Ceretec, Inc. today announced that it has introduced an FDA-listed nitric oxide gas product (NO-Diff™ Nitric Oxide 800 ppm Lung Diffusion Mixture) for use in membrane diffusing capacity (DLNO) testing in pulmonary function laboratories in the U.S.
Ceretec's NO-Diff™ is a gas product classified by the FDA as a Class 1 medical device; however, it will be produced for Ceretec by its medical gas partner in a pharmaceutical GMP facility. Alex Stenzler, Ceretec's Vice President, explained, "Use of nitric oxide 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." He added, "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." Ceretec anticipates a generic pharmaceutical nitric oxide product will enter the U.S. market after regulatory approval for distribution and following the expiration of the relevant Ikaria patents.
Nitric oxide gas is one of the most important molecules naturally produced in the human body. It performs functions in every organ system and is responsible for vessel tone, the body's natural defense mechanisms as well as cell growth and healing functions.
About Ceretec, Inc.
Ceretec is a privately held corporation that is managed by a group of industry veterans involved in developing and producing innovative, cutting-edge medical device and pharmaceutical products.