A senior secured term loan will support the further development of VERO Biotech’s GENOSYL® Delivery System, a proprietary tankless and portable delivery system for the administration of GENOSYL® (nitric oxide) gas, for inhalation
ATLANTA, Jan. 19, 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 the close of a senior secured term loan of $50 million from Runway Growth Capital LLC (“Runway”), a leading provider of growth loans to both venture and non-venture backed companies seeking an alternative to raising equity.
VERO Biotech (formerly known as GeNO LLC) is a biotechnology company focused on the design, development, and commercialization of next-generation products to meet the needs of patients with a variety of pulmonary and cardiac diseases. VERO developed the GENOSYL® Delivery System (GENOSYL DS), the first and only “tankless” inhaled nitric oxide delivery system approved by the U.S. Food and Drug Administration (FDA). The GENOSYL DS transforms the delivery and use of nitric oxide, a vasodilator proven to play a critical role in the care of patients with adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate. The GENOSYL® Delivery System was authorized by the U.S. FDA for expanded emergency use access for patients with cardiopulmonary complications associated with COVID-19; was granted an emergency IND for at-home use; and approved for interhospital transport use in ground, fixed-wing and rotary-wing transport environments.
“After much due diligence, it was clear that Runway understands the nuances of our business,” said Brent V. Furse, CEO and President, VERO Biotech. “Working with a premier lender like Runway who gets us, and has a reputation for being a flexible and understanding partner, is integral to fueling our marketing and product development to ensure greater access to our proprietary tankless, cassette-based GENOSYL Delivery System.”
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).
About Runway Growth Capital LLC
Runway Growth Capital LLC is the investment advisor to investment funds, including Runway Growth Credit Fund Inc., which are lenders of growth capital to companies seeking an alternative to raising equity. Led by industry veteran David Spreng, these funds provide senior term loans of $10 million to $50 million to fast-growing companies based in the United States and Canada. For more information on Runway Growth Capital LLC and its platform, please visit our website at www.runwaygrowth.com.