Contacts: Tony Viscogliosi, Spine Solutions, Inc. (212) 583-9700
Nick Kilsby, EKK-PR Inc. (203) 406-8800 ext. 21


New York, November 14: A dramatic demonstration in Malaysia of spinal disc replacement surgery has prompted the government there to invest $130,000 to enable five hospitals to offer ‘ProDisc’ treatment to patients. Spine Solutions GmbH, the German-based international subsidiary of Spine Solutions, Inc., said the news is likely to open up other markets for ProDisc in the region.

In August of this year, a relative of Malaysia’s Health Minister, Chua Jui Meng, was the patient in a ‘live’ surgical demonstration performed by Dr. Kumar Selva of ProDisc for 45 Malaysia surgeons. By mid-October, the outcome of the procedure prompted Health Minister Meng to announce “a major advancement in spine surgery” and the multi-hospital program.

Dr. Selva, head surgeon at the University of Kuala Lumpur Spine Unit, will oversee the new program, having received extensive training in the procedure in Germany from Dr. Rudolph Bertagnoli, in Straubing, and at Spine Solutions’ research facility in Tuttlingen.

Winnifried Koenig, International Sales Director at Spine Solutions, said: “ProDisc’s success in Malaysia has important, positive implications throughout the Asia/Pacific region. To date, the results in Malaysia and extensive trials at the Samsung Medical Center in Korea suggest that ProDisc has a bright future in the region.”

In Korea, the company has trained eleven surgeons at five university hospitals who last month performed more than 30 surgeries with ProDisc. The trials are being supervised by Professors Chung and Lee, specialists in orthopedics and spine treatment respectively.

Koenig noted that similar trials will begin in Japan next year and a recent demonstration at a world congress of spine specialists in Singapore by Dr. Michael Mayer of Berlin, Germany has prompted interest in Japan for ProDisc at the National University Hospital.

Anthony G. Viscogliosi, CEO of Spine Solutions, Inc., said: “The acceptance of ProDisc as an alternative to spine fusion (a standard approach in the US for spine repair) has made it the pre-eminent technology and the market share leader in seven key European countries, Israel and South Africa.

The procedure is designed to restore full mobility to patients by using techniques and materials similar to those used in knee and hip replacement. Since its introduction, in Germany, in 1990, more than 1,600 surgeries have been performed worldwide – most of these in the last two years as long-term results confirm its efficacy.
Currently, the ProDisc total disc replacement technology is in an FDA Investigational Device Exemption (IDE) clinical study and is not marketed in the US. The company anticipates commercialization in 2005, only after receipt of FDA Pre-Market Approval.

“Based on long term clinical data, from an original series of patients treated during the period 1990-1993, clinical testing in the US was approved by the FDA in only 64 days – record speed. We’ve so far enrolled more than 300 patients at 18 clinical sites around the nation,” Viscogliosi said.

Spine Solutions, Inc., is a privately-owned company established in 1999 and based in New York City. Its principal international market subsidiary, Spine Solutions GmbH is based in Tuttlingen, Germany. The company’s ProDisc technology is currently available to patients in 24 countries, with more than 200 surgeons qualified to perform disc replacement surgery in 125 health care centers.

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