break into the home market with the e100 device sometime in 2009, says Kelly, adding that the sector has greater potential than the hospital market. The plan is to initially sell the system to recovering stroke victims who have used the system while in therapy, and partner with rehab clinics to fit patients with a properly sized device. There are about 3 million chronic stroke survivors with upper extremity paralysis in the U.S., Kelly says, and many of them could benefit from additional use of the e100 system after therapy. Though it’s rare, it’s not unheard of to market neurological devices without insurance reimbursements directly to patients. Bethesda, MD-based prosthetic and medical devices maker Hangar Orthopedic Group (NYSE:[[ticker:HGR]]), for instance, sells a neuro-stimulation device known as the “WalkAide” to patients who pay for the product without reimbursement. (The firm didn’t publish sales figures for the product, but Kelly tells me the firm made $9.1 million on the device in 2008.)
To provide further validation of the e100, Myomo is supporting a 20-patient clinical study of the device at the Drake Center rehab clinic in Cincinnati. The study is intended to show that the device is effective as an adjunct to therapy provided by a clinician. The trial is expected to wrap up by the end of this year, and Kelly says Drake researchers are expected to present positive results from the first two patients in the study during the 2009 American Occupational Therapy Association Conference in Houston later this week.
“Everything about the technology continues to stand up against scrutiny and is as promising as it has always looked,” Kelly says, “and the challenge is to put one foot in front of the other and put the infrastructure in place so people can take advantage of it.”