PRESS RELEASES

Contacts: Anthony Viscogliosi or Michael Will Nick Kilsby
Spine Solutions Inc. (212) 750-2099 EKK (203) 406-8800 ext 21

SPINE SOLUTIONS REPORTS RAPID GROWTH IN PRODISC IMPLANTS AND QUALIFIED SURGEONS IN 2002

New York, NY – January 7: Spine Solutions, Inc., the maker of ProDisc, the leading total artificial disc replacement system, reported sharp increases in 2002 of qualified surgeons and implantations of ProDisc.

Worldwide, during the year, more than 200 surgeons in 24 countries performed the procedure compared with 33 during 2001, resulting in sales of more than 2000 ProDisc products compared with 350 in 2001.

Germany is currently leading the world in the use of artificial discs as an alternative to fusion techniques for treating chronic degenerative disc disease of the spine. In 2002, surgeons there have performed more than 1,500 ProDisc implantations, an increase of more than 1,115 over 2001, according to Anthony G. Viscogliosi, CEO of Spine Solutions. “We’re seeing the fruits of more than a decade of development in a technology that promises to be the new gold standard for treating chronic back pain. In the US, ProDisc is in FDA Investigational Device Exemption (IDE) clinical trials at 16 medical centers with a target enrollment of up to 500 patients. Data permitting and contingent upon Pre-Market Approval (PMA), we expect ProDisc to be available commercially in the U.S. by 2005 or sooner,” Mr. Viscogliosi said.

A recent German court decision to nullify a patent held by Waldemar Link GmbH & Co. is thought to have helped heighten interest in ProDisc. “We believe that the momentum is being supplied by spiking interest among leading surgeons and university hospitals. As a result, we’re hopeful that the use of ProDisc will be confirmed as the standard procedure in all spine surgeries that meet established indications,” according to Michael D. Will, EVP/International Operations at Spine Solutions.

Separately, Spine Solutions announced that its ProDisc ‘C’ cervical disc replacement system had received a European Union CE Mark. Dr. Rudolph Bertagnoli, in Straubing, Germany and Dr. Thierry Marnay, in Montpellier, France are participating in a series of clinical trials of the ProDisc ‘C’ cervical disc replacement system that commenced in December, 2002.

The ProDisc total disc replacement system for use in both lumbar and cervical (or neck) regions of the spine is designed with materials long used in orthopedic implantation devices, including knee and hip replacements. It consists of three elements: a core of ultra-high-molecular-weight polyethylene that attaches to the top and bottom pieces of two cobalt-chromium alloy end-plates.

The system is designed to restore near natural range-of-motion, kinematics and biomechanics of the spine. Cases-to-date indicate a significantly shorter hospital stay and faster post-operative recovery period compared to fusion surgery.

Spine Solutions, Inc. is a privately held company established in 1999 and based in New York City.
 
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