Dr. Scott Augustine wants to breathe a little fresh air into allergy treatment. Or more specifically, a bubble of fresh air.
Augustine, a successful but controversial medical device inventor, is raising $5 million to back PureZone Technologies LLC. The Eden Prairie start-up is developing a pillow-based air filtration system that creates a bubble of fresh air around allergy patients while they sleep.
Backed by a well-received clinical study, PureZone hopes to win over skeptical allergy doctors already wary of the glut of gee-whiz air cleaning devices on the market today that promise relief to allergy sufferers.
While such devices have become staples on television infomercials, they lack scientific credibility, experts say.
Although PureZone's pillow system doesn't require approval from the Food and Drug Administration, the company sponsored a small clinical study last year that yielded promising results.
"We wanted to construct a study that met all of that skepticism in the most difficult environment -- allergists themselves," said CEO Josh Waldman, a veteran medical device entrepreneur recruited by Augustine to run PureZone. "If we can convince them that this a valid product, we felt with all of the array of air purifiers, we would be different."
PureZone has plenty of competition. Halo Innovations Inc. of Minnetonka is already selling the PureNight Pure Air System that blows clean air overhead from an arm attached to a filter under the bed. Some experts also note there are ways to control allergies that are much cheaper than PureZone and PureNight, which cost several hundreds of dollars. Medicare does not cover consumer products.
PureZone is the second company to spin out of Augustine Biomedical+Design in Eden Prairie, a research and development and incubator firm founded by Augustine in 2003. The first, Hot Dog LLC, has raised $3 million to develop an electric blanket that warms hospital patients. The device is an updated competitor of an air-based warming blanket, also invented by Augustine, that's now used in hospitals across the world.
Augustine Biomedical's business model -- invent products, spin off start-ups, attract investors, then sell off companies -- is a more efficient way to commercialize technology, Augustine said. Plus, it allows Augustine to retain his core R&D team.
"Our objective is to create products and to create value but not to get big," Augustine said. "I think this is a huge opportunity. The big companies in the medical device industry are doing very little R&D. They just buy other companies. We can be the supplier of those companies."
Given his past legal problems, Augustine is relieved to return to what he says he does best: start new companies. In 2004, Augustine pleaded guilty to reduced charges of defrauding Medicare. He was sentenced to five years probation, banned from Medicare for five years, and ordered to pay a $2 million fine. His company at the time, Augustine Medical, paid more than $12 million in fines.
Since the Medicare ban won't expire until March 2010, Augustine's three sons oversee U.S. distribution for Hot Dog.
"I feel terrific" to innovate again, Augustine said. "You hate to have taken a couple of years out of your life to do something wasteful like fighting the U.S. government."
Augustine is still defiant, insisting he acted in good faith and was the victim of overzealous prosecutors.
He worries, though, the case has tarnished his reputation, especially with potential investors.
"You always worry," Augustine said. "My friends know who I am and what I do. People who know me I don't worry about. People who don't know me, they may only know what they know through a newspaper article. During the big fight, the other team was doing all of the talking and we weren't saying anything."
High hopes
Augustine has high hopes for PureZone because he says allergy patients have such a tough time sleeping at night. To relieve symptoms, doctors recommend patients remove the sources of allergens from the house, such as rugs or pets. But patients rarely do, Waldman said.
"People won't get rid of their cats and dogs," he said. "They'd just as soon get rid of their spouse."
Air purifiers are only effective within six inches of the device before mixing with dirty air, Waldman said. The PureZone system aims to create a constant bubble of clean air around a patient's head by attaching a HEPA filter to a specially designed dual-chamber pillowcase of microdenier allergen barrier fabric.
According to a 2008 clinical study of 35 patients conducted by the Minneapolis-based Clinical Research Institute, patients suffering from chronic allergies on average reported sleeping better and felt a meaningful reduction in allergy symptoms like itchy eyes and runny noses.
"It impressed me," said Dr. Allan Stillerman, a board certified allergist with Allergy & Asthma Specialists PA in Minneapolis, who conducted the study. "The device affects the personal air space of patients using it during the night in a fixed location, a significant period of time when they are exposed to allergens like dust mites and cat and dog hair. Other devices may remove particles, but here the patient is not sleeping with his face on an air purifier."
Stillerman presented his findings in March to the annual conference of the American Academy of Asthma Allergy and Immunology in Washington, D.C.
Dr. James Sublett, a clinical professor and section chief of pediatric allergy at the University of Louisville School of Medicine, praised the study.
"Overall, it seems like a good, well-controlled study," Sublett said. "It showed some statistically significant improvement in symptom scores. I think the [PureZone] concept might be helpful" to allergy patients.
No magic bullets
But Sublett said there is no one magic bullet against allergy symptoms and recommends patients continue to remove particle sources from homes. He also notes the PureZone study is small, which makes it difficult to determine whether the device can provide long-term benefits.
Sublett said other devices, like $70 air conditioner and furnace filters, might be more cost effective than PureZone, priced at $389. (Sublett is founder of AllergyZone, a Louisville-based filter maker.) Patients must also replace the PureZone HEPA filter, which can cost another $100 a year, he said.
Waldman says PureZone will be ready for sale in October via its website. In the meantime, the company is partnering with the Mayo Clinic in Rochester to test the device on children and teenagers who suffer from asthma. PureZone has already developed a chair-based system and hopes to make portable devices for air travelers.
"That's the magic of what we are doing," Waldman said. "The bubble doesn't disappear."
Thomas Lee • 612-673-7744