GENOSYL® DS is the first and only tankless inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration
VERO Biotech Inc., a fast-growing commercial business dedicated to improving the lives of patients through innovative technologies, today announced the funding of up to $100 million in a Series E financing round led by MVM Partners (MVM), which included participation from a strategic investor. Funds from the round will support the expanded commercialization of the GENOSYL® Delivery System (GENOSYL® DS).
GENOSYL® DS is the first and only tankless inhaled nitric oxide (NO) delivery system approved by the U.S. Food and Drug Administration (FDA). NO dilates blood vessels to treat severe pulmonary hypertension, a life-threatening condition that can occur in neonates and patients with respiratory distress. Unlike tank-based systems, GENOSYL® DS generates NO at the bedside using a small disposable cassette. This eliminates the need for hospitals to manage bulky tanks and helps to simplify clinical workflow.
"As MVM is committed to supporting the growth of companies with innovative technologies to treat unmet medical needs, it was clear MVM is the right fit for our next stage of growth," said Brent V. Furse, CEO and President, VERO Biotech. "MVM has a deep understanding of our business, and we will be able to leverage MVM's experience in bringing innovative products to market, driving growth, making strategic acquisitions, and establishing new standards of care in medicine. VERO's partnership with MVM will ensure greater access to our proprietary tankless, cassette-based GENOSYL Delivery System."
Eric Bednarski, Partner of MVM commented: "VERO Biotech has a best-in-class technology that improves the clinical care of patients requiring inhaled nitric oxide therapy. GENOSYL has gained significant market traction with adoption by some of the top hospitals in the US. We are extremely impressed by the management team and excited to partner with VERO Biotech to help the company achieve its near- and long-term goals."
Indication 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 with an easy-to-use interface and portability features.
About VERO Biotech VERO Biotech Inc. (formerly known as GeNO LLC) is 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 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.
About MVM Partners MVM has invested in innovative, high growth healthcare businesses since 1997. With teams in Boston and London, MVM has a successful track record of investing across most healthcare sub-sectors, including medical technology, pharmaceuticals, diagnostics, contract research and manufacturing, and digital health. In aggregate, MVM has raised investment vehicles totaling over $1 billion. SOURCE VERO Biotech LLC