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Understanding the Unmet Need in
Managing Arterial Bleed
Trauma and its Impact

#1

Prevalence:
Trauma is a leading cause of death and disability in the U.S., particularly impacting those under 65 years of age. More than 10% of the U.S. population suffer nonfatal injuries annually.

Leading

Leading Cause of Death:
Injury ranks as the third leading cause of death overall in the U.S., and the primary cause among individuals aged 1 to 44 years.

Shock

Hemorrhagic Shock:
This condition is the second-leading cause of early deaths among the injured, surpassed only by central nervous system (CNS) injuries.

Trauma

Trauma Death Statistics:
Hemorrhage accounts for 30% to 40% of trauma-related deaths. However, unlike most CNS injuries, hemorrhage is more amenable to interventions to reduce mortality and morbidity.

The Devastating Statistics of Traumatic Deaths

Annual Traumatic Deaths

Approximately 79,000 traumatic deaths occur annually in the U.S., with 30-40% resulting from hemorrhage.

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Types of Traumatic Deaths

The major causes include non-hemorrhagic traumatic deaths and deaths from hemorrhage.

 

Research References: For more detailed information, see the studies by DiMaggio C, et al. (2016) and Kauvar DS, et al. (2006).

 

The Critical First Hours: Hemorrhage in Trauma

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Prehospital Period

Hemorrhage contributes to 33% to 56% of deaths during the prehospital period, often being the cause of death before EMS arrival.

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Immediate Impact

Hemorrhage is responsible for over 80% of operating room deaths post-major trauma and nearly 50% of deaths in the first 24 hours of trauma care.

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Types of Hemorrhagic Bleeds

Common forms include hematoma, laceration, puncture wound, crushing injury, and gunshot wounds.

 

Further details can be found in the study by Kauvar DS, et al. (2006) and the Cleveland Clinic website.

Gun Violence in the United States:  A Closer Look

39,707

Firearm-Related Deaths:
In 2019, there were 39,707 deaths from firearms in the U.S., with homicides accounting for 37% of these deaths.

115,000

Non-Fatal Injuries:
Approximately 115,000 non-fatal firearm injuries occur annually in the U.S.

$229 Billion

Economic Impact:
The annual cost of gun injury exceeded $229 billion in 2012, representing about 1.4% of the U.S. GDP.

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Firearm Ownership:
31% of U.S. households have firearms, with 22% of American adults personally owning one or more firearms.

 

Sources: Data sourced from University of California, Davis and Boston Globe (2022).

The Science Behind SEAL

Chitosan's Role:

Chitosan, a linear polysaccharide composed of β--linked D-glucosamine and N-acetyl-D-glucosamine, has been a trusted component in bleeding management since 2003. It adheres to fibrinogen, enhancing platelet adhesion and promoting rapid blood clotting and hemostasis.     

SEAL's Unique Formulation:

Offered as an aerosolized version of chitosan, SEAL is available in three sizes:

Small (1.5 oz) OTC • Medium (2.5 oz) Rx •  and Large (7.1 oz) Rx.

Offered as an aerosolized version of chitosan. Packaged in a single-use aluminum aerosol can, it is designed for efficiency and ease of use.

 

Application and Indications

Prescription (Rx)

Professional use version of SEAL Hemostatic Wound Spray Rx is indicated for moderate to severe external bleeding wounds, including emergency temporary external treatment and controlling severe bleeding, for use under the supervision of a healthcare professional and is available in two sizes, 2.5oz and 7.1oz.

 

Over-the-Counter (OTC)

Available in a 1.5oz version, SEAL Hemostatic Wound Spray OTC is indicated for the local management of minor bleeding such as minor lacerations, minor cuts and minor abrasions. Made for consumer use in a non-professional setting.

9 Key Value Drivers of SEAL

Rapid Action:

When applied to a wound and combined with manual pressure, SEAL quickly forms a strong, comprehensive seal, preventing further bleeding.

Use Settings:

Ideal for non-hospital settings including by patients or caregivers, institutions like schools, prisons, police, EMTs, and the military.

Life-Saving Device:

Recognized as a critical tool in trauma care.

Ease of Use:

Simple administration with application time under 5 seconds.

Effective in Studies:

In animal studies, SEAL demonstrated 50% less blood loss compared to other chitosan-based dressings or granules.

Versatile Application:

Suitable for complex 3D wound architectures, including forced application into openings like gunshot wounds.

Adaptable in Challenging Conditions:

Effective under windy, wet, or low-light conditions.

Portability:

Compact and easy to carry, making it ideal for a variety of settings.

Acessibility

Accessibility:

Can be administered by patients, professionals, or caregivers.

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