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Market Opportunity

Ischemix is developing novel cytoprotective compounds to prevent and treat serious diseases/conditions. The initial focus of the Company has been prevention of hospital-acquired kidney injury (HA-AKI) and cardiac injury associated with PCI. CMX-2043 is also currently conducting additional preclinical development to confirm initial studies that showed efficacy of the drug for treatment of traumatic brain injury.

Hospital-acquired acute kidney injury (HA-AKI)

Ischemix has selected HA-AKI as a target indication because:

  • Acute kidney injury has a high incidence in the US and the rest of the world
  • There are no drug therapies currently approved for acute kidney injury
  • Hospital-acquired AKI constitutes at least a majority of the total incidence of acute kidney injury
  • Patients at risk of HA-AKI are an identifiable and addressable population

Hospital-acquired AKI Statistics

  • 3 million plus annual incidence (WW)
  • 700,000 est. annual deaths (WW)
  • More than 1.8 million cases annually (US)
  • $10 billion est. annual cost to health care system (US)
  • Incidence of AKI progressing to dialysis increased 10% per year (US 2000-2009)
  • Transient AKI is associated with a significant risk of de novo chronic kidney disease or dialysis (hazard ratio = 1.91)

The patient populations that contribute the largest number of HA-AKI diagnoses in the US annually are:

Population Description Annual Frequency Est. Incidence of HA-AKI
Intensive care unit patients 5,000,000 16-67%
Diagnostic cardiac catheterizations – higher-risk 400,000 25-30%
Diagnostic cardiac catheterizations – lower-risk 600,000 5%
Coronary artery bypass surgeries 400,000 5-30%

Periprocedural Cardiac Injury

Ischemix has selected periprocedural cardiac injury as a target indication because:

  • Periprocedural cardiac injury has a significant incidence in the US and the rest of the world
  • There are no drug therapies currently approved for periprocedural cardiac injury
  • Procedural injury in patients undergoing PCI and CABG procedures is associated with increased morbidity and mortality
  • The most severe form of periprocedural cardiac injury is periprocedural myocardial infarction (PMI or heart attack), also referred to as type 4(a) MI

Global patient populations susceptible to periprocedural cardiac injury:

  • 1.3 million therapeutic cardiac catheterizations (PCIs) (US, Europe and Japan)
  • 580,000 coronary artery bypass surgeries (US, Europe and Japan)

Frequency and estimated resulting periprocedural cardiac injury in the US annually is:

Population Description Annual Frequency Est. Incidence of
Type 4(a) MI
Therapeutic cardiac catheterization (PCI) 600,000 up to 16%
Coronary artery bypass surgery (CABG) 400,000 up to 20%

Percutaneous coronary intervention (PCI) is a common procedure in which a balloon is inserted into a blood vessel to repair an obstruction and a stent is inserted to keep the blood vessel from re-occluding. In a CABG procedure, a new blood vessel is connected from the aorta to the coronary artery to bypass the blocked section of the coronary artery and improve the blood supply to the heart. The most common periprocedural injury during the PCI and CABG is myocardial infarction.

Community-Acquired Acute Kidney Injury (CA-AKI)

In addition to HA-AKI, other forms of acute kidney injury occur outside the hospital each year due to trauma (principally automobile accidents), the ingestion of ethylene glycol or carbon tetrachloride, and overdoses of acetaminophen and other nephrotoxic substances. Ischemix intends to evaluate the use of CMX-2043 or its analogs as a treatment for CA-AKI from these causes.