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Press Release
Waltham, MA – November 15, 2006 –
HyperMed’s OxyVu-1™ has just received U.S. Food and
Drug Administration (FDA) approval for its flagship diagnostic
device, the OxyVu-1™. The non-invasive OxyVu-1 Hyperspectral
Oxygenation Measurement System is immediately available to provide
healthcare professionals with a highly useful tissue image map
which reports quantitative values of oxyhemoglobin (HT-Oxy), deoxyhemoglobin
(HT-Deoxy) and oxygen saturation (HT-Sat).
Dr. Jenny Freeman, President and CEO of HyperMed, commented that
"We are pleased now that the OxyVu System has received 510K
approval. It is the culmination of a decade of research and development
at HyperMed and it now permits us to deliver this important new
tissue assessment tool to the medical community.” Dr. Freeman
further added: “We extend our appreciation to the National
Institute of Health, the Juvenile Diabetes Research Foundation,
the US Army, NASA, the American Diabetes Association for their
efforts in testing and evaluating the OxyVu-1™ product.”
These institutions and our collaborators at many other of the
country’s leading academic research hospitals deserve much
gratitude from us here at HyperMed for providing the foundation
for our commercial launch and also from the patient population
who will greatly benefit from this product. “HyperMed’s
OxyVu-1™ technology provides physicians the opportunity
to significantly reduce complications associated with diabetic
foot ulcers and peripheral arterial disease, which today cost
the United States medical system over $15 billion annually”,
said Rick Lifsitz, SVP of Corporate Development at HyperMed.
The OxyVu-1™ enables the efficient collection of data from
over a million points, producing a 2-dimensional map of the state
of tissue oxygenation, essential to assess the “Oxygen Anatomy.”
Medical professionals that benefit from HyperMed’s OxyVu-1
include vascular surgeons, foot and ankle surgeons, endocrinologists,
orthopedists and wound healing professionals.
A Broad Range of Hyperspectral Applications
Hyperspectral Technology (HT) has previously been used by the
military and more recently has been applied to the study of physiologic
and pathologic changes in animal and human tissue. This technology
will now be able to provide previously unavailable diagnostic
information in medical applications. In addition to studies of
patients with diabetic foot ulcers and peripheral arterial disease,
HyperMed has conducted research in the areas of shock, breast
cancer and endoscopy. HyperMed is at the forefront of these technological
advancements, with 7 issued and 19 pending and provisional patents.
About HyperMed, Inc.
HyperMed is the leader in applying hyperspectral analysis to
medical applications. Having been presented at numerous national
and international meetings including the American Diabetes Association,
the American Heart Association, American Association for the Surgery
of Trauma, and the World Congress of Cardiothoracic Surgery and
published in numerous journals, including The Lancet, The Journal
of Trauma, Microvascular Complications Today, HyperMed’s
technology is now commercially available to address diabetic foot
ulcers and peripheral arterial disease in the form of OxyVu-1™.
For more information about HyperMed, Inc, and the OxyVu System
please visit website www.hypermed-inc.com.
Press Contacts:
HyperMed, Inc.
Richard Lifsitz
SVP, Corporate Development
781-487-5760
rlifsitz@hypermed-inc.com
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