CleveMed - Wireless Electroencephalogram- BioRadio
Home-based medical tests weren’t on American consumers’ radar in the 1990s, when inventor Robert Schmidt could be found walking around trade shows with electrodes on his head. He had the right hair cut for it, he says (he’s bald), and he was determined to spread the word about his new technology—the first wireless, digital electroencephalogram (EEG) device.
“We were the only ones in the world who could do that at the time,” says Schmidt, founder of Cleveland Medical Devices, now CleveMed.
In those days, EEG equipment for evaluating the brain’s electrical activity was the size of two file cabinets, and incorporated a sensitive amplifier that couldn’t be closely paired with a radio because of electromagnetic interference. With such cumbersome and finicky equipment, the idea of patients administering their own complex medical tests in the comfort of home seemed far-fetched. But Schmidt found a way to use digital technology to create a tightly integrated, compact wireless device that could collect and transmit information about human physiology. He called the device BioRadio, which was at the heart of his portable EEG.
Not long after Schmidt introduced BioRadio, he learned that the Air Force was looking for a system to relay data from airplanes for test flight monitoring. Bombs or missiles strapped to wings or underneath planes were being blown off to assure control of release, and the Air Force needed a way to understand what was happening in the process—to transmit data from strain gauges, accelerometers, and gyroscopes to a transceiver on the ground. Around 1999, with support from the Air Force Small Business Innovation Research (SBIR) program, CleveMed began work on an improved version of BioRadio that became MicroRadio, a small, low-cost flight-test-data acquisition system that could withstand severe environmental conditions and deliver data between a plane and a ground receiver through two radio bands at ranges up to 50 miles.
“The Air Force SBIR allowed us to improve our BioRadio to a much more stable next-generation device,” Schmidt says. “It could take shock and high vibration, and work in all kinds of environments.”
The ruggedized and enhanced technology enabled by the Air Force SBIR work became a platform for additional devices developed by CleveMed, notably in the area of sleep apnea. Obstructive sleep apnea (OSA) causes shallow breathing or even a brief cessation of breathing during sleep. Lack of oxygen to the brain results in a neural message to wake up, which can happen repeatedly over the course of the night, diminishing the quality of rest. Around the time of the SBIR work, medical researchers were beginning to recognize that OSA contributed to high blood pressure, heart attack, heart disease, stroke, obesity, and diabetes, leaving doctors increasingly interested in testing for the condition. CleveMed developed its first OSA testing device, the Crystal Monitor® in 2000, which evolved into today’s SleepView® Monitor. The SleepView® Monitor simplified, streamlined, and digitized OSA equipment so patients could take the test in their own beds. The data could then be downloaded to a certified sleep physician and a diagnosis provided to the patient. (Next generation testing protocol will allow a patient to arrange for an OSA test and complete it at home entirely through telemedicine and Internet data exchange.)
Testing in sleep labs presents problems to patients and physicians alike. Sleep lab tests are expensive for patients, and people don’t like sleeping in a foreign space while being monitored. On the medical side, missed appointments and other problems in sleep labs mean loss of time and money for doctors and hospitals. Schmidt estimates that conducting a sleep test at home cuts 80 to 90 percent of the cost. The small size and light weight of CleveMed’s sleep technology allows it to be sent across the US with minimal shipping costs. The market for OSA testing is now around $3 billion with estimates it will reach $5 billion or more by 2020. CleveMed has become a leader in that field, and has spun off three companies: Great Lakes Neuro Technologies, NeuroWave Systems Inc., and Flocel Inc., all of which offer product lines with roots in the SBIR-supported technology.
Great Lakes Neuro Technologies produces a monitor for people with Parkinson’s disease that provide doctors the information they need to ensure patients are getting the correct drug at the right dose. The company, which Schmidt says sells products on all seven continents, also developed software to help retune a Deep Brain Stimulator, a system with a probe that goes into the brain to help stop Parkinson’s tremors.
NeuroWave Systems picked up CleveMed’s EEG technology, which it further developed into a monitor the size of a matchbook that is worn on the forehead somewhat like a bandage (with electrodes). Schmidt reports the monitor is being developed for the military to assess head injuries when a person is not conscious or has impaired cognition to check for seizures, traumatic brain injury, and concussion. NeuroWave also sells anesthesia monitoring equipment, and is researching anesthesia control for the Army and Navy. According to Schmidt, the Army is interested in developing a closed-loop system in which an EEG is used to control the pumps for anesthesia and analgesia. Schmidt notes that the Navy is looking at the next step, where a closed-loop system could function completely without human operation, allowing wounded warriors to be transported without medical supervision via drone to a hospital.
The third company, Flocel, Inc., grows human brain cells for in vitro testing for drug discovery. “This is one of the things that wouldn’t have happened had it not been for the Air Force SBIR,” says Schmidt. “The circuitry we built for that improved radio and amplifiers has been in a lot of these different products.”
A sister company to CleveMed, Orbital Research, was founded to conduct research related to aerospace, including munitions flight control. Orbital also has received contracts for medical research, including development of dry electrodes for electrocardiograms (ECG) and development of a miniature oxygen and carbon dioxide sensing system that has been tested by pilots on the F-22 Raptor.
“The Air Force contract was very important for us to be able to stay alive and have clients and be able to grow our technology and our staff,” says Schmidt. “It was a huge deal.” It’s been a steady climb from Robert Schmidt’s early trade show days, and now CleveMed is now on the forefront of 21st century home-based tests and telemedicine, with technological advances made under the Air Force SBIR at the core of the company’s success nearly two decades later.
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