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inventing Salubria biomaterial, David N. Ku, M.D., Ph.D.,
President and CEO, founded SaluMedica in 1998. Dr. Ku is a
Regents' Professor and Lawrence P. Huang Chair of Engineering
Entrepreneurship at the Georgia Institute of Technology, and
is Professor of Surgery at Emory School of Medicine. He received
an M.D. from the Emory School of Medicine, a Ph.D. in Aerospace
Engineering from the Georgia Institute of Technology, and
a B.A. in Engineering from Harvard University. The invention
of Salubria marks the first new biomaterial designed specifically
for medical implants in years.
The company has integrated a compliant Quality System according
to the requirements of the FDA and European International
Standards Organization (ISO), allowing it to achieve ISO-9001,
EN 46001 and EN ISO 13485 certification.
Just eighteen months after the Company's inception, SaluMedica's
team developed its first product, the SaluBridge Nerve Cuff
for peripheral nerve repair. SaluBridge received FDA market
clearance for the US in late 2000, followed by the CE mark
in 2001 for sale in Europe, and the Medical Device License
for sale in Canada in early 2002.
The Company's second product, SaluCartilage,
is designed to replace cartilage surfaces worn out by arthritis
and sports injury. Damaged articular cartilage may be cored
out and replaced with SaluCartilage to provide a smooth, load-bearing
joint surface. This procedure offers a less invasive and more
cost-effective alternative to current therapies. SaluCartilage
was granted the CE Mark in April 2002, allowing for sale in
Europe. The Company selected instrumentation maker Arthrex
as the ideal partner to market and sell the product. The FDA
submission required for sale in the US is on-going.
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