Vapotherm(R) Precision Flow(TM) Receives FDA 510(k) Clearance

Aug 07, 2008, 01:00 ET from Vapotherm, Inc.

    STEVENSVILLE, Md., Aug. 7 /PRNewswire-USNewswire/ -- Vapotherm, the
 global leader in High Flow Oxygen Therapy products, has received 510(k)
 clearance from the Food and Drug Administration (FDA) for Precision
 Flow(TM), the first high flow humidification system to integrate gas
 blending, flow control and humidification technology into one device for
 the optimal conditioning of nasal cannula inspired gases.
     Other Vapotherm products are currently used in neonatal, pediatric and
 adult applications in hundreds of hospital locations throughout the US and
 in over twenty countries. "The Vapotherm brand has become synonymous with
 the category of high flow oxygen therapy. Precision Flow(TM) illustrates
 our continued commitment to raising the technology standard and delivering
 to the respiratory community the state of the art in noninvasive
 respiratory assistance," said Robert Storey, President and CEO of
     Precision Flow(TM) was developed with extensive input from clinical
 professionals in neonatology, pediatrics and adult respiratory care. The
 result is a device that combines performance, safety and ease of use for
 optimal patient outcomes. "Vapotherm has been utilized with great success
 in our neonatal unit. The new device offers our staff the same high flow
 therapy benefits, with improved ease of use and performance features," said
 Dr. Eleri Adams of the John Radcliffe Hospital at Oxford, England, a major
 teaching hospital of NHS who has recently begun using Precision Flow(TM).
     With the FDA clearance, the Company has initiated full-scale
 production. Precision Flow(TM) is exclusively distributed in the US by a
 network of specialty medical sales and marketing organizations. "The
 Vapotherm product line has been a top performer for us," said Don Reiter,
 President of Special Respiratory Care, Inc., a leading distributor of
 respiratory products. "Based on feedback and early orders from our
 customers, we expect Precision Flow(TM) to dominate the high flow market in
 our region."
     Vapotherm, Inc. is a privately held manufacturer of respiratory care
 devices for hospitals and home care use based in Stevensville, Maryland.
 The Company is dedicated to the development of innovative, noninvasive
 technologies for respiratory therapy, especially for the treatment of
 chronic lung and acute breathing disorders. For more information, visit
     Amy Elias
     Profiles, Inc.

SOURCE Vapotherm, Inc.