Vapotherm Announces FDA 510(k) Clearance for HVT 2.0 Next Generation Platform

Aug 30, 2021

Vapotherm, Inc. (NYSE: VAPO), (“Vapotherm” or the “Company”), today announced it has received 510(k) clearance from the US Food and Drug Administration for HVT 2.0. This next generation system is designed to provide high velocity therapy using an integrated air source, eliminating the need for wall air or any pressurized air source. It is estimated that 50% of U.S. hospital beds don’t have wall air. When paired with an oxygen source, the HVT 2.0 will support patients whether they need respiratory support in the hospital or home setting. The Company is planning a limited commercial release of HVT 2.0 in the United States in the fourth quarter of 2021.

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