Cloth PAP mask maker Circadiance wants to introduce a pediatric face mask that will fit and be soft to the skin of babies and children who require noninvasive ventilation.
Circadiance will seek crowdfunding support for the development of pediatric face masks. The company has developed a line of soft cloth face masks for adult noninvasive ventilation. Circadiance plans to enhance its product line to fit all patients who need noninvasive ventilation, including infant patients. Noninvasive 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.
David Groll, CEO of Circadiance, says in a release, “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 it 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.
Preliminary research on 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 says, “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 launched a pledge campaign [http://www.circadiance.com/pledge] to determine if there is adequate interest to move forward with a crowdfunding 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 crowdfunding campaign,” Groll says. The crowdfunding phase would be initiated later in 2014 using Indiegogo as the platform.
A successful crowdfunding campaign is often viewed as “third-party validation” of a product idea. Said Groll, “One of the benefits of crowdfunding 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 noninvasive ventilation.
With adequate funding, Circadiance expects to bring a pediatric face mask to the market in about 1 year.