LifeGel™ Absorbable Hemostatic gel

The first and only absorbable hemostatic agent to receive an FDA breakthrough designation.1

THe First1

On December 20, 2022, Medcura received FDA Breakthrough Device Designation for its LifeGel flowable technology that controls bleeding during surgery, for procedures where swelling cannot be tolerated.

LifeGel is the only absorbable surgical hemostatic technology that has received breakthrough designation from the FDA, for its "no-swell" properties.1 This is the first of its kind in the multi-billion dollar market for surgical hemostatic technologies.

Once approved, LifeGel will be the only absorbable hemostatic agent labeled: “Due to its no-swell properties, LifeGel can be used in surgical procedures where swelling cannot be tolerated.”

The FDA grants this distinctive breakthrough status to expedite the development of devices assessed with the potential to provide more effective treatment for life-threatening, irreversible or debilitating diseases or human conditions (in addition to other criteria).

the Difference

Current and popular hemostatic flowable technologies can swell.2-9 For complex medical procedures, swelling hemostatic agents can cause nerve injury and even paralysis when used in confined areas.5

See FDA Public Health Notification (Paralysis in Absorbable Hemostatic Agent).

Unlike other flowable hemostatic agents, LifeGel does not swell as it is fully hydrated and ready-to-use.1,2‍

Saline was added on top of LifeGel and a currently available flowable hemostatic matrix competitor. This video shows hemostatic agent swelling comparison after 20 minutes.

LifeGel™ for Spine Surgery

Today, surgeons performing spinal procedures have to weigh the risks of using flowable hemostatic agents to control bleeding, against the potential for adverse swelling events. Some popular hemostatic agents may swell after application, potentially causing serious adverse events when applied in bony and confined areas.2-9 

The Medcura mission is to accelerate FDA approval for LifeGel™ clinical trials and focus on the spine surgery space, where the risk of swelling in hemostatic agents is the greatest and the market opportunity is the largest.

From there, the path to proving safety and efficacy and the practical and differentiating benefits of being ready-to-use, and easy-to-use, will provide a dynamic runway for initiating a new standard—across the surgical spectrum.

LifeGel aims to address the challenges of current flowable hemostatic agents for spinal procedures. Additional features and benefits for surgical hemostasis include:

No Swelling

Our LifeGel formulation does not swell, potentially mitigating risks associated with swelling hemostatic agents (paralysis, vessel compression, etc.).

Ready to use

LifeGel can be stored at room temperature and requires no mixing or preparation, with great potential to reduce time and waste waste of unused product in the operating room.10

cost-effective

The hemostatic matrix of LifeGel is purposefully designed to be cost-effective and sustainable to produce.*

antimicrobial PROPERTIES

The proprietary base material of LifeGel retains its inherent antimicrobial properties of chitosan, potentially reducing the colonization of bacteria that may lead to infection.11

Relatively transparent

LifeGel's relatively transparent formula allows for greater visibility of the bleeding lesion and clot formation.

mucoadherence

Unlike other flowables, LifeGel both mucoadheres to inverted and vertical tissues.**

See LifeGel in action

With the FDA Breakthrough Designation, the possibility of substantially less cost and antimicrobial features, I believe LifeGel will become the new standard of care to stop bleeding for spine surgery procedures.

Jacob Rodman

CEO Raleigh Neurological Clinic, NC

Compared to current flowable hemostatic agents, LifeGel is ready to use and does not need to be reconstituted or mixed. Being ready to use is a major advantage of LifeGel compared with current flowable hemostatic agents.

Paul McAfee, MD, MBA

Medstar Orthopedic Institute, MD

With the experience we've gained through extensive pre-clinical testing, LifeGel has shown to be easy and intuitive to use while demonstrating a remarkable ability to reliably control a wide range of challenging bleeding situations.

Dr. Ken Renkens

Medcura Chief Medical Officer

The science behind the innovation

Learn more about the development of our proprietary hemostatic platform.

See the Science

Peer-reviewed proof points

Medcura has published extensively in multiple high-impact journals, demonstrating LifeGel's™ safety and efficacy.

publications

December 5, 2023

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.

Read More ➞
December 5, 2023

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.

Read More ➞
December 5, 2023

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

LifeGel™ for Cardiac Surgery

LifeGel™ is uniquely suited for cardiovascular surgery, given its ability to grip and stick to motile, vertical and inverted bleeding sites. The inherent antimicrobial properties of LifeGel™ make it an ideal product to control bleeding during cardiovascular surgery.10

Cardiovascular surgeons face the challenge of surgical site infection pre- and post-cardiac procedures. From sternal edges to pacemaker pockets, cardiovascular surgery sites are prone to mycobacterial colonization and potentially life-threatening complications, that can also severely impede a patient's recovery.

ANTIMICROBIAL PROPERTIES

The proprietary base material of LifeGel retains its inherent antimicrobial properties of chitosan, potentially reducing the colonization of bacteria that may lead to infection.11

READY TO USE

LifeGel can be stored at room temperature and requires no mixing or preparation, with great potential to reduce time and waste of unused product in the operating room.10

COST-EFFECTIVE

The hemostatic matrix of LifeGel is purposefully designed to be cost-effective and sustainable to produce.*

Mucoadherence

Unlike other flowables, LifeGel both mucoadheres to inverted and vertical tissues.**

Relatively TRANSPARENT

LifeGel's relatively transparent formula allows for greater visibility of the bleeding lesion and clot formation.

no swelling

Our LifeGel formulation does not swell, mitigating risks associated with swelling hemostatic agents (potentially mitigating
paralysis, vessel compression, etc.).

See LifeGel in action

I was impressed with the product’s ease of use and efficacy. LifeGel performed well on suture lines, ePTFE grafts, and diffuse epicardial bleeding.

Brian Bruckner, MD

Baptist Memorial, TN

The LifeGel technology will be well-suited for cardiothoracic surgery... with a hemostasis platform that has the potential to transform the surgical hemostasis market.

Abbas Ardehali, MD

UCLA School of Medicine

The science behind the innovation

Learn more about the development of our proprietary hemostatic platform.

See the Science

Peer-reviewed proof points

Medcura has published extensively in multiple high-impact journals, demonstrating LifeGel's™ safety and efficacy.

publications

December 5, 2023

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.

Read More ➞
December 5, 2023

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.

Read More ➞
December 5, 2023

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

LifeGel™ for Minimally-Invasive Surgery

When working with tiny incisions and camera guidance, any bleeding can quickly obscure the surgical site and compromise the procedure. LifeGel™ is clear when applied, to provide, optimal visibility and ease-of-use of during MIS procedures.

LifeGel is relatively transparent and applies clear, making it easier to use with more visibility of bleed sites and clot progress. Regardless of the angle or orientation of application, LifeGel mucoadheres to achieve hemostasis quickly — and removes easily.

Mucoadherence

Unlike other flowables, LifeGel both mucoadheres to inverted and vertical tissues.**

READY TO USE

LifeGel can be stored at room temperature and requires no mixing or preparation, with great potential to reduce time and waste of unused product in the operating room.10

Relatively TRANSPARENT

LifeGel's relatively transparent formula allows for greater visibility of the bleeding lesion and clot formation.

COST-EFFECTIVE

The hemostatic matrix of LifeGel is purposefully designed to be cost-effective and sustainable to produce.*

DOES NOT SWELL

Our LifeGel formulation does not swell, potentially mitigating risks associated with swelling hemostatic agents (paralysis, vessel compression, etc.).

ANTIMICROBIAL PROPERTIES

The proprietary base material of LifeGel retains its inherent antimicrobial properties of chitosan, potentially reducing the colonization of bacteria that may lead to infection.11

See LifeGel in action

LifeGel easily attached to vertical surfaces where other flowable hemostatic agents would not have stayed in place. Being ready-to-use is a great advantage especially in an emergency.

Phillip Shadduck, MD, General Surgeon

NC Specialty Hospital and Duke Regional Hospital

I think LifeGel could be especially beneficial for radical prostatectomies and partialnephrectomies. The ability to deliver LifeGel through small catheters and applicators could be a game changer.

Carmin Kalorin, MD

WakeMed Raleigh Medical Park, NC

The science behind the innovation

Learn more about the development of the proprietary LifeGel hemostatic platform.

See the Science

Peer-reviewed articles

December 5, 2023

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.

Read More ➞
December 5, 2023

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.

Read More ➞
December 5, 2023

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
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Disclaimer

LifeGel and its application tips are currently in development. All intended uses and/or indications for use for this medical device and its application tips have not been cleared or approved by the FDA.

References

* 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.fdanews.com/articles/210821-medcura-receives-breakthrough-device-designation-for-lifegel-to-manage-surgical-bleeding?v=preview
  2. Arista ® AH Absorbable Hemostatic Particles, Instructions for Use,; Warnings. Davol Inc. Subsidiary of C. R. Bard, Inc., Warwick, RI; 2015, Arista-AH
  3. Gelfoam ® absorbable gelatin compressed sponge, USP, Instructions for Use; Warnings.  Pfizer, Pharmacia & Upjohn Company LLC, New York, NY; 05/2022
  4. Gelfoam ® absorbable gelatin powder from absorbable gelatin sponge, USP, Instructions for Use; Warnings.  Pfizer, Pharmacia & Upjohn Company LLC, New York, NY; 05/2022,
  5. PerClot ® Polysaccharide Hemostatic System, Instructions for Use, Warnings. Starch Medical Inc., San Jose, CA, Uploaded 2019, PerClot-IFU
  6. Surgicel ® Powder, Absorbable Hemostatic Powder, Instructions for Use, Contraindications. Ethicon, LLC, San Lorenzo, Puerto Rico; 05/2017
  7. Surgicel ® SNoW Absorbable Hemostatic, Instructions for Use, Contraindications; Adverse Events.  Ethicon, LLC, San Lorenzo, Puerto Rico; 05/2013
  8. SurgifloTM Hemostatic Matrix Kit, Essential Product Information, Warnings; Precautions. Ethicon Johnson and Johnson Surgical Technologies; 2022, SURGIFLO-Hemostatic-Matrix-Brochure
  9. SurgicelTM Original/ Surgicel NU-KNIT/ Surgicel Fibrillar Absorbable Hemostats, Instructions for Use, Contraindications; Adverse Events. Ethicon, Neuchâtel, Switzerland; 06/2013
  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

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