PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights certain information about us, this offering and selected information contained elsewhere in or incorporated by reference into this prospectus supplement and the accompanying prospectus. This summary is not complete and does not contain all of the information that you should consider before deciding whether to invest in our securities. For a more complete understanding of our company and this offering, we encourage you to read and consider carefully the more detailed information in this prospectus supplement and the accompanying prospectus, including the information incorporated by reference into this prospectus supplement and the accompanying prospectus, and the information referred to under the heading “Risk Factors” in this prospectus supplement on page S-9 and in the documents incorporated by reference into this prospectus supplement and the accompanying prospectus.
Overview
We are a wearable medical robotics company, specializing in myoelectric braces, or orthotics, for people with neuromuscular disorders. We develop and market the MyoPro product line, which 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 deformed arm to enable and improve functional activities of daily living, or ADLs, in the home and community. It is custom constructed by a trained professional during a custom fabrication process for each individual user to meet their specific needs. Our products are designed to help regain function in individuals with neuromuscular conditions due to brachial plexus injury, stroke, traumatic brain injury, spinal cord injury and other neurological disorders.
We have relationships with physicians and therapists who generate patient referrals, and we utilize digital ads on various platforms as well as television ads to reach patients who are potential candidates for our product. Once the prospective patient contacts us or is referred to us, either our trained clinical staff or a trained Orthotics and Prosthetics, or O&P, provider will evaluate the patient for their suitability as a candidate. Initial evaluations by our trained clinical staff are often conducted using telehealth techniques, followed by an in-person clinical evaluation of the candidate. Based on this evaluation, if the patient is deemed a potential candidate, the patient enters our pipeline. Our pipeline was 1,263 patients and 1,046 patients at September 30, 2024 and 2023, respectively, with 645 patients added to the pipeline in the quarter ended September 30, 2024, and with 15% of our September 30, 2024 patient pipeline representing Medicare patients. Prior to delivering our device to a Medicare patient or obtaining authorizations from commercial insurance companies, the patient’s medical records are collected and reviewed to make sure the device is appropriate for their condition and a prescription is always obtained from a physician. Once these documents are obtained, a pre-authorization request is submitted to the patient’s commercial insurer. If we receive a pre-authorization, we proceed to measure the patient’s arm, a process we refer to as shape capture. Arm measurements are being done in many cases using a digital measurement kit supplied to the patient. We then use those measurements to 3D print orthotic parts, which are used to fabricate the MyoPro and then deliver it to the patient. For a Medicare patient, we will commence shape capture once we are in possession of all relevant medical records and have assessed that the patient meets our inclusion criteria. Once we receive a pre-authorization for a payer, an order from an O&P provider or the Veterans Administration, or VA, or a Medicare patient is qualified for delivery based on receipt of appropriate medical documentation, the patient enters our backlog. Our backlog consisted of 230 patients, 275 patients, 282 patients and 316 patients as of December 31, 2023, March 31, 2024, June 30, 2024 and September 30, 2024, respectively, with our September 30, 2024 backlog including 114 Medicare Part B patients. Further, we recognized revenue related to the sale of 107 units, 91 units, 158 units and 161 units during the quarters ended December 31, 2023, March 31. 2024, June 30, 2024 and September 30, 2024, respectively, and our “book-to-bill” ratio, which reflects the number of units that are booked versus ultimately billed, net of any drops from our backlog, was 1.42, 1.49, 1.04 and 1.21 as of December 31, 2023, March 31, 2024, June 30, 2024 and September 30, 2024, respectively. Since we are directly providing the device to the patient and then billing insurance ourselves, we refer to this process as direct billing. We also call on O&P practices in the United States,