First Patient Enrolled in SImmetry Sacroiliac Joint Fusion Clinical Study - Applied Clinical Trials

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First Patient Enrolled in SImmetry Sacroiliac Joint Fusion Clinical Study


First Patient Enrolled in SImmetry Sacroiliac Joint Fusion Clinical Study

PR Newswire

MINNETONKA, Minn., May 29, 2014 /PRNewswire/ -- Zyga Technology, Inc. announced the first patient enrollment in Sacroiliac Fusion Study (SAIF), a prospective, single-arm post-market study designed to evaluate fusion and pain reduction following use of the SImmetry® Sacroiliac Joint Fusion System. The study will be performed at a single center and will include up to 15 patients.

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"Clinical studies such as SAIF are critical to demonstrate the empirical value of Sacroiliac (SI) Joint Fusion," stated Dr. Noel D. Goldthwaite, MD, who performed the surgery. "This kind of objective data may show payers, other physicians, and of course those suffering from SI Joint Dysfunction the clinical and economic benefits of true SI Joint arthrodesis including decortication and bone grafting."

The Centers for Disease Control and Prevention lists low back pain (LBP) as the second most common cause of disability in US adults[i]. It has been reported that up to 30% of all chronic low back pain derives from the SI Joint[ii], but the condition has not been widely acknowledged due to challenges in diagnosis and a lack of treatment options.

"The introduction of the SImmetry System, a minimally invasive SI Joint fusion procedure that utilizes proven orthopedic principles of decortication, grafting and fixation, is the first step in providing a viable treatment option for SI Joint Dysfunction," said Jim Bullock, president and chief executive officer of Zyga. "Now, through SAIF and additional planned clinical studies, we will demonstrate the clinical and economic value of the true SI Joint arthrodesis allowing for consistent insurance coverage and availability to patients in need."

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 under-served 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. Zyga Technology is headquartered in Minnetonka, Minn. For more information, visit www.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] Cohen SP et al. (2013) Sacroiliac Joint pain: A Comprehensive Review of Epidemiology, Diagnosis and Treatment.  Expert Rev Neurother; 13(1):99-116

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CONTACT:
Paul Hess
Tel 612 698 9955
phess@zyga.com

SOURCE Zyga Technology, Inc.

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