ATLANTA, March 11, 2021 /PRNewswire/ -- Traditional tank-based delivery systems for Inhaled Nitric Oxide in the hospital setting can deplete financial and labor resources as compared with a novel tankless, cassette-based delivery system, according to a new publication in the Spring 2021 issue of the journal Respiratory Therapy. The issue was released on March 8, 2021.
The review – authored by Ricky W. Bowen, VERO Biotech, Atlanta, GA; Jeff Thompson, Floyd Medical Center, Rome, GA*; and Charles V. Pollack, University of Mississippi Medical Center, Jackson, MS* – found that there are both obvious and relatively hidden real and opportunity costs with the use of tank-based iNO delivery systems versus the tankless alternative. According to the authors, the most frequently cited explanation for limited use of iNO in hospitals is cost, reflecting acquisition cost and not total expense. The light weight, portability, ease of use, greatly decreased and simplified storage space requirements, and ergonomic and economic advantages of the tankless system warrant quantitative evaluation, including a formal time-in-motion study, the authors concluded.
The innovative tankless cassette-based delivery system, GENOSYL DS, was developed by VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care. In December 2020, only one year after the U.S. Food and Drug Administration (FDA)'s initial approval of the innovative GENOSYL Delivery System for the administration of inhaled Nitric Oxide, additional approval was granted for use both during interhospital and intrahospital patient transport and in the magnetic resonance imaging suite. The approval comprises the broadest transport label available in the acute-care setting, including MRI and transport by ground, fixed-wing, and rotary wing conveyances.
The Respiratory Therapy authors identified three distinct yet interrelated factors that can have a profound impact on the cost of using a tank-based delivery system for iNO:
- Storage and Logistical Considerations: Space is always in short supply in today's healthcare facilities. Tank storage is generally relegated to the hospital loading dock, which takes up valuable hospital "real estate" and is inconvenient for quick accessing.
- Ergonomic Considerations: Most tank-based delivery systems are so heavy that they require transport by more than one hospital staff member, making the traditional system highly inefficient. Moreover, the risk of dropping and injuring both staff and the equipment is significantly greater with the tank-based system.
- Economic Considerations: Contracts for tank-based systems tend to be more complicated than that for the simpler, tankless system. The hospital may also incur cost for inadvertently incompletely closed tanks, which may continue to leak NO and accrue usage charges; this cannot occur with the tankless cassette-based system.
About Inhaled Nitric Oxide
Nitric oxide is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, nitric oxide targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate.
Prior to the approval of the GENOSYL Delivery System, the only way to provide iNO was via large, pressurized gas cylinders and associated delivery systems.
GENOSYL (nitric oxide) gas, for inhalation, is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.
Important Safety Information
- GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood.
- Abrupt discontinuation of GENOSYL (nitric oxide) gas, for inhalation may lead to worsening oxygenation and increasing pulmonary artery pressure.
- Methemoglobin levels in the blood increase with the dose of nitric oxide; following discontinuation or reduction of nitric oxide, methemoglobin levels return to baseline over a period of hours.
- Methemoglobin, NO2, and PaO2 should be monitored during nitric oxide administration.
- In patients with pre-existing left ventricular dysfunction, GENOSYL may increase pulmonary capillary wedge pressure leading to pulmonary edema.
- The most common adverse reaction is hypotension.
- Nitric oxide donor compounds may have an additive effect with GENOSYL on the risk of developing methemoglobinemia.
- GENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems or nasal cannulas should be used in conjunction with GENOSYL.
Please visit www.vero-biotech.com for the full Prescribing Information for GENOSYL.
About GENOSYL DS
GENOSYL DS is VERO Biotech's lead product. This proprietary delivery system eliminates the need for large nitric oxide tanks and the associated logistical burden. GENOSYL DS is a tankless and portable system engineered with redundant backup features, which delivers a constant concentration of inhaled nitric oxide gas to patients and the easy-to-use interface and portability features.
About VERO Biotech LLC
VERO Biotech LLC (formerly known as GeNO LLC) is a biotechnology company focused on the design, development, and commercialization of next-generation products to address the unmet medical needs of patients with a variety of pulmonary and cardiac diseases.
VERO Biotech LLC is dedicated to improving the lives of patients by leading the development of innovative technologies for inhaled nitric oxide delivery in the acute care hospital setting and beyond, wherever inhaled nitric oxide treatment is needed.
Forward Looking Statements
This press release and any statements of representatives of VERO Biotech LLC related thereto that are not historical in nature contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, without limitation, statements with respect to VERO Biotech's plans, objectives, projections, expectations and intentions and other statements identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "seeks," "intends," "plans," "potential" or similar expressions, including statements with respect to the potential effects of its products and plans to assess and undertake next steps for VERO Biotech LLC. These statements are based upon the current beliefs and expectations of VERO Biotech's management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various risk factors (many of which are beyond VERO Biotech's control).
(*) Consultants to VERO Biotech
Contact: Ray Russo (908) 313-7172
SOURCE VERO Biotech LLC