What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-02-13 compared with 2023-11-07 · 237 added, 248 removed, 21 unchanged (96% of the section changed)

Management’s Discussion

and Analysis of Financial Condition and Results of Operations.

The following discussion

and analysis of our financial condition and results of operations should be read in conjunction with our unaudited Condensed Financial

Statements and related notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q, and our audited financial

statements and related notes thereto included in Part II, Item 8 of our Annual Report on Form 10-K for the fiscal year ended June

30, 2023 (“fiscal 2023”).

Electromed, Inc.

“our,” “us,” “Electromed” or the “Company”) develops and provides innovative airway

clearance products applying High Frequency Chest Wall Oscillation (“HFCWO”) technologies in pulmonary care for patients

We manufacture, market and sell

products that provide HFCWO, including the SmartVest® Airway Clearance System (“SmartVest System”) that includes

our newest generation SmartVest Clearway® Airway Clearance System (“Clearway”), previous generation SmartVest SQL®,

and related garments and accessories to patients with compromised pulmonary function.

The SmartVest Clearway, which received 510(k)

clearance from the U.S.

Food and Drug Administration in December 2022, provides patients with proven quality of life outcomes while

offering a state-of-the-art patient experience with a simple touch screen user interface, small footprint and lightest HFCWO generator

on the market.

Our products are sold in both

the home health care market and the hospital market for inpatient use, which we refer to as “hospital sales.” Since

2000, we have marketed the SmartVest System and its predecessor products to patients suffering from bronchiectasis, cystic fibrosis,

and other chronic pulmonary conditions which require external chest manipulation to enhance mucus transport.

Additionally, we offer

our products to a patient population that includes neuromuscular disorders such as cerebral palsy, muscular dystrophies, amyotrophic

lateral sclerosis (“ALS”), patients with post-surgical complications or who are ventilator dependent and patients who

have other conditions involving excess secretion and impaired mucus transport.

The SmartVest System is often

eligible for reimbursement from major private insurance providers, health maintenance organizations (“HMOs”), state

Medicaid systems, and the federal Medicare system, which we believe is an important consideration for patients considering an HFCWO

course of therapy.

For domestic sales, the SmartVest System may be reimbursed under the Medicare-assigned billing code (E0483)

for HFCWO devices if the patient has cystic fibrosis, bronchiectasis (including chronic bronchitis or COPD that has resulted in

a diagnosis of bronchiectasis), or any one of certain enumerated neuromuscular diseases and myopathies, and can demonstrate that

another less expensive physical or mechanical treatment did not adequately mobilize retained secretions.

Private payers consider

a variety of sources, including Medicare, as guidelines in setting their coverage policies and payment amounts.

Critical Accounting Estimates

For a description

of our critical accounting estimates and assumptions used in the preparation of our financial statements, including the unaudited

Condensed Financial Statements in this Quarterly Report on Form 10-Q, see Note 1 and Note 2 to our unaudited Condensed Financial

Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q and Part II, Item 7, and Note 1 to our audited financial

statements included in Part II, Item 8, of our Annual Report on Form 10-K for fiscal 2023 .

There were no material

changes in our critical accounting estimates and assumptions since the filing of our Annual Report on Form 10-K for fiscal 2023.

Results of Operations

Net revenues for the

three months ended September 30, 2023 and 2022 are summarized in the table below.

Three Months Ended September 30,

Discussion and Analysis of Financial Condition and Results of Operations.

following discussion and analysis of our financial condition and results of operations should be read in conjunction with our

unaudited Condensed Financial Statements and related notes thereto included in Part I, Item 1 of this Quarterly Report on Form

10-Q, and our audited financial statements and related notes thereto included in Part II, Item 8 of our Annual Report on Form

10-K for the fiscal year ended June 30, 2023 (“fiscal 2023”).

(“we,” “our,” “us,” “Electromed” or the “Company”) develops and

provides innovative airway clearance products applying High Frequency Chest Wall Oscillation (“HFCWO”) technologies

in pulmonary care for patients.

manufacture, market, and sell products that provide HFCWO, including the SmartVest® Airway Clearance System (“SmartVest

System”) that includes our newest generation SmartVest Clearway® Airway Clearance System (“Clearway”), previous

generation SmartVest SQL®, and related garments and accessories to patients with compromised pulmonary function.

The SmartVest

Clearway, which received 510(k) clearance from the U.S.

Food and Drug Administration in December 2022, provides patients with

proven quality of life outcomes while offering a state-of-the-art patient experience with a simple touch screen user interface,

small footprint and lightest HFCWO generator on the market.

products are sold in both the home health care market and the hospital market for inpatient use, which we refer to as “hospital

sales.” Since 2000, we have marketed the SmartVest System and its predecessor products to patients suffering from bronchiectasis,

cystic fibrosis, and other chronic pulmonary conditions which require external chest manipulation to enhance mucus transport.

Additionally, we offer our products to a patient population that includes neuromuscular disorders such as cerebral palsy, muscular

dystrophies, amyotrophic lateral sclerosis (“ALS”), patients with post-surgical complications or who are ventilator

dependent and patients who have other conditions involving excess secretion and impaired mucus transport.

SmartVest System is often eligible for reimbursement from major private insurance providers, health maintenance organizations

(“HMOs”), state Medicaid systems, and the federal Medicare system, which we believe is an important consideration

for patients considering an HFCWO course of therapy.

For domestic sales, the SmartVest System may be reimbursed under the Medicare-assigned

billing code (E0483) for HFCWO devices if the patient has cystic fibrosis, bronchiectasis (including chronic bronchitis or COPD

that has resulted in a diagnosis of bronchiectasis), or any one of certain enumerated neuromuscular diseases and myopathies and

can demonstrate that another less expensive physical or mechanical treatment did not adequately mobilize retained secretions.

Private payers consider a variety of sources, including Medicare, as guidelines in setting their coverage policies and payment

Accounting Estimates

a description of our critical accounting estimates and assumptions used in the preparation of our financial statements, including

the unaudited Condensed Financial Statements in this Quarterly Report on Form 10-Q, see Note 1 and Note 2 to our unaudited Condensed

Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q and Part II, Item 7, and Note 1 to our audited

financial statements included in Part II, Item 8, of our Annual Report on Form 10-K for fiscal 2023 .

were no material changes in our critical accounting estimates and assumptions since the filing of our Annual Report on Form 10-K

for fiscal 2023.

of Operations

revenues for the three and six months ended December 31, 2023 and 2022 are summarized in the table below.

Three Months Ended

Increase (Decrease)

Homecare Revenue

Homecare Distributor Revenue

Hospital Revenue

International Revenue

Total Revenue

Homecare revenue .

Homecare revenue increased by $1,521,000, or 15.8%, for the three months ended September 30, 2023 compared to the same period

in fiscal 2023.

The increase was primarily due to an increase in referrals, approvals and reimbursement rates.

The increase in

referrals was due to an increase in direct sales representatives and the increase in approvals was due to an increase in reimbursement

Increase (Decrease)

Homecare distributor

Homecare distributor revenue increased by $19,000, or 3.4%, for the three months ended September 30, 2023

compared to the same period in fiscal 2023.

Hospital revenue.

Hospital revenue increased by $116,000, or 29.7%, for the three months ended September 30, 2023 compared to the same period

in fiscal 2023.

This increase was primarily due to an increase in sales representatives focused on the hospital market.

International revenue .

International revenue increased by $10,000, or 12.3%, for the three months ended September 30, 2023 compared to the same period

in fiscal 2023.

Gross profit increased

to $9,498,000, or 77.1% of net revenues, for the three months ended September 30, 2023, from $8,331,000 or 78.2% of net revenues,

in the same period in fiscal 2023.

The increase in gross profit in dollars for the three months ended September 30, 2023 was primarily

due to increased revenue.

Gross margin rate decreased year over year as a result of increased material and labor costs.

Operating expenses

Selling, general and

administrative expenses.

Selling, general and administrative (“SG&A”) expenses were $9,150,000 for the three

months ended September 30, 2023, representing an increase of $1,161,000 or 14.5%, compared to the same period in the prior year.

Payroll and compensation-related

expenses increased by $882,000, or 18.1%, to $5,766,000 for the three months ended September 30, 2023, compared to the same period

in the prior year.

The increase was primarily due to salaries and incentive compensation related to the higher average number of

sales, sales support and marketing personnel, and reimbursement personnel to process higher patient referrals.

We have also continued

to provide regular merit-based increases for our employees and are regularly benchmarking our compensation ranges for new and existing

employees to ensure we can hire and retain the talent needed to drive growth in our business.

Field sales employees totaled 59

as of September 30, 2023, 51 of which were direct sales representatives, compared to 53 field sales employees and 44 direct sales

representatives as of September 30, 2022.

Travel, meals and entertainment

expenses increased $23,000, or 2.6%, to $917,000 for the three months ended September 30, 2023, compared to the same period in

the prior year.

The increase was primarily due to the impacts of inflation on airfare and lodging and costs associated with our

annual sales meeting as well as a higher average number of direct sales representatives.

Total discretionary marketing

expenses increased $274,000, or 108.3%, to $527,000 for the three months ended September 30, 2023, compared to the same period

in the prior year.

The increase was primarily due to an investment in market research, direct-to-consumer and direct-to-physician

Professional fees decreased

$120,000, or 8.4%, to $1,311,000 for the three months ended September 30, 2023, compared to the same period in the prior year.

Professional fees are primarily for services related to legal costs, shareowner services and reporting requirements, information

technology technical support and consulting fees.

The decrease was primarily due to legal fees in Q1 fiscal 2023 related to a reimbursement

project that did not recur in Q1 fiscal 2024.

International

Homecare revenue increased by $1,936,000, or 18.0%, for the three months ended December 31, 2023, compared to the same period in the prior year.

For the six months ended December 31, 2023, homecare revenue was $23,821,000, representing an increase of $3,457,000, or 17.0%, compared to the same period in the prior year.

The increase in revenue was due to an increase in direct sales territories and efficiencies recognized within our reimbursement department as a result of recent investments made to streamline the claims process in the six months ended December 31, 2023.

Hospital revenue was $619,000, an increase of $30,000, or 5.1%, for the three months ended December 31, 2023,

compared to the same period in the prior year.

For the six months ended December 31, 2023, hospital revenue was $1,126,000, an

increase of $146,000, or 14.9%, compared to the same period in the prior year.

The increases were primarily due to an increase

in sales representatives focused on the hospital market.

distributor revenue .

Homecare distributor revenue decreased by $56,000, or 16.7%, for the three months ended December

31, 2023, compared to the same period in the prior year.

For the six months ended December 31, 2023, homecare distributor revenue

was $853,000, a decrease of $37,000, or 4.2%, compared to the same period in the prior year.

The decreases in homecare distributor

sales were primarily a result of the timing of distributor purchases that can cause significant fluctuations in reported revenue

on a quarterly basis.

International

International revenue was $122,000, an increase of $50,000, or 69.4%, for the three months ended December

31, 2023, compared to the same period in the prior year.

For the six months ended December 31, 2023, international revenue was

$213,000, an increase of $60,000, or 39.2% over the prior year primarily driven off the timing of international orders.

profit increased to $10,545,000, or 77.0% of net revenues, for the three months ended December 31, 2023, from $8,682,000, or 74.0%

of net revenues, in the same period in the prior year.

Gross profit increased to $20,043,000, or 77.1% of net revenues, for the

six months ended December 31, 2023, from $17,013,000, or 76.0% of net revenues, in the same period in the prior year.

The increases

in gross profit as a percentage of net revenues compared to the same period in the prior year were primarily due to decreased

shipping expenses as well as increased material costs in the prior year to expedite inventory purchases which did not recur in

the current year.

general and administrative expenses.

Selling, general and administrative (“SG&A”) expenses were $8,175,000

and $17,325,000 for the three and six months ended December 31, 2023, respectively, representing increases of $921,000 and $2,082,000,

or 12.7% and 13.7%, respectively, compared to the same periods in the prior year.

and compensation-related expenses were $5,625,000 and $11,390,000 for the three and six months ended December 31, 2023, respectively,

representing increases of $796,000 and $1,301,000, or 16.5% and 12.9%, respectively, compared to the same periods in the prior

The increases in the current year periods were primarily due to salaries and incentive compensation related to the higher

average number of sales, sales support, marketing, and reimbursement personnel to process higher patient referrals.

continued to provide regular merit-based increases for our employees and are regularly benchmarking our compensation ranges for

new and existing employees to ensure we can hire and retain the talent needed to drive growth in our business.

Field sales employees

totaled 58 as of December 31, 2023, 49 of which were direct sales representatives, compared to 57 field sales employees and 48

direct sales representatives as of December 31, 2022.

meals and entertainment expenses were $745,000 and $1,693,000 for the three and six months ended December 31, 2023, respectively,

representing increases of $26,000 and $61,000, or 3.6% and 3.7%, respectively, compared to the same periods in the prior year.

The increases in the current year periods were due to higher travel costs and an increased number of sales territories.

discretionary marketing expenses were $252,000 and $791,000 for the three and six months ended December 31, 2023, respectively,

representing an increase of $70,000 and $422,000, or 38.5% and 114.4%, respectively, compared to the same periods in the prior

The increases were primarily due to an investment in market research, direct-to-consumer and direct-to-physician marketing.

fees were $934,000 and $2,244,000 for the three and six months ended December 31, 2023, respectively, representing decreases of

$97,000 and $218,000, or 9.4% and 8.9%, respectively, compared to the same periods in the prior year.

Professional fees are primarily

for services related to legal costs, shareowner services and reporting requirements, information technology technical support

and consulting fees.

The decreases were primarily due to legal fees in fiscal 2023 related to a reimbursement project that did

not recur in fiscal 2024.

and development expenses .

Research and development (“R&D”) expenses decreased $92,000, or 30.9%, to

$206,000 for the three months ended September 30, 2023 compared to the same period in the prior year.

The decrease was

primarily due to reduced costs associated with our SmartVest Clearway platform development which has now been launched into

the Homecare market.

Interest income, net

interest income increased $73,000, or 1,820.2%, to $77,000 for the three months ended September 30, 2023, compared to the same

period in the prior year.

The increase is due to increased savings rates associated with cash balances.

Income tax expense

Income tax expense was estimated

at $64,000 for the three months ended September 30, 2023 and the income tax benefit was estimated at $33,000 for the three months

ended September 30, 2022.

The effective tax rates were 29.3% and (68.8%) for the three months ended September 30, 2023 and 2022,

respectively.

The income tax expense for the three months ended September 30, 2022 included a discrete tax benefit of $44,000 related

to the exercise of stock options.

Net income for the three

months ended September 30, 2023 was $155,000 compared to $81,000 for the same period in the prior year.

The increase in net income

was primarily due to increased revenue.

Liquidity and Capital Resources

Cash Flows and Sources of Liquidity

Cash Flows from Operating Activities

For the three months ended

September 30, 2023, net cash used in operating activities was $244,000.

Cash flows provided by operating activities consisted of

net income of $155,000, non-cash expenses of $585,000, a decrease in accounts receivable of $675,000 and a decrease of prepaid

expenses of 901,000.

These cash flows from operating activities were offset by a decrease in accrued compensation of $1,174,000,

a decrease in accounts payable and other accrued liabilities of $863,000, an increase in inventory of $240,000, an increase in

contract assets of $57,000 and a decrease in income tax payable of $226,000.

The decrease in accrued compensation was primarily

due to the payment of annual incentives.

Cash Flows from Investing Activities

For the three months

ended September 30, 2023, cash used in investing activities was $133,000.

Cash used in investing activities consisted of $109,000

of expenditures for property and equipment and $24,000 in expenditures for intangible asset costs.

Cash Flows from Financing Activities

For the three months

ended September 30, 2023, cash provided by financing activities was $29,000, consisting of cash received upon stock option exercises.

Adequacy of Capital Resources

Our primary working capital

requirements relate to adding employees to our sales force and support functions, continuing infrastructure investments, and supporting

general corporate needs, including financing equipment purchases and other capital expenditures incurred in the ordinary course

Based on our current operational performance, we believe our working capital of $30,419,000 and available borrowings

under our existing credit facility will provide sufficient liquidity to meet our anticipated working capital and other liquidity

needs for the next twelve months from the date of this report.

Our credit facility provides

us with a revolving line of credit.

Interest on borrowings on the line of credit accrues at the prime rate (8.50% on September

30, 2023) less 1.00% and is payable monthly.

There was no outstanding principal balance on the line of credit as of September 30,

2023 or June 30, 2023.

The amount eligible for borrowing on the line of credit is limited to the lesser of $2,500,000 or 57.00%

of eligible accounts receivable, and the line of credit expires on December 18, 2023, if not renewed.

As of September 30, 2023,

the maximum $2,500,000 was available under the line of credit.

Payment obligations under the line of credit are secured by a security

interest in substantially all of our tangible and intangible assets.

The documents governing

our line of credit contain certain financial and nonfinancial covenants that include a minimum tangible net worth of not less than

$10,125,000 and restrictions on our ability to incur certain additional indebtedness or pay dividends.

Any failure to comply with

these covenants in the future may result in an event of default, which if not cured or waived, could result in the lender accelerating

the maturity of our indebtedness, preventing access to additional funds under the line of credit, requiring prepayment of outstanding

indebtedness, or refusing to renew the line of credit.

If the maturity of the indebtedness is accelerated or the line of credit

is not renewed, sufficient cash resources to satisfy the debt obligations may not be available and we may not be able to continue

operations as planned.

If we are unable to repay such indebtedness, the lender could foreclose on these assets.

For the three months ended

September 30, 2023 and 2022, we spent $109,000 and $241,000, respectively, on property and equipment.

We currently expect to finance

planned equipment purchases with cash flows from operations.

We may need to incur additional debt if we have an unforeseen need

for additional capital equipment or if our operating performance does not generate adequate cash flows.

While the impact of the macroeconomic

factors such as inflation are difficult to predict, we believe our cash, cash equivalents and cash flows from operations will be

sufficient to meet our working capital, capital expenditure, operational cash requirements for fiscal 2024 and the foreseeable

We will continue to evaluate our projected expenditures relative to our available cash and evaluate financing alternatives

in order to satisfy our working capital and other cash requirements.

Information Regarding Forward-Looking Statements

Statements contained in

this Quarterly Report on Form 10-Q that are not statements of historical fact should be considered forward-looking statements within

the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities

Exchange Act of 1934, as amended (the “Exchange Act”).

Forward-looking statements include, but are not limited to,

statements regarding:

our business strategy, including our intended level of investment in R&D and marketing activities;

expectations with respect to earnings, gross margins and sales growth, industry relationships, marketing strategies and international

Research and development (“R&D”) expenses were $107,000 and $313,000 for the three

and six months ended December 31, 2023, respectively, representing decreases of $47,000 and $139,000, or 30.5% and 30.8%, respectively,

compared to the same periods in the prior year.

The decreases were primarily due to reduced costs associated with our SmartVest

Clearway platform development which has now been launched into the Homecare and hospital markets.

interest income for the three and six months ended December 31, 2023, was $96,000 and $173,000, respectively, compared to $7,000

and $11,000, respectively, for the same periods in the prior year.

The increases were primarily due to increased savings rates

on higher cash balances.

tax expense was estimated at $685,000 and $749,000, and the effective tax rate was 28.8% and 28.9%, for the three and six months

ended December 31, 2023, respectively.

Estimated income tax expense for the three and six months ended December 31, 2023 includes

a discrete tax expense of $1,000 and a discrete tax benefit of $1,000, respectively, related to the exercise of stock options.

tax expense was estimated at $304,000 and $271,000, and the effective tax rate was 23.7% and 20.4%, for the three and six months

ended December 31, 2022, respectively.

Estimated income tax expense for the three and six months ended December 31, 2022, includes

a discrete tax expense of $1,000 and a discrete tax benefit of $43,000, respectively, related to the exercise of stock options.

income for the three and six months ended December 31, 2023, was $1,674,000 and $1,829,000, respectively, compared to $977,000

and $1,058,000 for the same periods in the prior year.

The increase in net income in the three months ended December 31, 2023,

and six months ended December 31, 2022, was driven primarily by homecare revenue growth, an increase in gross profit margin, and

an increase in interest income.

and Capital Resources

Flows and Sources of Liquidity

Flows from Operating Activities

six months ended December 31, 2023, net cash provided by operating activities was $3,227,000.

Cash flows provided by operating

activities consisted of net income of $1,829,000, non-cash expenses of $1,214,000, a decrease in accounts receivable of $1,142,000,

and a decrease in prepaid expenses and other assets of $1,104,000.

These cash flows from operating activities were offset by a

decrease in accounts payable and other accrued liabilities of $1,171,000, an increase in inventory of $509,000, a decrease in

accrued compensation of $212,000, an increase in contract assets of $87,000, and a decrease of taxes payable of $83,000.

decrease in accounts receivable is primarily due to an increased focus on cash receipts from our cash collections team.

in prepaid expenses and other assets, as well as the decrease in accounts payable and other accrued liabilities are primarily

due to a litigation settlement payment related to our previously disclosed cyber security breach.

The payment to the settlement

fund during the first quarter of fiscal 2024 for the settlement amount of $825,000 was covered by insurance resulting in a reduction

in other current assets and other accrued liabilities.

Flows from Investing Activities

the six months ended December 31, 2023, cash used in investing activities was $220,000.

Cash used in investing activities consisted

of $180,000 of expenditures for property and equipment and $40,000 in expenditures for intangible asset costs.

Flows from Financing Activities

the six months ended December 31, 2023, cash provided by financing activities was $55,000, consisting of cash received upon stock

option exercises.

of Capital Resources

primary working capital requirements relate to adding employees to our sales force and support functions, continuing infrastructure

investments, and supporting general corporate needs, including financing equipment purchases and other capital expenditures incurred

in the ordinary course of business.

Based on our current operational performance, we believe our working capital of $32,692,000

and available borrowings under our existing credit facility will provide sufficient liquidity to meet our anticipated working

capital and other liquidity needs for the next twelve months from the date of this report.

credit facility provides us with a revolving line of credit.

Interest on borrowings on the line of credit accrues at the prime

rate (8.50% on December 31, 2023) less 1.00% and is payable monthly.

There was no outstanding principal balance on the line of

credit as of December 31, 2023, or June 30, 2023.

The amount eligible for borrowing on the line of credit is limited to the lesser

of $2,500,000 or 57.00% of eligible accounts receivable, and the line of credit expires on December 17, 2025, if not renewed.

As of December 31, 2023, the maximum $2,500,000 was available under the line of credit.

Payment obligations under the line of

credit are secured by a security interest in substantially all our tangible and intangible assets.

documents governing our line of credit contain certain financial and nonfinancial covenants that include a minimum tangible net

worth of not less than $10,125,000 and restrictions on our ability to incur certain additional indebtedness or pay dividends.

failure to comply with these covenants in the future may result in an event of default, which if not cured or waived, could result

in the lender accelerating the maturity of our indebtedness, preventing access to additional funds under the line of credit, requiring

prepayment of outstanding indebtedness, or refusing to renew the line of credit.

If the maturity of the indebtedness is accelerated

or the line of credit is not renewed, sufficient cash resources to satisfy the debt obligations may not be available and we may

not be able to continue operations as planned.

If we are unable to repay such indebtedness, the lender could foreclose on these

the six months ended December 21, 2023, and 2022, we spent $180,000 and $687,000, respectively, on property and equipment.

currently expect to finance planned equipment purchases with cash flows from operations or borrowings under our credit facility.

We may need to incur additional debt if we have an unforeseen need for additional capital equipment or if our operating performance

does not generate adequate cash flows.

the impact of macroeconomic factors such as inflation are difficult to predict, we believe our cash, cash equivalents and cash

flows from operations will be sufficient to meet our working capital, capital expenditure, operational cash requirements for

fiscal 2024 and the foreseeable future.

We will continue to evaluate our projected expenditures relative to our available

cash and evaluate financing alternatives to satisfy our working capital and other cash requirements.

Regarding Forward-Looking Statements

contained in this Quarterly Report on Form 10-Q that are not statements of historical fact should be considered forward-looking

statements within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section

21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

Forward-looking statements include,

but are not limited to, statements regarding:

our business strategy, including our intended level of investment in R&D and

marketing activities;

our expectations with respect to earnings, gross margins and sales growth, industry relationships, marketing

strategies and international sales;

estimated sizes of markets into which our products are or may be sold;

our business strengths and competitive advantages;

our business strengths

and competitive advantages;

our ability to grow additional sales distribution channels;

our intent to retain any earnings for use in operations rather than

paying dividends;

our expectation that our products will continue to qualify for reimbursement and payment under government and

private insurance programs;

our intent to retain any earnings for

use in operations rather than paying dividends;

our expectation that our products will continue to qualify for reimbursement and

payment under government and private insurance programs;

our intellectual property plans and practices;

the expected impact of applicable regulations on our

the expected impact of

applicable regulations on our business;

our beliefs about our manufacturing processes;

our expectations and beliefs with respect to our employees and our relationships

our expectations and beliefs with respect

to our employees and our relationships with them;

our belief that our current facilities are adequate to support our growth plans;

our expectations with respect to ongoing

compliance with the terms of our credit facility;

our expectations regarding the ongoing availability of credit and our ability

to renew our line of credit;

our expectations with respect to ongoing compliance with the terms of our credit facility;

our expectations regarding the ongoing

availability of credit and our ability to renew our line of credit;

enhancements to our products and services;

expected excise tax exemption for the SmartVest System;

expected excise

tax exemption for the SmartVest System;

and our anticipated revenues, expenses, capital requirements and liquidity.

Words such as “anticipate,” “believe,”

“continue,” “could,” “estimate,” “expect,” “intend,” “may,”

“ongoing,” “plan,” “potential,” “project,” “goal,” “target,”

“should,” “will,” “would,” and similar expressions, including the negative of these terms,

are intended to identify forward-looking statements but are not the exclusive means of identifying such statements.

believe these forward-looking statements are reasonable, they involve risks and uncertainties that may cause actual results to

differ materially from those projected by such statements.

Such statements involve known and unknown risks, uncertainties and other

factors that may cause our actual results or our industry’s actual results, levels of activity, performance or achievements

to be materially different from the information expressed or implied by the forward-looking statements.

Factors that could cause

actual results to differ from those discussed in the forward-looking statements include, but are not limited to, the following:

• ability to obtain reimbursement from Medicare, Medicaid, or private insurance

payers for our products including potential adverse impact with an expiration of the Centers for Medicare and Medicaid Services

waiver for certain respiratory diseases;

• component or raw material shortages, changes to lead times or significant

price increases;

• adverse changes to state and federal health care regulations;

• our ability to maintain regulatory compliance and to gain future regulatory

approvals and clearances;

• entry of new competitors including new drug or pharmaceutical discoveries;

• adverse economic and business conditions or intense competition;

• the risks associated with our planned salesforce expansion;

• wage and component price inflation;

• technical problems with our research and products;

• the risks associated with cyberattacks, data breaches, computer viruses

and other similar security threats;

• changes affecting the medical device industry;

• our ability to develop new sales channels for our products such as the homecare

distributor channel;

• adverse international health care regulation impacting current international

• our ability to renew our line of credit or obtain additional credit as necessary;

• our ability to protect and expand our intellectual property portfolio.

as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”

“intend,” “may,” “ongoing,” “plan,” “potential,” “project,”

“goal,” “target,” “should,” “will,” “would,” and similar expressions,

including the negative of these terms, are intended to identify forward-looking statements but are not the exclusive means of

identifying such statements.

Although we believe these forward-looking statements are reasonable, they involve risks and uncertainties

that may cause actual results to differ materially from those projected by such statements.

Such statements involve known and

unknown risks, uncertainties and other factors that may cause our actual results or our industry’s actual results, levels

of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking

that could cause actual results to differ from those discussed in the forward-looking statements include, but are not limited

to, the following:

to obtain reimbursement from Medicare, Medicaid, or private insurance payers for our

products including potential adverse impact with an expiration of the Centers for Medicare

and Medicaid Services waiver for certain respiratory diseases;

or raw material shortages, changes to lead times or significant price increases;

changes to state and federal health care regulations;

ability to maintain regulatory compliance and to gain future regulatory approvals and

of new competitors including new drug or pharmaceutical discoveries;

economic and business conditions or intense competition;

risks associated with our planned salesforce expansion;

and component price inflation;

problems with our research and products;

risks associated with cyberattacks, data breaches, computer viruses and other similar

security threats;

affecting the medical device industry;

ability to develop new sales channels for our products such as the homecare distributor

international health care regulation impacting current international business;

ability to renew our line of credit or obtain additional credit as necessary;

ability to protect and expand our intellectual property portfolio.

list of factors is not exhaustive, however, and these or other factors, many of which are outside of our control, could have a

3 unchanged sentences

Forward-looking

statements speak only as of the date on which the statements are made, and we undertake no obligation, and expressly disclaim any

such obligation, to update any forward-looking statement for any reason other than as required by law, even if new information

statements speak only as of the date on which the statements are made, and we undertake no obligation, and expressly disclaim

any such obligation, to update any forward-looking statement for any reason other than as required by law, even if new information

becomes available or other events occur in the future.

4 unchanged sentences

are expressly qualified in their entirety by the cautionary statements set forth herein.

Quantitative and Qualitative Disclosures About Market Risk.

As a smaller reporting company, we are not required

to provide disclosure pursuant to this Item.

and Qualitative Disclosures About Market Risk.

a smaller reporting company, we are not required to provide disclosure pursuant to 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-Q

Item 2. Management’s Discussion and Analysis