LDR Spine Secures FDA Approval to Conduct the First Clinical Trial for a
Second-Generation Cervical Artificial Disc
Austin, TX (February 1, 2006)
LDR Spine, a total spine solution company, announced today
that it obtained approval for an Investigational Device
Exemption (IDE) from the United States Food and Drug
Administration (FDA). This allows the company to conduct a
pivotal human clinical trial to investigate the safety and
effectiveness of the Mobi-C® cervical artificial disc. This
is the only active one and two-level clinical trial approved
by the FDA for an artificial cervical disc and the first
FDA-approved study of a second-generation cervical disc
device.
The purpose of the investigation is to establish the safety and effectiveness of the Mobi-C cervical disc prosthesis. The Mobi-C has been used outside the United States since November 2004. Clinical results from Europe were included as part of the investigational application for the Mobi-C clinical study in the United States. The product is currently available in 20 countries throughout Europe and Asia. Texas Back Institute, the largest freestanding spine specialty clinic in the United States, will be the lead clinical site in the investigational study.
“For over two years we worked closely with a strong group of spine surgeons
to develop Mobi-C and it has been well received, resulting in over 300
implantations in patients outside the United States to date,” said Christophe
Lavigne, Founder and CEO of LDR Médical. “We listened to surgeons who wanted a
surgical technique similar to implanting a cervical cage, and we believe the
Mobi-C honors their input and is unique in the marketplace. The FDA’s approval
to conduct a one and two-level clinical trial in the United States is an
important step towards bringing this exceptional second-generation device to
U.S. patients.”
Mobi-C has the distinction of being the first second-generation artificial cervical disc to begin U.S. IDE trials. It is commonly used to treat degenerative disc disease in the cervical spine. Its purpose is to restore normal biomechanical function after disc excision, provide pain relief, and at the same time avoid subsequent degeneration at adjacent levels. Mobi-C uses mobile-bearing technology and contained mobility for better replication of anatomical movements, providing a more natural range of mobility that includes six degrees of freedom. It also provides for one-step implantation, which simplifies the surgical technique.
“Our investment to fund this important study will exceed $15 million over a
three to five year period,” said Steve Whitlock, President and CEO of LDR Spine.
“We realize that having both a one and two level clinical trial adds additional
costs, but we believe it provides surgeons with more options for treating their
patients and gives LDR Spine a strategic market advantage because 95 percent of
cervical fusion procedures involve one or two levels, a 60 percent increase over
single level procedures alone.”
“The physician feedback we have received on Mobi-C indicates that it may be the easiest device to implant of those currently in development," said Robert Faulkner, managing director and senior analyst for medical devices at JMP Securities. "Ease of use, development of clinical data for multi-level procedures, and the product's self-centering feature appear likely to make Mobi-C a leading entrant in this potential $1 billion market in the U.S."
The study will begin in February 2006 and will follow patients for two years. It will include up to 20 medical centers throughout the United States.
LDR Spine supplies U.S. surgeons with innovative spinal solutions in partnership with LDR Médical of Troyes, France. LDR Spine works closely with surgeons to develop implantable systems and instrumentation that restore optimum stability and mobility to patients, and make spine surgery more reproducible and easier to perform. More information is located at www.ldrspine.com.
For More Information:
Company Contact:
James Burrows, VP of Product Commercialization, LDR
(512) 344-3307
jamesburrows@ldrspine.com