The US Food and Drug Administration (FDA) has granted orphan drug designation to GeNO for use of inhaled nitric oxide (NO) in treatment of persistant pulmonary hypertension of the newborn (PPHN).
The orphan drug designation was granted based on a plausible hypothesis for clinical superiority over the approved nitric oxide product.
NO is delivered via the company's GeNOsyl MVG-2000 delivery system, comprising a primary delivery system, a backup system, the NO gas analyzer and the nitrogen dioxide gas analyzer.
GeNO president and founder David Fine said the company's goal is to use its proprietary chemistry and delivery apparatus to provide low-dose inhaled NO that provides a level of purity that cannot be attained with currently available treatments.
"We believe our technology has the potential to be a transformative therapy for patients suffering from rare diseases like PPHN for whom there are limited treatment options, and we are committed to advancing the clinical and commercial development of our nitric oxide delivery platforms because of the dramatic benefit they may have on the lives of patients," Fine added.
In addition to MVG-2000 system, the company is developing a gas cylinder system for hospitals and outpatients, a ventilator-based platform for intensive care units, and a pocket-sized ambulatory system for chronic outpatients.
