Vapotherm Announces FDA Clearance for HVT 2.0 Next Generation Platform

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Vapotherm, Inc., 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.

“Clearance of HVT 2.0 enables us to provide high velocity therapy to Patients throughout the hospital, which is very important when ICU beds become scarce. It will allow hospitals to leverage their general care floors and potentially reduce emergency room crowding and wait times. We will also use this next generation platform, combined with the Vapotherm Access digital remote Patient monitoring platform, to begin learning how to treat complex lung disease Patients in the home,” said Joe Army, President and CEO of Vapotherm.

About Vapotherm

Vapotherm, Inc. is a publicly traded developer and manufacturer of advanced respiratory technology based in Exeter, New Hampshire, USA. The company develops innovative, comfortable, non-invasive technologies for respiratory support of patients with chronic or acute breathing disorders. Vapotherm is focused on the development and commercialization of its proprietary Vapotherm high velocity therapy® products which are used to treat patients of all ages suffering from respiratory distress. Over 3.0 million patients have been treated with the use of Vapotherm high velocity therapy systems. For more information, visit www.vapotherm.com.

Vapotherm high velocity therapy is mask-free noninvasive ventilatory support and is a front-line tool for relieving respiratory distress—including hypercapnia, hypoxemia, and dyspnea. It allows for the fast, safe treatment of undifferentiated respiratory distress with one tool. The Precision Flow system’s mask-free interface delivers optimally conditioned breathing gases, making it comfortable for patients and reducing the risks and care complexities associated with mask therapies. While being treated, patients can talk, eat, drink and take oral medication.