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 2025.
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 20% of such individuals may be medically qualified candidates for a MyoPro whose insurance may reimburse for the device, which has been increased to include Medicare Part B beneficiaries. 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. Though not all of these new chronic patients are suitable for a MyoPro, we believe that approximately 50,000 of these new patients per year could be. It is estimated that 75% of all strokes occur in people aged 65 and over. With Medicare Part B poised to begin reimbursing on a lump sum basis for the MyoPro and Medicare Advantage plans obligated to follow suit assuming medical necessity is demonstrated, we believe our market opportunity is substantial.
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. 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, the Centers for Medicare and Medicaid Services, or CMS, issued two codes for the MyoPro, L8701 and L8702. In November 2023, CMS reclassified the MyoPro into the brace benefit category, effective January 1, 2024. Previously, CMS had classified the MyoPro as durable medical equipment, which is reimbursed on a rental basis. With the classification as a brace, the MyoPro is eligible to be reimbursed on a lump sum basis by CMS as it is by all other commercial insurance payers. In addition, CMS has also published preliminary payment determinations for the MyoPro Motion W (L8701) of approximately $31,000 and the MyoPro Motion G or approximately $62,000. The fees are expected to be finalized by the end of February 2024. Should the final fee published by CMS not be significantly lower than the preliminary fee, we expect that volume from the O&P channel will increase in the future as O&P providers become more certain regarding reimbursement and the fee they will receive. We cannot provide assurance that the preliminary fees posted by CMS will be finalized in their current amounts or at all.
We hold 24 patents in the U.S. and various countries, which expire at various times from 2027 through 2039, and have 14 pending patent applications in the US and international markets. Our intellectual property also consists of trade secrets related to myoelectric control software and mechanical designs from over ten years of R&D and product development activity.
We are headquartered in Boston, Massachusetts.