Investigational Devices

For nearly two decades, inhaled Nitric Oxide (NO) has been a life-saving intervention for hundreds of thousands of patients in Europe and the US, especially hospitalized infants with acute pulmonary hypertension. Inhaled NO relaxes the blood vessels in the lungs without causing a drop in systemic blood pressure, which can be dangerous and is a significant disadvantage with other currently available therapies. The current inhaled NO treatment is transported and stored in cumbersome tanks.

Third Pole is currently working towards developing a clinic-ready inhaled NO therapy delivery system. The core technology of the device is based on innovations developed by the head of Third Pole’s Scientific Advisory Board, Professor Warren Zapol at Harvard’s Massachusetts General Hospital. Professor Zapol was flying from Boston to Los Angeles to visit a colleague, who won the Nobel Prize for the discovery of NO’s biological role, when lightning inspired his pioneering idea to use electric current to produce NO. After meticulous follow-up work in his lab, and careful testing over several years, Professor Zapol and the Third Pole team developed an investigational device that uses proprietary technology to produce pure NO for inhalation on-demand from air, enabling bedside and portable therapeutic use.

An animation of Nitric Oxide's effect on the lungs

Third Pole’s technology has been featured on the cover of Science Translational Medicine, July 2015, where it was demonstrated that an investigational device created by researchers at Massachusetts General Hospital could produce NO. Later, in a study published in the November 2016 edition of American Journal of Respiratory and Critical Care Medicine, Professor Zapol and his collaborators provided NO from their devices to 6 healthy volunteers and 6 PH patients. 

Nitric Oxide

Nitric Oxide (NO) is a gas that is produced by the body and has the unique ability to relax blood vessels in the lungs without causing a dangerous drop in systemic blood pressure, which can be dangerous and is a significant disadvantage with other currently available therapies.

Researchers, some of whom are now part of the Third Pole team, discovered in the early 1990s that nitric oxide can be delivered therapeutically to the lungs to treat respiratory failure due to pulmonary hypertension in premature babies. Inhaled NO was also shown to be superior to extra-corporeal membrane oxygenation in neonates, a process which causes surgical damage by taking blood from the vessels in the neck for artificial oxygenation, and requires the use of blood thinners that can cause hemorrhaging and strokes. In December 1999, the US Food and Drug Administration (FDA) approved inhaled NO for the treatment of hypoxic respiratory failure (HRF) in term or near-term infants.

For nearly two decades, inhaled NO has been a life-saving intervention for hundreds of thousands of patients in Europe and the US, especially hospitalized infants to treat acute pulmonary hypertension. Today, inhaled NO is administered to around 30,000 babies and adults a year. In Europe, inhaled NO is also approved as a selective pulmonary vasodilator, to relax the vasculature of the lungs in cardiac surgery in adults.

Nitric Oxide is not without its risks. Too much inhaled Nitric Oxide can cause methemoglobinemia. Cessation of inhaled Nitric Oxide therapy can cause “rebound” pulmonary hypertension.

Despite being a well-established therapy, access to and applications for inhaled NO have stagnated. There have been no major innovations since the first-generation tank-based delivery paradigm established in the early 1990s, when a patent was granted in the United States to the Massachusetts General Hospital for the use of inhaled nitric oxide in pulmonary hypertension.

The current inhaled NO treatment is transported and stored in cumbersome tanks, which have the following drawbacks:

  • Costly fleets of compressed gas cylinders limit availability to developed markets with infrastructure to transport, maintain, return and refill tanks of a gaseous pharmaceutical
  • Compressed gas cylinders make it difficult to transport patients between facilities and within a hospital

Inhaled Nitric Oxide is often one of the costliest drugs administered in neonatal intensive care units. In the United States, the cost of 5 days of treatment for persistent pulmonary hypertension of the newborn is about $14,000.

Third Pole personnel do not provide answers or advice about individual medical conditions.

The Third Pole NO generator is being studied to evaluate safety and effectiveness.  It is an investigational product not currently cleared or approved in the United States.