ORTHOCON(R) Receives CE Mark and Health Canada Medical Device License for HEMASORB(R)
By Orthocon Inc., PRNEWednesday, April 20, 2011
Absorbable Bone Hemostat Matrix Cleared For Clinical Use and Sale in Europe and Canada
IRVINGTON, New York, April 21, 2011 - 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 markets.
About ORTHOCON
Founded in 2005, ORTHOCON develops, manufactures, markets, and sells
implantable products that stop bone bleeding. ORTHOCON's technology platform
is also being developed to enable controlled, local drug delivery to the
treatment site.
ORTHOCON is funded by leading international venture capital investment
firms. The company occupies 8,000 square feet at its state-of-the-art
facility in Irvington, New York. For more information, please visit
www.orthocon.com.
Jenny Enrico, +1-914-357-2617, enrico at orthocon.com
Tags: April 21, canada, Irvington, New York, Orthocon Inc., Western Europe