Two could be the start of something good for ImThera Medical (San Diego) and its aura6000 neurostimulation device for treating tongue-based Obstructive Sleep Apnea (OSA). After all, the company just reported the devices implantation in two of the 12 patients that are enrolled in its pilot study of the device in Belgium.
If results, (which should be available in the first half of 2010) look promising, then the company could solidify its path to a bonafide treatment of OSA, a condition that afflicts more than 800,000 patients in this country each year and has a broad range of complications including heart disease and stroke.
In addition to heart disease and stroke, other potential complications of OSA include abnormal heart rhythm, excessive carbon dioxide levels in the blood, high blood pressure and sleep deprivation. A person with OSA basically stops breathing (apnea) for periods throughout the night. Resulting symptoms can include: abnormal daytime sleepiness, awakening unrefreshed, depression, lethargy, memory difficulties, morning headaches, personality changes, poor concentration and overall restless sleep which is rife with loud snoring.
"If our results are favorable from this pilot study, then the next step is to apply for an IDE from the FDA and start a clinical trial within the U.S.," Marcelo Lima, chairman/president/CEO of ImThera Medical, told Medical Device Daily.
He added that the company expected to gain the CE mark by next October.
The product remains one of the primary devices the company is trying to launch. Aura6000 was developed nearly three years ago, with product development and engineering of the device starting in March of 2008.
The company said that the device differs from more established treatments of OSA. While Continuous Positive Airway Pressure (CPAP) is the established therapy, studies show that only 54% of patients comply with CPAP. The aura6000 is based on ImThera's Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy, delivering neurostimulation to the tongue during sleep.
Neurostimulation is a trendy approach these days to treat a variety of conditions because it offers a new level of efficacy coupled with low rates of complications and side effects compared with drugs and surgery to treat the same ailments.
In fact, neurostimulation as a sector has been growing at an average rate of 16% per year since 2007 and a study by Scientia Advisors (Cambridge, Massachusetts) projects growth rates of 14% to 23% for certain technologies through 2012. This melding of neurobiology and a medical device is typically reversible too (Medical Device Daily, Aug. 21, 2009).
To achieve its goal of treating OSA, ImThera's device, which is comprised of an electrode and a pulse generator, is implanted in two places in the body. The electrode is place slightly around the break of the jaw near the hypoglossal nerve. The pulse generator is placed along the chest.
External components include a patient's controller/charger and a physician's notebook PC which includes the aura6000 Clinical Manager THN Sleep Therapy physician software. Targeting multiple tongue muscles to deliver therapy; it operates in open loop, continuous mode during sleep.
So far the company said that the two implantation procedures went smoothly and took about 90 minutes to complete. There also weren't any surgical complications and speech, swallowing and tongue sensibility were not disturbed by the surgery.
"Implantation varies from 90 to 70 minutes," Lima said. "Our expectation is that it will take 60 minutes or less to implant [once surgeons become more familiar with the procedure]."
The aura6000 stimulates the hypoglossal nerve to verify system and nerve integrity. Nearly one week post surgery the patients underwent an in-laboratory Polysomnography (PSG) tradition process during which stimulation parameters were determined.
Using a multi-contact electrode and a programmable implantable pulse generator (IPG), the system delivers muscle tone to key tongue muscles to prevent the tongue from collapsing into the upper airway during sleep.
"ImThera's mission is to provide a safe and effective alternative for OSA patients that will not or cannot comply with CPAP," he said. "With a simple implant procedure, patients are expected to sleep better, without obstructive apnea events, which will ultimately help them achieve a better quality of life, while reducing the effects of the many serious comorbid consequences of OSA."
ImThera is private and is sufficiently funded with a $5 million investment that will take the company through 2010, according to the company. With no partners, the new firm plans to produce its own devices, build a sales force in the U.S. and look for dealers and distributors in Europe.
Omar Ford, 404-262-5546;