IRVINGTON, N.Y., April 21, 2011 /PRNewswire/ — ORTHOCON, Inc.,
a privately-held therapeutic device company, today announced that
DEKRA and Health Canada have cleared its HEMASORB Absorbable
Bone Hemostat Matrix for clinical use and sale in Europe and
Canada.
HEMASORB is a ready-to-use, biocompatible, water
resistant, and absorbable putty designed to rapidly stop bleeding
when applied to damaged or cut bone. Control of bleeding from cut
bone is a problem in many operative procedures including spine,
orthopedic, cardiac, and craniomaxillofacial surgeries. Excessive
bleeding during surgery may impair the surgeon’s view of the
operative field, may result in the need for blood transfusions, and
may be associated with post-operative complications. ORTHOCON
estimates that over 3.5 million patients undergoing surgeries in
the United States, Europe, and Canada each year could benefit from
the intra-operative use of HEMASORB.
“We are pleased that HEMASORB has been cleared for
clinical use and sale in Europe and Canada,” said John J. Pacifico,
President and Chief Executive Officer of ORTHOCON. “We are
confident HEMASORB will provide surgeons in Europe and
Canada with an innovative and cost-effective tool to assist in
their management of intra-operative bone bleeding, and we fully
expect HEMASORB to become the standard of care for bone
hemostasis.”
HEMASORB, previously cleared by the Food and Drug
Administration (FDA) via the 510(k) premarket notification
process, was first introduced in the U.S. in 2010. The product has
been approved for sale at leading hospitals throughout the United
States and is used successfully by hundreds of surgeons. ORTHOCON
will continue to focus its efforts on increasing adoption of
HEMASORB in the U.S. and is actively pursuing product
distribution partnerships in Europe and Canada to ensure
HEMASORB becomes widely available to surgical patients in
these ma
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