Technology

Protonated Bioadhesive Technology (PBT®)

Axio Biosolutions employs the proprietary Protonated Bioadhesive Polymer technology (PBT®) to make its biopolymer-based haemostats, drug delivery systems and scaffolds with tailorable bioadhesive properties. These preparations are unique in a sense that they adhere to the tissues when needed and easily detach when their job is done.

How it works

The essence of PBT® technology lies in maximizing the bioadhesive properties of native chitosan without chemical modifications in its backbone. Structurally, chitosan is a natural polysaccharide composed of monomers of glucosamine and N-acetyl glucosamine. Chitosan gets its cationic (+ve) charge through the protonation of primary amines ( NH 2 ) groups present in its glucosamine subunits. However, this protonation is pH-dependent, at a pH above 6.5 chitosan undergoes neutralization and loses the positive charge at the physiological pH of 7.4. Researchers have developed numerous chemical derivatives of chitosan to improve its cationic properties at physiological conditions. However, such chemical modifications often lead to other drawbacks such as inconsistency, increased processing costs, risk of toxicity, and reduction in chitosan’s molecular weight. Hence, we formulated chitosan with the (PBT®), which only relies on the physical properties and microscopic morphology of this natural material to maximize its cationic charge.

Indications
  • Gunshot wounds
  • Puncture or Stab wounds
  • Blast injuries
  • Cuts, Lacerations, Abrasions
  • Arterial and Venous bleeding
  • Neck and Head Trauma injuries
Diagram illustrating Axiostat’s mechanism of action in five stages: Compression, Charge-based Adhesion, Plasma Sorption, Platelet Activation, and Haemostasis, showing how the product stops bleeding by promoting clot formation
  • Combined effect of bio-adhesion and strong blood clot formation induces instant haemostasis.
  • Rapid blood plasma absorption and Entrapment of clotting factors and blood cells in the porous structure due to electrostatic interaction
  • Maximization of inherent bio adhesion property of native chitosan without any chemical modification in chitosan backbone
  • Creation of a robust seal at the combat injury site due to platelet activation and fibrin formation
  • Faster haemostasis than natural blood clotting cascade
  • Easy removal from combat injury site due to the neutralization at physiological pH
Illustration showing Axiostat hemostatic dressing, packing and applying pressure to a heavy bleeding wound, with red blood cells interacting with the dressing's surface, highlighting its charge-based adhesion and clotting mechanism
Bar graph comparing average bleeding control times between Standard Gauze (13.08 minutes) and Axiostat (2.13 minutes), based on a clinical study published in the Indian Journal of Emergency Medicine, indicating significantly faster haemostasis with Axiostat
How it works

The essence of PBT® technology lies in maximizing the bioadhesive properties of native chitosan without chemical modifications in its backbone. Structurally, chitosan is a natural polysaccharide composed of monomers of glucosamine and N-acetyl glucosamine. Chitosan gets its cationic (+ve) charge through the protonation of primary amines ( NH 2 ) groups present in its glucosamine subunits. However, this protonation is pH-dependent, at a pH above 6.5 chitosan undergoes neutralization and loses the positive charge at the physiological pH of 7.4. Researchers have developed numerous chemical derivatives of chitosan to improve its cationic properties at physiological conditions. However, such chemical modifications often lead to other drawbacks such as inconsistency, increased processing costs, risk of toxicity, and reduction in chitosan’s molecular weight. Hence, we formulated chitosan with the (PBT®), which only relies on the physical properties and microscopic morphology of this natural material to maximize its cationic charge.

Haemostasis Process on application of Axiostat
Illustration showing how Axiostat interacts with blood at a wound site. The positively charged Axiostat dressing attracts negatively charged blood cells, promoting rapid clotting and forming a physical barrier over the wound
Bar graph comparing average bleeding control times: Standard Gauze at 13.08 minutes and Axiostat at 2.13 minutes. Based on a clinical study on trauma patients published in the Indian Journal of Emergency Medicine, Volume 2, No. 2, July-December 2016
Indications
  • Deep injuries
  • Gunshot injuries
  • Head & Neck Trauma
  • Cuts & Lacerations
  • Lower extremities
Ordering information table for Axiostat MIL88: NSN Code 6510-72-057-0464, product size 8cm x 8cm, packaging box of 10. Also available in MIL300 and L150 variants
  • Combined effect of bio-adhesion and strong blood clot formation induces instant haemostasis.
  • Rapid blood plasma absorption and Entrapment of clotting factors and blood cells in the porous structure due to electrostatic interaction
  • Maximization of inherent bio adhesion property of native chitosan without any chemical modification in chitosan backbone
  • Creation of a robust seal at the combat injury site due to platelet activation and fibrin formation
  • Faster haemostasis than natural blood clotting cascade
  • Easy removal from combat injury site due to the neutralization at physiological pH
Ordering information table for Axiostat MIL88: NSN Code 6510-72-057-0464, product size 8cm x 8cm, packaging box of 10. Also available in MIL300 and L150 variants
Ordering information table for Axiostat MIL88: NSN Code 6510-72-057-0464, product size 8cm x 8cm, packaging box of 10. Also available in MIL300 and L150 variants
How it works

The essence of PBT® technology lies in maximizing the bioadhesive properties of native chitosan without chemical modifications in its backbone. Structurally, chitosan is a natural polysaccharide composed of monomers of glucosamine and N-acetyl glucosamine. Chitosan gets its cationic (+ve) charge through the protonation of primary amines ( NH 2 ) groups present in its glucosamine subunits. However, this protonation is pH-dependent, at a pH above 6.5 chitosan undergoes neutralization and loses the positive charge at the physiological pH of 7.4. Researchers have developed numerous chemical derivatives of chitosan to improve its cationic properties at physiological conditions. However, such chemical modifications often lead to other drawbacks such as inconsistency, increased processing costs, risk of toxicity, and reduction in chitosan’s molecular weight. Hence, we formulated chitosan with the (PBT®), which only relies on the physical properties and microscopic morphology of this natural material to maximize its cationic charge.

Indications
  • Deep injuries
  • Head & Neck Trauma
  • Arterial & Venous bleeding
  • Scalp injuries
  • Cuts & Lacerations
  • Limb injuries
  • Gunshot wounds
  • Cuts, Lacerations, Abrasions
Mechanism Points
Step 1: Charge based adhesion between the blood components and Axiostat.
In this step, due to the presence of negative charge on the blood components, the RBCs, platelets and fibrinogen get captured within the positively charged Axiostat.
Step 2: Platelet activation via Toll-like Receptors (TLR).
Axiostat stimulates the TLR, which, in turn, aid in the activation of the platelets for the steps leading to initiation of the activation of the blood clotting cascade.
Step 3: Clotting cascade activation.
Factor Xa is the key factor in the blood clotting cascade where the intrinsic and extrinsic pathway join together. Axiostat enhances the expression of Factor Xa (FXa) activity which leads to thrombin generation.
Step 4: Fibrin microthrombi (plug) formation at the bleeding site.
In this step, thrombin leads to formation of fibrin to create a network that captures blood components and forms a robust seal at the bleeding site to achieve haemostasis

Axiostat is easy-to-apply and can also be easily removed by irrigating with salt-water.

Reference: PNAS Carousel and Publication

Illustration of a soldier receiving wound care on the shoulder and a side view of a head injury wrapped in a bandage with visible blood
Bar chart comparing hemostasis time: Standard gauze (13.08 minutes) vs. Axiostat (2.13 minutes), based on a 2016 clinical study
Ordering info table for product L150 with NSN code 6510-72-057-0462, size 7.6cm x 150cm, individually packaged. Also available: MIL300 and L88
Illustration showing how Axiostat interacts with blood at a wound site. The positively charged Axiostat dressing attracts negatively charged blood cells, promoting rapid clotting and forming a physical barrier over the wound
Illustration showing how Axiostat interacts with blood at a wound site. The positively charged Axiostat dressing attracts negatively charged blood cells, promoting rapid clotting and forming a physical barrier over the wound
Illustration showing how Axiostat interacts with blood at a wound site. The positively charged Axiostat dressing attracts negatively charged blood cells, promoting rapid clotting and forming a physical barrier over the wound
Illustration showing how Axiostat interacts with blood at a wound site. The positively charged Axiostat dressing attracts negatively charged blood cells, promoting rapid clotting and forming a physical barrier over the wound
Illustration showing how Axiostat interacts with blood at a wound site. The positively charged Axiostat dressing attracts negatively charged blood cells, promoting rapid clotting and forming a physical barrier over the wound

Our Key Regulatory Approvals/ Certifications

BIS Certificate, Axiostat: Axiostat BIS Certificate showcasing compliance with Indian quality and safety standards
BIS Certificate
 Axiostat: Axiostat CE Certificate indicating compliance with European health, safety, and performance standards
CE Certificate - Axiostat
Axiostat ISO 13485:2016 certification for quality management in medical device manufacturing
ISO 13485:2016
Axiostat products USFDA 510(k) cleared—Patch (K202830), Chitosan Haemostatic Dressing (K172324), and Gauze (K222909)—for safe and effective bleeding control
USFDA 510k Cleared

Axiostat Patch: 510k K202830

Axiostat Chitosan Haemostatic Dressing: 510k K172324

Axiostat Gauze: 510K K222909

Axiostat MIL300 (Z-Fold) 0460, MIL88 Patch 0464, and L150 Rolled Gauze 0462—NSN-coded for battlefield use

MIL300 (ZFold):
6510-72-057-0460

MIL88:
6510-72-057-0464

L150 (Rolled Gauze):
6510-72-057-0462

Serving

300+

Batallions Globally

Ideal for

IFAK, BFNA

& Bullet proof vests

 

30+

Annual Training Programs

Scientific Advisory Board

Dr. Shiladitya Sengupta of Harvard Medical School and MIT, member of Axiostat’s Scientific Advisory Board
Dr Shiladitya Sengupta

Harvard Medical School, MIT

Dr. S V Mahadevan of Stanford University Medical Center, member of Axiostat’s Scientific Advisory Board
Dr S V Mahadevan

Stanford University Medical Center

For Urgent Supplies Call at +91 7227952419
Military Desk - Axiostat
Original text
Rate this translation
Your feedback will be used to help improve Google Translate