COVID-19 Patient with PH Treated with iNO Via Genosyl, VERO Biotech Announces

The first person with coronavirus disease 2019 (COVID-19) complicating pulmonary hypertension (PH) has received at-home treatment with inhaled nitric oxide (iNO), delivered through the Genosyl system, according to VERO Biotech, manufacturer of Genosyl.

The PH patient with COVID-19 infection was treated under the terms of an emergency investigational new drug (IND) application that was filed with the U.S. Food and Drug Administration (FDA).

Nitric oxide is a powerful vasodilator — it causes blood vessels to relax and widen, which lowers the pressure within those vessels. PH is characterized by high blood pressure in blood vessels that supply the lungs (pulmonary arteries). iNO is typically used in PH patients to lower the pressure in lung blood vessels.

The Genosyl system is a technology used to deliver iNO at a constant concentration to patients, with an easy-to-use interface and portability features.

Unlike previously existing delivery systems, Genosyl does not use tanks of pressurized gas, which are physically cumbersome and can create logistical burdens. The system works without tanks, making it well-suited for application in hospital intensive care settings, and amenable to home use.

“Treating patients at home with a tankless system to deliver iNO represents a new paradigm in the management of pulmonary hypertension,” Michael Gentile, a registered respiratory therapist and vice president of medical affairs at Vero Biotech, said in a press release.

In addition to treatment with iNO, the patient was given oxygen therapy (delivered via nasal canula), and a team of clinicians carefully monitored the patient remotely. This allowed the patient to receive treatment without the need for hospitalization, and it mitigated the need for other, more intensive respiratory treatment.

“Application of VERO’s tankless inhaled nitric oxide system at home under physician supervision is particularly critical during a time of crisis when hospital beds and ventilators are in short supply,” said Brent V. Furse, president and CEO at VERO Biotech. 

Of note, the Genosyl system is currently approved, in combination with other appropriate treatments (such as ventilation), for treating infants born at or near term (after 34 weeks of pregnancy) who have certain breathing difficulties indicative of PH.