ORTHOCON, a developer, manufacturer and seller of implantable products that stop bone bleeding, has received the US Food and Drug Administration (FDA) 510(k) clearence for its HEMASORB Apply.
HEMASORB Apply, a proprietary, custom-designed applicator preloaded with HEMASORB Absorbable Bone Hemostat Matrix, is provided in a syringe-like applicator.
HEMASORB is absorbable, biocompatible and water resistant.
The product enables application of HEMASORB to stop bone bleeding during surgical procedures and in treating traumatic injuries.
HEMASORB Apply provides surgeons with a tool to assist in their management of intra-operative bone bleeding.
ORTHOCON president and CEO John Pacifico said both HEMASORB and HEMASORB Apply are differentiated from wax-like hemostats, and they are changing the way surgeons think about surgical hemostasis.
ORTHOCON’s technology platform is also being developed to improve bone healing and enable controlled, local drug delivery to the treatment site.