A Medical Device Daily

OtoSonics (Cleveland) says it wants 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, it could help cut down on the overuse of antibiotics to treat earaches that would get better on their own, according to the company.

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.

"The clinical statistics from around the world shows that 80% of all incidences of otitis media will resolve on their own, meaning without antibiotic intervention," said Robert Purcell III, president/chief operating officer for OtoSonics.

"What we practice in the states is, 80% 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.

Enter ConfirMEE, which is designed to bounce 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, chairman/CEO of ElectroSonics Medical (Cleveland), parent company of OtoSonics.

According to the company, the device is one of two legacy technologies of Biomec (Cleveland), 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. Greatbatch (Clarence, New York), acquired most of Biomec's assets in 2007 for $11.4 million.

Headed by Jones, 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. OtoSonics is also the parent company of PneumoSonics (Cleveland), which is developing a device that uses radar waves to detect collapsed lungs.

Fluid in the inner ear often doesn't mean infection, according to the company. 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% accurate at spotting fluid in the ear, and 80% accurate at telling whether the fluid is infected, Purcell said.

The company is getting ready to start preclinical trials at six U.S. locations. 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, VP of engineering for OtoSonics, is refining the workings of the device, Purcell said. The group hopes to have its device through FDA approvals and onto the market by next year.

In other financing activity, American HomePatient (Brentwood, Tennessee) said it has entered into a forbearance agreement with NexBank, SSB, the agent for its senior debt, and a majority of the senior debt holders.

Roughly $226 million was due to be repaid in full on the maturity date of Aug. 1. The parties to the forbearance agreement have agreed to not exercise, prior to Sept. 1, any of their rights or remedies for the company's failure to repay the debt in full on the maturity date.

American HomePatient is a home healthcare provider with operations in 33 states. Its product and service offerings include respiratory services, infusion therapy, parenteral and enteral nutrition, and medical equipment for patients in their home.