First Patient Enrolled in Glyder Facet Restoration Clinical Study

Sponsor to Participate in 2014 North American Spine Society Annual Meeting

News provided by

Nov 11, 2014, 12:30 ET

MINNETONKA, Minn., Nov. 11, 2014 /PRNewswire/ -- 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, today 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. multicenter single-arm study. The study will be performed at five sites and will include up to 20 patients.

The Glyder Facet Restoration Device offers patients a long-term surgical treatment for low back pain caused by facet joint degeneration.

"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.

"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."

Zyga Technology will be in Booth 222 the 2014 North American Spine Society (NASS) annual meeting November 12 through 15. The NASS meeting brings together spine care professionals from all over the world to share information on techniques, procedures, best practices and new technologies.

About 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.

About Zyga Technology

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. For more information, visit zyga.com.

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

CONTACT:
Paul Hess
Tel 612 698 9955
[email protected]

Photo - http://photos.prnewswire.com/prnh/20141024/154338

Logo - http://photos.prnewswire.com/prnh/20110118/CG30384LOGO

SOURCE Zyga Technology, Inc.