What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-02-11 compared with 2024-11-12 · 278 added, 224 removed, 23 unchanged (96% of the section changed)

Management’s 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, 2024 (“fiscal 2024”).

(“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 November 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 generator footprint and comfortable, lightweight vests.

products are sold in both the homecare 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 2024 .

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

for fiscal 2024.

of Operations

revenues for the three months ended September 30, 2024, and 2023 are summarized in the table below.

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, 2024 (“fiscal 2024”).

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 November 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 generator footprint and comfortable,

lightweight vests.

Our products are sold in both

the homecare 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 2024 .

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 2024.

Results of Operations

Net revenues for the

three and six months ended December 31, 2024, and 2023 are summarized in the table below.

Three Months Ended December 31,

Six Months Ended

Homecare distributor

Homecare revenue.

Homecare revenue increased by $1,925,000 or 15.2%, for the three months ended December 31, 2024, compared to the same period

in the prior year.

For the six months ended December 31, 2024, homecare revenue was $27,804,000, representing an increase of $3,983,000,

or 16.7%, compared to the same period in the prior year.

The increases were primarily due to increases in referrals and approvals,

driven by an increase in direct sales representatives, higher net revenues per approval, and efficiencies within our reimbursement

Hospital revenue.

Hospital revenue was $723,000, an increase of $104,000, or 16.8%, for the three months ended December 31, 2024, compared

to the same period in the prior year.

For the six months ended December 31, 2024, hospital revenue was $1,413,000, an increase

of $287,000, or 25.5%, compared to the same period in the prior year.

The increases were primarily due to increased capital and

disposable demand.

Homecare distributor

Homecare distributor revenue increased by $527,000, or 188.2%, for the three months ended December 31,

2024, compared to the same period in the prior year.

For the six months ended December 31, 2024, homecare distributor revenue was

$1,394,000, an increase of $541,000, or 63.4%, compared to the same period in the prior year.

The increases 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 and increased demand from our distribution partners.

Other revenue .

Total Revenue

Homecare revenue increased by $2,058,000, or 18.5%, for the three months ended September 30, 2024, compared

to the same period in fiscal 2024.

The increase in revenue was due to an increase in referrals driven by an increase in direct

sales representatives, higher net revenues per approval, and efficiencies within our reimbursement department.

Hospital revenue increased by $183,000, or 36.1%, for the three months ended September 30, 2024, compared to

the same period in fiscal 2024.

This increase was primarily due to an increase in capital and disposable demand.

distributor revenue .

Homecare distributor revenue increased by $14,000 or 2.4%, for the three months ended September

30, 2024, compared to the same period in fiscal 2024.

The change in Homecare distributor sales was primarily a result of the

timing of distributor purchases that can cause fluctuations in reported revenue on a quarterly basis.

Other revenue increased by $89,000, or 97.8%, for the three months ended September 30, 2024, compared to the

same period in fiscal 2024.

The increase in other revenue was primarily due to the timing of international distributor purchases and

purchases by customers that do not fall within the other markets described above, which can cause fluctuations in reported revenue

on a quarterly basis.

Though we have not identified a material impact to our net revenues for the three months ended

September 30, 2024, we continue to monitor the potential impact of natural disasters such as hurricanes, which may have an impact on

providers and their patients getting access to our product.

profit increased to $11,491,000, or 78.3% of net revenues, for the three months ended September 30, 2024, from $9,498,000, or

77.1% of net revenues, in the same period in fiscal 2024.

The increase in gross profit dollars for the three months ended September

30, 2024, was primarily due to increased revenue volume and a higher average net revenue per device.

The gross margin rate increased

year over year driven by a higher average net revenue per device.

general and administrative expenses.

Selling, general and administrative (“SG&A”) expenses were $9,387,000

for the three months ended September 30, 2024, representing an increase of $237,000 or 2.6%, compared to the same period in the

payroll and compensation-related expenses including health insurance benefits and other compensation increased by $691,000, or

12.0%, to $6,457,000 for the three months ended September 30, 2024, compared to the same period in the prior year.

in the current period was primarily due to increases in share-based compensation associated with the vesting of performance-based

equity awards, salaries, and incentive compensation related to the higher average number of sales, sales support, marketing, 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 including share-based compensation 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 60 as of September

30, 2024, 53 of which were direct sales representatives, compared to 59 field sales employees and 51 direct sales representatives

as of September 30, 2023.

meals and entertainment expenses increased $47,000, or 5.1%, to $964,000 for the three months ended September 30, 2024, compared

to the same period in the prior year.

The increase in the current year was primarily due to a higher average number of direct

sales representatives and higher travel costs.

discretionary marketing expenses decreased $263,000, or 49.9%, to $264,000 for the three months ended September 30, 2024, compared

to the same period in the prior year.

The decrease was primarily due a one-time investment in market research in the prior year

that did not recur in the three months ended September 30, 2024.

fees decreased $171,000, or 13.0%, to $1,140,000 for the three months ended September 30, 2024, 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 clinical fees in the prior year

related to the finalization of a clinical study that did not recur in the three months ended September 30, 2024.

and development expenses.

Research and development (“R&D”) expenses decreased $40,000, or 19.4%, to $166,000

for the three months ended September 30, 2024, compared to the same period in the prior year.

The decrease was primarily due to

reduced costs associated with our SmartVest Clearway platform development in the prior year which has now been launched into the

Homecare and Hospital markets.

income increased by $1,796,000, to $1,938,000 for the three months ended September 30, 2024, compared to the same period in the

The increase is primarily due to an increase in revenue and gross profit and growth in selling, general and administrative

expense growth tracking below revenue growth.

interest income increased $118,000, to $195,000 for the three months ended September 30, 2024, compared to the same period in

Other revenue was $132,000, an increase of $10,000, or 8.2%, for the three months ended December 31, 2024, compared to the

same period in the prior year.

For the six months ended December 31, 2024, other revenue was $312,000, an increase of $99,000,

or 46.5%, compared to the same period in the prior year.

The increase in other revenue was primarily due to the timing of international

distributor purchases and timing of purchases by customers that do not fall within the other markets described above, which can

cause fluctuations in reported revenue on a quarterly basis.

We continue to monitor

the potential impact of natural disasters such as hurricanes and wildfires, which may have an impact on providers and their patients

getting access to our product.

However, we have not identified a material impact to our net revenues caused by such events for

the three or six months ended December 31, 2024.

Gross profit increased to $12,627,000,

or 77.7% of net revenues, for the three months ended December 31, 2024, from $10,545,000, or 77.0% of net revenues, in the same

period in the prior year.

Gross profit increased to $24,118,000, or 78.0% of net revenues, for the six months ended December 31,

2024, from $20,043,000, or 77.1% of net revenues, in the same period in the prior year.

The increases in gross profit dollars and

percentage were primarily a result of an increased revenue volume and higher net revenue per device.

Operating expenses

Selling, general and

administrative expenses.

Selling, general and administrative (“SG&A”) expenses were $9,834,000 and $19,221,000

for the three and six months ended December 31, 2024, respectively, representing increases of $1,659,000 and $1,896,000, or 20.3%

and 10.9%, respectively, compared to the same periods in the prior year.

Payroll and compensation-related

expenses were $6,875,000 and $13,332,000 for the three and six months ended December 31, 2024, respectively, representing increases

of $1,250,000 and $1,942,000, or 22.2% and 17.1%, respectively, compared to the same periods in the prior year.

The increases in

the current year periods were primarily due to the accelerated recognition of share-based compensation associated with the vesting

of performance-based equity awards, and salaries and incentive compensation related to the higher average number of sales, sales

support, marketing, 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, including share-based compensation,

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

employees totaled 60 as of December 31, 2024, 54 of which were direct sales representatives, compared to 58 field sales employees

and 49 direct sales representatives as of December 31, 2023.

Travel, meals and entertainment

expenses were $993,000 and $1,957,000 for the three and six months ended December 31, 2024, respectively, representing increases

of $248,000 and $264,000, or 33.3% and 15.6%, respectively, compared to the same periods in the prior year.

The increase in the

current year was primarily due to a higher average number of direct sales representatives and higher travel costs.

Total discretionary marketing

expenses were $355,000 and $619,000 for the three and six months ended December 31, 2024, respectively, representing an increase

of $103,000 and a decrease of $172,000, or an increase of 40.9% and a decrease of 21.7%, respectively, compared to the same periods

in the prior year.

The increase in the three-month period was due to increased investment in our direct-to-consumer advertising,

while the decrease in the six-month period was primarily due to a one-time investment in market research in the prior year that

did not recur in the six months ended December 31, 2024.

Professional fees were

$1,179,000 and $2,319,000 for the three and six months ended December 31, 2024, respectively, representing increases of $245,000

and $75,000, or 26.2% and 3.3%, 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

The increase for the three and six months ended December 31, 2024, was primarily related to legal fees associated with intangible

assets and increased expense recognition associated with the board of directors’ equity compensation.

Research and development expenses .

Research and development (“R&D”) expenses were $251,000 and $417,000 for the three and six months ended December

31, 2024, respectively, representing increases of $144,000 and $104,000, or 134.6% and 33.2%, respectively, compared to the same

periods in the prior year.

The increases were primarily due to increased average headcount and external spend related to product

enhancements and on-going product maintenance.

Operating income

Operating income increased by

$279,000 or 12.3% to $2,542,000 for the three months ended December 31, 2024, compared to the same period in the prior year.

income increased by $2,075,000 or 86.3% to $4,480,000 for the six months ended December 31, 2024, compared to the same period in

the prior year.

The increase is due to increased savings rates on higher cash balances.

tax expense was estimated at $659,000 for the three months ended September 30, 2024, compared to an estimated income tax expense

of $64,000 for the three months ended September 30, 2023.

The effective tax rates were 30.9% and 29.3% for the three months ended

September 30, 2024, and 2023, respectively.

The income tax expense for the three months ended September 30, 2024, included a discrete

tax benefit of $4,000 primarily related to the vesting of restricted stock awards.

income for the three months ended September 30, 2024, was $1,474,000 compared to $155,000 for the same period in the prior year.

The increase is primarily due to an increase in revenue and gross profit in both the three- and six-month periods,

as well as a lower growth rate in selling, general and administrative expenses in the six-month period.

Interest income, net

interest income for the three and six months ended December 31, 2024, was $152,000 and $347,000, respectively, compared to $96,000

and $173,000, respectively, for the same periods in the prior year.

The increase is primarily due to increased savings rates on

higher cash balances.

Income tax expense

Income tax expenses were estimated

at $726,000 and $1,385,000, and the effective tax rate was 26.9% and 28.7%, for the three and six months ended December 31, 2024,

respectively.

Estimated income tax expense for the three and six months ended December 31, 2024, includes a discrete tax benefit

of $135,000 and $139,000, respectively, related to the exercise of stock options and the vesting of restricted stock awards.

Income 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 current tax

benefit of $1,000 and $1,000, respectively, related to the exercise of stock options.

Net income for the three

and six months ended December 31, 2024, was $1,968,000 and $3,442,000, respectively, compared to $1,674,000 and $1,829,000 for

the same periods in the prior year.

The increase in net income was primarily due to increased revenue and gross profit.

and Capital Resources

Flows and Sources of Liquidity

Flows from Operating Activities

the three months ended September 30, 2024, net cash provided by operating activities was $2,309,000.

Cash flows provided by operating

activities consisted of net income of $1,474,000, non-cash expenses of $917,000, a decrease in accounts receivable of $967,000,

a decrease in inventory of $278,000, and an increase in accounts payable and accrued liabilities of $806,000.

These cash flows

from operating activities were offset by a decrease in accrued compensation of $1,743,000, an increase in prepaid expenses and

other assets of $266,000, a decrease in income tax payable of $89,000, and an increase in contract assets of $35,000.

in accrued compensation was primarily due to the payment of previously accrued annual incentives.

Flows from Investing Activities

the three months ended September 30, 2024, cash used in investing activities was $58,000.

Cash used in investing activities consisted

of $37,000 of expenditures for property and equipment and $21,000 in expenditures for intangible asset costs.

Flows from Financing Activities

the three months ended September 30, 2024, cash used by financing activities was $4,467,000, consisting of $4,536,000 used to

repurchase common stock and $15,000 used to pay taxes for equity issued on a net basis.

These amounts were partially offset by

cash received from the issuance of common stock upon the exercise of options of $84,000.

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 approximately

$33,591,000 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.

maintain a credit facility that was last amended in December 2023, which provides us with a revolving line of credit.

on borrowings on the line of credit accrues at the prime rate (8.0% as of September 30, 2024) less 1.0% and is payable monthly.

There was no outstanding principal balance on the line of credit as of September 30, 2024, or June 30, 2024.

The amount eligible

for borrowing on the line of credit is limited to the lesser of $2,500,000 or 57.0% of eligible accounts receivable, and the line

of credit expires on December 18, 2025, if not renewed.

As of September 30, 2024, 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 three months ended September 30, 2024, and 2023, we spent approximately $37,000 and $109,000, respectively, on property and

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

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 2025 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;

Liquidity and Capital Resources

Cash Flows and Sources of Liquidity

Cash Flows from Operating Activities

For the six months ended

December 31, 2024, net cash provided by operating activities was $5,460,000.

Cash flows provided by operating activities consisted

of net income of $3,442,000, non-cash expenses of $2,144,000, a decrease in accounts receivable of $558,000, a decrease in inventories

of $500,000 and an increase in accounts payable and accrued expenses of $434,000.

These cash flows from operating activities were

offset by an increase in income taxes receivable, net of $791,000, an increase in prepaid expenses and other assets of $279,000,

an increase in contract assets of $278,000, and a decrease in accrued compensation of $270,000.

Cash Flows from Investing Activities

For the six months ended

December 31, 2024, cash used for investing activities was $295,000.

Cash used for investing activities consisted of $270,000 in

expenditures for property and equipment and $25,000 in expenditures for intangible asset costs.

Cash Flows from Financing Activities

For the six months ended

December 31, 2024, cash used for financing activities was $5,010,000.

Cash used for financing activities consisted of $4,536,000

used for our share repurchase program and $820,000 for taxes paid on net share settlement of stock awards, partially offset by

$346,000 from the issuance of common stock upon exercise of options.

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 approximately $35,522,000 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.

a credit facility that was last amended in December 2023, which provides us with a revolving line of credit.

Interest on borrowings

on the line of credit accrues at the prime rate (7.5% as of December 31, 2024) less 1.0% and is payable monthly.

There was no outstanding

principal balance on the line of credit as of December 31, 2024, or June 30, 2024.

The amount eligible for borrowing on the line

of credit is limited to the lesser of $2,500,000 or 57.0% of eligible accounts receivable, and the line of credit expires on December

18, 2025, if not renewed.

As of December 31, 2024, 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.

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 six months ended December

31, 2024, and 2023, we spent approximately $270,000 and $180,000, respectively, on property and equipment.

We 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.

While 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 2025 and the foreseeable

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.

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

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 business;

the expected impact of applicable regulations on our

our beliefs about our manufacturing processes;

our expectations and beliefs with respect

to our employees and our relationships with them;

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

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.

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

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;

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.

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;

• 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.

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.

You should carefully review the disclosures, and any risk factors described

You should carefully review the disclosures and the risk factors described

in this and other documents we file from time to time with the Securities and Exchange Commission (the “SEC”), including

2 unchanged sentences

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

and Qualitative Disclosures About Market Risk.

a smaller reporting company, we are not required to provide disclosure pursuant to this Item.

Quantitative and Qualitative Disclosures About Market Risk.

As 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