of the patients have travelled from countries all over the world to participate in this first study of the MAGEC System being conducted at key international centers. The possibility of having only a single minimally invasive procedure to be followed up by a series of five-minute non-invasive adjustments is quite compelling to both these young patients and their parents. The initial procedures to position the MAGEC implants, as well as the non-invasive adjustments, have been completed very smoothly and without complications. We look forward to the formal presentation of the results of this study later this year."