NEW YORK, Oct. 11, 2006 (PRIMEZONE) -- Paradigm Spine, LLC, a developer of novel posterior non-fusion spinal implant solutions, announced today that the first two surgeries had been completed successfully in its IDE trial for coflex(tm), a functionally dynamic interspinous implant for the treatment of patients suffering from lumbar spinal stenosis.
The first-ever coflex(tm) implant in the United States was performed on October 4th, 2006, at the Loveland Surgical Center in Loveland, CO, by renowned spine surgeon, Dr. Kenneth Pettine, co-inventor of the Maverick(tm) artificial disc. Dr. Pettine implanted two coflex(tm) devices in a two-level surgery.
"I am honored to have had the opportunity to perform this milestone procedure using the coflex(tm) implant," said Dr. Pettine. "The device is an important new option for treating patients with moderate to severe lumbar spinal stenosis and the procedure went smoothly. I look forward to continued participation in this trial," he added.
The second coflex(tm) surgery was performed by eminent spine surgeon, Dr. John Thalgott, on October 9th, 2006, at Valley Hospital in Las Vegas, NV.
Dr. Thalgott said, "Implantation of the coflex(tm) device, combined with a surgical decompression, is a simple, low-risk procedure that is capable of providing significant pain relief, without resorting to fusion, for many patients suffering from spinal stenosis."
Paradigm Spine received FDA approval earlier this year for the prospective randomized controlled clinical study involving 460 patients at up to 20 sites within the U.S. The coflex(tm) device will be compared with pedicle-screw fusion, the current standard of care.
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.
Marc R. Viscogliosi, chief executive officer of Paradigm Spine, said, "It is gratifying to have superb surgeons such as Dr. Pettine and Dr. Thalgott leading our clinical trial. The coflex(tm) device has over 12 years of clinical history outside the United States, with more than 20,000 patients. These initial procedures keep us on our schedule of enrolling patients in the trial that we anticipate will eventually benefit thousands of patients in the U.S."
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 initiated a U.S. multi-center IDE clinical trial of the coflex(tm) implant in October, 2006.
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.
For more, visit: www.paradigmspine.com
The Paradigm Spine, LLC logo is available at http://www.primezone.com/newsroom/prs/?pkgid=2929