Glyder Facet Restoration Clinical Study for Lumbar Spine

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Zyga Technology, Inc., a medical device company focused on the design, development and commercialization of minimally invasive products to treat underserved conditions of the lumbar spine, announced the first patient enrollment in DUET (A Multi-Site Study of the Zyga GlyDer Facet Restoration Device in Subjects with LUmbar FacET Pain Syndrome), a U.S. multi-center single-arm study. The study will be performed at five sites and will include up to 20 patients.

"Lumbar" is derived from the Latin word "lumbus," meaning lion, and the lumbar spine earns its name. It is built for both power and flexibility - lifting, twisting, and bending. In human anatomy, the lumbar vertebrae are the five vertebrae between the rib cage and the pelvis. They are the largest segments of the vertebral column and are characterized by the absence of the foramen transversarium within the transverse process (as it is only found in the cervical region), and by the absence of facets on the sides of the body. They are designated L1 to L5, starting at the top. The lumbar vertebrae help support the weight of the body, and permit movement.

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Lumbar spinal stenosis is a condition whereby either the spinal canal (central stenosis) or one or more of the vertebral foramina (foraminal stenosis) becomes narrowed. If the narrowing is substantial, it causes compression of the spinal cord or spinal nerves, which causes the painful symptoms of lumbar spinal stenosis, including low back pain, buttock pain, and leg pain and numbness that is made worse with walking and relieved by resting.

"The Glyder device fills a significant gap in the care continuum for facet joint pain," stated Reginald J. Davis, MD, FACS, Chief of Neurosurgery at Greater Baltimore Medical Center, who performed the surgery.

"When conservative treatments such as facet injection or rhizotomy fail to provide relief for these patients, our only recourse has been to perform a fusion, a procedure that eliminates motion and permanently alters the natural movement of the spine. The Glyder Device is designed to provide long-term relief of facet joint pain through a non-fusion procedure that preserves surrounding anatomy and future treatment options."

The Centers for Disease Control and Prevention lists low back pain (LBP) as the second most common cause of disability in U.S. adults (i). It has been reported that over 30 percent of all chronic low back pain derives from the facet joint (ii) , with an estimated 3.2 million facet joint interventions performed annually.

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"It is rare and exciting to develop a truly novel technology that fills such a clear unmet clinical need," said Jim Bullock, president and chief executive officer of Zyga. "With the DUET clinical study, as well as a 150-patient Post Market Registry in the E.U. to be launched later this year, we continue to build the clinical evidence needed to support market adoption of the Glyder Facet Restoration Device."

The Glyder Facet Restoration Device is intended to provide relief from lumbar facet pain, restoring facet joint function while preserving native anatomy. The device consists of two small polymer discs that cover the articulating surfaces of the facet joint. The company is currently sponsoring a 20-patient, five-site feasibility study of the Glyder technology in the U.S. and recently received CE Mark on the device.

Zyga Technology is dedicated to the research, development and commercialization of solutions that provide empirical clinical and economic value in the treatment of underserved conditions of the spine. The company is currently marketing the SImmetry Sacroiliac Joint Fusion System, a minimally invasive procedure intended for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

• (i) Centers for Disease Control and Prevention. Prevalence of disabilities and associated health conditions among adults United States, 1999. JAMA. 2001; 285(12):1571-1572.
• (ii) DePalma M et al. What is the source of chronic low back pain and does age play a role? Pain Med 2011; 12:224 - 233

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