The gas product, classified as Class 1 medical device by the FDA, will be produced by the company’s medical gas partner in a pharmaceutical GMP facility.
The company said NO gas, which is naturally produced in the human body, maintains vessel tone, develops natural defense mechanisms as well as initiates cell growth and healing functions.
Ceretec vice president Alex Stenzler said use of NO gas for diffusing capacity testing offers new insights into the structure of the alveolar-capillary membrane, which is important for understanding the progression of diseases that affect the lungs such as interstitial pulmonary fibrosis.
"We will be offering this gas only to institutions who have approval to perform this diagnostic pulmonary function measurement so as to not induce infringement of patents held by Ikaria Corporation that expire in January 2013," Stenzler added.