advanced signal processing software,
non-invasive
sensors, and a lightweight battery unit. The product is worn to support the dysfunctional joint and as a
functional aid for reaching and grasping, but has also been proven to have therapeutic benefits for some users to increase motor control.
The MyoPros control technology utilizes an advanced
non-invasive
human-machine interface based
on
non-invasive,
patented electromyography, or EMG, control technology that continuously monitors and senses, but does not stimulate, the affected muscles. The patient self-initiates movement through his or
her weakened muscle signals that indicate the intention to move. In addition to supporting the weakened limb, the MyoPro functions as a neuro-muscular prosthetic by restoring function to the impaired limb similar to a myoelectric prosthetic for an
amputee. It is prescribed by physicians and provided by medical professionals certified to fit orthotics and prosthetics as a custom fabricated myoelectric elbow-wrist-hand orthosis.
In addition to applications for stroke patients, we believe our technology may be used to increase upper extremity movement affected by
diagnoses such as peripheral nerve injury, spinal cord injury, other neurological disorders, cerebral palsy, muscular dystrophy and traumatic brain injury.
Our strategy is to establish ourselves as the market leader in myoelectric limb orthotics, and to build a set of products, software
applications, and value-added services based upon our patented technology platform. While we currently focus on upper extremity orthotics, our future products may include devices for the shoulder, leg, knee, and ankle, sized for both adults,
adolescents and children, along with
non-medical
applications for industrial and military markets. We expect to introduce our MyoPro device for pediatric use in 2019.
We estimate that the addressable market for products directed to patients with upper extremity paralysis, such as our MyoPro, may total
$10.0 billion, based on 3.0 million existing cases of upper extremity paralysis and our estimate that 25% of such individuals may be medically qualified candidates for a MyoPro. In addition, based on an estimated 350,000 new cases each
year, we believe this market is expected to grow by $1.2 billion per year. Using similar estimates for countries outside of the United States, we believe that the total worldwide market potential for products addressing upper extremity
paralysis may reach $30.0 billion.
We utilize patient screening days to identify potential patients that could be fitted with our
MyoPro device. In the third quarter of 2018, we organized over 100 screening days across the United States, after test marketing this approach with O&P channel partners earlier in the year.
Reimbursement amounts for our MyoPro devices currently range for $20,000 to $60,000 per unit, depending on the MyoPro model. The selling price
of our MyoPro devices to our channel partners range from $10,000 to $25,000 per unit depending on the MyoPro model. We expect the Centers for Medicare and Medicaid Services, or CMS, to issue new codes and decisions relating to coverage policy
determination and reimbursement amounts for our MyoPro products in the first half of 2019. However, there is no specified timetable for such a CMS decision, and there is no guarantee that one will be issued in this timeframe. In addition, we cannot
predict the impact of any such decision on the amounts that we may be reimbursed by private insurance companies, if any.
We are the
exclusive licensee of U.S. patents for the myoelectric limb orthosis device based on technology originally developed at MIT in collaboration with medical experts affiliated with Harvard Medical School. We have licensed 2 patents across 1 patent
family to protect our technology. We also hold 10 issued patents in the U.S. and various countries and have 2 pending patent applications. Our devices are currently referred for patients at leading rehabilitation facilities, including, among others,
the Mayo Clinic, Cleveland Clinic, Walter Reed National Military Medical Center, and VA hospitals across the country.