EXETER, N.H – Vapotherm, Inc., a developer and manufacturer of advanced respiratory technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its All Patient Circuit (APC™) which now includes therapy settings for neonatal and infant patients. The cleared APC enables the HVT 2.0 high velocity therapy system to deliver therapy across a 2–45 L/min flow range using a single disposable patient circuit.
EXETER, N.H., December 8, 2025 – Vapotherm, Inc., a leader in advanced respiratory support technologies, today announced a strategic partnership with Flight Medical Innovations Ltd. to bring the newly cleared VentO2ux™ ventilator to customers in the United States. The collaboration expands Vapotherm’s portfolio beyond high velocity therapy devices to a broader platform of respiratory support solutions spanning the continuum of care.
Vapotherm, Inc., a global leader in mask-free noninvasive respiratory support, announced its HVT® 2.0 system has received Authority to Operate (ATO) certification under the Department of Defense’s (DoD) Risk Management Framework (RMF).
Vapotherm, Inc., the global leader in mask-free noninvasive respiratory support, is proud to announce the publication of a new clinical study, Effect of Single-Prong Cannula Design with High Velocity Therapy: Comparable Efficacy at Lower Gas Flow Rates, in Critical Care Explorations. The study demonstrates that the ProSoft® Unicorn™ Cannula, a single-prong high velocity therapy cannula, provides comparable relief of dyspnea at a significantly lower flow rates compared to traditional dual-prong cannulas.
Vapotherm, Inc., a leader in mask-free noninvasive respiratory support, introduces the Unicorn Cannula, an innovative single-prong addition to the ProSoft® series. Designed to enhance CO₂ clearance and patient comfort, the Unicorn Cannula retains the proven small-bore technology while enhancing therapy effectiveness.
The publication of “High-Velocity Nasal Insufflation vs Non-Invasive Positive Pressure Ventilation for Moderate Acute Exacerbation of COPD in the ED”
Dr. Jessica Whittle, Chief Medical Officer of Vapotherm, emphasized the company’s commitment to improving the lives of hypercapnic patients in the home. “Our mission is to improve quality of life and reduce hospital readmissions for patients who struggle with respiratory disease. Access365 will provide optimal treatment at home, especially for COPD patients, by combining the known benefits of nocturnal NIV with the comfort of high velocity therapy for daytime use.”
Partnership enables Vapotherm to build a robust and secure solution 80% faster than the standard development timeline to meet data visualization and device management goals for HVT® 2.0 and future Home system
