Healthcare Industry News:  lumbar spinal stenosis 

Devices Neurosurgery Orthopaedic

 News Release - May 19, 2006

Spine Surgeons Dr. Adelt and Dr. Bertagnoli Present Follow Up Data On Patients Receiving the coflex(TM) Interspinous Implant

Two Papers Involving 246 Patients Over 4 Years

NEW YORK, May 19 (HSMN NewsFeed) -- Prominent German spine surgeons, Dieter Adelt, MD and Rudolf Bertagnoli, MD announced encouraging results in separate studies of a total 246 stenosis patients receiving Paradigm Spine's coflex(TM) spinal implant. The surgeons spoke to more than 1,500 colleagues attending the sixth annual Spine Arthroplasty Society (SAS) meeting in Montreal last week.

The coflex(TM) device is a U-shaped titanium alloy surgical implant indicated for use in patients with moderate to severe spinal stenosis, with neural element compromise, resulting in claudication and/or radicular symptoms isolated to 1 or 2 levels, in the region of L1 to L5. It is currently classified in the U.S. as an investigational device only.

Dr. Adelt, a neurosurgeon at the Ostseeklinik in Damp, Germany, implanted 240 patients with the coflex(TM) interspinous device between February, 2002 and November, 2004. His study evaluated 200, or 83%, of the patients. Spinal stenosis was found in 76% of the study group. Of these, Dr. Adelt said that 143 (86%) experienced relief in severe low back pain sufficient to significantly increase their walking distance.

Dr. Adelt commented, "These results indicate that the coflex(TM) procedure allows patients to improve not only by decompressing the neural structures but also by reducing back pain."

He added that 91% of patients reported being satisfied or very satisfied and 93% said that they would have the surgery again.

Dr. Bertagnoli, a surgeon at the ProSpine Centers in Straubing and Bogen, Germany, presented to SAS attendees results of a 12-month follow up on 46 patients treated with the coflex(TM) interspinous implant. The patients, median age of 63, had been diagnosed with secondary spinal canal stenosis, either with or without hypertrophic facet joints. As some patients received implants at more than one level, a total of 60 devices were implanted by Dr. Bertagnoli.

He reported that the results showed consistent reductions in six- and twelve-month post-operative disability and pain scores compared with pre- operative scores.

"The coflex(TM) interspinous implant offers a simple surgical treatment strategy with a low risk potential. Not a single patient was dissatisfied with the outcomes of their surgery," Dr. Bertagnoli reported.

Marc R. Viscogliosi, Chairman and CEO of Paradigm Spine, said: "Our first priority is the patient and, with these results, I am very optimistic about the potential for the coflex(TM) implant to improve patients' quality of life without the need for radical surgery such as fusion."

"The coflex(TM) implant now has an impressive clinical history among more than 15,000 patients being treated for low back pain and lumbar spinal stenosis," he added.

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 34 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 is planning to implement in the U.S. a multi-center IDE clinical trial of the coflex(TM) implant.

Paradigm Spine's other core platform is the Orthobiom(TM) technology, also 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.

In total, the company has raised almost $30 million in three rounds, including the latest Series C funding of $14 million, announced on May 8th, 2006.

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.

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Source: Paradigm Spine

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