Local engineer has eyes set for FDA approval of invention

The answer to a request from a friend looking for help in reducing his pain from rheumatoid arthritis could be the next big thing in medical science, not just for people who suffer from pain, but for the treatment of autism as well.

Hollis Risley, a South Walton engineer, responded to his friend Ernie Parks request to design something that would provide relief from the pain he suffered due to barometric pressure changes.

The result is the Rejuvenator, which provides treatment called, Elevated Pressure Therapy. The new medical device has been submitted for Federal Drug Administration approval.

"I did what I could to invent a device that came close to replicating a hyperbaric chamber for him," said Risley. "The Rejuvenator brings pressure levels up enough to replicate the perfect day."

"The first prototype weighed 450 pounds," Risley said. "I loaded it in a truck and headed to Dallas (Parks' hometown) to try it out."

Parks told Risley he found significant relief from the arthritic pain and with that success Risley decided to seek a patent for the prototype.

Parks, impressed with his own results, contacted two friends from Louisiana to come try the chamber. They were skeptical, but made the trip.

Beth Gaudin, who suffers from lumbar disc disease, decided to humor Parks and try the chamber before making the trek home.

"I hadn't been able to ride in a car for more than 30-40 minutes at a time," she said. "After just 40 minutes of treatment I was able to make the four-hour trip without stopping. I had no pain in my back for three days, which impressed me."

Her husband, Dr. David Gaudin, was less than impressed, he was skeptical.

"I had doubts, which is normal with us (doctors)," said Gaudin. "Although we know some pain is linked to barometric levels, I wasn't convinced this device would have lasting results."

Beth Gaudin requested a chamber be sent to her home and used it daily for two weeks.

"I logged my treatment everyday," she said. "After twice daily treatment for two weeks there were significant results. I no longer take pain medication and haven't suffered a migraine for months."

This led Dr.Gaudin to work with Risley. Gaudin formed a clinical study group from his own practice.

"I set up three categories to study, osteoarthritis, rheumatoid arthritis and fibromyalgia," Gaudin said. "I looked for patients with the most difficult problems for the study group, and they had to commit to twice daily treatments for two weeks without compensation."

The data was tracked using the WOMAC Pain Scale, the same scale used in the Vioxx study performed by the pharmaceutical companies.

The group consisted of 81 patients, aged 70 to 80, on pain medications. Some had diabetes and a few had pace makers, according to Gaudin.

The study showed the treatment was 82 percent more effective than the prescribed medication.

"We began the study in February of 2003 and since then two other doctors have done studies," Gaudin said. "The medical community is slow to change. We have to prove the device is safe and effective."

Dr. Janice Buckley, who practices family medicine in Pensacola, contacted Risley to discuss other work being done with autistic children and pressure therapy.

"I met with a family whose grandson has autism" Risley said. "And a 12-week treatment was set up."

At the end of the trial, Risley said there were significant changes in the child's behavior and attitude.

"I wanted to continue this research," said Risley. "My thought at this point was, "Wow, what a difference this machine could make in the lives of so many people.'"

With one child in 150 diagnosed with autism, the usual pressure therapy is in a hyperbaric chamber under medical supervision.

Risley believes his invention will allow families access to pressure therapy they otherwise could not afford.

Answering the call for a test study for children in Okaloosa and Walton counties, Jennifer Hongyee brought her daughter, Madison, to meet Risley and began treatment.

Hongyee said she could see noticeable changes in Madison's behavior with the rise and fall of barometric pressure.

"I was hopeful when I heard about other results," she said. "I didn't want her to be on anti-depressants forever." Which, according to Hongyee is accepted medical treatment for children with autism.

Madison was prescribed Zoloft when she was two, and had never slept at night for more than three hours and had visible behavioral problems, said Hongyee.

"I have a chamber at home and we use it everyday," she said. "And her behavioral therapist said she is showing signs of natural childhood development now."

Hongyee has maintained a journal of changes since beginning the pressure therapy at home.

"Madison is a different child. Before treatment she had fits, would rock constantly (which referred to as stimming) and there was no affection," Hongyee said. "Today, she communicates, she gives and receives hugs, dresses herself and sleeps through the night."

Madison, now six, no longer takes Zoloft.

Doing a study that includes children with autism requires a special exemption, which Risley has obtained.

During his research he found his chamber, unlike the hyperbaric device, doesn't intimidate autistic children. Children with autism, according to Risley's research, can't stay still for extended lengths of time.

"My chamber allows for more than one person to be inside," he said. "A child with autism can move around during therapy."

"The Rejuvenator can also be used daily unlike the hyperbaric chamber which uses oxygen during treatment," said Risley.

 "The next step is FDA approval," he said.

For FDA approval Risley must show six months of scientific data from several studies. He and Dr. Gaudin are petitioning universities and children's hospitals requesting participation in a double blind study, in which neither the participant nor the administer know who is receiving treatment, to prevent bias or a placebo effect.

Just how long it will take for FDA approval is unknown. Risley is working with an FDA consultant who is helping him get all the documentation needed for approval.

"The FDA is a difficult arm of the government," he said. "They need to see this is totally safe, effective and ethical."

"With current data from the initial study, the behavioral changes in Madison Hongyee and Beth Gaudin's testimony," Risley said. "The addition of clinical double blind studies will assist in proving to the FDA the safety and effectiveness of the Rejuvenator."