In addition to stroke patients, we believe our technology may be used on medically appropriate patients to improve upper extremity movement in patients with peripheral nerve injury, spinal cord injury, cerebral palsy, traumatic brain injury, and other neurological disorders, depending on the individual patient’s condition.
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, sized for adults, adolescents and children. We expect to introduce our MyoPal device for pediatric use during calendar year 2024.
The addressable market in the United States for products directed at all individuals with upper extremity paralysis, such as our MyoPro, is substantial, based on an estimated prevalence population of 3 million existing cases of upper extremity paralysis and our estimate that up to 10% of such individuals may be medically qualified candidates for a MyoPro whose insurance may reimburse for the device. This estimate does not include Medicare Part B candidates which would become eligible for the MyoPro based on re-classification into the brace category. because the Centers for Medicare and Medicaid Services, or CMS, considers the device durable medical equipment, or DME, reimbursed on a rental basis. We believe that if CMS expands access to the MyoPro, the number of medically qualified candidates for our device would approximately double, since approximately 50% of seniors carry Medicare Part B coverage. In addition, approximately 250,000 new patients are added to the prevalence population each year in the United States as a result of strokes, brachial plexus injuries and other afflictions, although not all of these new chronic patients are suitable for a MyoPro.
To assess whether an individual is a medically-qualified candidate for a MyoPro, we and our distribution partners utilize a variety of techniques to evaluate patients, including tele-health video conference sessions, in-person screening days at various locations, particularly outside the U.S., and evaluations at clinical facilities where therapists and physicians refer patients for a MyoPro, which requires a physician’s prescription to be reimbursed by insurance. We use various media, including television and social media to educate individuals about the MyoPro solution for their impaired limbs, and receive referrals from O&P providers and hospitals such as the Mayo Clinic, Cleveland Clinic, and VA Medical Centers.
In most cases, private health insurance companies pay for the MyoPro device, either to us directly or to an O&P provider depending on the patient’s insurance plan and the terms of sale. If we are serving the patient directly, then we bill the payer, and if an O&P provider is responsible for working with and delivering the MyoPro to the patient, then we sell the custom-fabricated MyoPro device to the O&P provider at a wholesale price, to which they add their clinical services. In November 2018, CMS issued two codes for the MyoPro, L8701 and L8702. We continue to be in discussions with CMS regarding reimbursement for the MyoPro, with those discussions centering on the appropriate benefit category for the device. We believe the MyoPro should be covered as a custom-fabricated orthosis, or brace, while CMS is currently listing the device as DME. In June 2023, CMS proposed a new rule that would classify the MyoPro as brace instead of DME. This distinction is relevant for how the device would be reimbursed. A brace, or orthosis, is reimbursed on a lump sum basis, while DME is reimbursed as a rental over thirteen months under a capped rental program. The new rule proposed by CMS aligns Medicare with the lump-sum reimbursement currently received from commercial payers, VA hospitals, worker’s compensation, and state Medicaid plans. There is no timetable for CMS to finalize the proposed rule, however that is expected to occur before the end of the year. Further, while CMS stated that it intends to publish a fee for the MyoPro at an upcoming public meeting, there can be no assurance that the fee will be published at the next public meeting, or at all. In addition, if CMS publishes a fee for the MyoPro, there is no guarantee that such fee will be sufficient or that any such decisions will actually increase access to the MyoPro 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 2 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, which