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Item 7. Management’s Discussion and Analysis

2023-03-31 compared with 2022-05-13 · 322 added, 428 removed, 13 unchanged (98% of the section changed)

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements regarding our business development plans, clinical trials,

regulatory reviews, timing, strategies, expectations, anticipated expenses levels, projected profits, business prospects and positioning with respect to market, demographic and pricing trends, business outlook, technology spending and various

other matters (including contingent liabilities and obligations and changes in accounting policies, standards and interpretations) and express our current intentions, beliefs, expectations, strategies or predictions.

These forward-looking

statements are based on a number of assumptions and currently available information and are subject to a number of risks and uncertainties.

Our actual results could differ materially from those anticipated in these forward-looking statements as a

result of various factors, including those set forth under the sections titled “Cautionary Note Regarding Forward-Looking Statements” and “Risk Factors” and elsewhere in this Annual Report on Form 10-K.

The following discussion should be read in

conjunction with our consolidated financial statements and related notes thereto included elsewhere in this Annual Report on Form 10-K.

We are a shock wave technology company using a patented system of noninvasive, high-energy, acoustic shock waves for regenerative medicine and other applications.

Our initial focus is regenerative medicine

utilizing noninvasive, acoustic shock waves to produce a biological response resulting in the body healing itself through the repair and regeneration of tissue, musculoskeletal, and vascular structures.

Our lead regenerative product in the United States is the dermaPACE ® device, used for treating diabetic foot ulcers, which was

subject to two double-blinded, randomized Phase III clinical studies.

On December 28, 2017, the FDA granted the Company’s request to classify the dermaPACE ® System

as a Class II device via the de novo process.

As a result of this decision, the Company was able to immediately market the product for the treatment of diabetic foot ulcers as described in the de novo request, subject to the general control provisions of the FD&C Act and the special controls identified in this order.

On August 6, 2020, we entered into an asset purchase agreement (the “Asset Purchase Agreement” or “Acquisition”) with Celularity Inc.

(“Celularity”) pursuant to which we acquired Celularity’s

UltraMIST® assets (“UltraMIST®” or the “Assets”).

The UltraMIST® System provides through a fluid mist a low-frequency, non-contact, and pain free ultrasound energy deep inside the wound bed that promotes healing from within.

The ultrasound

acoustic waves promote healing by reducing inflammation and bacteria in the wound bed, while also increasing the growth of new blood vessels to the area.

The UltraMIST® System treatment must be administered by a healthcare professional.

proprietary technology has been cleared by the U.S.

Food and Drug Administration (FDA) for the promotion of wound healing through wound cleansing and maintenance debridement combined with ultrasound energy deposited inside the wound that

stimulated tissue regeneration.

In connection with the Asset Purchase Agreement, on August 6, 2020, we entered into a license and marketing agreement with Celularity pursuant to which Celularity granted to the Company a

license to the Celularity wound care biologic products, Biovance® and Interfyl® (the “License Agreement”).

The License Agreement provides the Company with an exclusive license to use, market, distribute and sell Biovance® in the “Field” and

“Territory” (each as defined in the License Agreement), and a non-exclusive license to use, market, distribute and sell Interfyl® in the Field in the Territory.

The License Agreement has an initial five-year term, after which it automatically

renews for additional one-year periods, unless either party gives written notice at least 180 days prior to the expiration of the current term.

In May 2021, the Company received notification that it is not in compliance with the Biovance portion

of the License Agreement with Celularity.

Our portfolio of healthcare products and product candidates activate biologic signaling and angiogenic responses, including new vascularization and microcirculatory improvement, helping to restore the body’s normal

healing processes and regeneration.

We intend to apply our Pulsed Acoustic Cellular Expression (PACE ® ) technology in wound healing, orthopedic, plastic/cosmetic and

cardiac conditions.

The Company is marketing its dermaPACE ® System for treatment usage

in the United States and will continue to generate revenue from sales of the European Conformity Marking (CE Mark) devices and accessories in Europe, Canada, Asia, and Asia/Pacific.

The Company generates revenue streams from product

sales, licensing transactions, dermaPACE ® treatments and other activities, and with its recent acquisition of the UltraMIST® assets, SANUWAVE now combines two highly

complementary and market-cleared energy transfer technologies used in the dermaPACE® and UltraMIST® Systems and two human tissue biologic products (Biovance® and Interfyl®), which creates a platform of scale with an end-to-end product offering in

the advanced wound care market.

Our lead product candidate for the global wound care market, dermaPACE ® , has received FDA clearance for commercial use to treat

diabetic foot ulcers in the United States and the CE Mark allowing for commercial use on acute and chronic defects of the skin and subcutaneous soft tissue.

We believe we have demonstrated that our patented technology is safe and effective in

stimulating healing in chronic conditions of the foot and the elbow through our United States FDA Class III Premarket Approvals (“PMAs”) approved OssaTron® device, and in the stimulation of bone and chronic tendonitis regeneration in the

musculoskeletal environment through the utilization of our OssaTron, Evotron®, and orthoPACE® devices in Europe and Asia.

We are focused on developing our Pulsed Acoustic Cellular Expression (PACE) technology to activate healing in:

wound conditions, including diabetic foot ulcers, venous and arterial ulcers, pressure sores, burns and other skin eruption conditions;

orthopedic applications, such as eliminating chronic pain in joints from trauma, arthritis or tendons/ligaments inflammation, speeding the healing of fractures (including nonunion or delayed-union

conditions), improving bone density in osteoporosis, fusing bones in the extremities and spine, and other potential sports injury applications;

plastic/cosmetic applications such as cellulite smoothing, graft and transplant acceptance, skin tightening, scarring and other potential aesthetic uses;

cardiac applications for removing plaque due to atherosclerosis improving heart muscle performance.

In addition to healthcare uses, our high-energy, acoustic pressure shock waves, due to their powerful pressure gradients and localized cavitational effects, may have applications in secondary

and tertiary oil exploitation, for cleaning industrial waters, for sterilizing food liquids and finally for maintenance of industrial installations by disrupting biofilms formation.

Our business approach will be through licensing and/or

partnership opportunities.

The worldwide spread of the COVID-19 virus is expected to result in a global slowdown of economic activity which is likely to decrease demand for a broad variety of products, including from our

We have experienced a disruption of our supply channels which will continue for an unknown period of time until the global supply chain can return to the pre- disease status.

Also, the pandemic may cause continued or additional actions

by hospitals and clinics such as limiting elective procedures and treatments and limiting clinical trial activities and data monitoring.

These factors have had and we expect that they will continue to have a negative impact on our sales and our

results of operations, the size and duration of which we are currently unable to predict.

Clinical Trials and Marketing

The FDA granted approval of our Investigational Device Exemption (IDE) to conduct two double-blinded, randomized clinical trials utilizing our lead device product for the global wound care market, the dermaPACE ® device, in the treatment of diabetic foot ulcers.

On December 28, 2017, the FDA determined that the criteria at section 513(a)(1)(A) of (B) of the FD&C Act were

met and granted the de novo clearance classifying dermaPACE ® as Class II and available to be marketed immediately.

Also, our dermaPACE ® device has received the European CE Mark approval to treat acute and chronic defects of the skin and

subcutaneous soft tissue, such as in the treatment of pressure ulcers, diabetic foot ulcers, burns, and traumatic and surgical wounds.

The dermaPACE ® is also

licensed for sale in Canada, Australia, New Zealand, Brazil, Mexico, and South Korea.

We are actively marketing the dermaPACE ® to the European Community, Canada, Brazil, Mexico, and Asia/Pacific, utilizing distributors

in select countries.

Financial Overview

Since inception in 2005, our operations have primarily been funded from the sale of capital stock, notes payable, and convertible debt securities.

We expect to devote substantial resources for the commercialization

of the dermaPACE ® System and will continue to research and develop the non-medical uses of the PACE technology, both of which will require additional capital

We incurred a net loss of $27.3 million and $30.9 million for the years ended December 31, 2021 and 2020, respectively.

These factors and the events of default on the notes payable create substantial doubt about the Company’s ability

to continue as a going concern for a period of at least twelve months from the financial statement issuance date.

Our operating losses create substantial doubt about our ability to continue as a going concern.

Although no assurances can be given, we believe that potential additional issuances of equity, debt or other potential

financing may provide the necessary funding for us to continue as a going concern for the next year.

See “Liquidity and Capital Resources” for further information regarding our financial condition.

The continuation of our business is dependent upon raising additional capital to fund operations.

Management’s plans are to obtain additional capital in 2022 and 2023 through

investments by strategic partners for market opportunities, which may include strategic partnerships or licensing arrangements, or raise capital through the conversion of outstanding warrants, the issuance of common or preferred stock,

securities convertible into common stock, or secured or unsecured debt.

These possibilities, to the extent available, may be on terms that result in significant dilution to our existing shareholders.

In addition, there can be no assurances that

our plans to obtain additional capital will be successful on the terms or timeline we expect, or at all.

Although no assurances can be given, management believes that potential additional issuances of equity or other potential financing

transactions as discussed above should provide the necessary funding for us.

If these efforts are unsuccessful, we may be required to significantly curtail or discontinue operations or obtain funds through

financing transactions with unfavorable terms.

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, which contemplate

continuation of the Company as a going concern and the realization of assets and satisfaction of liabilities in the normal course of business.

The carrying amounts of assets and liabilities presented in the financial statements do not necessarily

purport to represent realizable or settlement values.

The consolidated financial statements do not include any adjustment that might result from the outcome of this uncertainty.

Our consolidated financial

statements do not include any adjustments relating to the recoverability of assets and classification of assets and liabilities that might be necessary should we be unable to continue as a going concern.

Since our inception, we have incurred losses from operations each year.

As of December 31, 2021, we had an accumulated deficit of $183.9 million.

Although the size and timing of our future operating losses are

subject to significant uncertainty, we anticipate that our operating losses will continue over the next few years as we incur expenses related to commercialization of our dermaPACE ® system for the treatment of diabetic foot ulcers in the United States.

If we are able to successfully commercialize, market and distribute the dermaPACE ®

system, then we hope to partially or completely offset these losses in the future.

Although no assurances can be given, we believe that potential additional issuances of equity, debt or other potential financing, as discussed above, may provide

the necessary funding for us to continue as a going concern for the next year.

We cannot reasonably estimate the nature, timing and costs of the efforts necessary to complete the development and approval of, or the period in which material net cash flows are expected to be generated from, any

of our products, due to the numerous risks and uncertainties associated with developing and marketing products, including the uncertainty of:

the scope, rate of progress and cost of our clinical trials;

future clinical trial results;

the cost and timing of regulatory approvals;

the establishment of successful marketing, sales and distribution channels and partnerships, including our efforts to expand our marketing, sales and distribution reach through joint ventures and other contractual arrangements;

the cost and timing associated with establishing reimbursement for our products;

the effects of competing technologies and market developments;

the industry demand and patient wellness behavior.

Any failure to complete the development of our product candidates in a timely manner, or any failure to successfully market and commercialize our product candidates, would have a material adverse effect on our

operations, financial position and liquidity.

A discussion of the risks and uncertainties associated with us and our business are set forth under the section entitled “Risk Factors – Risks Related to Our Business”.

The worldwide spread of the COVID-19 virus is expected to result in a global slowdown of economic activity which is likely to decrease demand for a broad variety of products, including from our customers, while

also disrupting supply channels and marketing activities for an unknown period of time until the disease is contained.

Also, the pandemic may cause continued or additional actions by hospitals and clinics such as limiting elective procedures and

treatments and limiting clinical trial activities and data monitoring.

We expect all of these factors to have a negative impact on our sales and our results of operations, the size and duration of which we are currently unable to predict.

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in

accordance with United States generally accepted accounting principles.

The preparation of our consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and

On an ongoing basis, we evaluate our estimates and judgments, including those related to the estimate of the fair value of embedded conversion options and warrants.

We base our estimates on authoritative literature and pronouncements, historical experience and on various other assumptions 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.

Our actual results may differ from these estimates under different assumptions or conditions.

The results of our operations for any historical period

are not necessarily indicative of the results of our operations for any future period.

In addition, there are other items within our financial statements that require estimation but are not deemed critical as defined above.

Changes in these and other

items could still have a material impact upon our financial statements.

The following accounting policies are deemed critical.

Revenue Recognition

We recognize revenue in accordance with two different

Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) standards:

1) Topic 606 and 2) Topic 842.

In accordance with ASC 606, we apply the following the five-step model:

(1) identify the contract(s)

with a customer, (2) identify the performance obligation(s) in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when (or as) the

Company satisfies a performance obligation.

We recognize revenue primarily from the following types of contracts under ASC 606:

(1) sales of products, accessories and parts, (2) licensing fees, (3) other revenue, (4) shipping and handling

The company also recognizes rental revenue under ASC 842 where we have determined that these are operating leases and we recognize the revenue in the period where it is billed to the customer.

However, under the pay per use agreement,

the Company will earn revenues based on the number of times the device is used.

Under the guidance Lease payments based on usage of the device are variable lease payments and should be recorded in the period in which the obligation for the

payment is incurred.

Derivative Liability’s from Embedded

Conversion Options and Warrants – Under ASC Topic 815 the company classified certain convertible instruments as having embedded conversion options which qualified as derivative financial instruments to be separately accounted for.

company also under ASC Topic 815 determined that certain warrants also qualified as derivative financial instruments.

Various valuations models were used to estimate the fair value of these derivative financial instruments that are classified as

derivative liabilities on the consolidated balance sheets.

The models include subjective input assumptions that can materially affect the fair value estimates and as such are subject to uncertainty.

The material assumptions for the selected

subjective inputs have not changed for the reporting period, except for the expected volatility, which is estimated based on the actual volatility during the most recent historical period of time equal to the remaining life of the instruments.

Results of Operations for the Years ended December 31, 2021 and 2020

The following table sets forth our consolidated statement of operations for the fiscal years ended December 31, 2021 and 2020, and the change between the two years

(dollars in thousands):

For the Years Ended

Total Revenue

Cost of Revenues

The following Management’s Discussion and Analysis of Financial Condition and Results of Operations provides information management believes to be relevant to understanding the financial condition and results of

operations of the Company.

The discussion focuses on our financial results of operations for years ended December 31, 2022, and 2021.

You should read this discussion and analysis in conjunction with our consolidated financial statements and related

notes thereto on December 31, 2022, and 2021, and for years 2022, and 2021, which are presented within Part II Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.

Amounts reported in thousands within this annual

report are computed based on the amounts in thousands, and therefore, the sum of the components may not equal the total amount reported in thousands due to rounding.

As discussed in Item 8.

Financial Statements and Supplementary Data, in Note 3, we have restated our unaudited quarterly financial information for the quarter ended

March 31, 2022, quarter and six months ended June 30, 2022, and quarter and nine months ended September 30, 2022.

Accordingly, Management’s Discussion and Analysis of Financial Condition and Results of Operations have been revised for the

effects of this restatement.

Executive Summary

We realized significant revenue growth during the year ended December 31, 2022, with a 29% growth in revenue to $16.7 million for the year ended December 31, 2022, as compared to $13.0 million in 2021.

Gross margins

also increased to 74% from 62% in 2021.

As the Company continues to focus on profitable growth, we have also reduced our operating loss by 37% to $9.0 million for the year ended December 31, 2022.

Net loss for the year ended December 31, 2022, was $10.3 million, or ($0.02) per basic and diluted share, compared to a net loss of $27.3 million, or ($0.05) per basic and diluted share, for the year ended December 31,

We continue to focus on profitable growth and reduction in operating expenses.

We believe these improvements sets the stage for additional growth as we head into 2023.

Results of Operations

The following table sets forth our consolidated statement of operations:

For the Years Ended December 31,

(in thousands)

Cost of revenue

Operating expenses:

2 unchanged sentences

Research and development

Impairment of intangible assets

Depreciation and amortization

2 unchanged sentences

Income tax expense

Revenues and Cost of Revenues

Revenues for the year ended December 31, 2022, were $16.7 million, compared to $13.0 million for the same period in 2021, an increase of $3.7 million or 29%.

Revenue resulted primarily from sales in Europe and

Asia/Pacific of our orthoPACE devices and related applicators and sales in the United States and Asia/Pacific of our dermaPACE ® devices and related applicators as

well as UltraMIST® product sales after the August 6, 2020 Acquisition.

The primary driver for the revenue increase were a full year of sales of the UltraMIST® product for the year ended December 31, 2021, as compared to approximately five months

of sales totaling $3.7 million for the year ended December 31, 2020.

Cost of revenues for the year ended December 31, 2021 were $5.0 million, compared to $1.2 million for the same period in 2020.

The increase in cost of revenues was primarily driven by sales of the UltraMIST®

product subsequent to the August 6, 2020 Acquisition.

Gross profit as a percentage of revenues was 62% for the year ended December 31, 2021, compared to 71% for the same period in 2020.

The decrease in gross profit as a percentage of revenues in

2021 was primarily due the increase in higher margin sales in the third and fourth quarter of 2020 offset by the minimum purchase fee related to the acquisition that was recorded in the first and second quarters of 2021 with no associated

Research and Development Expenses

Research and development expenses for the year ended December 31, 2021 were $1.1 million, compared to $1.2 million for the same period in 2020, a nominal decrease.

The decrease in research and development expenses

in 2021, as compared to 2020, was due to contracting expenses for temporary services, increased services related to the dosage study in Poland and increased expenses related to electrical testing for the device as well as the acquisition of

additional of employee to support the UltraMIST® products that occurred during the year ended December 31, 2020.

Selling and Marketing Expenses

Selling and marketing expenses for the year ended December 31, 2021 were $8.6 million as compared to $5.2 million for the same period in 2020, an increase of $3.4 million, or 66%.

The year-over-year increase in

sales and marketing expenses in 2021 was a result of a full year of sales and marketing expenses related to operating the UltraMIST® business compared to approximately five months of UltraMIST® operations as a result of the August 6, 2020

General and Administrative Expenses

General and administrative expenses for the year ended December 31, 2021 were $11.7 million as compared to $13.7 million for the same period in 2020, a decrease of $2.0 million, or 15%.

The decrease in 2021 as

compared to 2020, was primarily due to the higher costs in 2020 resulting from the acquisition-related transaction expenses, share-based compensation for services, higher lease and payroll-related to costs subsequent to the August 6, 2020

Acquisition, as well as increased consulting and IT costs associated with the integration of the Acquisition.

Impairment of Intangible Assets

During the fourth quarter of 2020, the Company determined that the intangible asset for customer relationships related to the biological products was impaired due to significant shortfalls in

sales of the products during that period compared with the sales projections used to determine the fair value the intangible asset as of the August 6, 2020 acquisition date.

The Company does not expect sales of biological products to sufficiently

At December 31, 2020, the Company recorded a $7.2 million impairment charge for this intangible asset.

The Company has determined that there is no impairment charge for the year ended December 31, 2021.

Depreciation and Amortization Expenses

Depreciation and amortization operating expenses were $784 thousand for the year ended December 31, 2021 versus $781 thousand for the same period of 2020.

Other Income (Expense)

Other income (expense) was a net expense of $13.1 million for the year ended December 31, 2021, as compared to a net expense of $5.7 million for the same period in 2020, a net expense increase of $7.4 million.

change was driven by increased interest expense of $4.7 million, and a loss on the issuance of debt of $3.6 million, partially offset by the decrease of the change in the fair value of derivative liability of $1.2 million.

The increased interest

expense was the result of higher levels of debt outstanding during 2021 compared with 2020 and the change in fair value of the derivative liability relates to warrants issued during 2021.

Net loss for the year ended December 31, 2021 was $27.3 million, or ($0.05) per basic and diluted share, compared to a net loss of $30.9 million, or ($0.08) per basic and diluted share, for the same period in 2020.

The decrease in the net loss was primarily a result of higher 2021 operating and other expenses, partially offset by increases in revenues/gross margin as noted above.

The increase in net sales was primarily driven by the growth

of the UltraMIST ® system.

Cost of Revenue

Cost of revenues for the year ended December 31, 2022, was $4.3 million, compared to $5.0 million for the same period in 2021.

Gross profit as a percentage of revenues was 74% for the year ended December 31, 2022,

compared to 62% for the same period in 2021.

The increase in gross profit as a percentage of revenues in 2022 was primarily due to the increase in sales of the UltraMIST system which has higher profit margins.

General and Administrative

General and administrative expenses for the year ended December 31, 2022, were $12.6 million as compared to $11.7 million for the same period in 2021, an increase of $0.9 million, or 7%.

The increase in 2022 as

compared to 2021, was primarily due to the higher legal costs related to patent work and securities work.

Selling and Marketing

Selling and marketing expenses for the year ended December 31, 2022, were $7.4 million as compared to $8.6 million for the same period in 2021, a decrease of $1.1 million, or 13%.

The year-over-year decrease in sales

and marketing expenses in 2022 was a result of cost saving initiatives taken by management.

Research and Development

Research and development expenses for the year ended December 31, 2022, were $0.6 million, compared to $1.1 million for the same period in 2021.

The decrease in research and development expenses in 2022, as compared to

2021, was primarily due to the reduction in employees.

Other Income (Expense), net

Other expense, net consists of the following:

Interest expense

Change in fair value of derivatives

Loss on issuance of debt

Gain/(loss) on extinguishment of debt

Loss on foreign currency exchange

Other expense, net

nm - not meaningful

Other expense totaled $1.3 million for the year ended December 31, 2022, as compared $13.1 million for the same period in 2021, a decrease of $11.8 million or 90%.

The decrease was primarily driven by an increased gain

from the change in the fair value of derivative liability of $19.3 million, offset by increased interest expense of $7.0 million.

The increased interest expense was the result of higher levels of debt outstanding during 2022, due to new issuances of

convertible debt, compared with 2021.

The change in fair value of the derivative liability relates to warrants issued during 2022 with the convertible debt.

Liquidity and Capital Resources

As of December 31, 2021, our cash, cash equivalents and marketable securities totaled $.6 million.

We have incurred a net loss of $27.3 million and $30.9 million for the years ended

December 31, 2021 and 2020, respectively and cash used for operating and capital investment in the business was $6.9M We expect to

continue to incur substantial negative cash flows from operations for the first half of 2022

Our expected cash requirements for the next 12 months and beyond are largely based on the commercial success of our products and the level of

targeted investment in our commercial strategies.

These conditions as well as the events of default on various notes payable raise substantial doubt about our ability to continue as a going concern.

We have historically funded our operations from the sale of our common stock, issuance of notes payable, and the exercise of warrants.

year ended December 31, 2021, we received net proceeds of approximately $5.1 million net from such activities, and as of December 31, 2021, our cash, cash equivalents and marketable securities totaled $.6 million.

The company has material cash requirement in 2022 including past due payables, contract obligations to our critical vendors, notes in default, registration and other

penalties related to notes payable, warrants, and registration right agreements.

Management’s plans to address the short-term and liquidity needs are to obtain additional capital in 2022 and 2023 through

convertible into common stock, or secured or unsecured debt.

These possibilities, to the extent available, may be on terms that result in significant dilution to our existing shareholders.

Although no assurances can be given, management believes

that potential additional issuances of equity or other potential financing transactions as discussed above should provide the necessary funding for us.

If these efforts are unsuccessful, we may be required to significantly curtail or discontinue

operations or obtain funds through financing transactions with unfavorable terms .

Beyond the next 12 months, we expect to devote substantial resources for the commercialization of the dermaPACE ® System and will continue to research and develop the next generation of our technology as well as the non-medical uses of the PACE

technology, both of which will require additional capital resources.

We also plan to devote resources to the continued commercialization of the dermaPACE and UltraMIST ® product including hiring of new employees, expansion of our

international business and continued research and development of next generation of our technology as well as non-medical uses of our technology

Our existing resources are unlikely to allow us to conduct all the activities that we believe could be beneficial for our future growth.

result, we will need to seek additional funds in the future or curtail or forgo some or all such activities.

If we seek to and are unable to raise funds on favorable terms, or at all, we may not be able to support our commercialization efforts

or increase our research and development activities and the growth of our business may be negatively impacted.

As a result, we may be unable to compete effectively.

Changes, including those relating to the payer and competitive landscape, our

commercialization strategy, our development activities and regulatory matters, may occur beyond our control that would cause us to consume our available capital more quickly.

Master Equipment Lease

On January 26, 2018, the Company entered into a Master Equipment Lease with NFS Leasing Inc.

(“NFS”) to provide financing for equipment purchases to enable the Company to begin

placing the dermaPACE ® System in the marketplace.

This agreement provides for a lease line of up to $1,000,000 with a

term of 36 months, and grants NFS a security interest in the Company’s accounts receivable, tangible and intangible personal property and cash and deposit accounts of the Company.

In 2020 and 2021, the Company entered into additional

equipment leases under the Master Equipment Lease and they are included in property, plant and equipment as a right of use asset with a related finance lease liability in our consolidated balance sheets.

Series C convertible preferred stock certificate of designation

On January 31, 2020, the Company filed a Certificate of Designation of Preferences, Right and Limitations of Series C Convertible Preferred Stock of the Company with the Nevada Secretary of State which amended our

Articles of Incorporation to designate 90 shares of our preferred stock as Series C Convertible Preferred Stock.

Although we have no other shares of preferred stock currently outstanding and no present

intention to issue any additional shares of preferred stock or to create any additional series of preferred stock, we may issue such shares in the future.

Convertible notes payable

On August 6, 2020, the Company entered into a letter agreement (the “HealthTronics Agreement”) with HealthTronics pursuant to which the Company paid off all outstanding debt due and owed to

HealthTronics, including the notes payable.

Pursuant to the HealthTronics Agreement, as consideration for the extinguishment of the debt due to HealthTronics, (i) the Company paid to HealthTronics an amount in cash equal to $4.0 million, (ii)

HealthTronics exercised all of its outstanding Class K Warrants to purchase 7,200,000 shares of common stock, (iii) the Company issued to HealthTronics a convertible note payable in the amount of $1.4 million, and (iv) the Company and

HealthTronics entered into a Securities Purchase Agreement dated August 6, 2020 pursuant to which the Company issued to HealthTronics an aggregate of 8,275,235 shares of common stock and an accompanying Class E warrant to purchase up to an

additional 8,275,235 shares of common stock.

The warrant has an exercise price of $0.25 per share and a three-year term.

The convertible promissory note, with principal amount of $1.4 million, matured on August 6, 2021 and has not been repaid.

The Company’s failure to pay the outstanding principal balance when

due constituted an event of default under the terms of the convertible note payable and, accordingly, it began accruing interest of 2% in addition to the 12% initial rate as of the date of the default.

In the event that the Seller Note has not been repaid prior to January 1, 2021, HealthTronics may elect to convert the outstanding principal amount plus any accrued but unpaid interest thereon

into shares of the Company’s common stock, at a conversion price of $0.10 per share.

As this conversion option is contingent, the conversion option has not been bifurcated from the host instrument as of December 31, 2020.

The convertible

promissory note is expressly subordinate to the NWPSA “Senior Secured Notes” described in Note 13.

The Company may prepay the outstanding principal balance, together with any accrued but unpaid interest without premium or penalty.

On May 28, 2020, the Company received proceeds from a loan in the amount of $454 thousand (the “PPP Loan”) from Truist Bank, as lender, pursuant to the Paycheck Protection Program (“PPP”) under

the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”).

The PPP Loan matures on May 28, 2022 and bears interest at a rate of 1% per annum.

Commencing December 12, 2020, the Company is required to pay the lender equal monthly

payments of principal and interest.

The PPP Loan is evidenced by a promissory note dated May 28, 2020 (the “Note”), which contains customary events of default relating to, among other things, payment defaults and breaches of representations,

warranties and covenants.

The PPP Loan may be prepaid by the Company at any time prior to maturity with no prepayment penalties.

All or a portion of the PPP Loan may be forgiven by the U.S.

Small Business Administration (“SBA”) upon application by the Company beginning 60 days but not later than 120 days after loan

approval and upon documentation of expenditures in accordance with the SBA requirements.

The ultimate forgiveness of the PPP Loan is also predicated upon regulatory authorities concurring with management’s good faith assessment that the current

economic uncertainty made the loan request necessary to support ongoing operations.

If, despite the Company’s good-faith belief that given the circumstances the Company satisfied all eligibility requirements for the PPP Loan, the Company is later

determined to have violated any applicable laws or regulations or it is otherwise determined that the Company was ineligible to receive the PPP Loan, the Company may be required to repay the PPP Loan in its entirety and/or be subject to

additional penalties.

In the event the PPP Loan, or any portion thereof, is forgiven pursuant to the PPP, the amount forgiven is applied to outstanding principal.

Under the terms of the PPP Loan, the Company may be eligible for full or partial

loan forgiveness in the third quarter of 2020.

The Company completed the application for loan forgiveness during the third quarter of 2021.

The Company received a letter from the SBA dated August 27, 2021 forgiving $454 thousand of the PPP Loan

principal and $6 thousand of interest.

On June 10, 2020, the Company secured a loan offered by the U.S.

Small Business Administration (“SBA”) under its Economic Injury Disaster Loan assistance program (“EIDL”) in light of the impact

of COVID-19 pandemic on the Company’s business.

The principal amount of this loan was $150 thousand and interest accrued at the rate of 3.75% per annum.

This loan was repaid in full on August 5, 2020 with proceeds from the NWPSA Senior Notes as

part of the conditions of that agreement.

Senior Secured promissory notes

On August 6, 2020, the Company entered into a Note and Warrant Purchase and Security Agreement (the “NWPSA”), with the noteholder party thereto and NH Expansion Credit Fund Holdings LP, as

As a result, the Company issued a $15,000,000 Secured Promissory Note (the “Senior Notes”) and Warrant exercisable into shares of the Company’s common stock (the “Warrant”) in exchange for cash to support operations, repay outstanding debt

and close on the acquisition of the UltraMIST® assets from Celularity, among other transactions.

The Company received net proceeds from issuing the Notes and NH Warrant of $13.3 million.

The NWPSA provides for (i) the sale and purchase of secured

notes in an aggregate original principal amount of $15 million and (ii) the issuance of 13,091,160 warrants equal to 2.0% of the fully-diluted common stock of the Company as of the issue date.

The warrant has an exercise price of $0.01 per share

and a 10-year term.

The warrant agreement contains a put option.

Upon payment in full of the Note, the holder has the ability to require the Company to purchase the warrants from the holder for cash.

Accordingly, the warrant has been classified

as a derivative liability.

The holder has the option to exercise the put any time between the payment of the Note and the expiration of the warrants.

The Note has a maturity date of September 30, 2025 and accrues interest at a rate that is the

(a) the greater of the quarter end prime rate or 3% plus (b) 9%, due in quarterly arrears.

The Senior Notes are secured by substantially all assets of the Company including in the event of default placing bank accounts under a control

agreement, copyrights, trademarks, patents, applications, registered and unregistered, licenses, designs, held or acquired after August 6, 2020 by the Company.

The Company was in default of the minimum liquidity provisions of the Senior Secured Promissory Notes beginning in October 2020 and, accordingly, the Senior Promissory Notes began accruing

interest of 5.0% in addition to the stated rate as of the date of default.

Convertible promissory notes – 2020

On August 6, 2020, the Company entered into an asset purchase agreement with Celularity, pursuant to which the Company acquired Celularity’s UltraMIST® assets.

A portion of the aggregate

consideration of $24.0 million paid for the assets included the issuance of a promissory note to Celularity in the principal amount of $4.0 million.

The Seller Note had a maturity date of August 6, 2021 and was not repaid.

The Company’s failure

to pay the outstanding principal balance when due constituted an event of default under the terms of the Seller Note and, accordingly, it began accruing additional interest of 5.0% in addition to the 12.0% initial rate, as of the date of default.

In the event that the Seller Note had not been repaid prior to January 1, 2021, Celularity may elect to convert the outstanding principal amount plus any accrued but unpaid interest thereon

into shares of the Company’s common stock, at a conversion price of $0.10 per share.

As this conversion option is contingent on a future event, the conversion option has not been bifurcated from the host instrument as of December 31, 2020.

Seller Note is expressly subordinate to the NWPSA Senior Notes described above under “Senior Secured Promissory Notes.” The Company may prepay the outstanding principal balance, together with any accrued but unpaid interest without premium or

On June 5, 2020, the Company entered into a Securities Purchase Agreement with investor LGH Investments LLC (the “Investor”) for (i) a Promissory Note (the “Convertible Promissory Note”) in the

original principal amount of $1.2 million, convertible into shares of common stock, (ii) warrants entitling the Investor to acquire 1,075,000 shares of common stock (the “Warrants”) and (iii) 200,000 restricted common shares in the Company as an

inducement grant (the “Inducement Shares”).

Such note contained certain default provisions, as defined, resulting in net proceeds of $1.1 million.

As part of the Securities Purchase Agreement, the Company established a reserve of shares of its

authorized but unissued and unreserved common stock in the amount of 11,000,000 shares for purposes of exercise of the Warrant or conversion of the Convertible Promissory Note.

The Convertible Promissory Note matures on February 5, 2021 and

includes a one-time interest charge of 8% to be applied on the issuance date to the original principal amount.

The Investor can convert the Convertible Promissory Note and interest at any time prior to maturity to the number of shares of common

stock, equal to the amount obtained by dividing (i) the amount of the unpaid principal and interest on the note by (ii) $0.25.

The Warrants have an exercise price of $0.35 per share and have a term of five years and recorded as a liability by the

With respect to the Inducement Shares, in the event the Company’s share price has declined on the date on which the Investor seeks to have the restricted legend removed on such shares, the Company agrees to issue the Investor additional

shares such that the aggregate value of the Inducement Shares equals the aggregate value of the Inducement Shares as of June 5, 2020.

The Inducement Shares were issued on September 11, 2020 and included in common stock and additional paid in

We may also attempt to raise additional capital if there are favorable market conditions or other strategic considerations even if we have sufficient funds for planned operations.

To the extent that we raise

additional funds by issuance of equity securities, our shareholders will experience dilution and we may be required to use some or all of the net proceeds to repay our indebtedness, and debt financings, if available, may involve restrictive

covenants or may otherwise constrain our financial flexibility.

To the extent that we raise additional funds through collaborative arrangements, it may be necessary to relinquish some rights to our intellectual property or grant licenses on terms

that are not favorable to us.

In addition, payments made by potential collaborators or licensors generally will depend upon our achievement of negotiated development and regulatory milestones.

Failure to achieve these milestones would harm our

future capital position.

April 2021 Securities Purchase Agreement and Warrants

On April 20, 2021, the Company entered into a Securities Purchase Agreement (the “Leviston Purchase Agreement”), with Leviston Resources, LLC, an accredited investor (“Leviston”) for the sale

by the Company in a private placement (the “Private Placement”) of (i) the Company’s future advance convertible promissory note in an aggregate principal amount of up to $3.4 million (the “Leviston Note”) and (ii) a warrant to purchase an

additional 16,666,667 shares of common stock of the Company (the “Leviston Warrant”).

The Leviston Warrant has an exercise price of $0.18 per share and a four-year term.

The closing of the Private Placement occurred on April 20, 2021 (the

“Leviston Closing Date”).

As noted above, on April 20, 2021, the Company issued the Leviston Note to the Purchaser in an aggregate principal amount of up to $3.4 million (the “Aggregate Amount”), which shall be

advanced in disbursements by the Purchaser (“Leviston Disbursements”), as set forth in the Leviston Note.

On May 14, 2021, the Leviston Note was amended to increase the Aggregate Amount to $4.2 million.

On April 21, 2021, the Purchaser advanced

a Leviston Disbursement of $750 thousand, which is net of an original issue discount of 8%.

On May 14, 2021, the Purchaser advanced a second Leviston Disbursement of $750 thousand, also net of an original issue discount of 8%.

A $250 thousand

Leviston Disbursement was made on September 3, 2021, which was subject to the same terms and conditions of the April and May Leviston Disbursements.

In addition, a $500 thousand disbursement was made on September 3, 2021 in accordance with

notes issued to five institutional investors (the “Five Institutions’ Notes”), which were subject to substantially the same terms and conditions as the Leviston Disbursements.

Cash flows (uses) from operating, investing and financing activities - For the years ended December 31, 2021 and 2020, net cash used by operating

activities was $6.4 million and $12.7 million, respectively, primarily consisting of compensation costs, research and development activities and general corporate operations.

The decrease in the use of cash for operating activities for the year

ended December 31, 2021, as compared to the same period for 2020, of $6.1 million, or 47%, was primarily due to the decrease in the net loss, a decrease in accounts receivable, as well as decreases in accrued interest, and interest payable,

related parties, partially offset by increases in certain non-cash expenses, such as depreciation and amortization, bad debt expense, amortization of debt issuance costs and original issue discount, and change in fair value of derivative

liability and increases in accounts payable and accrued expenses.

Net cash used by investing activities in 2021 was $529 thousand as compared to net cash used by investing activities of $20.1 million in 2020.

The decrease is primarily due to the $20,000,000 Acquisition of

UltraMIST® on August 6, 2020.

Net cash provided by financing activities for the year ended December 31, 2021 was $5.1 million, which consisted of proceeds from convertible promissory notes of $1.9 million, cash received from accounts receivable

factoring of $1.7 million, proceeds from notes payable of $940 thousand, less principal payments of $436 thousand on debt and finance lease obligations.

Net cash provided by financing activities for the year ended December 31, 2020 was $33.4

million, which consisted of proceeds from PIPE offerings of $21.4 million, proceeds from notes payable of $13.3 million, advances from related parties of $23 thousand, net proceeds from sales of convertible preferred stock and convertible

promissory notes totaling $3.6 million, proceeds from SBA loans of $614 thousand, and proceeds from exercises of stock options and warrants totaling $48 thousand, less principal payments totaling $5.6 million on debt and finance lease

Cash and cash equivalents decreased by $1.8 million for the year ended December 31, 2021 and cash and cash equivalents increased by about $676 thousand for the year ended December 31, 2020.

Contractual Obligations

Our major outstanding contractual obligations relate to operating leases for our two facilities and office equipment, as well purchase and supplier obligations for product component materials and equipment, and our

notes payable, related parties.

In August 2016, we entered into a lease agreement for 7,500 square feet of office space for office, research and development, quality control, production and warehouse space which expired on December 31, 2021.

February 1, 2018, we entered into an amendment to the lease agreement for an additional 380 square feet of office space for storage which expired on December 31, 2021.

On January 2, 2019, we entered into a second amendment to the lease agreement

for an additional 2,297 square feet of office space for office space which expired on December 31, 2021.

Under the terms of the lease, we pay monthly rent of $14,651, subject to a 3% adjustment on an annual basis.

As part of its August 6, 2020 Acquisition, we became party to a lease agreement for 8,199 square feet of office space for office, research and development, quality control, and warehouse space which expires on

August 31, 2023.

Under the terms of the lease, the Company pays monthly rent of $7,051, with escalation of approximately 2% on May 1 of each lease year.

Also on August 6, 2020, the Company became party to a lease for office equipment that requires monthly payments of $669 through May 31, 2025.

We have developed a network of suppliers, manufacturers, and contract service providers to provide sufficient quantities of product component materials for our products through the development, clinical testing and

commercialization phases.

We have a manufacturing supply agreement with Swisstronics Contract Manufacturing AG in Switzerland, a division of Cicor Technologies Ltd., covering the generator box component of our

PACE devices.

We have a manufacturing supply agreement with Minnetronix for the UltraMIST® devices and the Dynamic Group for UltraMIST® applicators.

Celularity is our current supplier of the Biovance and Interfyl product lines.

Subsequent Events, for information regarding disputes with Celularity and Minnetronix.

On August 6, 2020 the Company assumed obligations for a purchase order for UltraMIST® devices from Celularity related to purchases of UltraMIST® devices from Minnetronix.

This purchase order had a remaining

purchase commitment of $1,058,170.

This purchase agreement also calls for production delay fees of 1.25% of the committed inventory if the Company delays production.

There is also a cancelation clause of 20% of the remaining balance in the event

that the Company delays production for more than six months.

For additional details, see “Contingencies” in Note 20 of the Notes to Consolidated Financial Statements.

Since inception, the Company has incurred losses from operations each year.

As of December 31, 2022, we had an accumulated deficit of $194.2 million.

Historically, our operations

have primarily been funded from the sale of capital stock, notes payable, and convertible debt securities.

In August and November 2022, the Company raised new funding through two issuances of convertible notes payable with an aggregate principal

amount of $20.2 million, consisting of $16.0 million in newly raised capital and $4.2 million in refinanced accrued expenses, previous notes payable, and fees.

The convertible notes bear interest at a rate of 15% per annum and have a conversion

price of $0.04 per share of common stock.

The conversion price of the convertible notes is subject to adjustment, including if the Company issues or sells shares of common stock for a price per share less than the

conversion price of the convertible notes or if the Company lists its shares of common stock on The Nasdaq Capital Market and the average volume weighted average price of such common stock for the five trading days preceding such listing is less

than $0.04 per share;

provided, however, that the conversion price shall never by less than $0.01.

The August and November 2022 financings also included two tranches of warrants, each of which is exercisable for an aggregate of 504.4 million shares of common stock at exercise prices of $0.04, and $0.067,

respectively.

The exercise price of the warrants is subject to adjustment, including if the Company issues or sells shares of common stock or Share Equivalents (as defined in the warrants) for an effective

consideration price less than the exercise price of the warrants or if the Company lists its shares of common stock on The Nasdaq Capital Market and the average volume weighted average price of such common stock for the five trading days

preceding such listing is less than $0.04 per share;

provided, however, that the exercise price of the warrants shall never be less than $0.01 per share.

The warrants have a five-year term.

In August 2020, the Company issued a Senior Secured Promissory Note Payable (the “Senior Secured Note”) to NH Expansion Credit Fund Holdings L.P.

pursuant to which the Company had outstanding debt of

$19.2 million as of December 31, 2022.

Interest is charged at the greater of the prime rate or 3% plus 9%, paid quarterly.

As of December 31, 2022, the Company is in default of the minimum liquidity provisions on the Senior Secured Note and, as a

result, is accruing interest at the default interest rate of an incremental 5%.

Interest expense on the Senior Secured Note totaled $5.9 million and $3.1 million for the years ended December 31, 2022, and 2021, respectively.

See Notes 10 and 11 to the consolidated financial statements in Part II Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information regarding additional debt

commitments, the convertible notes and accompanying warrants issued in August and November 2022, and the Senior Secured Note.

The following table presents summarized cash flow information:

For the period ended December 31,

(in thousands)

Cash flows used by operating activities

Cash flows provided by (used by) investing activities

Cash flows provided by financing activities

Cash Flows from Operating Activities

The largest driver of cash flows from operations is the change in fair value of derivative liabilities connected to our convertible debt and warrants issued with the August and November 2022

The Company recognized a gain on these liabilities of $16.7 million for the year ended December 31, 2022, and a loss totaling $2.6 million for the year ended December 31, 2021.

Cash Flows Provided by Financing Activities

Cash flows provided by financing activities increased primarily from the proceeds of $16.2 million from the issuance of the convertible promissory notes discussed above in this section, Liquidity and

Capital Resources.

Going Concern

The continuation of our business is dependent upon raising additional capital to fund operations.

We expect to devote substantial resources for the expansion and continued

commercialization of our UltraMist and PACE systems, which will require additional capital resources.

This, as well as the events of default on various notes payable, raise substantial doubt about our ability to continue as a going concern.

Management plans to obtain additional capital in 2023 through the conversion of outstanding warrants, issuance of common or preferred stock, securities convertible into common stock, or secured or unsecured debt.

These possibilities, to the

extent available, may be on terms that result in significant dilution to our existing stockholders.

Although no assurances can be given that our plans to obtain additional capital will be successful or on the terms or timeline we expect,

or at all, management believes that potential additional issuances of equity or other potential financing transactions, as discussed above, should provide the necessary funding for us over the next 12 months.

efforts are unsuccessful, we may be required to significantly curtail or discontinue operations or obtain funds through financing transactions with unfavorable terms.

The Company aims to achieve positive operating cash flows in the first half of 2023 as resources are devoted to grow revenue of the UltraMIST and PACE systems while managing

operating spend.

We believe that sales growth and positive operating cash flows will be enabled by investment in new leadership in sales, operations, and finance departments and strategically managing spend to enable growth.

See Note 2 to the consolidated financial statements in Part II Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K for additional information on our ability to continue as a going

Critical Accounting Policies and Estimates

We have used various accounting policies to prepare the consolidated financial statements in accordance with U.S.

Our significant accounting policies are disclosed in Note 4 to the consolidated financial

statements in Part II Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.

The preparation of the consolidated financial statements, in conformity with U.S.

GAAP, requires us to use judgment in making estimates and assumptions that affect the reported amounts of assets, liabilities, revenues,

and expenses.

These estimates reflect our best judgment about economic and market conditions and the potential effects on the valuation and/or carrying value of assets and liabilities based upon relevant information available.

We base our estimates

on historical experience and on various assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent

from other sources.

The following accounting policies and estimates are deemed critical:

Litigation Contingencies

We may be involved in legal actions involving product liability, intellectual property and commercial disputes, tax disputes, and governmental proceedings and investigations.

The outcomes of these legal actions are not

completely within our control and may not be known for prolonged periods of time.

In some actions, the enforcement agencies or private claimants seek damages that could require significant expenditures or result in lost revenues or limit our ability

to conduct business in the applicable jurisdictions.

Estimating probable losses from our litigation and governmental proceedings is inherently difficult, particularly when the matters are in early procedural stages, with incomplete scientific facts

or legal discovery;

involve unsubstantiated or indeterminate claims for damages;

potentially involve penalties, fines, or punitive damages;

or could result in a change in business practice.

The Company records a liability in the consolidated

financial statements for loss contingencies when a loss is known or considered probable, and the amount may be reasonably estimated.

If the reasonable estimate of a known or probable loss is a range, and no amount within the range is a better

estimate than any other, the minimum amount of the range is accrued.

If a loss is reasonably possible but not known or probable, and may be reasonably estimated, the estimated loss or range of loss is disclosed.

Our significant legal proceedings are

discussed in Note 21 to the consolidated financial statements in Part II Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.

Derivative Liability’s from Embedded Conversion Options and Warrants

The Company classified certain convertible instruments as having embedded conversion options which qualified as derivative financial instruments to be separately accounted for.

The Company also

determined that certain warrants also qualified as derivative financial instruments.

Various valuations models were used to estimate the fair value of these derivative financial instruments that are classified as derivative liabilities on the

consolidated balance sheets.

The models include subjective input assumptions that can materially affect the fair value estimates and as such are subject to uncertainty.

The material assumptions for the selected subjective inputs have not changed for

the reporting period, except for the expected volatility, which is estimated based on the actual volatility during the most recent historical period equal to the remaining life of the instruments.

Valuation of Intangible Assets and Goodwill

When we acquire a business, the assets acquired, and liabilities assumed are recorded at their respective fair values at the acquisition date.

Goodwill is the excess of the purchase price over the estimated fair value

of net assets of acquired businesses.

Intangible assets primarily include patents, trademarks, and customer relationships.

Determining the fair value of intangible assets acquired as part of a business combination requires us to make significant

These estimates include the amount and timing of projected future cash flows of each project or technology, the discount rate used to discount those cash flows to present value, and the assessment of the asset’s life cycle.

The estimates

could be impacted by legal, technical, regulatory, economic, and competitive risks.

The test for impairment of goodwill requires us to make several estimates to determine the fair value of the goodwill.

Our estimates associated with the goodwill

impairment test are considered critical due to the amount of goodwill recorded on our consolidated balance sheets and the judgment required in determining fair value.

We assess the impairment of goodwill at the consolidated level annually.

test definite-lived intangible assets for impairment when an event occurs, or circumstances change that would indicate the carrying amount of the assets or asset group may be impaired.

We assess the impairment of indefinite-lived intangible assets

annually and whenever an event occurs, or circumstances change that would indicate that the carrying amount may be impaired.

Our assessment for goodwill and intangible assets impairment is based on future cash flows that require significant judgment

with respect to future revenue and expense growth rates and other assumptions and estimates.

We use estimates that are consistent with the highest and best use of the assets based on a market participant’s view of the assets being evaluated.

results may differ from our estimates due to several factors including, among others, changes in competitive conditions, regulatory changes, results of clinical trials, and changes in worldwide economic conditions.

Recently Issued Accounting Standards

New accounting pronouncements are issued by the Financial Standards Board (“FASB”) or other standards setting bodies that the Company adopts according to the various timetables the FASB specifies.

The Company does

not expect the adoption of recently issued accounting pronouncements to have a significant impact on the Company’s results of operations, financial position or cash flow.

See Note 3 to the accompanying consolidated financial statements.

Off-Balance Sheet Arrangements

Since inception, we have not engaged in any off-balance sheet activities, including the use of structured finance, special purpose entities or variable interest entities.

Effects of Inflation

Due to the fact that our assets are, to an extent, liquid in nature, they are not significantly affected by inflation.

However, the rate of inflation affects such expenses as employee compensation, office space

leasing costs and research and development charges, which may not be readily recoverable during the period of time that we are bringing the product candidates to market.

To the extent inflation results in rising interest rates and has other

adverse effects on the market, it may adversely affect our consolidated financial condition and results of operations.

Information regarding new accounting pronouncements is included in Note 4 to the consolidated financial statements in Part II Item 8.

“Financial Statements and Supplementary Data” in this Annual Report on Form 10-K.

Restatement of Interim Financial Statements

Results of Operations for the Three Months Ended March 31, 2022

(In thousands)

Three Months ended March 31,

2022 Restated

Cost of revenue

General and administrative

Selling and marketing

Research and development

Depreciation and amortization

Operating Loss

Other Expense

Net Loss before income taxes

Revenues and Gross Margin

Revenues for the three months ended March 31, 2022, were $3.2 million compared to $2.1 million for the same period in 2021, an increase of $1.1

The increase was driven by sales of UltraMIST® devices and single-use accessories.

Gross margin as a percentage of revenue increased to 72.2% from 50.1% during the first quarter of 2022 as compared with the first quarter of the

The increase in gross margin percentages for the quarter was driven by higher sales of single-use accessories, which have a higher gross margin percentage, offset by the discontinuation of Biologics sales, which had a lower gross

margin percentage.

Operating Loss

Operating loss for the three months ended March 31, 2022, totaled $2.0 million loss compared to $4.4 million for the same period in 2021.

decrease in operating loss is due to higher gross margin on UltraMIST as well as a decrease in operating expenses, primarily general and administrative and research and development.

General and administrative expenses decreased $0.9 million or 30% for the three-month period ended March 31, 2022, compared with the same period of

This decrease was primarily due to registration penalties incurred in 2021 as well as a reduction in legal fees.

Research and development expenses decreased 53% to $166 thousand from $354 thousand during the first quarter of 2022 compared with the first quarter

The decrease was primarily due to lower employee compensation in the first quarter of 2022.

Other Expense

Other expense increased for the three months ended March 31, 2022, by $2.6 million to $3.1 million, as compared to $0.5 million for the same period in 2021.

increase in expenses is due to an increase in interest expense of $2.0 million, a loss on the issuance of debt of $3.4 million, partially offset by an increase in the change in fair value of derivatives of $2.8 million.

Results of Operations for the Three and Six Months Ended June 30, 2022

Three Months Ended June 30,

Six Months Ended June 30,

(in thousands)

2022 Restated

Cost of revenues

General and administrative

Selling and marketing

Research and development

Gain on disposal of assets

Depreciation and amortization

Operating loss

Other income (expense), net

Net income (loss) before taxes

Revenues and Gross Margin

Revenues for the three month-period ended June 30, 2022, were $3.9 million compared to $2.9 million for the same period of 2021, an increase of

$1.0 million.

Revenues for the six months ended June 30, 2022, were $7.1 million compared to $5.0 million for the same period in 2021, an increase of $2.1 million.

The increase for both periods was driven by the continued increased sales of

UltraMIST® devices and single-use accessories.

Gross margin as a percentage of revenue increased to 71.8% from 64.0% during three-month period ended June 30, 2022, as compared with the same

period of 2021, and to 71.9% from 58.1% during the six-month period ended June 30, 2022, as compared with the same period of 2021.

The increase in gross margin percentages for the quarter was driven by higher sales of single-use accessories,

which have a higher gross margin percentage, offset by the discontinuation of Biologics sales in the first quarter of 2022, which had a lower gross margin percentage.

Operating Loss

Operating loss decreased $1.0 million to $3.0 million for the three months ended June 30, 2022 as compared to $4.0 million for the same period in

This was due to a decrease in selling and marketing and research and development, partially offset by an increase in general and administrative expenses.

Operating loss decreased $3.4 million to $5.0 million for the six months ended

June 30, 2022, as compared to $8.4 million for the same period in 2021.

The decrease for the six months ended June 30, 2022, was due to a decrease in all operating expense categories.

General and administrative expenses increased $0.8 million to $3.7 million for the three-month periods ended June 30, 2022, as compared to $2.9

million for the same period in 2021.

The increase is due to shares issued to consultants for services and an increase in legal fees for patents.

General and administrative expenses decreased $0.1 million or 2% for the six-month period ended

June 30, 2022, compared with the same period of 2021.

The decrease for the six-month period ended June 30, 2022, was primarily due to a reduction in the registration penalties and legal fees that were incurred during the same period in 2021.

Selling and marketing expenses decreased by $0.8 million or 34% for the three-month period ended June 30, 2022, as compared with the same period of

Selling and marketing expenses decreased by $913 thousand or 21% for the six-month period ended June 30, 2022, as compared with the same period of 2021.

The decrease was primarily due to a reduction in sales and marketing headcount during

Research and development expenses decreased 37% to $0.2 million from $0.3 million during the three-months period ended June 30, 2022, as compared

with the same period of 2021.

Research and development expenses decreased 46% to $0.3 million from $0.6 million during the six-month period ended June 30, 2022, as compared with the same period of 2021.

The decrease was primarily due to lower

employee compensation in 2022.

Other Income (Expense), Net

Other income for the three months ended June 30, 2022, totaled $4.7 million as compared to $4.6 million expense for the same period in 2021.

This change is

due to a gain recognized in the change in fair value of derivative liabilities totaling $7.9 million as compared to a loss totaling $0.5 million for the same period in 2021.

This was partially offset by an increase in interest expense for

the three months ended June 30, 2022, of $1.5 million as compared to the same periods in 2021.

Other income for the six months ended June 30, 2022, totaled $1.5million as compared to expense of $5.1 million for the same period in 2021.

This increase in other income was due to the gain recognized for the change in fair value of derivative liabilities totaling $11.3 million for the six months ended June 30, 2022, as compared to $44 thousand for the same period in 2021.

This was offset by an increase in interest expense totaling $3.5 million for the six months ended June 30, 2022.

Results of Operations for the Three and Nine Months Ended September 30, 2022

Three Months Ended September 30,

Nine Months Ended September 30,

(in thousands)

2022 Restated

Cost of revenues

General and administrative

Selling and marketing

Research and development

Gain on disposal of assets

Depreciation and amortization

Operating loss

Other income (expense), net

Net loss before taxes

Revenues and Gross Margin

Revenues for the three month-period ended September 30, 2022, were $4.2 million compared to $3.7 million for the same period of 2021, an

increase of $0.4 million.

Revenues for the nine months ended September 30, 2022, were $11.2 million compared to $8.7 million for the same period in 2021, an increase of $2.5 million.

The increase for both periods was driven by the continued

increased sales of UltraMIST® devices and single-use accessories.

Gross margin as a percentage of revenue increased to 72.2% from 58.3% during the three-month period ended September 30, 2022, as compared with

the same period of 2021, and to 72.1% from 58.2% during the nine-month period ended September 30, 2022, as compared with the same period of 2021.

The increases in gross margin percentage for the three and nine-months ended September 30,

2022, were driven by higher sales of single-use accessories, which have a higher gross margin percentage, and by the discontinuation of Biologics sales in the first quarter of 2022, which had a lower gross margin percentage.

Operating Loss

Operating loss for the three months ended September 30, 2022 decreased $0.9 million or 25% to $2.5 million, as compared to $3.3 million for the

same period in 2021.

Operating loss also decreased for the nine month period ending September 30, 2022, $4.3 million to $7.5 million operating loss, as compared to $11.8 million for the same period in 2021.

The decreases in operating

expenses are due to decreases in selling and marketing and research and development, offset by increases in general and administrative expenses.

General and administrative expenses increased $634 thousand or 22% for the three-month period ended September 30, 2022, compared with the same

period of 2021.

General and administrative expenses increased $524 thousand or 6% for the nine-month period ended September 30, 2022, compared with the same period of 2021.

The increase for the three-months were primarily due to increased

accounting costs as we transition from contractors to permanent employees.

The increase for the nine-month period ended September 30, 2022, were primarily due to consulting fees incurred in the second quarter and additional legal fees for

Selling and marketing expenses decreased by $500 thousand or 23% for the three-month period ended September 30, 2022, as compared with the same

period of 2021.

Selling and marketing expenses decreased by $1.4 million or 22% for the nine-month period ended September 30, 2022, as compared with the same period of 2021.

The decrease was primarily due to a reduction in sales and marketing

headcount during 2022 and increased cost management activities.

Research and development expenses decreased 47% to $157 thousand from $297 thousand during the three-month period ended September 30, 2022, as

compared with the same period of 2021.

Research and development expense as a percentage of revenue decreased from 8% during the three-month period ended September 30, 2021, to 4% for the same period in 2022.

Expense decreased 46% to $494

thousand, or 4% of revenue, from $923 thousand, or 11% of revenue, during the nine-month period ended September 30, 2022, as compared with the same period of 2021.

These decreases were primarily due to improved cost management in 2022.

Other Income (Expense), Net

Other income for the three and nine months ended September 30, 2022, totaled $1.3 million and $2.9 million, respectively.

This is an increase in income as

compared to expense for the three and nine months ended September 30, 2021, of $0.9 million and $6.0 million, respectively.

The change in derivative liability fair value is the largest driver for the change from other expense in 2021 to other

income in 2022.

The gain on derivative liabilities totaled $5.3 million and $16.6 million for the three and nine months ended September 30, 2022, respectively.

As compared to $1.6 million for the three and nine months ended September 30,

2021, respectively.

This was offset by increased interest expense, due to financings.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not required under Regulation S-K for “smaller reporting companies”.

As a “smaller reporting company” as defined by Item 10 of Regulation S-K, we are not required to provide the information required under this item.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 7. Management’s Discussion and Analysis