Traumatic Brain Injury (TBI)

In the United States, approximately 235,000 patients are hospitalized with TBI every year. 50,000 of these injuries are fatal.  A further 1,100,000 patients are treated for TBI in the emergency room.  The direct cost of care for patients with TBI, excluding inpatient care, is estimated at more than $25 billion annually.  CDC estimates that at least 5.3 million Americans, approximately 2% of the U.S. population, currently have a long-term or lifelong need for help to perform activities of daily living as a result of a TBI. TBI can cause a wide range of functional changes affecting thinking, sensation, language, and/or emotions. It can also cause epilepsy and increase the risk for conditions such as Alzheimer’s disease, Parkinson’s disease, and other brain disorders that become more prevalent with age.

There are currently no approved pharmaceutical therapies for TBI, with the only treatment being intracranial pressure management techniques such as craniotomy.

Stroke

Stroke is the third leading cause of death in the U.S., and the leading cause of serious long-term disability, with 5,400,000 stroke sufferers. There are 780,000 strokes in the U.S. each year, resulting in 280,000 fatalities. Annual costs to the healthcare system are estimated at $56.8 billion.  There is currently only one FDA-approved drug for the treatment of acute stroke, tPA (tissue plasminogen activator), a “clot-buster”. Because tPA must be administered within a three-hour therapeutic window from the onset of a stroke, the drug is used in only 3-6% of new stroke cases. Some 93-97% of stroke victims receive no drug-based treatment.  Mechanical thrombectomy as an intervention option for acute ischemic stroke is growing but is constrained to a small minority of patients.

Spinal Cord Injury (SCI)

Approximately 11,000 Americans sustain a SCI each year. The leading cause of SCI varies by age: motor vehicle crashes are the leading cause among persons under age 65 while among persons age 65 and older, falls cause most SCIs. Sports and recreation activities cause an estimated 18% of SCI cases. Secondary conditions such as pressure sores, respiratory complications, urinary tract infections, spasticity, and scoliosis are a major health issue for people living with SCI and all told, SCIs cost the nation an estimated $9.7 billion each year.

The only approved drug for treating SCI is methylprednisolone, a steroid medication, although its use is decreasing due to concerns over its efficacy and risk/benefit.