Devices Neurosurgery Orthopaedic Regulatory

 News Release - April 30, 2007

Paradigm Spine

Company's fourth non-fusion product to receive EU approval

NEW YORK, April 30 (HSMN NewsFeed) -- Paradigm Spine, LLC, a developer of innovative non-fusion spinal implant solutions, announced that it has received a European Union CE Mark for its DSS(TM) implantable dynamic spine stabilization system. The CE Mark will allow the company to begin marketing the DSS(TM) system in Europe and many other countries that recognize the certification.

The first surgery involving the DSS(TM) system was performed on April 27th, 2007 in Straubing, Germany by Dr. Rudolf Bertagnoli.

The DSS(TM) system is a pedicle-screw based, implantable dynamic spine stabilization system indicated for degenerative disc disease (DDD) of the lumbar spine. The DSS(TM) system incorporates a hybrid philosophy, combining elements of fusion and motion preservation.

The system was developed over a two-year period in close cooperation with Professor Hans-Joachim Wilke, a world-renowned Professor of Biomechanics from the University of Ulm in Germany, and Dr. Bertagnoli, the most experienced spine arthroplasty surgeon worldwide.

The modularity of the DSS(TM) system enables the combination of DSS dynamic couplers with DSS fusion couplers at adjacent levels. Therefore, one segment may have functionally dynamic stabilization (non-fusion) while an adjacent segment has rigid segmental fixation (fusion) under the same system.

The DSS dynamic coupler increases the stiffness of the affected motion segment and restricts the range of motion in flexion, extension, lateral bending and rotation while preserving motion. By selecting the appropriate size DSS dynamic coupler, the posterior segmental height can also be adjusted. The DSS fusion coupler provides rigid segmental fixation utilizing the same instrument set. One of the features and benefits of the system is the use of percutaneous screw positioning that facilitates a minimally invasive muscle- sparing approach.

Marc R. Viscogliosi, Chief Executive Officer of Paradigm Spine, said, "The DSS(TM) system is the product of collaborative thinking between two of the world's most experienced spine motion-preserving experts, from both a scientific and clinical point-of-view."

"The DSS(TM) system is one of the first truly dynamic stabilization systems because it increases segmental stiffness while controlling specific ranges of motion as the patient goes about his or her daily activities," he noted. "We are particularly excited to have benefited from the enthusiastic development efforts and significant contributions of Professor Wilke and Dr. Bertagnoli."

Professor Wilke said, "I worked very closely with the Company on incorporating the key strategic and scientific elements of the ranges and types of motion which need to be controlled by a true dynamic stabilization system. Specifically, we designed the system to focus on controlling 'active zone' motions, which are normally associated with pathologic painful arcs of motion."

Professor Wilke further added, "This product reflects what we have learned about the function of the human spine from multiple spine experiments over many years, based on studies conducted with our validated Finite Element model of a lumbar spinal segment."

Dr. Bertagnoli said, "The surgery on Friday [April 27] went very well and I believe the DSS(TM) system has the potential to become an important new option in the continuum of spine care. Having used most of the major spine arthroplasty products I, like Professor Wilke, am convinced of the uniqueness and potential impact of the DSS(TM) system for the treatment of my patients."

The DSS(TM) system is Paradigm Spine's fourth product to receive a CE Mark, following the coflex® interspinous implant, the DCI(TM) dynamic cervical implant, which received the CE Mark on December 5, 2006; and the coflex-F(TM) implant system which received the CE Mark on December 15, 2006.

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 40 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

Source: Paradigm Spine

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