Third Generation of Tankless Nitric Oxide System Genosyl Wins FDA OK

The new device with aid in care of newborns with pulmonary hypertension

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The U.S. Food and Drug Administration (FDA) has approved the third generation of Genosyl, Vero Biotech‘s tankless system for nitric oxide delivery, for use as part of care for newborns with pulmonary hypertension.

“The continuous innovation of the GENOSYL Delivery System represents our commitment to neonatal intensive care and the acute care hospital community in providing solutions to the challenges they face,” said Brent V. Furse, Vero’s president and CEO, in a company press release.

Denise Lauderbaugh, a clinician at Rady Children’s Hospital in San Diego, said the new system “will help me to work more efficiently.”

The third generation of Genosyl “has two cassettes in one console, and they are even smaller than before; it automatically activates and transitions to the second cassette when the first one is depleted; and I no longer have to transition from a primary to a standby console,” Lauderbaugh said. “I can care for my patients through the operation of just one console.”

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Nitric oxide, or NO, is a gas that acts as a vasodilator, reducing blood pressure by prompting blood vessels to relax and widen. Treatment with NO is part of standard therapy for persistent pulmonary hypertension of the newborn (PPHN), a condition wherein lung vessels are not open wide enough, leading to restricted oxygen and blood flow.

Traditional nitric oxide treatment used NO gas stored in tank-based systems, which are bulky and inconvenient. Instead of large canisters, the Genosyl system uses small disposable cassettes that can generate nitric oxide from the surrounding air, allowing for a more portable and convenient setup with a simpler workflow.

“We are grateful for the partnership and support we received with the launch of our innovative tankless GENOSYL Delivery System and this collaboration that has and will allow VERO Biotech to continue to expand on its mission to save lives, alleviate suffering and improve the health economics of acute care,” Furse said.

Vero recently announced it raised $30 million in new funding, which will aid development and marketing efforts for the Genosyl system. The funding came from healthcare investment firm Petrichor. As part of the agreement, Patrick Lally, a partner of Petrichor, has joined the Vero’s board of directors.

“VERO Biotech has rapidly established itself as a leader in neonatal intensive care through the commercial success of Genosyl [delivery system], with its tankless system representing the first innovation in the delivery of inhaled nitric oxide approved by the FDA in 20 years,” Lally said in a separate press release.

Furse said the funding shows the company’s commitment to the Genosyl system and to neonatal intensive care and hospital acute care.

“We are grateful for the partnership with Petrichor, the confidence they have placed in VERO Biotech, and their recognition of our commercial success to date and strategies for further expansion,” Furse said

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