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For Immediate Release:  
For Further Information:
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February 4, 2008  

Lee Moore
609-292-4791

Office of The Attorney General
- Anne Milgram, Attorney General

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Attorney General Announces Subpoena of Companies Involved in Development, Manufacture of Synthetic Spinal Disk

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TRENTON -- Attorney General Anne Milgram announced today that the state has issued subpoenas to Synthes Spine, Inc. , a Pennsylvania-based company that manufactures and markets a synthetic spinal disk known as ProDisc. The state also subpoenaed Viscogliosi Brothers, LLC, a New York-based investment firm that generated the start-up capital for the company that originally owned the device.

Viscogliosi Brothers formed Spinal Solutions, Inc., which originally owned the ProDisc device, and operated several investment funds whose main asset was Spine Solutions. Synthes, Inc., a global medical device company based in Switzerland, acquired Spine Solutions in 2003, and markets ProDisc under the corporate banner Synthes Spine.

The ProDisc is an artificial spinal disk approved by the federal Food and Drug Administration for use in patients in August 2006. The synthetic replacement disk has been surgically implanted in thousands of patients as an alternative to conventional spinal surgery, in which the vertebrae are fused to alleviate disk-related back pain.

According to Attorney General Milgram, the state subpoenas were issued today in New York and Pennsylvania and seek information spanning a time period from January 1, 1999 through the present.

Among other things, the subpoenas seek information concerning the investment backing that funded ProDisc’s development. The subpoenas also seek information concerning physician participation in, and the results of, clinical studies of ProDisc. It was largely on the basis of clinical study results presented in 2005 that FDA approved ProDisc for commercial sale and distribution in the United States.

A principal focus of the state’s inquiry is whether required disclosures were made regarding surgeons – including some licensed to practice in New Jersey -- who endorsed ProDisc as researchers and also had an investment interest in the device.

The state’s investigation is being conducted by the Affirmative Litigation Unit within the Division of Law.

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