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ORTHOCON®, Inc. Receives 510(k) Clearance to Market HEMASORB Apply™
Date:6/1/2011

IRVINGTON, N.Y., June 1, 2011 /PRNewswire/ -- ORTHOCON®, Inc., a privately-held therapeutic device company, today announced that the Food and Drug Administration cleared HEMASORB Apply™ for clinical use and sale in the United States.

HEMASORB Apply is a proprietary, custom-designed applicator preloaded with HEMASORB® Absorbable Bone Hemostat Matrix. The product is provided ready-to-use and enables precise application of HEMASORB to stop bone bleeding during surgical procedures and in treating traumatic injuries. Currently marketed bone hemostat products require surgeons to use their fingers or surgical instruments for application. Unlike bone waxes, HEMASORB is putty-like in consistency, does not require preparation, and is now provided in a syringe-like applicator. Furthermore, HEMASORB is absorbable, biocompatible, and water resistant.

Commenting on the significance of the HEMASORB Apply clearance, John J. Pacifico, ORTHOCON's President and Chief Executive Officer, said the following: "This regulatory clearance is an important achievement for ORTHOCON. There has been very little innovation in the bone hemostat field since bone wax was first introduced in the late 1800s. We believe that the widespread adoption of flowable surgical hemostats has created new opportunities for advanced surgical products that more efficiently and effectively control bone bleeding, and we are confident that HEMASORB Apply will help secure ORTHOCON's leadership position in this therapeutic category. Both HEMASORB and HEMASORB Apply are clearly differentiated from wax-like hemostats, and they are changing the way surgeons think about surgical hemostasis."

Since its initial market introduction in 2010, HEMASORB has been approved for sale at leading hospitals throughout the United States and has been used successfully by hundreds of surgeons. ORTHOCON is confid
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SOURCE ORTHOCON, Inc.
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