Axiostat Trauma

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Clinical Evidence

1

Title

An architecturally rational hemostat for rapid stopping of massive bleeding on anticoagulation therapy

Publication Details

Lee VK, Lee T, Ghosh A, Saha T, Bais MV, Bharani KK, Chag M, Parikh K, Bhatt P, Namgung B, Venkataramanan G. An architecturally rational hemostat for rapid stopping of massive bleeding on anticoagulation therapy. Proceedings of the National Academy of Sciences. 2024 Jan 30;121(5):e2316170121.
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1.

Hemostasis Mechanisms of Axiostat at the molecular level

2.

How does Axiostat stop massive bleeding on anticoagulation therapy

3.

Superior hemostasis efficacy of Axiostat, with a comparison to competing products including kaolin gauze, chitosan coated gauze.

Faster Hemostasis & Reduction of blood loss

  • Axiostat significantly reduces compression time by ~50% compared to Kaolin gauze to effectively achieving faster hemostasis in the swine carotid artery bleeding model for severe hemorrhage.
  • Axiostat also reduces the blood loss during haemostasis process significantly by 2x compared to kaolin gauze.

Charge based electrostatic interaction

Axiostat has ~2x higher positive surface charge than competitor kaolin based hemostats which helps in the capturing of major blood clotting components with in the Axiostat dressing for quick hemostasis.

Blood Clotting Cascade Activation

Axiostat dressing exhibited significantly higher FXa activity compared to chitosan-coated gauze and kaolin gauze which assists in the faster thrombin generation for rapid blood clotting process.

Robust Fibrin Microthrombi (Plug) Formation

Axiostat showed ~60x higher (1/BCI) value than kaolin gauze, indicating rapid and robust plug formation at the bleeding site to control massive bleeding.
  • The Hemostasis Mechanisms of Axiostat involves 4 major steps including charge-based interaction with blood components, platelet activation via Toll-like receptors (TLR), Clotting cascade activation (Factor X) and robust fibrin plug formation at bleeding sites.
  • As anticoagulant drugs do not interact with TLR receptors of platelets, Axiostat can control massive bleeding even in patients under anticoagulation therapy.
  • Axiostat stands out as the most effective advanced hemostatic dressing by demonstrating superior efficacy in rapid hemostasis and minimizing blood loss significantly in comparison with other marketed hemostats utilizing kaolin, cellulose, coatings or impregnation of chitosan granules.

2

Title

Evaluation of Hemostatic Effectiveness in a Standard Swine Hemorrhage Model of Severe Bleeding: A Comparative Study of Chitosan Gauze and Kaolin Gauze

Publication Details

Kumar A, Agrawal A, Bharani KK, Mavely L. Evaluation of Hemostatic Effectiveness in a Standard Swine Hemorrhage Model of Severe Bleeding: A Comparative Study of Chitosan Gauze and Kaolin Gauze. International Journal of Health Technology and Innovation. 2024 Aug 20;3(02):38-47.
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1.

Superior hemostasis effectiveness of Axiostat gauze, with a comparison to kaolin gauze

2.

Broad Spectrum Antimicrobial property of Axiostat gauze

3.

Safety profile evaluation of Axiostat gauze with particulate Release Test

Superior Hemostasis Efficacy and Improvement of Survival Rate

  • In this preclinical study, swine carotid artery is transecting by 50% resulting in a grade IV bleeding (blood loss of 100 mL/min).
  • Axiostat also reduces the blood loss during haemostasis process significantly by 2x compared to kaolin gauze.

Antimicrobial Efficacy of Axiostat Gauze

  • After 24 hours of contact time, Axiostat gauze showed more than 99.99% reduction of viable microorganisms against all the pathogenic microbial strains causes bleeding wound infection. Kaolin gauze has no antimicrobial property.
  • Axiostat gauze significantly reduce the post treatment blood loss by more than 80% as compared to Kaolin gauze (P<0.05). Axiostat gauze also demonstrated 100 % survival rate and improves the survival rate by 67 % than kaolin gauze.
Microscopic Analysis: Visually there is no disperse particulate matter observed in the extract of Axiostat Gauze at predetermined time point while dispersed particles were observed in the extract of kaolin gauze which Indicates that it releases the kaolin particles that can cause embolism.
Turbidimetry Analysis: In the turbidimetry analysis using uv spectrometry, it is observed that kaolin gauze shows significantly higher turbidity compared to Axiostat Gauze over the period which indicates that kaolin gauze releases the particles.
  • Axiostat gauze has a superior safety profile compared to kaolin gauze as indicated by the absence of particle release.
  • Axiostat gauze delivers faster hemostasis, reduces overall blood loss significantly, and improve the survival rate in comparison to kaolin gauze.
  • Axiostat gauze is an effective hemostatic dressing with additional benefits, including antimicrobial properties and biocompatibility, making it suitable for managing severe bleeding in emergency and trauma scenarios.
  • Axiostat gauze is an effective hemostatic dressing with additional benefits, including antimicrobial properties and biocompatibility, making it suitable for managing severe bleeding in emergency and trauma scenarios.

3

Title

Assessing the efficacy of haemostatic dressing Axiostat® in trauma care at a tertiary care hospital in India: A comparison with conventional cotton gauze

Publication Details

Ketan P, Anjali P, Rignesh P, Bhavika P, Priyank P, Dev P. Assessing the efficacy of haemostatic dressing Axiostat® in trauma care at a tertiary care hospital in India: A comparison with conventional cotton gauze. Indian J. Emerg. Med. 2016 Jul;2:93-9.
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1.

Quicker hemostasis efficacy of Axiostat, compared to conventional cotton gauze

2.

Ease of Application and Removal of Axiostat

Quick Hemostasis Efficacy

In Axiostat® demonstrated a significantly faster hemostatic time of 2.125 ± 1.35 minutes, compared to 13.08 ± 6.40 minutes with conventional cotton gauze.

Comfort Level for using Dressing

  • Axiostat® was easier to apply and remove compared to cotton gauze. Almost all patients using Axiostat® reported excellent ease of removal, while only 10% of patients with cotton gauze had good removal experience.
  • Axiostat® demonstrated superior hemostasis efficacy in trauma care settings, achieving faster hemostasis and better control of bleeding without any rebleeding incident when compared to conventional cotton gauze.
  • Patients treated with Axiostat® showed a higher success rate in preventing rebleeding after dressing removal, making it a more reliable option for bleeding wound management in trauma care
  • Axiostat® was easier to apply and remove, offering a more comfortable experience for patients.

4

Title

Assessing the efficacy of haemostatic dressing Axiostat® in trauma care at a tertiary care hospital in India: A comparison with conventional cotton gauze

Publication Details

Pre-hospital Hemorrhagic Control Effectiveness of Axiostat® Dressing Versus Conventional Method in Acute Hemorrhage Due to Trauma
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1.

Rapid hemostasis efficacy of Axiostat, compared to conventional cotton gauze

2.

Reduction of Blood loss with Axiostat, compared to cotton gauze

Faster Hemostasis Efficacy

Axiostat® significantly reduced hemostasis time (4.68 minutes) compared to conventional cotton gauze (18.56 minutes), making it more effective in controlling severe bleeding.

Reduction in Blood loss

Axiostat® effectively minimized the blood loss in patients , demonstrating its superior capability in hemorrhage management during emergencies.
  • Axiostat® significantly reduced the time required to achieve hemostasis, making it a more effective option for controlling bleeding in emergency trauma care.
  • Axiostat® demonstrates a higher success rate in achieving complete hemostasis, ensuring more consistent results in hemorrhage control.
  • The use of Axiostat® results in significantly less blood loss compared to conventional cotton gauze, improving overall patient outcomes during hemorrhagic events.
  • Axiostat® has no reported side effects such as skin sensitization, tissue damage or rebleeding, and it can be easily removed without leaving residue, ensuring cleaner and safer use

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Axio Biosolutions Private Limited, Ahmedabad, Gujarat, India