Myomo Stock

Myomo, Inc. (Myomo) operates as a wearable medical robotics company that offers functional improvement for those with neuromuscular disorders and upper limb paralysis.

The company develops and markets the MyoPro product line. A MyoPro is a myoelectric-controlled upper limb brace, or orthosis. The orthosis is a rigid brace used for the purpose of supporting a patient's weak or paralyzed arm to enable and help improve functional activities of daily living, or ADLs, in the home and community. It is custom-fabricated by trained professionals during a custom fabrication process for each individual user to meet their specific needs. The company's products are designed to help improve function in adults and adolescents with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury and other neurological disorders. The company primarily provides devices directly to patients and bill their insurance companies directly, a sales channel the company refers to as direct billing. Under direct billing, the company may evaluate, measure and fit the MyoPro devices using the company's own clinical staff or utilize the clinical consulting services of orthotics and prosthetics, or O&P, professionals, for which they are paid a fee. The company also sells its products through various other sales channels, including through O&P providers, the Veterans Administration, or VA, and to the company's distributors in certain accounts and geographic markets outside the United States.

The company's solution, the MyoPro custom fabricated limb orthosis, is for the upper limbs. The concept was originally pioneered in the 1960s, refined in the labs of MIT, and made commercially feasible through the company's efforts. Partial paralysis is severe muscle weakness or loss of voluntary movement in one or more parts of the body. The MyoPro is listed in the United States with the FDA as a Class II (510(k)-exempt) device (Biofeedback Device). It is the only current device able to help neuromuscular-impaired people regain function in weak arms and hands using their own muscle signals. The device consists of a portable arm brace made of a lightweight metal and includes advanced signal processing software, non-invasive sensors, small motors, and a lightweight battery unit. The product is worn to support the dysfunctional joint and as a functional aid for reaching and grasping and has also been shown to have therapeutic benefits for some users to increase motor control.

The MyoPro's 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 orthotic by helping regain function to the impaired limb similarly to a myoelectric prosthetic for an amputee. It is prescribed by physicians and provided by trained clinical professionals as a custom-fabricated myoelectric elbow-wrist-hand orthosis.

In addition to stroke patients, the company's 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.

The company's strategy is to establish itself as the market leader in myoelectric limb orthotics, and to build a set of products, software applications, and value-added services based upon the company's patented technology platform, sized for adults, adolescents and children. The company expects to introduce the company's MyoPal device for pediatric use during calendar year 2024.

To assess whether an individual is a medically-qualified candidate for a MyoPro, the company and its distribution partners utilize a variety of techniques to evaluate patients, including tele-health video conference sessions, in-person screening days at various locations, 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. The company uses various 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 the company directly or to an O&P provider depending on the patient's insurance plan. If the company is serving the patient directly, then the company bills the payer, and if an O&P provider is responsible for working with and delivering the MyoPro to the patient, then the company sells 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. The company continues to be in discussions with CMS regarding reimbursement for the MyoPro, with those discussions centering on the appropriate benefit category for the device. The MyoPro should be covered as a custom-fabricated orthosis, or brace, while CMS is listing the device as durable medical equipment, or DME. This distinction is relevant for how the device would be reimbursed. It is reimbursed on a lump sum basis if the benefit category is an orthosis, or as a rental over thirteen months under a capped rental program if it is determined that DME is the appropriate benefit category. The current determination of CMS differs from the lump-sum reimbursement received from commercial payers, VA hospitals, worker's compensation, and state Medicaid plans. A new rule has been published by CMS covering the process to request a benefit category change. In conjunction with the publication of this new rule, CMS invited the company to present the company's request to change the benefit category for the company's MyoPro device to a brace at its public meeting in June 2022. In September 2022, CMS published its determination, deferring its decision on the company's request, and further stating that coverage and payment for the MyoPro would be at the discretion of its regional Medicare billing contractors, known as the DME MAC's. The company intends to submit additional research for publication before the end of the first quarter of 2023, that is expected to add to existing evidence that the MyoPro is effective, reasonable, necessary and appropriate for Medicare beneficiaries. Once submitted for publication, the company intends to meet with the medical directors of the DME MAC's to discuss coverage and payment for the MyoPro and begin submitting claims for Medicare Part B beneficiaries. In January 2023, CMS published a notice stating that it intends to publish a proposed rule in the coming months regarding the scope of the Medicare Part B benefit for leg, arm, back and neck braces and newer technology devices. The company expects this rule to clarify whether CMS considers the MyoPro to be a brace or DME. There is no timetable for CMS to make any coverage or payment decisions, nor is there any guarantee that any such decisions will actually increase access to the MyoPro or result in reimbursement from payers, including Medicare. In addition, the company cannot predict the impact of any such decision on the amounts that the company may be reimbursed by private insurance companies, if any.

The company is 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 will expire by December 2023. The company also holds 20 issued patents in the U.S. and various countries and have multiple pending patent applications in the U.S. and international markets. These patents expand upon the MIT patents and extend the life of the company's patent portfolio to the year 2039.

Solutions

Beginning in 2022, the company enabled the use of remote measurement and 3D printing techniques in order to create the orthotic parts for the device, which has reduced the number of in-person visits by the company's clinical field staff.

The MyoPro can enable individuals to self-initiate and control movements of a partially paralyzed or weakened limb using their own muscle signals. When the user tries to move, the company's patented EMG control system uses sensors to detect the weak muscle signal and to activate a motor to move the limb in the desired direction. The user is in control of their own limb; the brace amplifies their weak muscle signal to regain function to the affected joint. Importantly, the EMG-driven device requires that users are actively engaged throughout the movement; if they stop trying to move, the device stops. With the company's product, a paralyzed individual, such as one who has suffered a brachial plexus injury, stroke or other neuromuscular disorder can experience improved function in performing ADLs, including feeding, reaching and lifting.

Each MyoPro brace is custom fabricated for each patient for optimum mobility and performance. To qualify for a MyoPro, candidates must meet a comprehensive set of requirements determined by a trained clinical professional during an evaluation. These criteria include long term partial paralysis, detection of a muscle signal sufficient to control the device, demonstrated cognitive abilities, and lack of other conditions that might limit the effectiveness or safety of the device such as use of certain pharmaceuticals, high levels of pain, or limits to range of motion, as well as falling within measurement limitations for the arm and hand to be able to fit into the device. Finally, candidates must have meaningful and achievable functional goals that can realistically be accomplished with the device that cannot otherwise be achieved with other interventions.

Sales and Marketing

The company's strategy is to establish itself as a market leader in myoelectric-controlled orthotics by building a set of products, software applications, and value-added services based upon the company's patented technology platform. In addition to the company's recent geographic expansion to serve more areas in the United States, the company is entering international markets via local partnerships and distribution arrangements to meet the large global need that exists for individuals with upper limb paralysis.

Competition

Some new products have been introduced that compete with the MyoPro from companies such as Vincent Systems and HKK in Germany.

Intellectual Property

The MyoPro is protected by two core patents exclusively licensed from MIT for the life of the patents. The first patent (U.S. Pat. No. 7,396,337) covers a powered orthotic device, worn over a patient's elbow or other joint that senses relatively low-level muscle signals in the vicinity of the joint generated by a patient. In response to the relatively low-level signals, the powered orthotic device moves, causing the patient's body part to move about the joint accordingly with adjustable force and assistance settings. The patent expires on December 1, 2023. The second patent (U.S. Pat. No. 7,367,958) covers a method of providing rehabilitation movement training for a person suffering from nerve damage, stroke, spinal cord injury, neurological trauma or neuromuscular disorder by moving a body part about a joint using a powered orthotic device. The patent claims methods that include moving the body part about the joint in two directions based on an EMG signal from a muscle associated with that body part or moving the body part about the joint in one direction based on the EMG signal and in another direction based on a return force in the absence of a sensed EMG signal. This patent expires on November 21, 2023, which represents the earliest patent expiration among Myomo's intellectual property portfolio.

The two patent licenses discussed above were granted pursuant to the MIT License. Under the MIT License, the company has been granted access to those certain patent rights in exchange for the payment of royalties, which vary based on the level of the company's net sales.

Myomo has 20 of its own issued patents as well. These additional patents cover the company's MyoPro Motion G product. The Motion G product, which allows for the movement of multiple joints as compared to a single joint, which is the technology that underlies the patents licensed from MIT. The Motion G generated 97% of the company's product revenue for the year ended December 31, 2022. In January 2013, Myomo's patent entitled Powered Orthotic Device was granted in Europe (European Patent No. 2079361), which is validated (in force) in six European countries. In June 2014, a substantially similar patent was granted in Japan (Japanese Patent No. 5557529). In November 2013 and January 2015, Myomo's two U.S. patents issued entitled Powered Orthotic Device and Method of Using Same (U.S. Pat. Nos. 8,585,620 and 8,926,534, respectively). On July 26, 2016, Myomo's third U.S. patent was issued (U.S. Pat. No. 9,398,994). In September 2020, Myomo's fourth U.S. patent was issued entitled Powered Orthotic Device and Method of Using the Same (U.S. Pat No. 10758394B2). Similar patents have been issued in China, Hong Kong, and Japan and is validated ( in force) in six European countries (European Patent No. 3307225). The company also has 4 pending U.S. patent applications and 11 foreign applications under examination. The company plans to continue to file additional patent applications over time. The longest term of the company's patents extends intellectual property rights until 2039.

In terms of trademarks, the terms Myomo, MyoPro, MyoPal and MyoCare are registered as trademarks with the U.S. Patent & Trademark Office. The company's trademarks were initially registered in 2013 and 2014. Within the first ten years from the registration dates shown above, the company will be required to complete two (2) 'maintenance' filings, one between the 5th and 6th years and the second between the 9th and 10th years. Each successive 10-year period thereafter the company will be required to complete a 'maintenance' filing between every 9th and 10th year.

Government Regulation

The MyoPro device and the company's operations including the company's supply chain and distribution channels are subject to regulation by the FDA and various other U.S. federal and state agencies.

The company has elected to list the MyoPro Family of products under a Class II device classification regulation for biofeedback devices.

While the company's device to be exempt from FDA premarket review, the company's device is subject to FDA's post-market requirements, which include compliance with the applicable portions of the FDA's Quality System Regulation, or QSR, facility registration and product listing, reporting of adverse medical events, and appropriate, truthful and non-misleading labeling, advertising, and promotional materials.

The company, together with Cogmedix, the company's primary contract manufacturer, actively maintain FDA 21 CFR Part 820 QSR and ISO 13485 Quality Management Systems for product design and development, manufacturing, distribution, and customer feedback processes.

The company has declared conformity to European Directives and apply the CE Mark for distribution of the MyoPro product line in Europe, and the company has a Medical Device License for Canada. In addition, Myomo has recently obtained certification of the company's Quality System, or QS, to the Medical-Device-Single-Audit-Program, or MDSAP. This certifies compliance of the QS for sales in the United States, Canada, Brazil, Australia, and Japan.

Manufacturing

Myomo's custom fabricated orthosis is consisted of two elements. The first is the electromechanical kit. The kit consists of the motor units, processor, sensors, and battery. Manufacturing for the electromechanical kit is provided by the company's supplier Cogmedix, a wholly owned subsidiary of Coughlin Companies in Worcester, MA.

History

Myomo, Inc. was incorporated in the state of Delaware in 2004.