Acute bleeding is a leading cause of death with no approved treatment and include the indications postpartum hemorrhage, intracranial hemorrhage, traumatic brain injury and trauma.
Currently, 20-40% of hemorrhage-related deaths are considered potentially preventable with rapid hemostatic control and improved resuscitation techniques.
Four Bleeding Indications with Significant Unmet Medical Need for Highly Differentiated Treatments
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Intracranial Hemorrhage
High incidence (25/100,000 w/w)
High mortality (annually, more than 20,000 individuals in the USA die of ICH)
High cost of follow-up care
No existing treatments
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Traumatic Brain Injury with active bleeding
High incidence (1.7M in US; 25-40% of severe and 3-12% of moderate TBI have intracranial bleeding)
Major cause of death (approximately 52,000 US deaths per year result from TBI)
No approved treatment (very high healthcare cost for follow-up treatment)
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Trauma, incl. ACOT (Acute Coagulopathy of Trauma)
2 million hospitalizations per year for trauma
Trauma is the #1 cause of death for Americans between 1 and 46 years old; 200,000 patients die from trauma per year in the USA out of which ~35% die from uncontrolled hemorrhage with ~50% occurring within 24 hours
No systemic hemostatic agents used for the treatment of severe bleeding are approved by FDA or EMA
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Peri- and Postoperative Bleeding
Peri- and Postoperative Bleeding in emergency or elective surgeries, incl. PPH, obstetric emergencies
The incidence rate of PPH is around 12% in Europe and North America with a mortality rate around 1 in 100,000 deliveries for USA
Unmet medical need exists for management of severe bleeding after failure of standard of care
Incremental cost per hospitalization associated with bleeding-related complications
Target Population
US
Trauma: 150,000
Traumatic Brain Injury (TBI): 140,000
Intracranial Hemorrhage (ICH): 60,000
Postpartum Hemorrhage (PPH): 16,000
EU 5 (UK, Spain, France, Germany, Italy)
Trauma: 125,000
Traumatic Brain Injury (TBI): 125,000
Intracranial Hemorrhage (ICH): 45,000
Postpartum Hemorrhage (PPH): 25,000
Japan
Trauma: 40,000
Traumatic Brain Injury (TBI): 50,000
Intracranial Hemorrhage (ICH): 15,000
Postpartum Hemorrhage (PPH): 5,000
Total Market Estimate*
*McKinsey & Company, 2014
A safe and effective treatment is needed.
There is no FDA- or EMA-approved systemic hemostatic agent for the treatment of severe bleeding. This represents an opportunity in a large market with unmet medical need.
To fill this void, Coagulant to pursuing a next generation FVIIa and novel antibodies directed to activated protein C (APC) to develop novel efficacious treatments for acute bleeding.