The
Science

Hydrophobically modified chitosan optimized for internal hemostasis

Biomaterial worth exploring

For decades, chitosan-based technologies have been used in the U.S. for external hemostasis, trauma, and military applications, for good reason. Chitosan is abundant, low-cost, and has inherent antimicrobial properties. Most importantly, chitosan rapidly controls bleeding by creating a mechanical barrier, supporting blood clotting through the process of mucoadhesion. 1-3 

While chitosan-derived polysaccharides are a proven hemostatic base, they can also pose challenges that include high endotoxin levels, long resorption times, foreign body reaction, inflammatory response, and formulation of granulomas in healing tissues.4-9 This is why chitosan-based resorbable hemostatic agents have not been approved by the FDA for use within the body previously, for non-trauma surgical applications. 

Unlocking the potential of chitosan

Medcura's process of hydrophobically modifying chitosan has unlocked its potential for solving bleeding challenges inside the body. Through rigorous biochemical research, experts at Medcura have developed a biopolymer that can be effectively and safely resorbed within the body.* For countless applications where biocompatible resorbability is essential, this represents an important evolution in bleeding control and hemostasis management.

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The
breakthrough

Years of research and development ultimately led to the formulation of a proprietary base-matrix of self-assembling, hydrophobically-modified chitosan, fatty acids, and other inert well characterized reagents. In feasibility studies, the biopolymer matrix base is designed to be biocompatible, with minimal foreign body response within the tissues, and is expected to resorb in approximately 8-12 weeks.**

The
breakthrough

Years of research and development ultimately led to the formulation of a proprietary base-matrix of self-assembling, hydrophobically-modified chitosan, fatty acids, and other inert well characterized reagents. In feasibility studies, the biopolymer matrix base is designed to be biocompatible, with minimal foreign body response within the tissues, and is expected to resorb in approximately 8-12 weeks.**

The
difference

The Medcura surgical LIFE™ Surgical Hemostasis Portfolio works to control bleeding through the mechanical action of mucoadhesion.*

The base material's mucoadhesive properties allow it to grip biologically wet tissue. Once applied, these modified biopolymers create a network of millions of non-covalent bonds, forming a mechanical barrier at the bleeding site. This prevents further bleeding and facilitates the formation of a clot at the application site, through blood immobilization, resulting in platelet and red blood cell aggregation at the gel and tissue surface. The resulting concentration of red blood cells and platelets within the gel and at the gel-tissue interface, creates a stable hemostatic plug.

LOWER
COST

Core hemostasis biopolymers are cost-effective and sustainable to produce, resulting in less cost compared to alternatives.*

STABLE &
READY TO USE

Products can be stored at room temperature and require no mixing or preparation, reducing time and avoiding costly waste of unused product in the operating room.4

ANTIMICROBIAL PROPERTIES

Proprietary base material retains its inherent antimicrobial properties of chitosan, potentially reducing the colonization of bacteria within the material that may lead to infection.5

SAFE &
BIOCOMPATIBLE

Base material designed to resorb in approximately 8-12 weeks, without the need for thrombin or its potential to cause protein sensitivities leading to coagulopathies.**

The opportunity for global healthcare

This novel technology affords Medcura a rich product extension pipeline across multiple disciplines and specialties – in both medical/surgical and consumer/retail industries. This unique, patent-protected biochemical base can be leveraged to address multiple hemostatic formats including gels, powders, foams, and more.*

Medcura Life™ Surgical Hemostasis Portfolio
“Arterial bleeding is the number one cause of death for soldiers today. Many victims would survive if there was a faster, more effective way to stop bleeding. New technologies like this one (Medcura) are desperately needed to save lives."

Stephen Hawking
Physicist, cosmologist, and author

The Data

Peer-reviewed journals, white papers, and clinical resources.

PUBLICATIONS

January 16, 2022

Foam Efficacy - Surgery

Background: In military combat settings, noncompressible closed cavity exsanguination is the leading cause of potentially survivable deaths, with no effective treatment available at point of injury. Conclusion: Intraperitoneal administration of hm-chitosan-based foam for massive, noncompressible abdominal bleeding improves survival in a lethal, closed-cavity swine model.

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February 20, 2014

Gel Efficacy - Royal Society of Chemistry

Polymer hydrogels have long been used to hold and culture biological cells within their three-dimensional (3-D) matrices. Typically, in such cases, the cells are passively entrapped in a mesh of polymer chains. Here, we demonstrate an alternate approach where cells serve as active structural elements (crosslinks) within a polymer gel network. The polymers used in this context are hydrophobically modified (hm) derivatives of common biopolymers such as chitosan and alginate.

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January 25, 2019

Safety Evaluation - Journal of Surgical Research

Background: A novel injectable expanding foam based on hydrophobically modified chitosan (HM-CS) was developed to improve hemostasis during surgeries. Conclusions: The internal safety observed in the HM-CS test group after abdominal implantation indicates that injectable HM-CS expanding foam may be an appropriate internal use hemostatic candidate.

Read More ➞
See all published articles

Patents

This novel technology affords Medcura a rich product extension pipeline across multiple disciplines and specialties – in both medical/surgical and consumer/retail industries. This unique, patent-protected biochemical base can be leveraged to address multiple hemostatic formats including gels, powders, foams, and more.*

FDA CLEARED

K172010
December 7, 2017
K192667
October 25, 2019
K182811
August 29, 2019
K180152
June 22, 2018
K143466
June 8, 2015

COMPREHENSIVE SURGICAL PORTFOLIO

The benefits of our versatile LIFE™ Surgical Hemostasis Portfolio provide smart solutions that extend from common surgical applications to complex specialties and beyond.

Across the surgical hemostasis industry, the Medcura platform represents potentially significant improvements and benefits over existing bleeding control technologies.*

See Life™ Surgical Hemostasis Portfolio

Join Us

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Disclaimer

LifeGel and other LIFE Surgical Portfolio formats, including application devices and tips are currently in development or feasibility. All intended uses and/or indications for use for these medical devices have not been cleared or approved by the FDA.

References

* Data on file at Medcura. Based on initial and ongoing development and testing.

**  Data on file at Medcura. Ongoing exploratory/development testing for safety and performance.

*** Data on file at Medcura. Ongoing research for time and cost efficiencies.

  1. https://www.mdpi.com/14220067/24/13/10540
  2. ‍Chen, Kuan-Yu, Yen-Cheng Chen, Tzu-Hsin Lin, Cheng-Ying Yang, Ya-Wen Kuo, and U. Lei. Hemostatic enhancement via chitosan is independent of classical clotting pathways—a quantitative study. Polymers 12, no. 10 (2020): 2391.
  3. Chen, K. Y., et al. Mechanics for the adhesion and aggregation of red blood cells on chitosan. Journal of mechanics 34.5 (2018): 725-732.
  4. Farrugia, Brooke L., et al. "The localisation of inflammatory cells and expression of associated proteoglycans in response to implanted chitosan." Biomaterials 35.5 (2014): 1462-1477.
  5. Tomihata, Kenji, and Yoshito Ikada. "In vitro and in vivo degradation of films of chitin and its deacetylated derivatives." Biomaterials 18.7 (1997): 567-575.
  6. Ueno, Hiroshi, et al. "Accelerating effects of chitosan for healing at early phase of experimental open wound in dogs." Biomaterials 20.15 (1999): 1407-1414.
  7. Kim, Howard, Charles H. Tator, and Molly S. Shoichet. "Chitosan implants in the rat spinal cord: biocompatibility and biodegradation." Journal of Biomedical Materials Research Part A 97.4 (2011): 395-404.
  8. Bhatt, Naman, et al. "Depyrogenation using plasmas: A novel approach for endotoxin deactivation using a dielectric barrier discharge at atmospheric pressure." Plasma Processes and Polymers 18.11 (2021): 2100089.
  9. Lee, Moon Hyun, et al. "Hemostatic Patches Based on Crosslinked Chitosan Films Applied in Interventional Procedures." Polymers 13.15 (2021): 2402.
  10. Wood, Elizabeth, Advance preparation tends to waste many absorbable hemostatic agents. OR Manager, 03/2017; https://www.ormanager.com/advance-preparation-tends-waste-many-absorbable-hemostatic-agents/
  11. ‍‍https://www.mdpi.com/1422-0067/24/13/10540