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Home Use of GENOSYL® Delivery System (DS) to Administer GENOSYL® (nitric oxide) gas for Inhalation for the Treatment of Pulmonary Hypertension Complicated by COVID-19 Infection Published in American Journal of Respiratory and Critical Care Medicine
ATLANTA, May 6, 2020 /PRNewswire/ -- GENOSYL DS, an innovative tankless delivery system for inhaled nitric oxide (iNO) was used by Stanford Medicine clinicians via telemedicine for outpatient, at-home treatment of a patient with pulmonary hypertension complicated by COVID-19, according to a case report published online on May 5, 2020 in the American Journal of Respiratory and Critical Care Medicine, a premier journal in pulmonary and critical care medicine. Access Case Report here.
The case, the first of its kind to report on at-home iNO treatment, involved a 34-year old female with vasoreactive idiopathic pulmonary arterial hypertension (iPAH) and concomitant COVID-19. This patient was successfully remotely managed by clinicians. The clinicians obtained an Emergency Investigational New Drug Application (EIND) from the U.S. Food and Drug Administration for the use of GENOSYL (nitric oxide) gas for inhalation, manufactured by VERO Biotech, a Georgia-based biotech company.
Roham T. Zamanian, MD, Associate Professor of Medicine, Stanford University School of Medicine, Department of Pulmonary and Critical Care Medicine, was the case report's lead author.
"Without well-established treatments, the COVID-19 pandemic is a threat to the health and care of PAH patients. This report is the first to our knowledge of outpatient telehealth management of an iPAH patient with COVID-19, and represents a first step towards support for in home use of iNO in PAH, as well as the potential use of iNO in patients with coronavirus-associated pulmonary disease in the outpatient environment," said Michael A. Gentile, Vice President of Medical Affairs, VERO Biotech and a co-author on the report. "While hospitals may readily stock the large, weighty tank system required for conventional delivery of iNO, the recent FDA approval of the GENOSYL tankless delivery system opens more realistic opportunities for out-of-hospital or even home use."
"VERO Biotech is pleased to play an important role in the treatment of patients with concomitant cardiopulmonary disease and COVID-19 infection," commented Brent V. Furse, President and CEO, VERO Biotech. "We designed our novel delivery system to ease the burden of care on respiratory therapists, not only in the hospital setting but also for outpatient use," he added.
Researchers have observed that the COVID-19 pandemic of a novel coronavirus, SARS-CoV-2, is associated with significant cardiopulmonary morbidity in some patients. As no specific antiviral therapy is available for SARS-CoV-2, treatment has been limited to supportive though sometimes intensive (particularly in older patients and those with comorbidities) measures, and has severely stretched global hospital staffing and equipment capacity in many countries. The advance in therapy reported in this case is an indication that home therapy with iNO may help ease those burdens.
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).
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SOURCE VERO Biotech LLC