Axio Biosolutions announces US FDA clearance for Ax-Surgi Surgical Hemostat
Ax-surgi becomes the first and only chitosan-based hemostat cleared for controlling severe surgical bleeding
Axio Biosolutions, a biomaterial focussed medtech company, announced the US Food and Drug Administration (FDA) 510(k) clearance for its latest innovation, Ax-Surgi Surgical Hemostat. With this, Ax-surgi has become the first and only chitosan-based hemostat cleared for controlling severe surgical bleeding.
Ax-Surgi is based on a novel biopolymer platform and controls bleeding through its bioadhesive action. It is indicated for temporary control of internal organ space bleeding for patients displaying Class III or Class IV bleeding. It can also be used for the control of severely bleeding wounds such as surgical wounds and traumatic injuries.
“We are glad to receive this first-of-its-kind clearance for a chitosan-based hemostat for surgical indication which can help surgeons to control severe bleeding in many difficult surgeries and prevent blood loss,” said Leo Mavely, Founder and Director of Axio Biosolutions. As healthcare costs continue to rise, surgeons are looking for effective measures to reduce the duration of surgeries. These factors are propelling the demand for better and cost-effective solutions for controlling severe bleeding during surgeries.
Many products ranging from standard lap sponges to absorbable hemostatic patches and sealants are available for surgical bleeding control. Most of these are indicated to control minor bleeding and hence a major challenge for surgeons is to select a suitable hemostat that can be used in different grades of bleeding. Many times surgeons keep multiple products opened and ready for use to manage any emergency bleeding during the surgery. This strategy inadvertently leads to increased surgery costs due to the wastage of resources.
Ax-surge will fill this gap by offering a rapid-acting hemostat for controlling moderate to severe bleeding from surgical and traumatic injuries. Ax-surgi is a ready-to-use, non-absorbable hemostat. It is composed of a 100 per cent chitosan pad attached to a non-absorbable gauze backing with X-ray detectable grid which works through Axio Biosolutions proprietary protonated bioadhesive technology.