New York, NY, June 10, 2014 – Paradigm Spine, LLC, a provider of innovative spinal implant technologies, is
pleased to announce the recent publication of two focal clinical research articles addressing both the costs and morbidity
associated with fusion procedures performed in the treatment of spinal stenosis, and separately its comparative
effectiveness relative to the Company’s coflex® Interlaminar Stabilization device and procedure.
In the recently-released publication titled “Comparative Cost Effectiveness of coflex® Interlaminar Stabilization
Versus Instrumented Posterolateral Fusion for the Treatment of Lumbar Stenosis” published in the March 2014 edition of
the Journal of Clincoeconomics and Outcomes Research, researchers suggest that the coflex® Interlaminar Stabilization
device and procedure is better utilized from a comparative effectiveness perspective for the treatment of lumbar spinal
stenosis, when compared to instrumented spinal fusion, with savings measured over a 5-year time table estimated to be
approximately $11,700 per surgical case.1
In a separate publication titled “Perioperative Outcomes, Complications, and Costs Associated with Lumbar
Lumbar Spinal Fusion in Older Patients with Spinal Stenosis and Spondylolisthesis” published in the June 2014 edition
of the Journal of Neurosurgery Spine, researchers highlight the incidence of patients undergoing lumbar decompression
and spinal fusion for the treatment of spinal stenosis and spondylolisthesis, with an emphasis on the rate of complications,
cost, and readmission rates for patients receiving these treatments.2
The significant amount of both revision surgery rates,
as well readmissions for complications of these decompression and fusion procedures are analyzed and discussed for a
dataset comprised of Medicare patients.
In considering the importance of both recent publications, Marc R. Viscogliosi, Chairman and Chief Executive
Officer of Paradigm Spine, LLC, stated “both publications highlight the common use of spinal fusion after
decompression of spinal stenosis, and unfortunately, display the high costs and revision rates associated with spinal
fusion in this older age group. We are pleased to see the coflex® Interlaminar Stabilization procedure being performed
more cost-effectively and with significant cost savings compared to spinal fusion in this Medicare age group. Controlling
costs and improving outcomes with less morbidity using minimally invasive techniques has to be a better alternative for
patients. This comparative effectiveness study highlights the information payors and patients have been waiting for.”
From the surgeon’s perspective, Hallett Mathews, MD, MBA, Chief Medical Officer of Paradigm Spine, LLC
notes the importance of the data to assist surgeons with difficult decisions regarding patient treatment selection and the
avoidance of costly mistakes. Dr. Mathews stated “fusion has been the mainstay of stabilization for decades now, and
these studies, along with the landmark studies published by Davis, et. al. in Spine, August 2013 and Davis, et. al. in JNS,
May 2013, prove to us that a less morbid, minimally invasive form of stabilization can occur after a decompression for
the treatment of moderate to severe lumbar spinal stenosis without the need for rigid segmental stabilization with a fusion.
Maintaining motion and not having to wait for arthrodesis has to be better for this patient group.” Dr. Mathews also
mentioned that “coflex® and its improved outcomes and operating efficiencies combined with reduced overall costs and
multiple sites of care, including the ambulatory surgery setting, truly improve value for all stakeholders.”
About Paradigm Spine, LLC
Paradigm Spine, LLC was founded in 2004 and remains focused on the design and development of solutions for the
treatment of spinal diseases. The Company’s signature product is the coflex® interlaminar stabilization device, which has
more than 20 years of clinical history and patients treated in more than 40 countries worldwide.
