In developing his cystic fibrosis treatments, Dr. Warren Warwick has seen his share of ups and downs.
It’s not that Warwick hasn’t had some good ideas. A former director and current senior advisor for the Minnesota Cystic Fibrosis Center in Minneapolis, Warwick developed a technology called high-frequency chest compression in 1987 to help cystic fibrosis patients breath easier. A year later, he and co-inventor Leland Hansen (a now-retired scientist from the University of Minnesota) introduced a product, called The Vest, that applied the technology.
The basic notion behind the Vest was to automate the process of chest tapping that helps patients clear mucus from their lungs. The Vest fits around a patient’s chest and back, connects to a generator, and rapidly inflates and deflates, oscillating from 5 to 20 times per second to push mucus into larger airways, where it can be coughed out. This can help patients live longer and more comfortable lives.
The Vest was marketed by a St. Paul company, Advanced Respiratory. In 1999, Electromed, a New Prague firm, launched a competing product called the MedPulse Smart-Vest. Advanced Respiratory sued for patent infringement and lost in 2003. That same year, an Indiana company Hill-Rom bought Advanced Respiratory.
Warwick continued to improve his original invention. The Vest used sine waveforms for oscillation, but Warwick was finding that a triangle wave looked more promising. Simply stated, the triangle wave delivers more pressure per pulse than a sine wave, the most common waveform occurring in nature.
Warwick and Hansen had tried to interest the University of Minnesota and Advanced Respiratory in the triangle waveform, but to no avail. So they licensed the technology to BioTherapeutics, an Edina company, in 2002. But two years later, BioTherapeutics went bankrupt.
Then, in 2004, things began to look up again for Warwick, when he met businessman Mario Nozzarella. A veteran engineer and business consultant, Nozzarella had founded Tricam, a Plymouth electronics manufacturer that he later sold. With his connections and know-how, Nozzarella was able to take the triangle waveform technology from prototype device to manufactured product in just over three months. Nozzarella founded a new company called RespirTech, based in St. Paul, to market the new wearable chest-compression product as the InCourage System.
In a study of eight of his patients in 2004, Warwick compared patient outcomes using the sine and triangle waveform devices and found that all patients produced more sputum with the triangle waveform device; the mean was 20 percent more. “The triangle form produced significantly more water than the sine waveform and makes it possible to move the mucus more effectively,” Warwick says.
Some other features distinguish the InCourage from its predecessors, according to Nozzarella. One is the jacket’s “quick fit” feature, which “remembers” your body size. “There’s a mechanism on the front that lines up when you pull it snug to your body,” he says. “Then three release tabs release it to exactly the same distance every time, so you know what that dimension is.”
The Cystic Fibrosis Foundation estimates that about 30,000 children and adults have cystic fibrosis, and that about 1,000 new cases are diagnosed every year. Warwick estimates that only about 70 percent of those patients are using high-frequency chest compression devices.
RespirTech started shipping InCourage Systems, which retail for $12,900, in October, shortly after the device received FDA approval. Nozzarella says RespirTech will eventually target other markets, such as people suffering from bronchiectasis, a progressive destruction of the bronchial walls. He says his 15-person company, which shipped out almost 100 units in 2005 and has a backlog of orders, will double its number of employees within the first few months of 2006.
Nozzarella doesn’t have cystic fibrosis, but he says he periodically uses the InCourage device to improve his own respiratory function. “I wear it sometimes when I feel a cold coming on or congestion,” he says. “I can tell the difference.”
