We want to introduce the pediatric face mask that will fit and be soft to the skin of babies and children who require non-invasive ventilation.
Circadiance has announced that it will seek crowd funding support for the development of pediatric face masks. Circadiance has developed a line of soft cloth face masks for adult non-invasive ventilation which are widely viewed as the most comfortable masks available. Circadiance plans to enhance its product line to fit all patients who need non-invasive ventilation, including infant patients. Non-invasive ventilation requires the use of a face mask, as opposed to invasive ventilation in which the ventilator is connected to the patient via a tube down the throat.
Clinician feedback consistently indicates none of the masks available today fit a pediatric patient’s face comfortably and without the potential for creating painful and unsightly sores. Known as facial pressure ulcers, they are typically caused by hard plastic respiratory masks attached tightly to the child’s face. As David Groll, CEO of Circadiance explains, “The use of hard plastic face masks with humidified air against delicate pediatric skin leads to skin breakdown and pressure ulcers, which can result in pain, infection and disfigurement as well as increased costs, length of stay, and litigation for the caretakers.”
Beyond pain and suffering, the problem is significant, particularly given that in 2008, the Centers for Medicare and Medicaid Services announced that they will not pay for additional costs incurred for hospital-acquired pressure ulcers. This change has resulted in an increased focus on preventive strategies and institutional scrutiny of pressure ulcers that develop in patients after hospital admission. The cost of one stage III or IV pressure ulcer may be between $5,000 and $70,000. There are currently no FDA-approved alternatives to hard plastic face masks for pediatric patients who require a non-invasive ventilation face mask.
Preliminary research of Circadiance’s face masks by some doctors and respiratory therapists suggests that soft cloth face masks reduce or completely avoid the occurrence of pressure ulcers for pediatric patients. Groll continued “We want to introduce the pediatric face mask that will fit and be soft to the skin of babies and children who require non-invasive ventilation”.
This effort will require significant investment by the company and Circadiance will need to raise the funds to develop this innovation. Yet, many professional investors are wary of the pediatric market as it is considered to be a relatively small market.
For this reason, Circadiance will launch a pledge campaign starting today to determine if there is adequate interest to move forward with a crowd funding campaign. “If the people who are most affected by this problem show enough interest in our solution to make a pledge of support, we will move forward with the crowd funding campaign” said Groll. The crowd funding phase would be initiated later in 2014 using Indiegogo as the platform.
A successful crowd funding campaign is often viewed as “third party validation” of a product idea. Said Groll “one of the benefits of crowd funding is that we can show professional investors how passionate the pediatric clinical community is about solving the problem of facial pressure ulcers. A successful campaign will not only provide us with funds and feedback from the people who know what the product should do, it will also show the investment community that there is a real need and a strong desire for a better solution.”
Proceeds from this effort will be used to design, test and secure regulatory approval of new face masks for pediatric non-invasive ventilation.
With adequate funding, Circadiance expects to bring a pediatric face mask to the market in about one year.
More information on this campaign is available online at https://circadiance.com/pledge.