NuMask Receives European CE Mark for Novel Ventilation Mask that Challenges 100-Year-Old BVM Facemask Design

LOS ANGELES, CA, July 24, 2009—

Sirens blare as paramedics arrive on the scene of a highway accident. First responders struggle to bag the unconscious victim—an obese man with a lumberjack's beard. The arriving paramedic tries to intubate the stout-necked man, but fails. After a few leaky breaths with the BVM, the medic tries to intubate for a second and third time, but repeatedly fails. Minutes have passed, and the victim is still without a breath of fresh air. The paramedic abandons the ET tube and urgently tries to create a seal with the BVM facemask, but with each squeeze of the bag, the victim's beard flutters from the burst of air that escapes from the side of the mask. A first responder grabs the bag and squeezes while the paramedic now uses both hands to press on the facemask. Vomit and mucous cover the inflated cuff of the mask and it slips to the right, then to the left. The paramedic struggles to maintain neutral alignment while repositioning the facemask. Still, the victim's beard flutters in the breeze of escaping air. In the end, despite all of the skilled efforts, the victim is pronounced dead.

NuMask, Inc. recently made available the entirely novel IntraOral Mask (IOM), which may be the perfect solution for the above paramedic's dilemma. According to NuMask, the IOM's intraoral design enables it to create perfect seals in virtually all patients—even in those that are obese, toothless or bearded.

While many devices are available for advanced airway management, BVM ventilation is still crucial in the minutes before utilization of these devices and in situations where advanced airway placement fails. Nevertheless, the problems with the traditional BVM facemask design are the same as they were 100-years-ago. That is, it is difficult or impossible to establish an airtight seal in many patients. With obesity in the United States higher than it has ever been, ventilation with the BVM facemask is only becoming less effective.

NuMask, Inc. announced today that it received the European CE Mark (Conformité Européene) for its IntraOral Mask and Oropharyngeal airway (OPA) used in bag-valve-mask (BVM) ventilation. This means that the IOM and OPA, which have been registered with the FDA and used in the United States since 2006, are now also available to European markets.

Design Advantage

The IOM, when properly placed, rests under the lips and outside the gums of a patient's mouth. Although the IOM is entirely novel in the field of airway management, it is based on a device that has been creating perfect seals for decades—the snorkel mouthpiece. "The beauty of the IntraOral Mask's design is that the seal is established entirely at the interface between the wings of the IOM and the interior of the patient's lips. So a single provider can easily create a perfect seal in almost any patient. All the while, the IOM still has an invasiveness and placement ease that is similar to the standard facemask," says Dr. David Isagholian, CEO of NuMask.

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