Contacts: Tony Viscogliosi, Spine Solutions, Inc. (212) 583-9700
Nick Kilsby, EKK-PR Inc. (203) 406-8800 ext. 21
NEW PRODISC SURGERY RECEIVES $130,000 BOOST FROM
MALAYSIA HEALTH MINISTRY
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
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.
Full information is available at www.spinesolutionsinc.com
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