Overview

There is widespread interest in creating an objective diagnostic for concussion, also known as mild traumatic brain injury (mTBI). This interest is driven by: recent awareness that repeated mTBI can cause serious brain damage; mTBI symptoms may appear months after the trauma; drastically increased rates of TBI in the Afghanistan and Iraq conflicts; and serious concerns over legal liability.

Traumatic Brain Injury

  • 1.7M people in the US suffer a traumatic brain injury (TBI) each year.1 80% of these are mild (mTBI).2
  • Some experts suggest that mTBI is grossly under-reported & misdiagnosed. In many cases this is because of the lack of effective diagnostic tools.3,4
  • Symptoms of mTBI include headache, blurred vision, nausea, dizziness & cognitive problems.
  • Symptoms usually resolve in 2 weeks5 but ~25% of patients experience symptoms up to 6 months later.6,7
  • Repeated mTBI can cause serious brain damage. Symptoms can include depression, serious cognitive problems, memory impairment, and early dementia.

Treatment

  • There is no effective therapeutic treatment for the mTBI itself, although some symptoms (e.g. depression) may be treatable. Most physicians recommend rest and analgesics soon after the mTBI.8
  • Recent work shows that it is important to avoid having another mTBI. Further injury could cause serious brain damage.

Diagnosis

  • mTBI is usually diagnosed using a standardized assessment tool, often the Glasgow Coma Scale (GCS). GCS includes assessment of symptoms, brief loss of consciousness, and patient/witness report of the trauma.9
  • In some cases, mTBI diagnosis is confirmed using a CT scan (the “gold standard”)
  • Many reports suggest that most cases of mTBI are never diagnosed. Reasons include:
    • Both GCS and CT scans are widely reported to be ineffective for diagnosing mTBI.10 They are still used because there is no alternative diagnostic.
    • It is common for those with mTBI to be unaware they are injured, or to want to “shake it off.”11
    • People who have suffered a mTBI may have no memory of the event, and could even be unaware that they are injured. There also may be no witnesses.

The driving demand for this diagnostic comes from four sources:

  • Physicians. Without a standard, objective diagnostic for mTBI, most of those afflicted are prematurely discharged from the hospital, often within one day.12 Patients will be left unaware that further mTBIs could cause more serious brain damage. Further, they will not know that they could experience neurological/ psychiatric problems months after the accident. These problems may be treatable.
  • The Department of Defense (DoD) wants to determine if a soldier in the field has just suffered an mTBI. This has become a serious problem recently - 20% of soldiers deployed to Iraq suffered “probable TBI.”13 Affected soldiers could then be removed from active duty to avoid further injury.
  • Professional (NFL) and collegiate (NCAA) athletic associations, want to determine if a player has just suffered an mTBI. That player would then be removed from the game.14
  • Biopharma. While “Big Pharma” has dropped development of TBI therapeutics for now,13 several small companies are in this space, such as Astrocyte,15 NeuroVive,16 and Neuren.17 Smaller companies and startups such as Medicortex,18 and Exosome18 are focused on companion diagnostics for such drugs.

The US government, NFL and venture capitalists now support early-stage development of an mBTI diagnostic.

  • In 2007, allocated $600 million for research and treatment, splitting the funds between TBI and PTSD.19
  • In 2013, NFL, Under Armour & GE Launched “Head Health”, which includes a 4-year, $40M R&D program offering $500,000 grants. It will award $20M to organizations developing new technologies.20
  • As of 2016, VCs have invested an estimated $150M in companies developing mTBI diagnostics.

According to several reports, the ideal mTBI diagnostic:

  • Provides objective, quantitative results
  • Is effective soon after the head trauma
  • Can be performed on-site – e.g. on the sidelines of a game, in the field after combat or in a front-line hospital.

MARKET

  • The size of this market is difficult to estimate, but $1B has been suggested.21
  • The most immediate consumers are likely to be the DoD and NFL.

COMPARISON OF DIAGNOSTICS/ASSESSMENTS.22,23,24,25,26,27,28

Technologies in Development

Academic/ Gov’t

  • Eye-tracking device – Samadani, NYU.29
  • Blood test for multiple biomarkers – Pappa, Orlando Regional Medical Center.30

Commercial

  • BrainScope – Quantitative Electroencephalography (QEEG). Received FDA clearance to replace NOC as a “gatekeeper” assessment prior to using a CT scan.31
  • Banyan Biomarkers – Multiplexed blood test using ELISA.
  • Royal Phillips – Banyan collaboration on handheld blood test.
  • Quanterix – Immunoassay tech company collaborating with Banyan on a lab diagnostic.
  • Abbott - Partnered with DoD to make a blood test for the i-STAT handheld device.32,33


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