ATLANTA, Dec. 15, 2020 /PRNewswire/ -- VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, today announced that the U.S. Food and Drug Administration (FDA) has approved use of the GENOSYL Delivery System for the administration of inhaled Nitric Oxide during interhospital patient transport and in the magnetic resonance imaging suite. The approval comprises the broadest transport label available in the mobile critical care setting.
The GENOSYL® DS is intended for use in the hospital 1.5 Tesla and 3.0 Tesla diagnostic imaging settings up to the 100 GAUSS line, and during ground, fixed wing, and rotary interhospital transport. Complete testing included appropriate standards per FDA and FAA requirements and proved the GENOSYL Delivery System and transport mount could withstand the use environments of ground, fixed wing, and rotary transport; shock and vibration testing; EMI / EMC testing; and static pull testing for crash safety. In addition, hospital transport experts were consulted, and flexibility of use was confirmed.
"Providing optimal care for patients needing inhaled nitric oxide during interhospital transport has long been a challenge for physicians, nurses, respiratory therapists and ambulance transport drivers," said Robert Newmyer, MD, Medical Director – Transport, Ann and Robert H Laurie Children's Hospital in Chicago, Illinois. "Transport vehicles are essentially mobile intensive care units and the GENOSYL Delivery System was tested and proven effective and safe in the various environments that recreated the critical care unit."
For use in interhospital patient transport, the primary and backup GENOSYL® DS console must be securely mounted within the transport vehicle per hospital / transport protocols. Prior to using the GENOSYL DS in patient transport, a cassette should be inserted into each console. Transport equipment weight should be calculated to assure transport system meets weight allowance.
"VERO Biotech is committed to customer collaboration on the design and individualized transport solutions with our proprietary tankless, cassette-based GENOSYL Delivery System for inhaled Nitric Oxide," said Brent V. Furse, CEO and President, VERO Biotech. "We are proud to have consulted and collaborated with respiratory care transport experts to best meet their patient care needs with this important advancement to support interhospital transport."
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).
SOURCE VERO Biotech LLC