You should read the following discussion and analysis of our financial condition and results of operations together with the section entitled "Selected Financial Data" and our audited financial statements and related notes included elsewhere in this report. This discussion and other parts of this report contain forward-looking statements that involve risks and uncertainties, such as our plans, objectives, expectations, intentions and beliefs. Our actual results could differ materially from those discussed in these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section entitled "Risk Factors" included elsewhere in this report.

Overview

We are a commercial-stage medical technology Company focused on developing, manufacturing, and commercializing minimally invasive solutions to meet the distinct uterine healthcare needs of women. We have established a broad product line of commercially available, minimally invasive alternatives to hysterectomy, which are designed to address the most common causes of abnormal uterine bleeding (AUB) in most uterine anatomies. Our solutions can be used in a variety of medical treatment settings and aim to address the drawbacks associated with alternative treatment methods and to preserve the uterus by avoiding unnecessary hysterectomies.

We offer a broad suite of products for the treatment of structural and non-structural causes of AUB in most uterine anatomies. Our devices are utilized by obstetrician-gynecologists (OB/GYNs) across a variety of medical treatment settings, including hospitals, ambulatory surgical centers (ASCs), and physician offices.

Prior to May 2020, we sold only one product, the Minerva ES Endometrial Ablation System (Minerva ES) for women with AUB attributed to a non-structural cause. In May 2020, we acquired certain assets from Boston Scientific Corporation (BSC), including all rights to the Genesys HTA Endometrial Ablation System (Genesys HTA), Symphion Operative Hysteroscopy System (Symphion), and Resectr Tissue Resection (Resectr) product lines. The assets acquired included all future value associated with the developed products and rights of ownership for the products. We did not assume any liabilities associated with BSC's product activities, except for an immaterial warranty liability for installed Genesys HTA controllers.

We utilize contract manufacturers for a significant portion of our products. This includes all of our controllers and significant subcomponents of our disposable devices. BSC manufactured the Genesys HTA and its ProCerva procedure set at its facility. In connection with the BSC product acquisition, we entered into a supply agreement with BSC relating to the Genesys HTA system and certain of its components. Pursuant to the supply agreement, BSC supplied us with systems and procedure sets until we had successfully transferred manufacturing to a third-party manufacturer, which occurred in 2022. The Symphion and Resectr products were previously manufactured for BSC by various third-party manufacturers. We continued to rely on the same manufacturers to supply us with these products and we have assumed those relationships directly.

We market and sell our products through a direct sales force in the United States. Our target customer base includes approximately 19,000 OB/GYNs practicing in hospitals, ASCs, and physician offices. As of December 31, 2022, our commercial team consisted of approximately 89 field-based personnel that call on OB/GYNs in all major U.S. markets. Our sales and marketing programs focus on educating physicians regarding the use of our products and on providing materials to help them educate their patients about our procedures. We also provide online patient-oriented educational materials about AUB and our products and procedures, which patients may use to consider and then discuss treatment options with their physicians.

In 2022, we generated revenue of $50.3 million, with a gross margin of 54.2% and a net loss of $34.1 million compared to revenue of $52.1 million, with a gross margin of 58.6% and a net loss of $21.5 million in 2021.

As of December 31, 2022, we had an accumulated deficit of $283.7 million, cash and cash equivalents of $6.9 million and $40.0 million principal outstanding under the CIBC Agreement before debt discount, exit fees and issuance cost.

Impact of the COVID-19 pandemic

The global COVID-19 pandemic presents significant volatility, uncertainty and risks to us and has had, and continues to have, far reaching impacts on our business, operations, and financial results and condition, directly and indirectly. The access to many hospitals and other customer sites may be or may periodically be, depending on the current COVID-19 infection rates in the applicable location, restricted to essential personnel, which negatively impacts our ability to promote the use of our products with physicians. Additionally, many hospitals and other surgery centers have in the past suspended, and may suspend or continue to suspend in the future, many elective procedures, resulting in a reduced volume of procedures using our products. Our customer behavior is impacted by the prevalence of COVID-19 and changes in the infection rates in the locations where our customers are located.

Quarantines, shelter-in-place and similar government orders have also impacted and may continue to impact, our third-party manufacturers and suppliers, and could in turn adversely impact the availability or cost of materials, which could disrupt our supply chain. We have taken a variety of steps to address the impact of the COVID-19 pandemic, while attempting to minimize business disruption. Essential staff in manufacturing and limited support functions continued to work from our Santa Clara headquarters



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following appropriate hygiene and social distancing protocols. To reduce the risk to our other employees and their families from potential exposure to COVID-19, until recently all other staff in our Santa Clara headquarters were requested to work from home.

Certain of these other employees had begun to return to our headquarters full or part-time during the third quarter of 2021, although we are reviewing the impact of COVID-19 on employee safety.

We are continuing to monitor the impact of the COVID-19 pandemic on our employees and customers and on the markets in which we operate and will take further actions that we consider prudent to address the COVID-19 pandemic, while ensuring that we can support our customers and continue to develop our products.

The Company continued to experience a lower than expected revenue in the twelve months ended December 31, 2022, a trend that continued from the prior year's comparable period. While reinstated hospital and ASCs closures for elective procedures due to COVID-19 have been lifted in the first half of 2022, a nationwide staffing shortage in the hospital work environment resulted in a negative impact on the numbers of ablation procedures scheduled in 2022.

The ultimate extent of the impact of the COVID-19 pandemic on us is highly uncertain and subject to change. This impact may result in a material, adverse impact on liquidity, capital resources, supply chain, operations, revenue and may affect third parties on which the Company relies, and could worsen over time. The extent of the continuing resurgence of COVID-19, the efficacy and extent of distribution of vaccines, and the impact of mutations of COVID-19 is unpredictable. Most of these developments and factors are outside of our control and could exist for an extended period of time even after the pandemic might end.

Key Financial Data

We measure out business using both financial and operating data and use the following metrics and measures to assess the performance of our overall business, including identifying trends affecting our business, formulating business plans, making strategic decisions and assessing operational efficiencies.

Components of our results of operations

Revenue

We currently derive substantially all our revenue from the sale of our products to hospitals, ASCs, and physician offices in the United States. We market and sell our products through a direct sales force. Nearly 100% of our revenue is point-in-time recognition for single-use (disposable) products and capital equipment. Sale of extended warranties on capital equipment represents less than 1% of revenue. Further, 98.1% of our total revenue is derived from the sale of single-use (disposable) products and therefore revenue from the sale of capital equipment, associated warranties and miscellaneous revenue is not disaggregated in our financial statements.

Cost of goods sold

Cost of goods sold consists primarily of costs related to materials, components and subassemblies, payroll, and personnel-related expenses for our manufacturing and quality assurance employees, including expenses related to stock-based compensation, manufacturing overhead, charges for excess, obsolete and non-sellable inventories, and royalties. Overhead costs include the cost of quality assurance, testing, material procurement, inventory control, operations supervision, and management personnel, an allocation of facilities and information technology expenses, including rent and utilities, and equipment depreciation. We record adjustments to our inventory valuation for estimated excess, obsolete, and non-sellable inventories based on assumptions about future demand, past usage, changes to manufacturing processes, and overall market conditions. We expect cost of goods sold to increase in absolute dollars as more of our products are sold.

Gross margin

We calculate gross margin as gross profit divided by revenue. Our gross margin has been, and will continue to be, affected by a variety of factors, including production volumes, the cost of direct materials, product mix, manufacturing costs, product yields, headcount, and cost-reduction strategies. We expect our gross margin percentage to increase over the long term to the extent we are successful in increasing our sales volume and are therefore able to leverage our fixed costs. However, we expect our gross margin to fluctuate from period to period based upon the factors described above and seasonality.

Operating expenses

Our operating expenses consist of sales and marketing costs, general and administrative costs, and research and development costs. We expect to continue to invest in these activities.



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Sales and marketing

We have made significant investments in building our commercial field organization and intend to make significant investments in sales and marketing activities in the future. Sales and marketing expense consist primarily of payroll and personnel-related costs for our sales and marketing personnel, including sales variable compensation, stock-based compensation expense, travel expenses, consulting, direct marketing, customer education, trade shows, and promotional expenses. Sales and marketing expense also includes expenses related to the amortization of the value of customer relationships acquired from BSC.

We anticipate that our sales and marketing expenses will increase as we strategically invest to expand our business. We expect to hire additional sales personnel and related account management and sales support personnel to capture an increasing amount of our market opportunity. We also expect to continue our brand awareness and targeted marketing campaigns. As we scale our sales and marketing activities, we expect these expenses to increase.

General and administrative expenses

General and administrative expenses consist primarily of payroll and personnel-related expenses, including salaries, employee benefit costs and stock-based compensation expense, professional fees for legal, patent, consulting, accounting and tax services, allocated overhead, including rent, equipment, depreciation, information technology costs and utilities, and other general operating expenses not otherwise classified as research and development expenses. We also recognize the change in value of the contingent consideration liability due to BSC for the potential future milestone payments in general and administrative expenses.

We anticipate that our general and administrative expenses will increase as a result of being a public company, as a result of increased personnel costs, including salaries, benefits and stock-based compensation expense, expanded infrastructure and higher consulting, legal, and accounting services associated with maintaining compliance with stock exchange listing, and requirements of the Securities and Exchange Commission, investor relations costs, and director and officer insurance premiums associated with being a public company.

Research and development expenses

Research and development expenses have included clinical studies to demonstrate the safety and efficacy of our products, as well as obtain and retain FDA approval. Current research and development expenses consist primarily of costs incurred for the development of our products. These costs consist of engineering and research programs associated with our products under development and improvements to our existing products. These costs include prototype materials, laboratory supplies, regulatory expenses, and an allocation of facility overhead costs. Research and development expenses also include payroll and personnel-related costs and stock-based compensation expense for our research and development employees and consultants and acquisition of technology with no alternative future uses. We also recognize the amortization cost of intangible assets acquired from BSC for developed technology and patents and trademarks in research and development expenses beginning in May 2020. We expense research and development costs as incurred. We intend to continue making significant investments in research and development, clinical studies, and regulatory affairs to support future regulatory submissions for retaining and expanding indications of our products, support continuous improvements to our products, and develop future products that address abnormal uterine bleeding in a minimally invasive manner.

Interest expense and income

Interest expense consists primarily of interest expense related to our term loan facilities and convertible notes, including amortization of debt discount and issuance costs. Interest income is predominately derived from investing surplus cash in money market funds.

Other income and expenses

Other income and expenses had primarily consisted of changes in the fair value of derivative liabilities and redeemable convertible preferred stock warrant liability and gain/loss in loan extinguishment of debt. Upon exercise or expiration of the warrants, the final fair value of the warrant liability was reclassified to stockholders' equity and we will no longer record any related periodic fair value adjustment. Upon the resolution in 2021 of the derivative liabilities and the conversion of the convertible notes, no further changes in fair value were recognized during 2022 in the statements of operations.



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Results of operations

Comparison of the years ended December 31, 2022 and 2021

The following table summarizes our results of operations for the periods indicated (in thousands, except percentage figures):


                                              For the Year
                                           Ended December 31,
                                            2022         2021        Change    % Change
Revenue                                 $   50,294   $   52,103   $  (1,809)     (3.5%)
Cost of goods sold                          23,052       21,580        1,472       6.8%
Gross profit                                27,242       30,523      (3,281)    (10.7%)
Operating expenses
Sales and marketing                         38,328       32,193        6,135      19.1%
General and administrative                  14,370       22,183      (7,813)    (35.2)%
Research and development                     5,443        5,292          151       2.9%
Total operating expenses                    58,141       59,668      (1,527)     (2.6%)
Loss from operations                      (30,899)     (29,145)      (1,754)     (6.0%)
Interest income                                 89           10           79   (790.0%)
Interest expense                           (3,222)     (11,728)        8,506      72.5%
Change in fair value of derivative
liabilities                                      -       38,007     (38,007)   (100.0%)
Loss on extinguishment of convertible
notes                                            -     (21,295)       21,295   (100.0%)
Gain on extinguishment of PPP loan               -        3,036      (3,036)   (100.0)%
Other expense, net                            (69)        (340)          271      79.7%
Net loss before income taxes              (34,101)     (21,455)     (12,646)    (58.9%)
Income tax expense                            (11)          (9)          (2)    (22.2%)
Net loss                                $ (34,112)   $ (21,464)   $ (12,648)    (58.9%)



Revenue

Revenue decreased by $1.8 million, or 3.5%, to $50.3 million in 2022, compared to $52.1 million in 2021. The decrease in revenue was primarily attributable to the decrease in volume of Minerva ES and Genesys HTA products, partially offset by increased Symphion product revenue.

For 2022 and 2021, sales of Minerva ES contributed 45.9% and 46.8% of revenue, respectively; sales of the Genesys HTA contributed 29.3% and 31.6% of revenue, respectively; sales of Symphion contributed 24.1% and 20.6% of revenue, respectively; and sales of other products and warranties contributed 0.7% and 1.0% of revenue, respectively.

Revenue was significantly impacted in 2021 by government and hospital restrictions on elective surgeries as a result of the COVID-19 pandemic. This trend continued in 2022 due to ongoing hospital constraints on elective surgeries and negatively impacted revenue during 2022. Additionally, recent inflation and negative economic outlook together with a nationwide staffing shortage in the hospital work environment had a negative impact on the numbers of procedures scheduled and contributed to a negative result on the Company's revenue in 2022 compared to the prior year period.

Cost of goods sold

Cost of goods sold increased by $1.5 million, or 6.8%, to $23.1 million in 2022, compared to $21.6 million in 2021. This result is due to growth in the sales volume of our Symphion products, as well as an increase in controller amortization expenses due to an increase in our installed base of controllers, partially offset by a reduction in sales volume and resulting material costs in Minerva ES and Genesys HTA products during the comparable periods.

Gross margin

Our gross margin decreased from 58.6% in 2021 to 54.2% in 2022. The decrease in gross margin was primarily due to a shift in products sold towards Symphion products, which contributes to a lower gross margin compared to Minerva ES and Genesys HTA products. Further, fixed overhead costs spread over a smaller base of product revenue resulting in a negative impact on the gross margin.

Sales and marketing expenses

Sales and marketing expenses increased by $6.1 million, or 19.1%, to $38.3 million in 2022 compared to $32.2 million in 2021. The increase was primarily due to growth in our sales force and related personnel and travel costs, increased marketing costs due to various new marketing initiatives pursued in 2022, as well as higher consulting and other services.



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General and administrative expenses

General and administrative expenses decreased by $7.8 million, or 35.2%, to $14.4 million in 2022, compared to $22.2 million in 2021. The decrease was primarily due to $9.1 million decrease in the fair value related to the contingent consideration liability associated with the BSC product revenue milestone which was not met in 2022, and thus no additional amounts are owed to BSC based on actual sales data and current forecast, a net $2.9 million decrease in legal expenses and contingent legal accruals in connection with our patent infringement lawsuit with Hologic and other corporate matters and lower consulting and accounting expenses, partially offset by an increase in D&O insurance expenses of $2.3 million, and an increase in compensation and personnel related expenses primarily due to higher headcount and wages amounting to $2.0 million in the aggregate.

Research and development expenses

Research and development expenses increased by $0.2 million, or 2.9%, to $5.4 million in 2022, compared to $5.3 million in 2021. Expenses were essentially flat as increased costs associated with ongoing research and development activities were mostly offset by a decrease in compensation and personnel related expenses.

Interest expense and income

Interest expense decreased by $8.5 million, or 72.5%, to $3.2 million in 2022, compared to $11.7 million in 2021, primarily due to conversion of the promissory notes in conjunction with the IPO and the lower interest rate of the CIBC loan compared to the prior loan that was repaid in 2021.

Other income and expenses


                                               For the Year
                                            Ended December 31,
(in thousands, except percentage
figures)                                    2022           2021        Change    % Change
Change in fair value of derivative
liabilities                             $        -    $    38,007   $ (38,007)   (100.0%)
Loss on extinguishment of convertible
notes                                            -       (21,295)       21,295     100.0%
Gain on extinguishment of PPP loan               -          3,036      (3,036)   (100.0%)
Change in fair value of redeemable
convertible preferred stock warrant
liability                                        -          (535)          535     100.0%
Other income (expense), net                   (69)            195        (264)   (135.4)%
Total                                   $     (69)    $    19,408   $ (19,477)   (100.4)%

Changes in fair value of derivative liabilities in 2021 resulted from the conversion of the convertible notes in the fourth quarter of 2021. During 2021, the fair value of the single derivative liability was determined to be zero primarily due to management's view on the key assumptions that changed the probabilities of a qualified financing, change of control and non-qualified financing which resulted in the derecognition of fair value of derivative liabilities of $38.0 million.

Loss on extinguishment of convertible notes relates to the amendment of the 2018 Note Agreements and the 2019 Note Agreements and was accounted for as a debt extinguishment, which resulted in a $21.3 million loss on extinguishment in other expenses for the year ended December 31, 2021.

Gain on extinguishment of PPP loan of $3.0 million recognized during 2021 was due to the PPP loan's principal and interest being forgiven in June 2021.

Change in fair value of redeemable convertible preferred stock warrant liability of $0.5 million was recognized during 2021 due to their conversion to common stock warrants in October 2021.

Non-GAAP financial measures

Adjusted EBITDA and Adjusted EBITDA Margin

EBITDA and Adjusted EBITDA are key performance measures that our management uses to assess our financial performance and are also used for internal planning and forecasting purposes. We believe that these non-GAAP financial measures are useful to investors and other interested parties in analyzing our financial performance because they provide a comparable overview of our operations across historical periods. In addition, we believe that providing EBITDA and Adjusted EBITDA, together with a reconciliation of net loss to each such measure, helps investors make comparisons between the Company and other companies that may have different capital structures, different tax rates, and/or different forms of employee compensation.

EBITDA and Adjusted EBITDA are used by our management team as an additional measure of our performance for purposes of business decision-making, including managing expenditures, and evaluating potential acquisitions. Period-to-period comparisons of EBITDA and Adjusted EBITDA help our management identify additional trends in our financial results that may not be shown solely by period-to-period comparisons of net income or income from continuing operations. EBITDA and Adjusted EBITDA have inherent limitations because of the excluded items, and may not be directly comparable to similarly titled metrics used by other companies.



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We calculate EBITDA as net income (loss) adjusted to exclude depreciation and amortization, interest (income) expense, net and income tax expense. We calculate Adjusted EBITDA by further excluding stock-based compensation expenses, loss on extinguishment of long-term debt and convertible notes, gain on extinguishment of PPP loan, change in fair value of redeemable convertible preferred stock warrant liability, change in fair value of contingent consideration liability and change in fair value of derivative liabilities. EBITDA margin represents EBITDA as a percentage of Revenues. Adjusted EBITDA margin represents Adjusted EBITDA as a percentage of Revenues. EBITDA and Adjusted EBITDA should be viewed as measures of operating performance that are supplements to, and not substitutes for, other measures of profitability under U.S. GAAP.

The following table provides a reconciliation of these non-GAAP metrics to net loss, which is the nearest GAAP number:


                                                          Years Ended December 31,
(in thousands, except percentage figures)                    2022             2021

Net loss                                               $     (34,112)    $    (21,464)
Depreciation and amortization                                  10,806           10,620
Interest (income) expense, net                                  3,133           11,718
Income tax expense                                                 11                9
EBITDA                                                       (20,162)              883
EBITDA margin                                                 (40.1%)             1.7%

Adjustments:


Loss on extinguishment of convertible notes                         -           21,295
Gain on extinguishment of PPP loan                                  -          (3,036)
Stock-based compensation expense                                6,978            6,817
Change in fair value of redeemable convertible
preferred stock warrant liability                                   -              328
Change in fair value of contingent consideration
liability                                                     (9,094)              427
Change in fair value of derivative liabilities                      -         (38,007)
Adjusted EBITDA                                        $     (22,278)    $    (11,293)
Adjusted EBITDA margin                                        (44.3%)          (21.7%)





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Liquidity and capital resources

Prior to our IPO in October 2021, we financed our operations primarily through private placements of equity securities, debt financing arrangements, and sales of our products. As of December 31, 2022, we had an accumulated deficit of $283.7 million, cash and cash equivalents of $6.9 million and a $40.0 million outstanding loan under the CIBC Agreement before debt discount and issuance cost. We incurred a net loss of $34.1 million during the year ended December 31, 2022.

On December 27, 2022, the Company entered into a Share Purchase Agreement (the "Purchase Agreement") for a private placement (the "Private Placement") with Accelmed Partners II L.P. ("Accelmed") and New Enterprise Associates 13, L.P. (each, a "Purchaser," and collectively, the "Purchasers"). Pursuant to the Purchase Agreement, the Company agreed to sell to the Purchasers an aggregate of 146,627,565 shares (the "Shares") of the Company's common stock, par value $0.001 per share, at a purchase price of $0.2046 per Share, which represented a 25% premium to the trailing five-day volume-weighted average price of the Company's common stock on December 23, 2022. On February 9, 2023, the Private Placement closed, and the Company issued the Shares to the Purchasers, resulting in aggregate gross proceeds to the Company of $30.0 million before deducting placement agent fees and estimated offering expenses of $3.2 million.

We prepared an internal forecast that includes alternatives to refinance our outstanding term loan and to potentially raise additional capital as needed over the next twelve months. As discussed above, on February 9, 2023, the Company closed the Private Placement, resulting in aggregate gross proceeds to the Company of $30.0 million before deducting placement agent fees and estimated offering expenses payable by the Company. Under the current terms of the outstanding term loan, we will begin repaying the principal balance starting in November 2023, the end of the interest only period. Should we fail to either refinance the CIBC Agreement or raise additional capital, the latest forecast represents the possibility that our cash and cash equivalents are not sufficient to fund our operations within the next twelve months.

As of December 31, 2022, we were in compliance with the financial covenants required by our CIBC Agreement. However, the inherent uncertainties described above may impact our ability to remain in compliance with these covenants over the next twelve months. A potential financial covenant violation, should it occur, would put us in technical default per the terms of the CIBC Agreement and provide for remedies to the bank per that agreement. This potential future covenant violation could impact our ability to fund our current business plan within the twelve months from the date of issuance of these financial statements. The presence of these conditions, individually or in the aggregate, raise substantial doubt about our ability to continue as a going concern within one year after the date that the financial statements are issued.

Management is considering raising additional capital through debt, equity or a combination financing in the future. However, such additional financings may not be available to us on acceptable terms, or at all. If we are unable obtain adequate financing on acceptable terms, we may terminate or delay the development of one or more of our products, delay sales and marketing efforts or other activities necessary to commercialize our products or modify our operations to operate within available resources. Failure to manage discretionary spending or raise additional financing as needed, may adversely impact our ability to achieve our intended business objectives. While we believe our plans will alleviate the conditions that raise substantial doubt, these plans are not entirely within our control and cannot be assessed as being probable of occurring.

CIBC

On October 8, 2021, we entered into the CIBC Agreement with Canadian Imperial Bank of Commerce (CIBC), which provides for a senior secured term loan in an aggregate principal amount of $40.0 million (the CIBC Loan), the full amount of which was funded at the closing of the CIBC Agreement.

The CIBC Loan provides for 24 months of interest-only payments followed by 36 equal monthly payments of principal, plus accrued and unpaid interest, with the final obligations due and payable in full on October 8, 2026. The CIBC Loan accrues interest at a floating rate equal to 2.5% above the prime rate, and the interest is payable monthly in arrears.

Future funding requirements

We expect to incur continued expenditures in the future in support of our commercialization efforts in the United States. In addition, we intend to continue to make investments in clinical studies, development of new products, and other ongoing research and development programs, plus incur additional expenses to expand our commercial organization and efforts. We expect to incur additional ongoing costs associated with operating as a public company.

As of December 31, 2022, we had cash and cash equivalents of $6.9 million. On February 9, 2023, the Company closed the Private Placement, resulting in aggregate gross proceeds to the Company of $30.0 million before deducting placement agent fees and estimated offering expenses payable by the Company. Based on our current planned operations, we expect to incur significant operating expenses as we continue to expand product sales and develop and commercialize new products. Our management believes that our operating losses and negative cash flows will continue into the foreseeable future.



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We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with product sales, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

the timing, receipt and amount of sales from our current and future products;

the cost and timing of establishing and growing sales, marketing and distribution capabilities;

the cost of preparing, filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights;

the terms and timing of any other collaborative, licensing and other arrangements that we may establish;

the degree of success we experience in commercializing future products;

the cost, timing and results of our clinical trials and regulatory reviews;

the emergence of competing or complementary technologies.

restructuring, refinancing, or repayment of debt

Summary Statements of Cash Flows

The following table sets forth the primary sources and uses of cash and cash equivalents for the periods presented below (in thousands):




                                                         For the Year Ended December 31,
                                                            2022                 2021
Net cash (used in) provided by:
Operating activities                                 $       (35,567)    $        (22,379)
Investing activities                                             (73)                (584)
Financing activities                                          (4,964)               46,212

Net (decrease) increase in cash and cash equivalents $ (40,604) $ 23,249

Cash flows used in operating activities

Net cash used in operating activities was $35.6 million in 2022, primarily attributable to a net loss of $34.1 million and a net change in our net operating assets and liabilities of $11.1 million, partially offset by non-cash charges of $9.6 million. Non-cash charges primarily consist of $10.8 million in depreciation and amortization, $7.0 million in stock-based compensation expense and $0.6 million in non-cash lease expense, partially offset by $9.1 million change in the contingent consideration liability associated with the BSC product revenue milestone. The change in net operating assets and liabilities was primarily due to $4.0 million increase in inventory due to strategic purchases of inventory, $0.7 million increase in other assets, $5.6 million decrease in accounts payable and accrued liabilities, and $0.8 million decrease in operating lease liability, partially offset by a $0.2 million increase in accrued compensation.

Net cash used in operating activities was $22.4 million in 2021, primarily attributable to a net loss of $21.5 million, $38.0 million in change in fair value of derivatives liabilities, $21.3 million loss on long-term debt extinguishment, $10.6 million in depreciation and amortization, $6.8 million in stock-based compensation expense, $5.8 million in interest expense from long-term debt and convertible notes, $3.0 million gain on extinguishment of PPP loan, $3.3 million in amortization of debt discount and debt issuance costs and a net change in our net operating assets and liabilities of $8.5 million. The net change in our net operating assets and liabilities are mainly driven by the increase in inventory off set by increase in accounts payable. The Company has increased its inventory on hand to be able to respond to an increase in future sales and to reduce the risk of future supply-chain issues.

Cash flows used in investing activities

Net cash used in investing activities was $0.1 million in 2022, used to purchase property and equipment.

Net cash used in investing activities was $0.6 million in 2021, which was mainly used to purchase property and equipment.



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Cash flows provided by financing activities

Net cash used in financing activities was $5.0 million in 2022, which primarily relates to $5.0 million payment of contingent consideration.

Net cash provided by financing activities was $46.2 million for 2021, which primarily relates to $69.8 million proceeds from our IPO, net of underwriting discount and commission, $39.0 million proceeds from issuance of convertible notes and lending under term loans, net of lender fees and costs, success fee and debt fees, partially offset by $35.4 million related to the Ares loan repayment and $25.0 million payment of delayed purchase obligation and Development Milestone.

Contractual Obligations and Commitments

Our contractual obligations and commitments relate primarily to our CIBC Loan and operating leases. In 2019, we entered into a lease agreement for our corporate headquarters, research and development facilities, and manufacturing and distribution centers, located in Santa Clara, CA. In July 2022, we entered into a new lease agreement for our corporate headquarters, which is expected to commence on June 1, 2023. See Note 7, "Debt" and Note 8, "Commitments and contingencies," to our financial statements for further information.

Critical accounting policies, significant judgments and use of estimates

Our financial statements have been prepared in accordance with GAAP. The preparation of our financial statements requires us to make assumptions, estimates, and judgments that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenue and expenses incurred during the reporting periods. Our estimates are based on our knowledge of current events and actions we may undertake in the future and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. We evaluate our assumptions, estimates and judgments on an ongoing basis. Our actual results may materially differ from these estimates under different assumptions, judgments or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management's judgments, and estimates. For more detail on our significant accounting policies, refer to Note 2 to our audited financial statements.

Revenue recognition

We generate revenue primarily from the sale of disposable devices and controllers that treat the root causes of abnormal uterine bleeding (AUB). We invoice hospitals, ambulatory surgical centers, and physician offices for the disposable products and pay commissions to the sales representatives.

We also provide controllers to customers under evaluation and long-term placement agreements. Under these agreements, we deliver the controller to the customer's facility without a fee and the customer agrees to purchase disposable products at a stated price over the term of the agreement. We retain title to the controllers. We, in general, do not enforce a minimum purchase requirement under these agreements. Terms range from several months to multiple years and may be extended or terminated upon mutual agreement. These types of agreements include an embedded lease, which is generally an operating lease, for the right to use a controller that is cancellable by either party with 30 days' notice. We recognize a portion of the revenue allocated to the embedded lease concurrent with the sale of disposable devices. We also offer extended warranty agreements to customers for controller defects, malfunctions, or system failures.

Revenue is recognized when the customer obtains controls of promised goods or services, in an amount that reflects consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Financial Accounting Standard Board (FASB) Accounting Standards Codification (ASC) 606, Revenue From Contracts With Customers (ASC 606), we perform the following five steps as prescribed by ASC 606:

(i)

identify the contract(s) with a customer;

(ii)

identify the performance obligations in the contract;

(iii)

determine the transaction price;

(iv)

allocate the transaction price to the performance obligations in the contract; and

(v)

recognize revenue when (or as) the entity satisfies performance obligations.

A contract with a customer exists when (i) we enter into a legally enforceable contract with a customer that defines each party's rights regarding the products to be transferred and identifies the payment terms related to these products, (ii) the contract has commercial substance, and (iii) we determine that collection of substantially all consideration for products that are transferred is probable based on the customer's intent and ability to pay the promised consideration.



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We identify performance obligations in contracts with customers, which may include our products and implied promise to provide free controllers. The transaction price is determined based on the amount expected to be entitled to in exchange for transferring the promised product to the customer.

We are entitled to the total consideration for the products ordered by customers, net of other transaction price adjustments. Our payment terms to customers are generally net 30 days. Payment terms fall within the one-year guidance for the practical expedient which allows us to forgo adjustment of the promised amount of consideration for the effects of a significant financing component. We exclude taxes assessed by governmental authorities on revenue-producing transactions from the measurement of the transaction price.

Assuming all other revenue recognition criteria are met, revenue is recognized when control of our products transfers to the customer. For sales in which our sales representative hand-delivers product directly to the hospital or ambulatory surgical center, control transfers to the customer upon this delivery. For sales in which products are shipped, control is transferred either upon shipment of the products to the customer, depending on the shipping terms and conditions. We recognize revenue relating to free controllers concurrent with the sale of disposable devices, as the lease is cancellable by either party with 30 days' notice. The amounts attributed to the leased controllers are insignificant. As permitted under the practical expedient, we do not disclose the value of unsatisfied performance obligations for contracts with an original expected length of one year or less.

We accept product returns at our discretion or if the product is defective as manufactured. Historically, the actual product returns have been insignificant to our financial statements. We elected to treat shipping and handling costs as a fulfillment cost and include them in the cost of goods sold as incurred. In those cases in which we bill shipping and handling costs to customers, we classify the amounts billed within revenue.

Derivative instruments

Embedded derivatives that are required to be bifurcated from their host contract are evaluated and valued separately from the debt instrument. Under the Ares Agreement, upon the occurrence of specified prepayment trigger events, including a default or a change in control, we may have been required to make mandatory prepayments of the borrowings. The prepayment premium was considered an embedded derivative, as the holder of the loan may exercise the option to require prepayment by us. The mandatory prepayment derivative liability was recorded at fair value upon entering into the Ares Agreement and was subject to remeasurement to fair value at each balance sheet date, with any changes in fair value recognized in the prior year statements of operations. See Note 7, "Debt" to our financial statements for further information.

The convertible notes contained embedded features, including a Qualified Financing put, Non-Qualified Financing put, and change of control put features that were bifurcated and accounted as derivative liabilities and recorded as a debt discount in 2018, 2019, and 2020 at each issue date. Debt discount was reported as a direct deduction to the carrying amount of the convertible notes and amortized using the effective interest rate over the life of convertible notes as interest expense. The embedded derivative features was recorded at fair value upon entering into the convertible notes and were subject to remeasurement to fair value at each balance sheet date, with any changes in fair values recognized in the statements of operations. See Note 7, "Debt" to our financial statements for further information.

Redeemable convertible preferred stock

We record all shares of redeemable convertible preferred stock at their respective fair values on the dates of issuance, net of issuance costs. The redeemable convertible preferred stock is recorded outside of permanent equity because while it is not mandatorily redeemable, in certain events considered not solely within our control, such as a merger, acquisition, or sale of all or substantially all of our assets (each, a deemed liquidation event), the redeemable convertible preferred stock will become redeemable at the option of the holders of at least a majority of the then outstanding preferred shares.

Redeemable convertible preferred stock warrants

Freestanding preferred stock warrants are accounted for in accordance with Financial Accounting Standard Board (FASB) Accounting Standards Codification (ASC) 480, Distinguishing Liabilities from Equity (ASC 480) and classified as liabilities on the balance sheet because the underlying preferred stock shares are redeemable upon occurrence of a deemed liquidation event. The warrants are subject to re-measurement at each balance sheet date with the change in fair value, if any, recognized in other income (expense), net in the statements of operations. We will continue to adjust the redeemable convertible preferred stock warrant liability for changes in fair value until the earlier of (i) exercise of the warrants, (ii) conversion into warrants to purchase common stock, or (iii) expiration of the warrants.

Recent accounting pronouncements

See Note 2 to our Financial Statements "Summary of Significant Accounting Policies" for information.

Emerging growth company status

In April 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an "emerging growth company" (EGC) can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised



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accounting standards. Thus, an EGC can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for new or revised accounting standards during the period in which we remain an emerging growth company; however, we may adopt certain new or revised accounting standards early.

We will remain an emerging growth company until the earliest to occur of: (i) the last day of the fiscal year in which we have more than $1.07 billion in annual revenue; (ii) the date we qualify as a "large accelerated filer," with at least $700.0 million of equity securities held by non-affiliates; (iii) the date on which we have issued more than $1.0 billion in non-convertible debt securities during the prior three-year period; and (iv) the last day of the fiscal year ending after the fifth anniversary of our IPO.

JOBS Act accounting election

The JOBS Act permits an "emerging growth company" such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to use this extended transition period under the JOBS Act until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies.

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