CLEVELAND, Ohio — OtoSonics Inc. is looking to raise $2 million from investors to help the company refine and test its device that uses ultrasonic waves to tell whether the fluid behind a child’s eardrum is infected.
The device, called ConfirMEE, not only could provide doctors with an effective diagnostic tool — a good one doesn’t exist — it could help cut down on the overuse of antibiotics to treat earaches that would get better on their own.
Most ear infections – common in infants and children — are caused by viruses, according to the Mayo Clinic. Antibiotics have no effect on viral infections. And the over-prescription of antibiotics can lead to drug-resistant bacteria, called “superbugs,” Mayo said.
With the Rise of AI, What IP Disputes in Healthcare Are Likely to Emerge?
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
“The clinical statistics from around the world shows that 80 percent of all incidences of otitis media will resolve on their own, meaning without antibiotic intervention,” said Robert L. Purcell III, president and chief operating officer for OtoSonics.
“What we practice in the states is, 80 percent of kids going to the doctor’s get antibiotics,” Purcell said. “The reason that is, the doctors are forced, because they don’t have good diagnostic tools … to treat the parent just as much as they are treating the patient.
“The parent comes in and says, ‘my child was up all night, tugging on his ears, crying. I need to go to work tomorrow. I need something,'” Purcell said.
A Personalized Approach to Medication Nonadherence
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Enter, ConfirMEE, which bounces ultrasonic waves off the eardrum and then analyzes the returning waves for information that would indicate infected fluid in the inner ear. The results take six seconds, said Trevor Jones, who is chairman and chief executive of ElectroSonics Medical Inc., parent of OtoSonics.
The device is one of two legacy technologies of Biomec Inc., the biomedical device company that from 1998 to 2007 developed technologies discovered by medical and academic institutions, and national laboratories, as well as by its own scientists. Most of Biomec’s assets were acquired in 2007 by Greatbatch Inc. of Clarence, N.Y., for $11.4 million.
Headed by Jones, a life member of the National Academy of Engineering and one of the first lifetime associate members of the National Academy of Science’s National Research Council, Biomec had won many federal research grants and had become known as an incubator and contract manufacturer of medical devices.
Jones and Purcell, who had been president of Biomec, kept the two technologies Greatbatch didn’t want so that they could continue to develop them. They incorporated ElectroSonics Medical the same year. Jones is chairman and chief executive of ElectroSonics, which is the parent of OtoSonics and PneumoSonics Inc. PneumoSonics is developing a device that uses radar waves to detect collapsed lungs.
Fluid in the inner ear often doesn’t mean infection. And children whose Eustachean tubes have not matured to enable drainage are prime candidates for fluid behind the eardrum, Purcell said. But doctors lack a good way of telling whether that fluid is infected and in need of antibiotic treatment.
Purcell and Jones visited a doctor in Costa Rica two weeks ago who punctures the eardrum with a needle during a procedure called tympanocentesis, extracts some of the fluid, and then cultures it for bacteria that would indicate infection. “Then and only then will he prescribe antibiotics to the patient,” Purcell said.
“Now as you can imagine, parents in the United States are not overly receptive to the concept of putting needles through infants’ ears, even though it’s a relatively painless procedure,” he said. “It just doesn’t happen in the states.”
Purcell and Jones are working with the Costa Rican doctor to determine how accurate their device is at detecting fluid behind the eardrum and determining whether that fluid is infected. So far, the device is 90 percent accurate at spotting fluid in the ear, and 80 percent accurate at telling whether the fluid is infected, Purcell said.
Tracey Wielinski, OtoSonics’ program director, is getting ready to run preclinical trials at six U.S. locations (pdf), including the Cleveland Clinic and the University of Cincinnati, Purcell said. Unlike the Costa Rican study and one in Israel that validate ConfirMEE through tympanocentesis, the U.S. studies will do so through myringotomy, the surgery to put small drainage tubes in the ears of mostly children.
Meanwhile, Alan Greszles, vice president of engineering for OtoSonics, is refining the workings of the device, Purcell said. The group hopes to have its device through U.S. Food and Drug approvals and into the market by next year.
[Photo credit:Â Betty G. Partin/Centers for Disease Control]
