Nitric oxide—a compound of one atom of nitrogen and one atom of oxygen—is a critically important molecule involved in many physiological and disease processes. This “startlingly simple” compound was dubbed Molecule of the Year in 1992 as it “unites neuroscience, physiology, and immunology, and revises scientists’ understanding of how cells communicate and defend themselves.” In 1998, Murad and Ignarro were awarded the Nobel Prize for their discoveries regarding nitric oxide as a signaling molecule in the cardiovascular system.
Inhaled Nitric Oxide as a therapeutic agent is ideally suited to its purpose—to effect dilation of pulmonary vessels, thereby lowering pulmonary artery pressures. Importantly, delivered to the lung, and with a very short half-life of a few seconds in the blood, inhaled NO’s effect is selective for the pulmonary vasculature, rather than systemic, as with other types of vasodilators.
Persistent pulmonary hypertension of the neonate (PPHN) with hypoxic respiratory failure is a serious condition in term or near-term newborns. Inhaled NO has revolutionized the treatment of PPHN, providing improved oxygenation and a reduced need for invasive extracorporeal membrane oxygenation (ECMO).3 This condition is currently the only FDA-approved indication for inhaled NO, Inhaled NO is recommended as first-line vasodilator therapy for PPHN in a Consensus Statement from the Pediatric Cardiac Intensive Care Society.
Inhaled NO treatment is indicated in the EU for PPHN, as well as for treatment of pulmonary hypertension in adult and pediatric patients undergoing cardiac surgery. Several major US insurers consider inhaled NO treatment ‘medically necessary’ (for purposes of reimbursement) for PPHN, for pediatric cardiac surgery patients with pulmonary hypertension, as well as diagnostic use to assess pulmonary vaso-reactivity in persons with pulmonary hypertension.
Innovation in Inhaled Nitric Oxide Delivery
The therapeutic potential of inhaled NO for cardiopulmonary conditions—some acute, some more chronic—may be held hostage by the cumbersome and costly delivery methods. Currently, the only way to provide NO for inhalation is via large, pressurized gas cylinders and complicated delivery systems.
Through a thorough understanding and application of scientific principles, Vero Biotech has developed an innovative and simple method for generating NO gas that frees patients and caregivers from cumbersome gas tanks, and delivers pure, precise amounts of NO to the patient, without toxic contaminants.
Given the very simple and direct purpose of NO, what are the key goals for effectively delivering inhaled NO to the patient, and how does Vero Biotech solve these problems?
- To provide a consistent, concentration of NO, minimizing spikes and lags in the desired dose
- To minimize NO2 inhalation
Vero Biotech’s chemists knew that rather than starting with NO gas—which has to be kept in large gas tanks under pressure —they could start with a different form of a nitrogen /oxygen compound (N2O4) and provide the right environment for that compound to be converted to NO gas on demand. With our proprietary technology, the right amount of NO is produced as required to dose the patient.
Our chemists also knew that when NO and oxygen mix in a ventilator circuit, toxic and unwanted NO2 is formed. Vero Biotech’s delivery systems use proprietary technologies to minimize NO2 formation, and to remove any formed as the NO/oxygen stream is delivered to the patient. The levels of NO2 are monitored, and are well below EPA exposure limits.
Vero Biotech’s engineers developed a delivery system that would not only provide this pure ‘tankless’ NO, but would do so as a consistent, uniform concentration, with minimal variation from the set dose. Because of the very short half-life of NO in the blood, a uniform delivery of NO to the lungs is important in maintaining the therapeutic dose.6
Vero Biotech’s innovative technology provides the solution for effective delivery of inhaled NO
Inhaled Nitric Oxide (NO) has the potential to benefit patients, from neonates to older adults with a range of cardiopulmonary conditions characterized by pulmonary hypertension–whether the patients are in critical care hospital settings, chronic care facilities, or even in the home.
We’re developing GēNOsyl® delivery systems to meet the needs of patients and critical care providers wherever inhaled NO is part of a treatment option. GēNOsyl® delivery systems are designed with simple principles in mind:
- NO gas is delivered to the patient in the most predictable way, as a constant concentration with minimal variability.
- Patient and clinician safety are paramount in Vero Biotech products, which provide pure NO without toxic NO2 contamination.
- GēNOsyl® delivery systems are intuitive to use, with simple assembly and straightforward operation.
- Vero Biotech technology untethers NO treatment from bulky and hazardous gas cylinders, allowing therapeutic use of NO wherever it’s needed by the patient.
- No special storage conditions are required, and components are easily disposed of.
Safety, ease of use, convenience, and value
Vero Biotech has designed its inhaled NO delivery systems to be
- safe, with redundant means for minimizing NO2 exposure, and elimination of hazardous gas cylinders
- straightforward to assemble and operate
- easy to use—requiring no special handling, storage or disposal
GēNOsyl® Advanced Delivery System (ADS)
The GēNOsyl® ADS is our lead product in development, developed for hospital/intensive care settings. The ADS is a portable, system engineered with failsafe, redundant backup features, which delivers a constant concentration of NO gas to patients.
GēNOsyl® Chronic DS
We’re developing a GēNOsyl® Chronic DS as a lightweight, ‘wearable’ system that can be worn comfortably by patients outside of the hospital setting. The same innovative technology for delivering inhaled NO in a small, portable delivery system, without cumbersome gas tanks, has the potential to provide expanded treatment options for patients with cardiopulmonary conditions.
This product is a new drug, limited by Federal law to investigational use