We are developing the GeNOsyl Acute DS to deliver a constant intra-breath concentration of therapeutic NO to patients who are on a ventilator in the hospital setting under close medical supervision. It can also be used with a nasal cannula or face mask. GeNOsyl Acute DS is comprised of a portable console and our single-use drug cassette. GeNOsyl Acute DS is designed to be simple and intuitive to use. Patient and user safety is paramount in GeNO product designs. GeNO’s nitric oxide delivery products are designed to deliver nitric oxide with levels of the impurity nitrogen dioxide (NO2) that are consistently less than the National Institute for Occupation Safety and Health (NIOSH) limit of 1 ppm.

GeNOsyl® Acute DS

The GeNOsyl Acute DS incorporates four components: the primary delivery system, a backup system, the NO gas analyzer and the NO2 gas analyzer. The GeNOsyl Acute DS injects a constant flow of nitric oxide (NO) gas into the inspiratory limb of the ventilator circuit to deliver a constant concentration of NO to the patient. It provides continuous integrated monitoring of inspired oxygen, NO and nitrogen dioxide (NO2) concentrations, and a comprehensive alarm system. Prior to reaching the patient, the gas passes through a small cartridge which serves two functions: 1) as a mixing chamber, and 2) to scrub out any NO2 which may be present, so as to deliver NO with extremely low levels of NO2 impurity.

GeNOsyl® Chronic DS

The wearable GeNOsyl Chronic DS contains gas monitoring and controls and a rechargeable battery as well as a separate, disposable cassette which includes a small integrated liquid NO2 reservoir together with two cartridges. There are no gas cylinders and no gas regulators. The cartridges have extra reserve capacity beyond the maximum amount of NO2 that can be stored in the reservoir. The second cartridge provides 100% redundancy to the main cartridge, which already has extra reserve capacity. In addition to serving as a redundant cartridge, the second cartridge converts any NO2 that may have formed in the tubing back to nitric oxide.

We are developing GeNOsyl Chronic DS to be a lightweight system that can be worn comfortably by patients for use outside of the hospital setting. The product is designed to deliver high purity NO to the patient 24 hours per day by means of a nasal cannula or a face mask. Battery management is expected to be similar to that of a cell phone, with a recharging capability from wall outlets, a recharger in an automobile, or from a back-up battery. The total weight of the controller, cassette and battery is designed to be less than 16 ounces.

CAUTION: The GeNO nitric oxide delivery systems have not yet been approved by the FDA for marketing purposes.