Description of Business |
12 Months Ended |
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Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | Note 1 — Description of Business Myomo Inc. (“Myomo” or the Company”) is a wearable medical robotics company that develops, designs, and produces myoelectric orthotics for people with neuromuscular disorders. The MyoPro ® myoelectric upper limb orthosis product is registered with the Food and Drug Administration as a Class II medical device. The Company provides the device to patients and bills their insurance companies directly, sometimes utilizing the clinical services of orthotics and prosthetics (“O&P”) providers for which they are paid a fee. The Company sells the product to O&P providers around the world and the Veterans Health Administration ("VA"). The Company was incorporated in the State of Delaware on September 1, 2004 and is headquartered in Boston, Massachusetts. Pursuant to an amended and restated certificate of incorporation, the Company is authorized to issue up to 75,000,000 shares of stock, consisting of 65,000,000 shares of common stock, par value $0.0001 and 10,000,000 shares of undesignated Preferred Stock, par value of $0.0001.
Going Concern and Management Plans
The Company incurred net losses of approximately $10,721,000 and $10,372,000 during the years ended December 31, 2022 and 2021, respectively, and has an accumulated deficit of approximately $88,783,000 and $78,062,000 at December 31, 2022 and 2021, respectively. Cash used in operating activities was approximately $10,234,000 and $9,548,000 for the years ended December 31, 2022 and 2021, respectively. The Company has historically funded its operations through financing activities, including raising equity and debt capital. In January 2023, the Company completed an equity offering under which it sold 13,169,074 shares of common stock and 6,830,926 pre-funded warrants at $0.325 per share, generating proceeds after fees and expenses of approximately $5.7 million. (See Note 13 - Subsequent Events for further discussion.) During the fourth quarter of 2022, the Company sold 692,914 shares of common stock under a Common Stock Purchase Agreement (the "Purchase Agreement") with Keystone Capital Partners ("Keystone"), generating proceeds after fees and expenses of approximately $0.4 million. (See Note 7 - Common Stock for further discussion.) During 2021, $12.1 million was received from the exercise of warrants, including $4.8 million in net proceeds in October 2021 from a transaction to induce the exercise of warrants issued in conjunction with its equity offering in February 2020 at a reduced exercise price of $5.00 per share. These financing activities, in addition to funding of $1.1 million received from sales of common stock under an At Market Sales Facility, or ATM facility, with Alliance Global Partners ("AGP") during the year ended December 31, 2021 is enabling the Company to sustain its operations. Considering the Company's cash balance as of December 31, 2022 and net proceeds from the equity offering in January 2023 and its cash used from operations during the year ended December 31, 2022, management believes there is substantial doubt regarding its ability to continue as a going concern. Management's operating plans are primarily focused on growing its revenues and limiting operating expenses through focusing its clinical and reimbursement efforts on patients with insurers that have previously reimbursed for the MyoPro. The Company believes the growth in its patient pipeline during 2022 provides an opportunity to accelerate its revenue growth in 2023. The Company has stopped activities geared toward increasing the number of payers that will reimburse for its products until the Company receives reimbursement for its products provided to Medicare Part B beneficiaries from the Centers for Medicare and Medicaid Services ("CMS"), or CMS states in intention to reimburse for its products. As a result, the Company has undertaken cost reduction activities, including the reduction of approximately 12% of its workforce in January 2023. This and other cost reduction efforts are expected to reduce its operating expense run-rate by approximately $2.0 million in 2023. With respect to CMS, the Company expects to meet with the medical directors of CMS's administrative billing contractors, referred to as the DME MAC's, before the end of the first quarter of 2023 to discuss coverage and reimbursement, and begin submitting claims on behalf of Medicare Part B beneficiaries as soon as practical thereafter. The Company's success is dependent upon reimbursement of its products by insurance companies and government-controlled health care plans such as Medicare and Medicaid in the United States and Statutory Health Insurance plans in Germany, which could prevent our revenues from growing to the level necessary to achieve cash flow breakeven. If public health restrictions on travel and patient interaction are broadly reinstated in 2023 due to new variants of COVID-19 and increasing infections in the U.S., that will have an adverse effect on the Company's business, and it is possible that the Company will need to raise additional capital to sustain its operations through 2023. The Company believes that it has access to capital resources through payment of the technology license fee associated with its joint venture in China, possible public or private equity offerings, exercises of outstanding warrants, additional debt financings, or other means; however, the Company may be unable to raise sufficient additional capital when it needs it or raise capital on favorable terms. As part of the Company's equity offering in January 2023, the Company agreed to not sell any shares of its common stock to Keystone under the Purchase Agreement or under its ATM Facility for a period of one year from the closing of the offering. The Company has remaining capacity under its Purchase Agreement with Keystone of approximately 1.0 million shares and approximately $0.3 million under its ATM Facility. However, due to its public float, the amount of securities the Company may sell from time to time under the registration statement which registered the ATM Facility may be subject to the limitations imposed by General Instruction I.B.6 of Form S-3. Further, selling the full $5 million to Keystone under the Purchase Agreement requires approval from shareholders to sell shares in excess of the exchange cap under the rules of the NYSE American. Should the Company consider debt financing, such a transaction may require the Company to pledge certain assets and enter into covenants that could restrict certain business activities or its ability to incur further indebtedness and may contain other terms that are not favorable to its stockholders or the Company.
If the Company is unable to obtain adequate funds on reasonable terms, the Company may be required to significantly curtail or discontinue operations or obtain funds by entering into financing agreements on unattractive terms. There can be no assurance that the Company will be successful in implementing its plans. |