Two little polyester balls, connected by a short piece of monofilament. Inventions — especially those with the potential to change the world — just don’t get any simpler than that.
Flu Fighter: The Undetectable Nasal Insert invented by local resident David Foggia could be used as a vaccine delivery system. The Observer/PHIL BULLOCK
David Foggia, a La Grande resident with a penchant for innovation, believes his Undetectable Nasal Insert, invented initially to help people cope with bad odors, has bigger, far more important applications. It could even play a role in fighting flu pandemics.
He’s so convinced, he’s asking the Food and Drug Administration to evaluate the device for use as a vaccine delivery system and a pathogen destroyer. And he’s hoping to see the day when health-conscious people everywhere are using it.“I would like this to get out and go around the world,” Foggia said. “I’d like other countries to find out about it.”
Foggia, the son of a doctor and a registered nurse from Lake Oswego, has little medical background himself, but confesses to a lifelong fascination with inventing.
A few years ago, while he was living in Santa Fe, N.M., he had a close friend who was caring for a sick relative. The friend had a hard time dealing with associated odors.
Foggia and the friend put their heads together and came up with the idea for the Undetectable Nasal Insert.
Wads of material treated with camphor material and stuffed into the nasal passages is by no means a new idea in odor control, but the UNI was different.
The polyester balls are very small, and they’re hooked together by a thin piece of monofilament. The device is all but invisible, comfortable to wear and is removed with the simple act of blowing the nose into a Kleenex.
Since his days in Santa Fe, Foggia has come to believe — and is now trying to convince the FDA — that the UNI should be used in the fight against communicable diseases, including H1N1, also known as swine flu.
Foggia recently submitted two Emergency Use Authorization requests to the FDA, saying there is a need for his product because of the current swine flu outbreak and also because of the danger of other influenza viruses mutating and being spread worldwide.
For vaccine delivery, the UNI would carry a precise dose of the vaccine and release it into the nasal passages over an extended period of time.
Foggia says the UNI as a vaccine delivery system may have a number of advantages over FDA-approved FluMist, a vaccine delivered by nasal spray. He said it may be possible to use less vaccine to get the same immunological response. Also, the vaccine flow rate can be slowed, and the flow rate can be stopped at any time.
The UNI may be better than FluMist for a number of other reasons as well, according to Foggia.
It’s softer and more pliable, has no sharp points. It can be self-administered in front of healthcare staff, and can’t be accidentally sprayed into the face of a patient or on to the clothes of a health care worker. There would be far less refuse to dispose of.
For use as a pathogen destroyer, Foggia has proposed treating the UNI with a proper solution of chlorhexadine gluconate, better known as CHG. He says that could be effective at killing or deactivating flu viruses entering the body through the nose.
“It could also be effective at killing viruses attempting to leave infected people,” he added.
Foggia said the FDA, faced with the spectre of a flu pandemic, is investigating many ideas for vaccine delivery and pathogen control.
He filed his Emergency Use Authorization Requests in August, and he is waiting for a reply. If the requests are accepted, there would be a 30-day waiting period in which the FDA would check to see if there are any potential problems with the device.
“After that I would follow FDA procedures for investigations,” Foggia said.
If the matter goes that far, Foggia plans to apply for grant funding to produce and test the UNI. He would very much like it if a pharmaceutical company heard about the UNI and offered to help.
About three months ago, Foggia did make contact with the Pan-American Health Organization, a division of the World Health Organization. Officials showed some interest.
“They said they were going to send the idea to world headquarters at Geneva, but I haven’t heard from them again,” he said.
He said he would be ecstatic if the product ended up being tested, licensed and sold around the world.
“That would be a dream come true,” he said. “I like to help people.”
He said the UNI could tip the scales against the flu and also help do away with the need for painful, stressful shots.
“People could use this new counter-measure to keep the virus from spreading. And for vaccine delivery, it could even play a role in phasing out injectibles,” he said.