Note: this post has been updated here.
GeNO LLC. of Cocoa, Florida recently announced that they are soon going to start Phase 2 trials of their Nitrosyl NO Delivery system, having received FDA Investigational New Drug (IND) clearance. The Nitrosyl device is a portable NO system the company claims delivers "pure" NO (as without admixture of NO2) while clipped to a belt. The ultimate goal would be for ambulatory NO therapy rather than the current standard of hauling large tanks and a complicated nitric oxide delivery device, but GeNO spokesperson Carla Burigatto said in an email that, "The first studies are in a hospital setting using the proprietary stand-alone gas cylinder to help diagnose pulmonary arterial hypertension, and the hope is that their technology not only adds helpful data but also reduces the monitoring, technology and complications of administering nitric oxide to patients."
We hope that Nitrosyl fares well in the trial because delivering NO in minuscule (<5-20) particle-per-million therapeutic doses is a very complicated business. From the product page:
The GeNO Nitrosyl™ Delivery technology works by passing pre-diluted NO2 gas in O2 or air through a small powder conversion reactor to generate nitric oxide in O2 or air at the therapeutic dose. The heart of the system is the reactor bed, which is made of ascorbic acid adsorbed on silica particles. The purity of the nitric oxide gas in O2 has been tested using a variety of instrumentation techniques. The NO2 level at the exit of the cartridge has been shown to be less than the NIOSH limit.
Paradoxically, although GeNO’s Nitrosyl™ Delivery Platform starts with NO2, it delivers nitric oxide to the patient essentially free of the NO2 impurity.