NEW YORK—March 13, 2007— Paradigm Spine, LLC announced today that internationally renowned neurosurgeon Dr. Carl Lauryssen today performed the first-ever California implantation of coflex™, a functionally dynamic interspinous implant for the treatment of patients suffering from lumbar spinal stenosis.
Dr. Lauryssen, consulting neurosurgeon to the Los Angeles Rams and to the medical unit of ABC News, performed the procedure at the Olympia Medical Center in Beverly Hills, where he is the Director of Research and Education.
Dr. Lauryssen is among a select group of neurosurgeons and orthopedic spine specialists participating in an Investigational Device Exemption (“IDE”) trial of the coflex™ device developed and marketed by Paradigm Spine, LLC. Paradigm Spine has FDA approval for a prospective randomized controlled clinical study involving 460 patients at up to 20 sites within the US. The coflex™ device will be compared with pedicle-screw fusion, the current standard of care.
Following the coflex™ case, Dr. Lauryssen stated, “The procedure went extremely well. The coflex™ device is simple to implant via a minimally invasive procedure, which reduces the patient’s time in the operating room as well as his recovery time. I am pleased to have been selected to participate in this important clinical trial. The coflex™ device provides an important new option in the continuum of treating lumbar spinal stenosis.”
Marc R. Viscogliosi, CEO of Paradigm Spine, said, “Dr. Lauryssen is respected and recognized for his high-quality research in spine care. We are pleased that he recognizes the value of a dynamically functional interspinous device designed to treat lumbar spinal stenosis following spinal decompression. Dr. Lauryssen is one of approximately twenty exceptional spine specialists in the US who will treat patients and collect data for this IDE trial. I am gratified by the enthusiasm at all our clinical sites, and believe we are on track for the timely completion of the trial.”
Dr. Gary Lowery, MD, PhD, and Executive Vice President of Research and Technology for Paradigm Spine added, “The coflex™ implant is designed to treat spinal stenosis, a common disease process primarily affecting patients between the ages of 50 and 70. The coflex™ device and procedure offer a non-fusion option that directly treats the stenotic pathology. Dr. Lauryssen’s colleagues outside the United States have embraced this device, successfully treating over 20,000 patients in the past 11 years.”
About Paradigm Spine, LLC
Paradigm Spine is a company focused on providing indication specific posterior non-fusion solutions for orthopedic spine surgeons and neurosurgeons focused on treating spinal conditions and diseases.
The company’s founding philosophy is “Surgeon Centric, Indication Specific, Data Driven”, and focuses on providing the best clinical outcomes for patients suffering from chronic back pain. The Company has 43 employees at its New York headquarters and office in Wurmlingen, Germany, including a 7-member direct sales force in Germany.
The company is concentrating on building a multi-product non-fusion portfolio. The company’s signature product is the coflex™ posterior, non-fusion interspinous dynamically-functional implant.
Paradigm Spine’s other core platform is the Orthobiom™ technology, which has been in development for over a decade. The Orthobiom™ technology treats adolescent idiopathic scoliosis, a condition that causes severe curvature of the spine that can be corrected surgically through a spinal fusion procedure. The Orthobiom™ system is a non-fusion alternative designed to preserve the motion and growth of the child’s spine. It is regarded as a revolutionary product with the potential to help the tens of thousands of children diagnosed annually with scoliosis.
Paradigm Spine, LLC was founded in 2004 by Viscogliosi Brothers, LLC (“VB”). Established by Marc R. Viscogliosi, John J. Viscogliosi and Anthony G. Viscogliosi in New York City in 1999, VB is the first venture capital/private equity and merchant banking firm dedicated to the $26.4 billion musculoskeletal/orthopedics device sector of the health care industry.
Today, VB is a leading independent firm, with a mission to create, build and finance companies founded on innovations developed by surgeons and uniquely focused on “life-changing” musculoskeletal/orthopedic technologies. VB has worldwide surgeon, industry and trade relationships and significant financial expertise in the musculoskeletal/orthopedic sector.
For more, visit: www.paradigmspine.com
First California Implant of Coflex™
Part of US IDE Trial Sponsored by Paradigm Spine, LLC