According to the NIH, preterm labor is the #1 cause of death for newborns. Their statistics for the US are saddening in terms of human tragedy as well as the immense burden these births place upon the healthcare system.

  • 1 in 8 births is preterm
  • Over a quarter of all US pregnancies are at-risk of preterm delivery . . . one+ million per year
  • Preterm delivery causes over 35% of all infant deaths
  • Common complications of preterm delivery include:
    • Respiratory distress
    • Intra-ventricular hemorrhage (brain bleed)
    • Heart and liver problems
    • Irreversible developmental problems such as blindness, and cerebral palsy
  • The healthcare system cost for each premature baby is typically between $20,000 and $400,000 . . . totaling over $25 billion per year in the US alone.
  • Globally, WHO reports that preterm births exceed 15 million
  • The global at-risk population is 33 million

Current therapies include progesterone injections, cerclage  (a stitch placed into the cervix to keep it closed) and a variety of drugs. These have proven inadequate as evidenced by the fact that there has been no reduction in the incidence of preterm delivery over the past 40 years.

Developing a solution is a high priority for numerous groups including WHO and the Gates Foundation. Cerulean Sleep will provide a solution for this highly visible, major unmet medical need.

While there are currently no viable competitors for Cerulean Sleep, there are numerous approaches in research that could become competitors in the future.

Potential competitors are likely to appear, but not within the next 5 years. The Gates Foundation, the March of Dimes and the Global Alliance to Prevent Prematurity and Stillbirth are encouraging and supporting a growth in research initiatives and collaborations.

Cerulean Sleep holds the most immediate, safe and effective promise to reduce the tragedies associated with preterm births.

The second major initiative is a pharmaceutical application derived from additional insights into melatonin. It offers promise as a kinder, more natural and much less dangerous labor induction agent than the current standard (Oxytocin), which produces a high incidence of fetal distress. The development strategy for the pharmaceutical will be assessed following the filings of the European and US regulatory submissions for the preterm labor device.

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