The need for further improved hemostats
Achieving hemostasis (bleeding control) is a critical focus of clinicians working in the surgical setting, given that uncontrolled surgical bleeding is associated with increased mortality rates and increased hospital length of stay and higher costs of care. The current set of available hemostatic products does not offer adequate solutions yet for controlling heavier bleedings, especially not for thin anti-coagulated blood.
To address this need, GATT has developed its NHS-POx technology platform to:
- enable controlling of heavier bleedings
- allow to transform a complete hemostatic portfolio to this extended hemostatic level
As hemostatic patches intrinsically allow for the strongest hemostatic characteristics due to the supporting mechanical structure of the patch, GATT is developing the GATT-Patch as its first product based on the NHS-POx technology:
- A sealing hemostatic patch for general surgery, enabling to control heavier/severe bleedings also for anticoagulated blood
- The GATT-Patch will have significant faster and stronger hemostatic characteristics than any other available hemostatic product and especially also will be more cost effective
The principle: a blank hemostatic carrier is coated with NHS-POx.
- This enables a stronger and faster hemostasis: the activated carrier hemostat becomes a much more effective cross-linking with (anti-coagulated) blood. The GATT-Patch medical device consists of a gelatin, collagen or ORC patch coated with NHS-POx. The NHS-POx contains many covalent binding groups that are able to cross link with blood proteins allowing to control heavier bleedings also for anti-coagulated blood. The NHS-POx coating in combination with the internal structure and absorbing functionality of the patch provides for a coagulation matrix that actively stops bleedings.
- This enables a strong adhesion/sealing function on surrounding wet tissue: the activated carrier hemostat becomes a much more effective cross linking with body fluids, water, blood on the tissue. The NHS-POx coating causes the patch to adhere to the surrounding wet tissue to further strengthen and “seal” the blood coagulation matrix and prevent re-bleeding.
GATT established several Proof-of-Concepts of the hemostatic potential of the NHS-POx technology in in-vivo tests on porcine spleen and liver.
The GATT-Patch, a gelatin carrier coated with NHS-POx, showed very strong capabilities to stop bleeding in heparinized pigs. Significantly better as used competitive reference products with the actually best performance available on the market.
GATT also established similar Proof-of-Concepts for GATT-Patches based on coated ORC/cellulose and collagen hemostatic patches.
Hemostatic powders can be used more efficiently than patches when the bleeding site is not easily accessible or smooth, and when multiple smaller bleeding sites have to be closed. Most available hemostatic powders or particles do not have an active hemostatic effect but instead increase the local coagulation factor concentrations by physical osmotic action and dehydration of the blood.
The GATT-Powder consists of a hemostatic powder (starch, gelfoam, others..) coated with the NHS-POx polymer (cross-linking with blood) + starch powder coated with the NHS-POx and POx-amine (cross-linking with body fluids, water, blood). When applied to a bleeding site the powder turns into a gel due to its osmotic action while at the same time binding to proteins present in the blood and on the surrounding tissue to speed up hemostasis.
The ambition and promise of the GATT-Powder:
- an instant and easy to use “one syringe solution” for controlling heavier bleedings, also for anti-coagulated blood
- superior to hemostatic gels, spray and newly introduced fibrin based hemostatic powder solutions
- especially also more costs effective.
In an in-vivo porcine test, the GATT-Powder, a starch carrier coated with NHS-POx, showed very strong capabilities to stop bleeding:
- Enhanced gel formation capacity
- Enhanced gel stability
- Highly active induced blood clotting