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Published on 5/9/2006 in the Prospect News Biotech Daily.

Paradigm Spine completes $14 million private placement; FDA approves IDE for coflex device

By Lisa Kerner

Erie, Pa., May 9 - Paradigm Spine, LLC said it completed a $14 million series C private placement.

Proceeds will be used to expand the company's coflex technology, fund clinical development of its Orthobiom system and grow Paradigm's portfolio of spine non-fusion technologies and intellectual property.

The series C financing was raised by investment bank Viscogliosi & Co, Inc. from spine and orthopedic surgeons and a select group of individual investors.

Including this latest financing round, Paradigm has raised $15.5 million in cash, foundational assets and intellectual property.

"With the close of this financing the Company is well funded and positioned to pursue our global vision," chairman and chief executive officer Marc R. Viscogliosi said in a news release.

"We intend to be the leading provider of indication-specific posterior non-fusion solutions that will provide surgeons with the best treatments to improve their patients' lives."

The company also announced that it has received an Investigational Device Exemption (IDE) from the Food and Drug Administration, allowing Paradigm to begin clinical trials for the coflex device (an interspinous implant.)

A total of 460 patients with lumbar spinal stenosis will participated in the prospective randomized controlled study at up to 20 sites. The study will compare the coflex device with pedicle-screw fusion, the current standard of care.

Paradigm is a New York City-based provider of posterior stabilization technologies to the international spine community.


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