Circadiance

Imagine wearing plastic boxers or slipping into a plastic nightie to bed every night. Or sleeping on plastic bed sheets. Sounds uncomfortable, right? 

So David Groll wondered why patients continued to wear plastic masks during their Continuous Positive Airway Pressure (CPAP) therapy, the standard treatment option for sleep apnea from which a steady stream of pressurized air is delivered from a hose, connected to CPAP machine, through a mask that patients wear during sleep.

While Groll praises its effectiveness, the discomfort from the mask tends to cause many patients to discontinue the therapy because the mask causes discomfort, irritation and sleep interruption due to air leakage, pressure from headgear, limited sleep positions, skin irritation, and noise.

"The therapy is the key to solving this," says Groll, president and founder of Murrysville, Pa.-based Circadiance, LLC. "It's self-administered by the patient and if they're not comfortable with the mask, they won't use it and will not benefit from the therapy. Since the masks are uncomfortable, about half of the people don't comply with the therapy."

Shortly after leaving the mask development group of Respironics, also located in Murrysville, Groll helped initiate the launch of a new company in the CPAP therapy business. Turned out that although the CPAP market continued to expand and more companies were entering into the fray, Groll noticed that the problems were still the same for people who suffered from sleep apnea.

That led Groll to form Circadiance, and in 2005, he began developing the SleepWeaver™ Nasal CPAP Mask, the only 100% cloth CPAP mask on the market today.

"Because it's made of cloth, it's softer and more comfortable for the patient," Groll explains.

An estimated 14 million Americans suffer from sleep apnea. For people who are suffering from sleep apnea, their muscles relax during sleep, causing soft tissue in the back of the throat to collapse and block the upper airway. This leads to partial reductions (hypopneas) and complete pauses (apneas) in breathing that last at least 10 seconds during sleep.

"The fundamental problem with the other masks is that you're putting pressure on the throat of the patient to splint it open while they sleep," Groll explains. "In order to get the mask to seal, you have to exert more pressure against the face of the patient than there is inside of the mask. Because you're exerting mechanical force against the patient's face, the force of the mask pushing on their face exceeds the perfusion pressure in the capillary vent in the tissue. Just by the nature of the technology, it's going to cause pressure sores and irritate their skin."

Groll knew that if he could change the material of the mask, more people will continue their therapy and get a better night's rest.

"I started thinking about what materials would work," he says. "Your face is a very intimate setting with lots of nerve endings and wearing a big piece of plastic all night just didn't seem natural to me."

For Groll, cloth was the answer. After numerous experiments and reiterations of a wide variety of cloths, he finally had that eureka moment after coming across a material that was used to create winter ski jackets.

"The property of it that makes it interesting is that it's impermeable to airflow, but it's breathable," he says. "It will pass water vapor but it doesn't pass air flow. So I started experimenting with that and came up with the SleepWeaver CPAP mask."

The next solution was to find a different way to connect the mask to the CPAP machine. The SleepWeaver uses the air inside of the mask—which blows up like a balloon—and it pushes against the face so the pressure holding it against the face is equal to the pressure trying to escape.

"By definition, it's an air pressure imbalance," he says. "All it takes is a slight additional force, or an additional tension of the headgear that holds the mask onto the patient's face, to create a seal. It works like a balloon and all points inside of the balloon are at the same pressure, so you get a leak-free seal, with no pressure points."

After launching the product on a limited test market basis in Western Pennsylvania in April 2007, Groll approached Pittsburgh Life Sciences Greenhouse (PLSG)—which provides capital investments and customized company formation and business growth services for life sciences enterprises—for assistance before a nationwide release.

"They really came through," says Groll."Not only have they given us funds [in the form of a convertible note which will become equity in the company], but they also have been very forthcoming and generous with their business advice, making introductions to funding sources, and other sources of business expertise. They looked at the specifics of my marketing program and sales policies, and helped me think through some of the challenges my business faces. In the long term, I think some of that will be more valuable than the investment."

By working in the medical device business in Pittsburgh for a long time, Groll was familiar with PLSG and the invaluable assistance they could offer.

"I spoke to several early stage, publicly-supported economic development organizations, and investment organizations, but it seemed like the mission of Pittsburgh Life Sciences Greenhouse just fit very closely to what I wanted to do," he says. "My message really resonated with them."

Groll expects his company to continue to thrive in Pennsylvania.

"We're a start-up with only have five employees today," he says. "My expectation is that my business will be much larger in several years. We hope to grow our staff and product offerings. We plan to introduce other products based on the same cloth technology and extend the product line. I see no reason why a business can't succeed in Pennsylvania if you have the right set of ingredients: a good product and well-tuned to fixing an important market problem."