Paradigm Spine Receives CE Mark for Dynamic Cervical Implant


NEW YORK, Dec. 8, 2006 (PRIME NEWSWIRE) -- Paradigm Spine, LLC, a developer of innovative posterior non-fusion spinal implant solutions, announced that it has received a European Union CE Mark for its Dynamic Cervical Implant (DCI). The CE Mark will allow Paradigm Spine to begin marketing the DCI in Europe and many countries around the world that recognize the certification.

The DCI is a titanium implant that is designed for patients suffering from early stage degenerative disc disease (DDD) in the cervical spine.

Paradigm's DCI was developed originally through collaboration between Guy Matge, MD and Fixano, SAS, both of France, in 2001. Fixano was acquired by Viscogliosi Bros., LLC, the founder of Paradigm Spine, in 2005.

The company's international operations unit, Paradigm Spine GmbH, in Wurmlingen, Germany, is managing the DCI marketing activities.

The DCI is a dynamic cervical nucleus-like replacement device designed to maintain flexion and extension as well as compression. It has a long-term clinical experience of up to four years in a multi-patient trial that has yielded positive results to date.

Marc R. Viscogliosi, Chief Executive Officer of Paradigm Spine, said, "With the benefit of the CE mark, we are planning to expand our marketing of the DCI to surgeons treating patients with early stage DDD. It is simple to implant through a minimally invasive procedure and promises to be a viable motion-preserving alternative to total disc replacement or fusion."

Dr. Matge, inventor of the device, said, "DCI is designed with axial compliance properties that closely mimic those of the intact segment of the cervical spine."

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 38 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(tm) posterior, non-fusion interspinous dynamically-functional implant. The company has commenced a multi-center IDE clinical trial of the coflex(tm) implant in the United States.

Paradigm Spine's other core platform is the Orthobiom(tm) technology, which has been in development for over a decade. The Orthobiom(tm) 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(tm) 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



            

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