In August 2010, Myomo Inc., a Cambridge, Mass.-based developer of neuro-robotic stroke rehabilitation technology, announced the launch of myomo@home, a program that enables impaired stroke survivors to purchase the company’s Myomo System, a neuro-robotic rehabilitation device that helps them increase movement in their arms, for home use.

The system has been used in clinical settings since 2008. Following completion of FDA safety requirements for use of the system in the home, it is now available directly to consumers with a physician’s prescription and the participation of a clinical partner or therapist.

Myomo provides therapist training and certification through a multilevel program that is completed either in person or live via the Web. Therapy protocols are customized for the individual patient, and follow-up is conducted to adjust treatment for the most potential improvement. Unlimited phone customer service is included with the program.

The Technology
The myomo@home program is anchored by the Myomo e100 NeuroRobotic System, a portable, wearable device that helps stroke survivors restore movement to partially paralyzed (hemi-paretic) arms using their own muscle signals. The system is indicated for use by stroke patients to facilitate muscle re-education and to maintain or increase range of motion.

Muscle re-education, achieved through directed, repeated movement of impaired limbs, is a core element of stroke rehabilitation. Neuroscience research has found that by engaging stroke patients in “repetitive task practice,” the brain can relearn muscle movement by creating new pathways to motor functions, helping restore the ability of limbs to move.

Using technology exclusively licensed from the Massachusetts Institute of Technology (MIT), the e100 employs a feedback-based, closed-loop system that facilitates muscle re-education by both amplifying and rewarding a stroke patient with desired arm movement, triggered by his or her own muscular activation.

The e100 unit consists of a portable elbow brace made of a lightweight frame of aerospace metal and noninvasive surface sensors for biceps and triceps. It incorporates patented EMG (electromyography) control software that continually monitors and senses the “sounds” made by muscles.

Patients initiate movement by generating their own muscular signals in the same fashion as they did prior to stroke. The system senses the muscle signals, and then processes the data to a motor on the device that enables the desired motion. This processing occurs so quickly that it is not apparent to the patient.

In a typical session, the e100 is placed on the patient, using padding to customize the fit. Next, the sensor is placed on the skin’s surface above the muscle group on which the therapy session will focus. The device automatically calibrates, using the electrical muscle activity signal that it reads from the patient’s muscle group. Finally, the therapist sets the amount of assist that is needed.

Successful use of the e100 enables the patient to first perform tasks-flipping a light switch, holding a cup, or carrying a laundry basket, for example-while wearing the device. Over time, however, patients can acquire the ability to perform these activities without it. The device has been clinically proven effective from two days to 21 years post-stroke.

The Business Case
Privately owned Myomo began in 2006. Its technology was originally developed at MIT in collaboration with medical experts affiliated with Harvard Medical School. Myomo entered the clinical market with the e100 in 2008, and began working with rehabilitation hospitals to define treatment protocols for the use of personal robotics technology. The devices are manufactured in Worcester, Mass. According to the company, there are more than 100 e100s currently in use.

The market myomo@home is attempting to penetrate is substantial. According to the American Heart Association’s Heart Disease and Stroke Statistics 2010 Update At-A-Glance, stroke is the third leading cause of death and the leading cause of adult disability in the United States. Among adults age 20 and older, the estimated prevalence of stroke in 2006 was 6.4 million.

The association’s statistical report also notes that each year 795,000 people experience a new or recurrent stroke, generating some $69.9 billion in direct and indirect costs, including hospital stays. Home-based stroke rehab using technology such as that developed by Myomo provides one way of chipping away at this cost.

A major challenge Myomo faces in expanding its penetration in the market for the e100 is that health insurance companies do not currently reimburse covered persons for its purchase. While the company looks forward to eventually having the device covered, its costs are now borne entirely by the end user. The price of the e100 is just less than $5,000, although the company currently offers a discount to partially offset the lack of insurance coverage available.