Twenty-nine. That's the number of muscles in your neck that help you swallow, and if they don't work in perfect synchrony, in less than two seconds, you could end up with liquid or food in your lungs.
Coughing that up can become more than just an uncomfortable feeling - lungs with food in them can build up bacteria that quickly lead to pneumonia. Or the misfired muscles could end up forcing a patient to need a feeding tube to get proper nutrition. Swallowing is a big deal, and we do it once every two minutes, or around 720 times a day.
"It's something we take for granted," said Rick McAdoo, a Fort Worth speech language pathologist. "But if any of those muscles or nerves get out of sync, you have problems."
A lot of people end up with this problem, called dysphagia. One in 25 adults in the U.S. experience swallowing problems, according to an analysis of the 2012 National Health Interview Survey. Stroke was the most common reason, followed by neurological disorders, then head and neck cancers.
Solving that condition has been something that McAdoo; Ronda Polansky, a Hurst speech language pathologist; and Russ Campbell, a Fort Worth physical therapist, have been working on for 24 years. The three joined forces in the early "90s while working as therapists at the hospital in North Richland Hills to figure out a better way to treat dysphagia using a combination of speech therapy exercises and electrical stimulation.
The result of their passion is a Fort Worth company called Ampcare. The startup took seven years to continue its research, get a patent and FDA approval and launch manufacturing for a trademarked system called the Effective Swallowing Protocol or ESP. But in the past three years, Ampcare has trained more than 1,000 therapists worldwide, sold more than 800 units of its muscle stimulators and generated more than $1 million in sales.
Based at Fort Worth's TechFW business incubator, Ampcare now is poised to grow exponentially in the next few years, according to its founders. And also to change thousands of lives for those who suffer from the swallowing problem.
"It is a very exciting time for us as we continue to grow, but more importantly, change the quality of lives for patients with swallowing disorders that receive ESP," said Campbell, president and CEO of Ampcare. "Our mission is to provide clinicians with a new standard of care in treating swallowing disorders through clinical research, innovative technology and education, thereby restoring the health status and quality of life of those suffering from swallowing disorders."
Seeing the Market
The medical device company has had a long and interesting journey. While McAdoo and Polansky worked together as speech therapists in what was then North Hills Hospital (now Medical City North Hills), they noticed an increase in dysphagia among their patient population.
But neither had been trained much in how to treat this problem, and there was very little in the way of a standard protocol.
"I had a total of one lecture on how to treat this in school," McAdoo said. The only treatment was a series of oral motor exercises to try to bring muscle strength and agility back from this large patient group who had suffered stroke, head injuries, neck cancer or neural diseases like Parkinson's or ALS.
But there was one problem: That therapy often didn't work. "None of it was demonstrated in research to be very effective," said McAdoo.
Part of the problem was the exercises were difficult for many patients to do, Polansky said.
"Often the patient was dealing with paralysis," she said. "You needed a strong patient to be able to do the therapy."
At the time, the therapists noticed the problems with swallowing were growing. At the time, 18 million Americans had dysphagia - or one in 17, Polansky said.
"Speech therapists were seeing 50 to 60 percent of their patients were having swallowing problems," she said. "And with the population aging, we saw those numbers growing."
Flintstones, Meet the Jetsons
It was while contemplating this problem when the group had their epiphany.
"I was taking one of my patients down to the gymnasium at the hospital for his physical therapy, and I noticed the gym was full of therapists using electrodes on big muscle groups," McAdoo said. "Here I was working with a cup of ice and a tongue depressor and seeing Russ working on arms and legs with electrodes. I felt like the Flintstones walking into the Jetsons."
At the time the Joint Commission, which accredits and certifies most of the hospitals and programs in the U.S., was encouraging cross-disciplinary practices to provide solutions to common health care problems, so McAdoo, Campbell and Polansky began to collaborate on the idea of using electrodes to stimulate the smaller muscles in the neck that were causing dysphagia.
"In 1997, we co-wrote an article, and when the Joint Commission came to our hospital, they said they had seen it and wanted to know more," Campbell said.
Over the next 10 years, the three continued to develop their protocol of combing certain muscle exercises with the electrode stimulation in order to strengthen the muscles and get the muscles and nerves to work together for safe swallowing. A further help with research of the product came through a mobile diagnostic company, DiagnosTex in Hurst, started by Polansky. This move enabled the group to continue researching its product while Polansky performed more than 15,000 barium swallowing studies.
"We didn't rush it," McAdoo said. "We wanted the data, and we wanted it to be safe. We did our due diligence."
By adding the electronic sensors to the exercise regime, Ampcare came to a striking conclusion: "We found that with the ESP protocol, there is a faster and better outcome for the treatment of dysphagia," Campbell said.
The research and scientific principles behind Ampcare's protocol are what's separating it from competition, said Christopher Watts, Ph.D., director of the Davies School of Communication Sciences and Disorders at Texas Christian University.
"Ampcare is unique in this," Watts said. "They are applying science-based methods to their protocol. They have peer-reviewed presentations and peer-reviewed publications demonstrating the effectiveness of exercises with the ESP protocol to activate muscles of swallowing."
There are a couple other businesses that market tools for neuromuscular electric stimulation for dysphagia, Watts said, but there is limited scientific information available which documents the specific protocols those tools use.
Using neuromuscular electric stimulation is "potentially game-changing" for the treatment of dysphagia, Watts said.
"My personal opinion is that neuromuscular electric stimulation is one of the standard rehabilitation tools for the care of dysphagia," he said. "When combined with a focused program of exercises which target the muscles of swallowing, it can mean the difference between eating a steak versus having it put through a blender or eating food on a plate in a family setting versus eating through a feeding tube. This has the potential to improve so many people's quality of life."
Ampcare's Rick McAdoo demonstrates how swallowing therapy works.
Seeking an Incubator
With research in hand, Ampcare was officially born in 2007. The company name includes "amp" or "ampere," a unit of electrical current used in the care for patients, Campbell said. Additionally, each letter in the company name represents one of the group's six children, with the "r" standing for the three principals" first names. Campbell became president and CEO, while Polansky and McAdoo have the title of vice president.
Although they had developed a new, improved treatment for a large patient group, none of the founders of Ampcare had much in the way of business startup experience. The idea of getting patents, FDA approval, manufacturing started, financing and marketing was more than daunting, they said.
TechFW was instrumental in helping the business grow, Campbell said.
"We were referred by a friend to consider an incubator/accelerator to assist with bringing our product to market," he said. "We visited a few accelerators - ones that provided investment for equity in the company but were never entrepreneurs. Others (like TechFW) required a quarterly fee for their services without requiring any equity and were entrepreneurs."
The group immediately liked the fact that TechFW did not require equity in their company, but instead charged $1,000 a quarter (pre-revenue; after that the fee goes to $1,500). Campbell also recalls being impressed by TechFW's director, Darlene Boudreaux, who previously created and sold her own biotech company, PharmFab.
"Darlene's assistance and experience have been instrumental in helping us realize the business value inside of our innovation," Campbell said. She encouraged Ampcare to apply for TechFW's Impact Award, and the company won first place and six months of free tuition.
"TechFW coaches and mentors entrepreneurs who have proprietary technology, to help them get their products from idea to the marketplace," Boudreaux said. "Our work is a little different with each of our clients, depending on what they need. Our clients tend to be executives who have left big companies to do something of their own, scientists or engineers who have invented something and want to get it to market, or professionals - like Ampcare - who found a better way to do something in their profession."
Clearing the FDA
Clearing the FDA hurdle was an important first step that TechFW helped with, Campbell said.
"Within days, Darlene had us interviewing FDA regulatory consultants from all over the country," Campbell said. "We decided on Ken Block Consulting in Richardson and quickly developed a strategy to submit to the FDA."
By October 2012, Ampcare had FDA approval for its electrode, and a year later, the company's entire Effective Swallowing Protocol had been cleared by the FDA for the treatment of dysphagia, Campbell said.
"We had tried for four years to get FDA clearance on our own, and KBC helped us get everything cleared in one year and nine months," Campbell said.
For manufacturing of its electrodes, hand-held powered muscle stimulators and orthotic brace for the neck, TechFW guided Ampcare to the University of Texas at Arlington's Texas Manufacturing Assistance Center. With UTA's help, Ampcare set up manufacturing for its electrodes in Minnesota, its posture brace in Kentucky and its muscle stimulator in China.
Once the product was in place, the group took to the road to begin teaching the system to speech therapists. Starting out in the DFW area, Ampcare's eight-hour training sessions developed into continuing education classes accredited by the American Speech-Language-Hearing Association – ASHA - in 2013.
Getting the ASHA accreditation was critical to educating the therapists in the new protocol, but the organization had a rigorous application process before getting approval for continuing education credits. Ampcare also had to successfully demonstrate adherence to ASHA's continuing education board standards for audiologists and speech language pathologists.
The classes have proved to be popular and have expanded beyond the U.S. to Japan, Hong Kong, and the United Kingdom. In 2016, the company began online and on-demand training on its website. And later this year, Ampcare will expand further, providing training in Australia, Latin America and South America.
"Our goal is to do four trainings a month, or 48 trainings a year, by 2018," Campbell said. The classes have proven to be another important piece for marketing their ESP: more than 70 percent of the therapists who get trained end up customers of Ampcare, he said.
The company is getting recognized in other ways as well. Ampcare won the international award at the Dysphagia Research Society in 2015 for its ESP protocol. The company also has presented at the United Kingdom Swallowing Research Group and the Japanese Society for Dysphagia Research. In 2014, Ampcare won the Tech Titan award for Technology Inventors from the Technology Association of North Texas.
Funding for Ampcare was originally through friends and family, but the company set up a bank loan and then an SBA loan through Southwest Bank, Campbell said.
Calling Investors
Now Ampcare is talking to a few investor groups for funding, including some local ones.
"We're talking to some people for a big scale up around the first of the year," McAdoo said.
Boudreaux sees potential in Ampcare's future. "Ampcare has made so much progress since they became a client a few years ago," she said. "They started selling and then grew those sales so much."
But beyond sales, Boudreaux sees a strong commitment by the Ampcare therapists.
"What I see in Ampcare is the passion that it will take for them to grow into a much bigger company, because they love what they can do for patients and the difference they can make in people's lives," she said.
- By Teresa Vonder Haar
