A correction for a software issue that led to errors in the delivery of nitric oxide
ATLANTA, July 22, 2021 /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 they voluntarily issued a correction to Software version 2.2.3 for GENOSYL® DS devices, which is classified as a Class 1 recall. VERO Biotech worked with the FDA to issue the recall communication and take action to correct the issue. As of May 14, 2021, all GENOSYL® DS devices affected by the recall were updated to the latest software version in the field. This correction did not require any removals of GENOSYL® DS devices. VERO continues to work with the FDA to close the recall.
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.
ENOSYL must be administered using a calibrated GENOSYL Delivery System. Only validated ventilator systems 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. 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.
MATHESON is a single source for industrial, medical, specialty and electronic gases, welding and safety supplies, gas handling equipment, high performance purification systems, engineering and gas management services, and on-site gas generation with a mission to deliver innovative solutions for global customer requirements.
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).
Contact: Shasha Zou (404) 692-0716
SOURCE VERO Biotech LLC