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SMI (Starch Medical Inc.) is a San Jose, CA based
medical device company engaged in the design, manufacture and
sale of innovative, absorbable surgical hemostats synthesized
from Absorbable Modified Polymers (AMP™), a proprietary, patent pending
technology. SMI has organized a global distribution
network for the marketing and sales of PerClot™ Polysaccharide Hemostatic System (PHS),
which launched in the 4th Quarter, 2008. The SealFoam™ absorbable polysaccharide hemostat was awarded a CE mark in December, 2008 and is currently in clinical evaluation studies.
SMI was founded by surgeons
and medical device industry executives who concentrated their
expertise to develop new, absorbable surgical hemostats to
satisfy clinically significant bleeding challenges. In
collaboration with well-known polymer engineers, biomaterial
scientists and surgeons, SMI has developed a
breakthrough hemostatic technology based on engineered,
polymeric, modified starch particles. AMP™ particles accelerate
significantly the physiologic clotting process and exhibit the
requisite features of safety, efficacy and absorbability.
In 2008, SMI established an
ISO 13485 certified Class 7 (Class 10,000) clean room to
manufacture its polymeric polysaccharide hemostats. Starch
Medical has a registered ISO 13485 quality control system and
is committed to delivering quality products and services in
strict compliance with all international standards. CE mark
for the PerClot™ Polysaccharide Hemostatic System and the
SuperClot™ Absorbable
Polysaccharide Hemostat was awarded in June, 2008.
SMI has patents pending for its AMP™ technology in the United States and
other major markets.
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