Vero Biotech gets okay for expanded access to its Genosyl DS iNO system to treat COVID-19 patients

The US FDA has granted “Expanded Access Emergency Use” to Vero Biotech immediately to use its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL® DS, in the treatment of cardiopulmonary symptoms associated with COVID-19.

The agency recently approved GENOSYL (NO) gas, for inhalation for the treatment of persistent pulmonary hypertension of the newborn (PPHN). It’s the only tankless inhaled NO device available in the US. The company’s press release continues:

PRESS RELEASE

Application of VERO’s tankless inhaled NO system is valuable during a time of crisis when hospital beds and ventilators are in short supply. The ability to have a portable device in either the hospital or home setting enables healthcare providers the flexibility to treat patients with iNO in various settings, and give patients more access to the care they need.

“In this time of a global pandemic and public health crisis, it is critical to explore all potential options for treating both the novel coronavirus and its associated cardiopulmonary conditions,” said Brent V Furse, President and Chief Executive Officer VERO Biotech. “Inhaled NO may provide important benefits and we at Vero Biotech intend to expedite and expand our research in this critical area. The application of home use of iNO—which was not been logistically viable until the approval of a tankless and portable system—may itself also play a role in limiting current demand for hospital beds and ventilators by patients suffering from symptoms due to COVID-19.”

Vero Biotech is also working with renowned global academic experts in infectious and cardiopulmonary diseases to evaluate the potential clinical benefits of GENOSYL in treating pulmonary manifestations of COVID-19.

GENOSYL 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.

GENOSYL is contraindicated in the treatment of neonates dependent on right-to-left shunting of blood. (See below for additional Important Safety Information.)

Vero Biotech‘s GENOSYL Delivery System (DS) is a compact and user-friendly NO delivery system, that will not only enable hospitals to reduce logistical burden as compared to the cumbersome tank-based systems currently available, but could provide greater patient access to this potentially life-saving drug.

About Inhaled NO

NO is a powerful molecule proven to play a critical role in a broad array of biological functions. In the airways, NO 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 system, the only way to provide iNO was via large, pressurised gas cylinders and complicated delivery systems.

About GENOSYL

GENOSYL DS is Vero Biotech‘s lead product specifically designed for the hospital intensive care setting. This proprietary delivery system eliminates the need for large NO tanks and the associated logistical burden. GENOSYL DS is a tankless and portable system engineered with failsafe, redundant backup features, which delivers a constant concentration of inhaled NO gas to patients and the easy-to-use interface and portability features.

ABOUT THE COMPANY

Vero Biotech LLC (formerly known as GeNO LLC) develops innovative technologies for inhaled NO delivery in the acute care hospital setting and beyond, wherever inhaled NO treatment is needed.

Source: OINDP News.

Link to Press Release.

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