Zyga Technology Receives CE Mark Approval for Glyder Facet Restoration Device

Approval signifies major milestone for emerging spine company

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Oct 27, 2014, 09:00 ET

MINNETONKA, Minn., Oct. 27, 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 CE Mark approval of the Glyder® Facet Restoration Device, offering patients a long-term surgical treatment for low back pain caused by facet joint degeneration.

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

"Zyga Technology is committed to providing clinically meaningful and economically viable solutions for underserved conditions of the spine," said Jim Bullock, president and CEO of Zyga Technology. "The Glyder device fills a gap in the current care continuum between short-term treatments such as injections and irreversible procedures such as lumbar fusion, which requires advanced degeneration and comorbidities such as intervertebral disc disease or radiculopathy."

The origin of chronic low back pain can be traced to the facet joints in approximately 31 percent of cases.^¹ In the U.S. alone, over 3.2 million facet joint interventions are performed each year.^2,3 For many patients, conservative treatments such as steroid injections and nerve ablation resolve pain at least in the short-term. When these treatments fail, however, there has not been a viable treatment to address the condition.

"We are pleased to be able to offer the Glyder Facet Restoration technology to patients suffering from symptomatic facet degeneration," commented Prof. Dr. Hans-Joerg Meisel, Director of Neurosurgery at Berufsgenossenschaftliche Clinic Bergmannstrost in Halle, Germany. "Our results in the Glyder clinical study demonstrated the potential long term benefits of this new technology. Now we can provide a minimally invasive solution that relieves pain without the need for lumbar fusion."

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 non-fusion, minimally invasive solution is designed to allow device implantation without sacrificing future treatment options—a new step in the care continuum for chronic lumbar facet pain. The company is currently sponsoring a 20-patient, five-site feasibility study of the Glyder technology in the U.S.

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. Earlier this month, Zyga was listed as one of five spine device companies ready for prime time by Beckers Spine. For more information, visit zyga.com.

¹ 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

² 2012 AMA RUC Database

³ Abdi et al, Epidural steroids in the management of chronic spinal pain: a systematic review. Pain Physician 2007; 10(1): 185 – 212

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SOURCE Zyga Technology, Inc.