The active substance in our INOpulse product candidate is pharmaceutical-grade nitric oxide. Nitric oxide is a molecule naturally produced in the endothelial lining of blood vessels that plays a significant role in vasodilation, or opening of the arteries, including arteries in the lung. When given to a patient with pulmonary hypertension (PH) who has constricted blood vessels in his or her lungs, it is anticipated that inhaled nitric oxide may be absorbed by the smooth muscles and, through a series of reactions, may help relax these muscles, which causes the blood vessels in the affected area to dilate or open. This is expected to reduce blood pressure in the lungs and therefore reduce the strain on the right ventricle of the patient’s heart and allow blood circulation to become more normal. Since inhaled nitric oxide is quickly inactivated after contact with blood, the product should act locally with minimal potential for systemic effects—an important safety consideration.
Inhaled nitric oxide (iNO), administered to ventilated patients by a dedicated in-hospital device, is marketed in many countries worldwide. We are now testing whether nitric oxide works in conditions where patients also have some form of pulmonary hypertension, such as pulmonary arterial hypertension (PAH), PH associated with chronic obstructive pulmonary disease (PH-COPD) and PH associated with idiopathic pulmonary fibrosis (PH-IPF).
The INOpulse device is designed to be portable for use by ambulatory patients on a daily basis inside or outside their homes. The device is programmed to automatically adjust based on a patient’s breathing pattern to deliver a constant and appropriate dose of the inhaled nitric oxide over time, independent of the patient’s activity level, thus ensuring more consistent dosing in the alveoli of the lungs. In addition, we have developed a proprietary triple-lumen nasal cannula which enables more accurate delivery of the dose to the patient. The INOpulse device is also compatible with many long-term oxygen therapy systems that operate via a nasal cannula. Our newest generation INOpulse device has approximately the same dimensions as a paperback book and weighs approximately 2.5 pounds. It has a simple and intuitive user interface and a battery life of approximately 16 hours when recharged, which takes approximately four hours and can be done while the patient sleeps.