Neurolumen In The News

Innovator profile: Neurolumen LLC in Oklahoma City

04-30-2011


 
Innovator profile: Neurolumen LLC in Oklahoma City

The desire to restore quality of life to people suffering from neuropathy has driven a local woman for years. Now Shelly Henry's work is paying off with the forthcoming manufacture of a medical device that uses low-level lasers to relieve symptoms.
 
Henry, a chemist biologist and co-owner of Salus Medical Clinic in Oklahoma City, has received approval from the Food and Drug Administration for her device, called Neurolumen.
 
Neurolumen is designed to help relieve pain and swelling and improve circulation in people who have neuropathy, a nerve disorder that often affects a person's legs and feet. She is first targeting diabetes — a disease that can lead to pain, tingling or a lack of sensation in a person's feet. Other populations that often suffer from neuropathy include people taking chemotherapy and people who are taking high doses of medications for AIDS, she said.
 
"Neuropathy can destroy people's lives," Henry said. "People are sitting at home because they can't feel their feet. People who used to dance and bowl, but they can't do it anymore. I want to be able to bring hope to them that it can come back."
 
Although the device doesn't provide a cure, Henry said, its potential to alleviate symptoms may open up another much-needed opportunity for diabetics — exercise.
 
"The very thing many diabetics need — to exercise and lose weight — is the last thing they want to do because it hurts," she said.
 
Neurolumen will be prescribed by a physician for a patient to use at home. Although trade secrets prevent Henry from explaining exactly how it works, the low-level laser — less than 500 milliwatts — increases circulation and nerve conductivity and decreases swelling. When people with diabetes can improve those functions, they stand a better chance of avoiding the fate of amputation, she said.
 
The device went through a 510K process, which has less stringent requirements than other FDA paths. Henry conducted a weeklong, 10- patient trial to show the efficacy and safety of the device. There are no known side effects, she said, but there is promising evidence that people are being helped. All 10 patients in the trial showed improvement in just a week's time, she said, including a man who was repeatedly falling because he couldn't feel his feet. This month she will conduct a 100-patient trial, working with additional doctors in the community, to further establish the effectiveness of the device. The device is designed to replace the manual treatment she is currently providing for patients in her clinic.
 
When she began working on the project two years ago, Henry said she saw little research or products available to help neuropathy patients, other than painkillers. The idea for the device came about after her daughter was badly injured in a car wreck and she began searching for alternatives to high doses of pain medication. She came across low-level lasers, but they were being imported from a foreign country. So she began researching and modifying the product. It not only helped her daughter, but it gained new life for neuropathy.
 
She said she anticipates the device will be covered by insurance and Medicare, and her research shows a savings of $15,000 per person from office visits or treatments they didn't have to make. For people who don't have health insurance, she'll offer free treatments at her clinic.
 
© Copyright 2010 Dolan Media Newswires