ECIA 10-K & 10-Q changes, risk factors and insider trading
Encision Inc. · OTC · Surgical & Medical Instruments & Apparatus · CIK 930775 · All filings on SEC.gov
At a glance
What changed in the latest 10-K
Risk Factors
Removed heading “Evaluation of Disclosure Controls and Procedures”
Removed heading “Changes in Internal Control over Financial Reporting”
Removed heading “Management’s Annual Report on Internal Control over Financial Reporting”
Largest changes
“Under the supervision and with the participation of our management, including our principal executive officer and principal financial officer, as of March 31, 2024, we conducted an evaluation of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended. …”see in full comparison
“In order to mitigate the foregoing material weaknesses, we have engaged an outside accounting consultant with significant experience in the preparation of financial statements in conformity with GAAP to assist us in the preparation of our financial statements to ensure that these financial statements are prepared in conformity with GAAP. We will continue to monitor the effectiveness of this action and make any changes that our management deems appropriate.”see in full comparison
“Management’s Annual Report on Internal Control over Financial Reporting”see in full comparison
“Management is responsible for establishing and maintaining adequate internal control over financial reporting. …”see in full comparison
Full comparison: every changed paragraph (17)
We
may need additional funding to support
our operations. We were formed in 1991 and have incurred losses of approximately $22$23 million
since that date. We have primarily financed
research, development and operational activities with issuances of our common stock and warrants,
the exercise of stock options to purchase
our common stock, loans, and, in some years, by operating profits. For the fiscal year ended
March 31, 2024,2025, our cash providedused byin operations
was $144,000.$54,948. At March 31, 2024,2025, we had cash and equivalents of $43,000.$257,433. If we are unable
to maintain cash flows sufficient to support
ongoing operations, we will need to seek additional financing. There is no assurance that
we will be able to raise additional capital
on acceptable terms or at all. If we raise additional funds through the issuance of equity
or convertible debt securities, the percentage
ownership of our existing stockholders could be diluted, and these newly issued securities
may have rights, preferences or privileges
senior to those of existing stockholders. If we raise additional funds through debt financing,
which may involve restrictive covenants,
our ability to operate our business may be restricted. If adequate funds are not available or
are not available on acceptable terms, if
and when needed, our ability to fund our operations, our business, results of operations and
financial condition could be materially and
adversely affected.
If
government regulations change or if we
fail to comply with existing and/or new regulations, we might miss market opportunities and experience
increased costs and limited growth.
The research, development, manufacturing, marketing and distribution of our products in the United
States and other countries are
subject to extensive regulation by numerous governmental authorities including, but not limited to, the
Food and Drug Administration.
Under the Federal Food, Drug and Cosmetic Act, medical devices must receive clearance from the Food and
Drug Administration through the
Section 510(k) pre-market notification process or through the lengthier pre-market approval process before
they can be sold in the United
States. The process of obtaining required regulatory approvals is lengthy and has required the expenditure
of substantial resources. There
can be no assurance that we will be able to continue to obtain the necessary approvals. As part of our
strategy, we also intend to pursue
commercialization of our products in international markets. Our products are subject to regulations
that vary from country to country.
The process of obtaining foreign regulatory approvals in certain countries can be lengthy and require
the expenditure of substantial resources.
We may not be able to obtain necessary regulatory approvals or clearances on a timely basis
or at all, and delays in receipt of or failure
to receive such approvals or clearances, or failure to comply with existing or future
regulatory requirements would have a material adverse
effect on our financial position, results of operations and cash flows. Tariffs
will may increase our material costs and, if they are fully
absorbed by us, then they will negatively affect our gross profit margins.
If
we fail to comply with the extensive regulatory
requirements governing the manufacturing of our products, we could be subject to fines,
suspensions or withdrawals of regulatory approvals,
product recalls, suspension of manufacturing, operating restrictions and/or criminal
prosecution. The manufacturing of our products
is subject to extensive regulatory requirements administered by the Food and Drug
Administration and other regulatory agencies. Inspection
of our manufacturing facilities and processes can be conducted at any time,
without prior notice, by the Food and Drug Administration
and such regulatory agencies. In addition, future changes in regulations or
interpretations made by the Food and Drug Administration or
other regulatory agencies, with possible retroactive effect, could adversely
affect us. Changes in existing regulations or adoption of
new regulations or policies could prevent us from obtaining, or affect the
timing of, future regulatory approvals or clearances. We may
not be able to obtain necessary regulatory approvals or clearances on a
timely basis in the future, or at all. Delays in receipt of, failure
to receive such approvals or clearancesclearances, and/or failure to comply
with existing or future regulatory requirements would have a material
adverse effect on our financial position, results of operations
operations, and cash flows.
Evaluation
of Disclosure Controls and Procedures
Under
the supervision and with the participation of our management, including our principal executive officer and principal financial officer,
as of March 31, 2024, we conducted an evaluation of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e)
and Rule 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended. Based on this evaluation, our principal executive
officer and principal financial officer have concluded that, based on the material weaknesses discussed below, our disclosure controls
and procedures were not effective as of such date to ensure that information required to be disclosed by us in reports filed or submitted
under the Securities Exchange Act were recorded, processed, summarized, and reported within the time periods specified in the SEC’s
rules and forms and that our disclosure controls are not effectively designed to ensure that information required to be disclosed by
us in the reports that we file or submit under the Securities Exchange Act is accumulated and communicated to management, including our
principal executive officer and principal financial officer, or persons performing similar functions, as appropriate to allow timely
decisions regarding required disclosure.
Changes
in Internal Control over Financial Reporting
There
have been no changes in our internal control over financial reporting that occurred during our fourth fiscal quarter that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Management’s
Annual Report on Internal Control over Financial Reporting
Management
is responsible for establishing and maintaining adequate internal control over financial reporting. As defined in Rules 13a-15(f) under
the Securities Exchange Act of 1934, internal control over financial reporting is a process designed by, or under the supervision of,
the Company’s principal executive, principal operating and principal financial officers, or persons performing similar functions,
and effected by the Company’s board of directors, management and other personnel, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external purposes in accordance with GAAP.
Our
internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records, that,
in reasonable detail, accurately and fairly reflect the transactions and dispositions of the Company’s assets; (2) provide reasonable
assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted
accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of the
Company’s management and directors; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.
Because
of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of
any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions,
or that the degree of compliance with the policies or procedures may deteriorate.
Our
management, including our principal executive officer and principal financial officer, assessed the effectiveness of our internal control
over financial reporting at March 31, 2024. In making this assessment, management used the criteria set forth by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO) in Internal Control—Integrated Framework (2013). Based on that assessment under
those criteria, management has determined that, as of March 31,2024, our internal control over financial reporting was not effective.
Our
internal controls are not effective for the following reason: (i) there is an inadequate segregation of duties consistent with control
objectives as management is comprised of only two persons, one of which is our principal executive officer and the other is the principal
financial officer.
In
order to mitigate the foregoing material weaknesses, we have engaged an outside accounting consultant with significant experience in
the preparation of financial statements in conformity with GAAP to assist us in the preparation of our financial statements to ensure
that these financial statements are prepared in conformity with GAAP. We will continue to monitor the effectiveness of this action and
make any changes that our management deems appropriate.
We
would need to hire additional staff to provide greater segregation of duties. Currently, it is not feasible to hire additional staff
to obtain optimal segregation of duties. Management will continue to reassess this matter to determine whether improvement in segregation
of duty is feasible. In addition, we would need to expand our board to include independent members.
Going
forward, we intend to evaluate our processes and procedures and, where practicable and resources permit, implement changes in order to
have more effective controls over financial reporting.
This
Annual Report does not include an attestation report of our registered public accounting firm regarding internal control over financial
reporting. Management’s report was not subject to attestation by our registered public accounting firm pursuant to the exemption
provided to issuers that are not “large accelerated filers” nor “accelerated filers” under the Dodd-Frank Wall
Street Reform and Consumer Protection Act.
Management's Discussion & Analysis (MD&A)
Largest changes
We recordsee in full comparisonrecordrevenue at a single point in time, when control is transferred to the customer, which is consistent with past practice. We will continuecontinueto apply our current business processes, policies, systems and controls to support recognition and disclosure. Our shipping policy is FOB Shipping Point. We recognize revenue from sales to stocking distributors when there is no right of return, other than for normal warranty claims. We have no ongoing obligations related to product sales, except for normal warranty obligations. We evaluated the requirement to disaggregate product revenue, and concluded that substantially all of its revenue comes from multiple products within a line of medical devices. Our engineering service contracts are billed on a time and materials basis and revenue is recognized over time as the services areperformed We maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. If the financial condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances would be required, which would increase our expenses during the periods in which any such allowances were made. The amount recorded as a provision for bad debts in each period is based upon our assessment of the likelihood that we will be paid on our outstanding receivables, based on customer-specific as well as general considerations. To the extent that our estimates prove to be too high, and we ultimately collect a receivable previously determined to be impaired, we may record a reversal of the provision in the period of such determination.performed.
“We maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. If the financial condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances would be required, which would increase our expenses during the periods in which any such allowances were made. …”see in full comparison
“During June 2020, we entered into a note agreement with U.S. Bank for $92,000. The note is for five years at a 5% interest rate and the proceeds were used to purchase equipment. The note is secured by the equipment.”see in full comparison
“During June 2022, we entered into a note agreement with U.S. Bank for $118,970. The note is for five years at a 6% interest rate and the proceeds were used to purchase equipment. The note is secured by the equipment.”see in full comparison
Gross profit. Gross profit insee in full comparisonFY24FY25 was$3,135,962,$3,511,286, which representedaandecreaseincrease of$896,571,$375,324, or22%,12%, from gross profit inFY23FY24 of$4,032,533.$3,135,962. Gross profit margin was 54% of net product revenue for FY25 and 48% of net product revenue forFY24 and 55% of net product revenue for FY 23.FY24. Gross profitdecreasedincreased in FY25 from FY24from FY23due principally tohigheraproductreductionvendorincostsmaterialandcostincreasedoninventoryhighreserves.volume product. InFY23FY25, we hadhighanmarginincrease in high-margin service revenue.Our product revenue from GPOs in FY23 was approximately 79% of our total product revenue. In FY24, we had increased product vendor costs that were not allowed to be passed on to our GPO customers for the fiscal year and resulted in a compressed gross profit margin.
“Certain prior year balances have been reclassified to conform with the current year presentation. In presenting the Company’s consolidated balance sheet at March 31, 2024, the Company presented $156,685 EIDL note payable as a line of credit. In presenting the Company’s consolidated balance sheet at March 31, 2025, the Company has reclassified the balance of $5,000 as part of Secured notes, a current liability, and the balance of $151,685 is presented as a part of Long-term liability in the accompanying March 31, 2025 financial statements.”see in full comparison
Full comparison: every changed paragraph (19)
Sales
and Marketing Expenses. We continue
our efforts to expand domestic and international distribution capability, and we
believe that sales
and marketing expenses will need to be maintained at a healthy level in order to expand our market visibility and
optimize the field sales
capability of converting new hospital customers to AEM technology.
Sales and marketing expenses
are expected to increase as we increase our marketing efforts to support our direct sales representatives.
In fiscal year 2024,2026, we expect
to have sixfive direct sales managers. Each direct sales manager also manages a separate territory.
Net Service
Service revenue. Net service revenue for FY25 was $337,628 and for FY24 net service revenue
was $153,913. Net service revenue for FY24 was $153,913, and for FY23 net service revenue was $463,356. Net service revenue for FY23 was for engineering
services performed under a Master Services Agreement with AurisVicarious Health, Inc. (“Auris Health”). Auris Health is a part ofSurgical
the Johnson & Johnson family of companies.Inc.. Under the agreement, we collaborated on the integration of AEM technology into monopolar
instrumentationand producedprovide bycertain Aurisrelated Healthdesign services for advancedelements
of Vicarious’ robotic surgical applications.system.
Gross
profit. Gross profit in FY24FY25 was $3,135,962,$3,511,286, which represented aan decreaseincrease of $896,571,$375,324, or 22%,12%, from gross profit in FY23FY24 of $4,032,533.$3,135,962.
Gross profit margin was 54% of net product revenue for FY25 and 48% of net product revenue for FY24 and 55% of net product revenue for FY 23.FY24. Gross profit decreasedincreased in FY25 from
FY24
from FY23 due principally to highera productreduction vendorin costsmaterial andcost increasedon inventoryhigh reserves.volume product. In FY23FY25, we had highan marginincrease in high-margin service revenue.
Our product revenue from GPOs in FY23 was approximately
79% of our total product revenue. In FY24, we had increased product vendor costs that were not allowed
to be passed on to our GPO customers for the fiscal year and resulted in a compressed gross profit margin.
Sales
and marketing expenses. Sales and marketing expenses were $1,634,124 in FY24, a decrease of $398,291, or 20%, from $2,032,415 in
FY23. The decrease was because of decreased commissions on decreased revenue.
GeneralSales
and administrativemarketing expenses. GeneralSales and administrativemarketing expenses were $1,520,727$1,689,503 in FY24,FY25, an increase of $33,931$55,379, or 2%,3%, from $1,486,796
$1,634,124 in FY23. FY24.
The increase was because of increased regulatorycommissions fees.and travel expenses.
ResearchGeneral
and developmentadministrative expenses. ResearchGeneral and developmentadministrative expenses were $621,894$1,400,611 in FY24,FY25, a decrease of $196,225$120,116 or 24%,8%, from $816,119
$1,520,727 in
FY23. FY24. The decrease was the resultbecause of decreased compensationregulatory fees, compensation, and outside services.service expenses in
FY25.
Research and development expenses. Research and development expenses were $593,152 in FY25, a decrease of $28,742 or 5%, from $621,894 in FY24. The decrease was the result of decreased compensation and outside services.
Other
(expense), net. Other (expense), net
of $48,218 for FY25, a decrease of $51,0002,782 foror FY246%, from 51,000 in FY25. This decrease was
primarily fordue to reduced interest expense of $62,373.expenses.
Net
(loss). loss. Net (loss) in FY24FY25 of $691,783$220,198 represented
a lossdecrease increase
of $367,838$471,585 compared to FY23FY24 net loss of $323,945.$691,783. The net loss increasedecrease was principally because
of lowerhigher service revenue,
increased product and service revenuemargins, and was partially offset by decreased operating expenses.
To
date, operating funds have been provided primarily
by issuances of our common stock and warrants, the exercise of stock options to purchase
our common stock, loans and, in some years, by
operating profits. To date, common stock and additional paid in capital totaled $24,371,795
$24,416,347 from our inception through March 31, 2024. 2025.
Our operations used $54,948 and provided $144,389 and used $861,485 of cash in FY24FY25 and FY23,FY24, respectively,
on net revenue of $6,585,882$6,555,315 and $7,348,514 $6,585,882
in FY24FY25 and FY23,FY24, respectively. Working capital was $1,206,252$1,036,850 at March 31, 20242025 compared
to $1,993,777$1,357,937 at March 31, 2023.2024. The decrease
in working capital was primarily caused by the FY24FY25 net lossloss, andwhich decreasedresulted inventories.in increased utilization of the Pathward line of credit,
a current liability. Current liabilities were $1,220,022$1,575,915 at March 31, 20242025 compared to $1,130,826$1,068,337 at March 31, 2023.2024.
On
November 15,2, 2022, we entered into a loan and security
agreement with Pathward, N.A. The loan is due on demand and has no financial covenants.
Under the agreement, we were provided with a line
of credit that is not to exceed the lesser of $1,000,000 or 85% of eligible accounts
receivable. The interest rate is prime rate plus
0.5%, with a floor of 6.75%, plus a monthly maintenance fee of 0.4%, based on the average
monthly loan balance. Interest is charged on
a minimum loan balance of $300,000, a loan fee of 0.5% at closing and annually, and an exit
fee of 3%, 2% and 1% during years one, two
and three, respectively. The balance under the line of credit is fully collateralized by invoices included in our accounts receivable.
During
June 2020, we entered into a note agreement with U.S. Bank for $92,000. The note is for five years at a 5% interest rate and the proceeds
were used to purchase equipment. The note is secured by the equipment.
The
minimum future U.S. Bank payment, by fiscal year, as of March 31, 2024 is as follows:
The
minimum future principal U.S. Bank payment, by fiscal
year, as of DecemberMarch 31, 20232025 is as follows:
During June 2022, we entered into a note agreement with U.S. Bank for $118,970. The note is for five years at a 6% interest rate and the proceeds were used to purchase equipment. The note is secured by the equipment.
The minimum future principal U.S. Bank payment, by fiscal year, as of March 31, 2025 is as follows:
We record
record revenue at a single point in time, when control is transferred to the customer, which is consistent with past practice. We will continue
continue to apply our current business processes, policies, systems and controls to support recognition and disclosure. Our shipping
policy is
FOB Shipping Point. We recognize revenue from sales to stocking distributors when there is no right of return, other than for
normal warranty
claims. We have no ongoing obligations related to product sales, except for normal warranty obligations. We evaluated
the requirement
to disaggregate product revenue, and concluded that substantially all of its revenue comes from multiple products within
a line of medical
devices. Our engineering service contracts are billed on a time and materials basis and revenue is recognized over
time as the services
are performed We
maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments.
If the financial condition of our customers were to deteriorate, resulting in an impairment
of their ability to make payments, additional allowances would be required, which would increase
our expenses during the periods in which any such allowances were made. The amount recorded as a provision for bad debts in each period
is based upon our assessment of the likelihood that we will be paid on our outstanding receivables, based on customer-specific as well
as general considerations. To the extent that our estimates prove to be too high, and we ultimately collect a receivable previously determined
to be impaired, we may record a reversal of the provision in the period of such determination.performed.
We maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. If the financial condition of our customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances would be required, which would increase our expenses during the periods in which any such allowances were made. The amount recorded as a provision for bad debts in each period is based upon our assessment of the likelihood that we will be paid on our outstanding receivables, based on customer-specific as well as general considerations. To the extent that our estimates prove to be too high, and we ultimately collect a receivable previously determined to be impaired, we may record a reversal of the provision in the period of such determination.
Certain prior year balances have been reclassified to conform with the current year presentation. In presenting the Company’s consolidated balance sheet at March 31, 2024, the Company presented $156,685 EIDL note payable as a line of credit. In presenting the Company’s consolidated balance sheet at March 31, 2025, the Company has reclassified the balance of $5,000 as part of Secured notes, a current liability, and the balance of $151,685 is presented as a part of Long-term liability in the accompanying March 31, 2025 financial statements.
What changed in the latest 10-Q
Risk Factors
In addition to the information set forth in this Form 10-Q, you should carefully consider the risk factors disclosed under the heading “Risk Factors” in Part I, Item 1A of our Annual Report on Form 10-K for the year ended March 31, 2025. There have been no material changes to our risk factors from those included in our Annual Report on Form 10-K for the year ended March 31, 2025.
No wording changes found in this section.
Full comparison: every changed paragraph (0)
Management's Discussion & Analysis (MD&A)
New heading “For the six months ended September 30, 2025, compared to the six months ended September 30, 2024.”
Largest changes
“We expect net losses to continue in connection with our ongoing activities, particularly as we continue to invest in commercialization and new product development. Based on our current planned operations, we do not believe that our current cash and cash equivalents balance of $71,731 as of September 30, 2025, will be sufficient to support our operations beyond the next 12 months from the date of issuance of these financial statements. We currently expect that our cash, cash equivalents, and line of credit will be sufficient to support our operations into the first quarter of fiscal year 2027. …”see in full comparison
“For the six months ended September 30, 2025, compared to the six months ended September 30, 2024.”see in full comparison
“Gross profit. Gross profit for the six months ended September 30, 2025, of $1,575,792 represented a decrease of 11% from gross profit of $1,771,145 for the six months ended September 30, 2024. Gross profit on total net revenue as a percentage of sales (gross margin) was 50% for the six months ended September 30, 2025, and 52% for the six months ended September 30, 2024. Gross profit declined for the six months ended September 30, 2025, due to reduced sales and an unfavorable change in product mix, with a lower proportion of higher-margin products in sales.”see in full comparison
During thesee in full comparisonthreesix months endedJuneSeptember 30, 2025, we usedused $115,508$242,149 of cash in our operating activities and used$6,535$55,148 for investments in property and equipment. AtJuneSeptember 30, 2025, we had$47,918$71,731 in cash and at March 31, 2025 we had $257,433 in cash available to fund future operations,ana decrease of$209,515$185,702 from March 31, 2025. The decreasetoin cash was principally the result of cash used by operatingactivitiesactivities.and repayment of borrowing from our line of credit.Our working capital was$1,172,666$1,375,301 atJuneSeptember 30,20252025, compared to $1,036,850 at March 31, 2025. The increase in working capital was principally the result of gross proceeds of the private placement of our common stock issued during the period.
Gross profit. Gross profit for the quarter endedsee in full comparisonJuneSeptember 30,20252025, of$878,459$697,333 represented a decrease of7%16% from the gross profit of$942,663$828,482 for the quarter endedJuneSeptember 30, 2024. Gross profit declined for the quarter ended September 30,2024.2025, due to reduced sales and an unfavorable change in product mix, with a lower proportion of higher-margin products in sales. Gross profit onproducttotal net revenue as a percentage of sales (gross margin) was55% and 58%46% for thequartersquarter endedJuneSeptember 30,20252025, and2024 respectively.47% for the quarter ended September 30, 2024.
Net loss. Net loss wassee in full comparison$41,133$267,833 for the quarter ended September 30, 2025, compared to a net loss of $170,262 for the quarter ended September 30, 2024. The increase in net loss for the quarter endedJuneSeptember 30,2025 compared to net income of $22,041 for the quarter ended June 30, 2024. The decrease to net income2025, was primarily because ofthereducedreducedsales volume and an unfavorable change in productsales during the period.mix.
Full comparison: every changed paragraph (51)
Certain statements contained in this section on Management’s
Discussion and Analysis are not historical facts, including statements about our strategies and expectations with respect to new and existing
products, market demand, acceptance of new and existing products, marketing efforts, technologies and opportunities, market and industry
segment growth, and return on investments in products and markets. These statements are forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995 and involve substantial risks and uncertainties that may cause actual results
to differ materially from those indicated by the forward-looking statements. All forward-looking statements in this section on Management’s
Discussion and Analysis are based on information available to us on the date of this document, and we assume no obligation to update such
forward-looking statements. Readers of this Form 10-Q are strongly encouraged to review the section entitled “Risk Factors”
in ourthe Form 10-K for the fiscal year ended March 31, 2025.
Encision Inc., a medical device company based in Boulder,
Colorado, has developed and markets innovative technology that provides unprecedented outcomes and patient safety in minimally invasive
surgery. Approximately one in every three and three surgeons may have a patient injury each year from preventable stray energy burns.
We believe
that ourthe patented Active Electrode Monitoring (“AEM®”) AEM EndoShield™ Burn Protection System is changing
the marketplace
for electrosurgical devices and laparoscopic instruments by providing a solution to a well-documented hazard unique to
laparoscopic surgery.
The Center for Medicare and Medicaid Services has published its Hospital-Acquired Condition Reduction Program. The
program has begun to
levy as much as a 1% penalty on Medicare reimbursements to hospitals in the lower quadrant of performance for selected
quality indicators,
including accidental puncture and laceration (“APL”). Examples of APL include the use of a cautery device
(electrosurgery)
or scissors to dissect a tissue plane that errantly causes an injury to underlying bowels.
We address market opportunities created by the increase
in minimally invasive surgery (“MIS”) and surgeons’ use of electrosurgery devices in these procedures. The product opportunity
exists in that monopolar and robotic electrosurgery instruments used in laparoscopic procedures provide excellent clinical resultsresults, but
are also susceptible
to causing inadvertent collateral tissue damage outside the surgeon’s field of view due to insulation failure
and capacitive coupling.
The risk of unintended electrosurgical burn injury to the patient in laparoscopic surgery has been well documented.
This risk poses a
threat to patient safety, including the risk of death, and creates liability exposure for surgeons and hospitals, as
well as increased
and preventable readmissions.
OurThe patented AEM technology provides surgeons with
the desired tissue effects while capturing stray electrosurgical energy that can cause unintended and unseen tissue injury that may result
in death. AEM Surgical Instruments are equivalent to conventional instruments in size, shape, ergonomics, functionality, and competitive
pricing, but they incorporate “Active Electrode Monitoring” technology to dynamically and continuously monitor the flow of
electrosurgical current, thereby helping to preventpreventing patient injury.injury from stray energy burns. With ourthe “shielded and monitored” instruments,
surgeons surgeons
can perform electrosurgical procedures more safely, effectively, and economically than is possible using conventional instruments
or alternative
energy sources.
The AEM system consists of shielded 5mm AEM Instruments
and an AEM monitor. The AEM Instruments are designed to function identically to the conventional 5mm instruments that surgeons are familiar
with, but with the added benefit of enhanced patient safety. OurThe entire line of laparoscopic instruments has anthe integrated AEM design
and includes the full range of instruments that are common in laparoscopic surgery today. The AEM monitor is compatible with most electrosurgical
generators and can also be adapted for use in robotic systems. AEM Surgical Instruments provide enhanced patient safety, require no change
in surgeon technique, and are cost-competitive. Thus, conversion to AEM Surgical Instruments is easy and economical.
AEM technology has been recommended and endorsed by
many groups involved in MIS. Surgeons, nurses, biomedical engineers, the medicolegal community, malpractice insurance carriers, and electrosurgical
device manufacturers advocate the use of AEM technology. To date, weWe have focused our marketing strategies to date on expanding the market awareness
of the AEM technology and our broad independent endorsements, and we have continued efforts to improve and expand the AEM technology penetration.
When a hospital or surgery center changes to AEM technology,
we receive recurring revenue from sales of replacement instruments. We believe that there is no directly competing technology to supplant
AEM products. The replacement market of reusable and disposable AEM products in hospitals and surgery centers that use our AEM technology
represented over 90% of our product revenue during the three and six months ended JuneSeptember 30, 2025.2024. This revenue stream is expected
to grow as the
base of accounts using AEM technology expands. In addition, we intend to further develop more disposable versions of more of
our AEM products in order
to meet market demands and expand our sales opportunities.
We have an accumulated deficit of $22,806,378$23,074,211 at JuneSeptember
30, 2025. A significant portion of our operating funds have been provided by issuances of our common stock and warrants and the exercise
of stock options to purchase our common stock, loans, and (in some periods) by operating profits. Should our liquidity be diminished in
the future because of operating losses, we may be required to implement cost reductions, seek additional capital.capital, or make such other operational
changes as may be required.
During the threesix months ended JuneSeptember 30, 2025, we
used used
$115,508$242,149 of cash in our operating activities and used $6,535$55,148 for investments in property and equipment. At JuneSeptember 30, 2025,
we had $47,918
$71,731 in cash and at March 31, 2025 we had $257,433 in cash available to fund future operations, ana decrease of $209,515$185,702 from
March 31, 2025.
The decrease toin cash was principally the result of cash used by operating activitiesactivities. and repayment of borrowing from our line of credit.
Our working capital was $1,172,666 $1,375,301
at JuneSeptember 30, 20252025, compared to $1,036,850 at March 31, 2025. The increase in working capital was principally the result of gross
proceeds of the private placement of our common stock issued during the period.
Our AEM surgicalSurgical instrumentsInstruments have been engineered
to provide a seamless transition for surgeons who are switching from conventional laparoscopic instruments. AEM technology has been integrated
into instruments that have the same look, feel, and functionality as conventional instruments that surgeons have been using for years.
The AEM product line encompasses the full range of instrument sizes, types, and styles favored by surgeons. Additionally, we continue
to improve quality and add to the product line. These additions include more disposable versions, the introduction of hand-activated instruments,
our enhanced scissors, our eEdge™ scissors, our EM3 AEM Monitor, our AEM EndoShield Burn Protection System, and the recent introduction
of our AEM 2X enTouch® Scissors. Hospitals can make a complete and smooth conversion to our product line, thereby advancing patient
safety in MIS with optimal convenience.
Installed Base of AEM Monitoring Equipment:
We believe that sales of our installed base of AEM products will increase as the inherent risks associated with monopolar and robotic
laparoscopic
electrosurgery become more widely acknowledged and as we focus on increasing our sales efficiency and continue to enhance
our product
line. We expect that the replacement sales of electrosurgical instruments and accessories will also increase as additional
facilities facilities
adopt AEM technology. We anticipate that the efforts to improve the productivity of sales representatives carrying the AEM
product line,
along with the introduction of next-generation products, may provide the basis for increased sales and profitable operations.
However, However,
these measures, or any others that we may adopt, may not result in either increased sales or profitable operations.
We believe that the unique performance of the AEM
technology and our breadth of independent endorsements provide an opportunity for continued market share growth. In our view, market awareness
and awareness of the clinical credibility of the AEM technology, as well as awareness of our endorsements, are improving, and we expect
this awareness to benefit our sales efforts for the remainder of the fiscal year 2026. Our objectives for the remainder of fiscal year 2026
2026 are to optimize sales execution, expand market awareness of the AEM technology, and maximize the number of additional hospital and surgery
surgery center accounts switching to AEM instruments while retaining existing customers. In addition, acceptance of AEM products depends
on surgeons’
preference for our instruments, which depends on factors such as ergonomics, quality, and ease of use, in addition
to the technological
and safety advantages of AEM products. If surgeons prefer other instruments to our instruments, our business results
will suffer.
Possibility of Operating Losses: We have an
accumulated deficit of $22,806,378$23,074,211 at JuneSeptember 30, 2025. A significant portion of our operating funds have been provided by issuances
of our
common stock and warrants and the exercise of stock options to purchase our common stock, loans, and (in some periods) by operating
profits. profits.
Should our liquidity be diminished in the future because of operating losses, we may be required to seek additional capital.
We have made
strides toward improving our operating results,results but due to the ongoing need to develop, optimize,optimize and train our direct sales
managers managers
and the independent sales representative network, the need to support the development of refinements to our product line, and
the need
to increase sustained sales to a level adequate to cover fixed and variable operating costs, we may operate at a net loss. Sustained
losses, losses,
or our inability to generate sufficient cash flow from operations to fund our obligations, may result in a need to implement cost
reductions, raise additional capital.capital, or make such other operational changes as may be required.
Revenue Growth: We expect to generate increased
product revenue in the U.S. from sales to new customers and from expanded sales to existing customers as the medical device industry stabilizes
and our network of direct and independent sales representatives becomes more efficient. We believe that the visibility and credibility
of the independent clinical endorsements for AEM technology will contribute to new accounts and increased product revenue in fiscal year
2026. We also expect to increase market share through promotional programs thatof placeplacing our AEM monitors at no charge ininto hospitals that
commit to standardizingstandardize with AEM instruments. However, all of these efforts to increase market share and grow product revenue will depend
in part on our ability to expand the efficiency and effective coverage range of our direct and independent sales representatives, as well
as maintain and, in some cases, improve the quality of our product offerings. The omission or delay of elective surgeries would negatively
impact the extent and timing of revenue growth. Service revenue represents design, developmentdevelopment, and product supply revenue from our agreements
with strategic partners.
We also have longer-term initiatives in place to improve
our prospects. We expect that the development of next-generation versions of our AEM products will better position our products in the
marketplace and improve our retention rate at hospitals and surgery centers that have changed to AEM technology, enabling us to grow our
sales. We are exploring overseas markets to assess opportunities for international sales growth.growth internationally. Finally, we intend to explore opportunities
to capitalize on our proven AEM technology via licensing arrangements and strategic alliances. These efforts to generate additional sales
and further the market penetration of our products are longer-term in nature and may not materialize. Even if we are able to successfully
develop next-generation products or identify potential international markets or strategic partners, we may not be able to capitalize on
these opportunities.
Sales and Marketing Expenses: We continue to
refine our domestic and international distribution capability, and we believe that sales and marketing expenses will decrease as a percentage
of net sales with an increasing sales volume.
Research and Development Expenses: Research
and development expenses are expected to increase to support quality improvement efforts and the development of refinements to our AEM product
product line and new products, which will further expand options for surgeons and hospitals.
For the quarter ended JuneSeptember 30, 2025, compared
to the quarter ended JuneSeptember 30, 2024.
Net Product revenue. Net product revenue for
for the quarter ended JuneSeptember 30, 20252025, was $1,492,832$1,481,802 compared to $1,591,960$1,653,820 for the quarter ended JuneSeptember 30, 2024, a decrease of 6%. 10%.
The decrease
in net product revenue is primarily due to a reduction in the sales of disposable products, which suggests a decrease in
the number of
procedures performed during this period. This reduction in procedural volume has, in turn, lowered the overall demand for
our products.
Net Service revenue. Net service revenue
for the quarter ended JuneSeptember 30, 20252025, was $109,896$46,248 compared to $38,971$101,568 for the quarter ended JuneSeptember 30, 2024.This2024. increaseThis decrease was
because primarilyof because
ofa short delay in services performed under a Master Services Agreement with Vicarious Surgical Inc. This decrease resulted from
a brief delay in services under the Master Services Agreement with Vicarious Surgical Inc., following a temporary project suspension by
the customer.
Gross profit. Gross profit for the
quarter ended JuneSeptember 30, 20252025, of $878,459$697,333 represented a decrease of 7%16% from the gross profit of $942,663$828,482 for the quarter ended JuneSeptember
30, 2024. Gross profit declined for the quarter ended September 30, 2024.2025, due to reduced sales and an unfavorable change in product mix,
with a lower proportion of higher-margin products in sales. Gross profit on producttotal net revenue as a percentage of sales (gross margin)
was 55% and 58%46% for the quartersquarter ended JuneSeptember 30, 20252025, and 2024
respectively.47% for the quarter ended September 30, 2024.
Sales
and marketing expenses:expenses. Sales
and marketing expenses of $404,601$395,793 for the quarter ended JuneSeptember 30, 20252025, represented a decrease
of 4%14% from sales and marketing expenses
of $423,237$458,480 for the quarter ended JuneSeptember 30, 2024. The decrease was becausedue to reduced salestrade shows and commission payable during the period.expenses.
General and administrative expensesexpenses. General
and administrative expenses of $328,198$358,639 for the quarter ended JuneSeptember 30, 20252025, represented a decrease increase of 7%4% from general and administrative
expenses of $351,903$373,405 for the quarter ended JuneSeptember 30, 2024. ThisThe decrease was because of reductionsdecreased inoutside theaccountants' use of contract servicescosts and reduced
regulatoryinsurance expenses.
Research and development expenses. Research
and development expenses of $165,440$201,392 for the quarter ended JuneSeptember 30, 20252025, represented an increase of 19%30% compared to $139,180$155,515 for
the quarter
ended JuneSeptember 30, 2024. The increase was becausedue ofto an increase ofin allocated resources for product development.
Net loss. Net loss was $41,133$267,833 for the quarter
ended September 30, 2025, compared to a net loss of $170,262 for the quarter ended September 30, 2024. The increase in net loss for the
quarter ended JuneSeptember 30, 2025 compared to net income of $22,041 for the quarter ended June 30, 2024. The decrease to net income2025, was
primarily because of thereduced reducedsales volume and an unfavorable change in product sales during the period.mix.
For the six months ended September 30, 2025, compared to the six months ended September 30, 2024.
Net Product revenue. Net product revenue for the six months ended September 30, 2025, was $2,974,634 compared to $3,245,779 for the six months ended September 30, 2024, a decrease of 8%. The decrease in net product revenue is attributable to decreased demand for our products.
Net Service revenue. Net service revenue for the six months ended September 30, 2025, was $156,144 compared to $140,539 for the six months ended September 30, 2024, an increase of 11%. Net service revenue for the six months ended September 30, 2025, was for engineering services performed under a Master Services Agreement with Vicarious Surgical Inc.
Gross profit. Gross profit for the six months ended September 30, 2025, of $1,575,792 represented a decrease of 11% from gross profit of $1,771,145 for the six months ended September 30, 2024. Gross profit on total net revenue as a percentage of sales (gross margin) was 50% for the six months ended September 30, 2025, and 52% for the six months ended September 30, 2024. Gross profit declined for the six months ended September 30, 2025, due to reduced sales and an unfavorable change in product mix, with a lower proportion of higher-margin products in sales.
Sales and marketing expenses. Sales and marketing expenses of $800,394 for the six months ended September 30, 2024, represented a decrease of 9% from sales and marketing expenses of $881,716 for the six months ended September 30, 2024. The decrease was the result of lower commission expenses.
General and administrative expenses. General and administrative expenses of $686,838 for the six months ended September 30, 2025, represented a decrease of 5% from general and administrative expenses of $725,310 for the six months ended September 30, 2024. The decrease was because of decreased outside accountants' costs and reduced insurance expenses.
Research and development expenses. Research and development expenses of $366,832 for the six months ended September 30, 2025, represented an increase of 24% compared to $294,695 for the six months ended September 30, 2024. The increase was the result of an increase in allocations to product development.
Net loss. Net loss was $308,966 for the six months ended September 30, 2025, compared to a net loss of $148,222 for the six months ended September 30, 2024. The increase in net loss for the quarter ended September 30, 2025, was primarily because of reduced sales volume, an unfavorable change in product mix, and increased allocation of resources to the development of new products.
The results of operations for the three and six months
ended ending
JuneSeptember 30, 2025, are not necessarily indicative of the results of operations for all or any part of the balance of the fiscal
year.
To date, a significant portion of our operating funds
funds have been provided by issuances of our common stock and warrants, the exercise of stock options to purchase our common stock, loans,
and (in some periods) by operating profits. Common stock and additional paid-in capital totaled $24,428,466$24,938,998 from inception through JuneSeptember
30, 2025.
We expect net losses to continue in connection with our ongoing activities, particularly as we continue to invest in commercialization and new product development. Based on our current planned operations, we do not believe that our current cash and cash equivalents balance of $71,731 as of September 30, 2025, will be sufficient to support our operations beyond the next 12 months from the date of issuance of these financial statements. We currently expect that our cash, cash equivalents, and line of credit will be sufficient to support our operations into the first quarter of fiscal year 2027. As such, there is substantial doubt about the Company’s ability to continue as a going concern. We may seek to utilize additional capital to expand our business, to pursue strategic investments, to take advantage of financing opportunities, or implement other strategies or initiatives.
On August 4, 2020, we received $150,000 in loan funding
from the U.S. Small Business Administration (“SBA”) under the Economic Injury Disaster Loan (“EIDL”) program administered
by the SBA, which program was expanded pursuant to the CARES Act. The EIDL is evidenced by a promissory notenote, dated August 1, 2021, in
the original principal amount of $150,000 with the SBA, the lender. Under the terms of the Note, interest accrues on the outstanding principleprincipal
at the rate of 3.75% per annum. The term of the Note is thirty years, though it may be payable sooner upon an event of default under the
Note.
During September 2020, we entered into a note agreement
with U.S. Bank for $92,000. The note is for five years at a 5% interest raterate, and the proceeds were used to purchase equipment. The note
is secured by the equipment.
During July 2022, we entered into a note agreement
with U.S. Bank for $118,970.$115,004. The note is for five years at a 6% interest raterate, and the proceeds were used to purchase equipment. The note
is secured by the equipment.
On November 2, 2022, we entered into a loan and security
agreement with Pathward, N.A. (formerly Crestmark Bank). The loan is due on demand and has no financial covenants. Under the agreement,
we were provided with a line of credit that is not to exceed the lesser of $1,000,000 or 85% of eligible accounts receivable. The interest
rate is the prime rate plus 0.5%, with a floor of 6.75%, plus a monthly maintenance fee of 0.4%, based on the average monthly loan balance.
Interest is charged on a minimum loan balance of $300,000, a loan fee of 0.5% at closing and annually, and an exit fee of 3%, 2%,2% and 1%
1% during years one, two, and three, respectively. The balance under the line of credit is fully collateralized by invoices included in
our accounts receivable.
Our operations used $115,508$242,149 of cash during the threesix
months endingended JuneSeptember 30, 2025, on net revenue of $1,602,728.$3,130,778. The amounts of cash used by operations for the threesix months endingended JuneSeptember
30, 30,
2025, are not necessarily indicative of the expected amounts of cash to be generated from or used in operations in fiscal year 2026.
As At
Juneof September 30, 2025, we had $47,918$71,731 in cash available to fund future operations and a line of credit for up to $679,560,$968,294, restricted
by eligible
account receivables.accounts receivable. Our working capital was $1,172,666$1,375,301 at JuneSeptember 30, 20252025, compared to $1,036,850 at March 31, 2025. Current
liabilities liabilities
were $1,277,873$1,071,571 at JuneSeptember 30, 2025, compared to $1,575,915 at March 31, 2025. We have a noncancelable lease agreement for
our facilities
at 6797 Winchester Circle, Boulder, Colorado. The lease expires October 31, 2028.
Operating lease ROU assets and operating lease liabilities
are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. ROU assets
also include any initial direct costs incurred and any lease payments made at or before the lease commencement date, less lease incentives
received. We use our incremental borrowing rate based on the information available at the commencement date toin determinedetermining the lease liabilities,
as our leases do not provide an implicit rate. Lease expense is recognized on a straight-line basis over the lease term.
On August 19, 2025, we completed a private placement of our common stock, issuing 5,000,000 shares at $0.10 per share for gross proceeds of $500,000. We intend to use the proceeds for working capital and general corporate purposes.
As of JuneSeptember 30, 2025, the following table shows
our our
contractual obligations for the periodperiods presented:
Our fiscal year 2026 operating plan is focused on
increasing new accounts, retaining existing customers, growing revenue, increasing gross profits, and conserving cash. We are investing
in research and development efforts to develop next-generation versions of the AEM product line. We have invested in manufacturing propertyequipment
and equipment to manufacture disposable scissors inserts internally and to reduce our cost of product revenue. We cannot predict with
certainty the
expected revenue, gross profit, net income or loss, and usage of cash for fiscal year 2026. If wethe arecurrent unabledownward tosales managetrend ourcontinues,
business operations in line with budget expectations, it couldwill have a material adverse effect on our business viability, financial position,
results of operations, and cash flows.
As of JuneMarch 30,31, 2025, net operating loss carryforwards
carryforwards totaling approximately $8.2 million are available to reduce taxable income in the future. The net operating loss carryforwards expire,
expire, if not previously utilized, at various dates beginning in the fiscal year ending March 31, 2025.2026. We have not paid income taxes
since our
inception. The Tax Reform Act of 1986 and other income tax regulations contain provisions that may limit the net operating loss carryforwards
carryforwards available to be used in any given year if certain events occur, including changes in ownership interests. We have established
a valuation
allowance for the entire amount of our deferred tax assetsasset since inception due to our history of losses. Should we achieve sufficient,
sufficient, sustained income in the future, we may conclude that some or all of the valuation allowance should be reversed. If some or all
of the
valuation allowance were reversed, then, to the extent of the reversal, a tax benefit would be recognized, which would result in
an increase in
to net income.
Our discussion and analysis of our financial condition
and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally
accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the
reported amounts of assets, liabilities, salessales, and expenses, and related disclosure of contingent assets and liabilities. On an ongoing
basis, we evaluate our estimates, including those related to bad debts, inventories, sales returns, contingencies, and litigation. We
base our estimates on historical experience and on various other 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. Actual results may differ from these estimates under different assumptions or conditions. We believe the following
critical accounting policies affect the more significant judgments and estimates used in the preparation of our financial statements.
We record revenue at a single point in timetime, when
control control
is transferred to the customer, which is consistent with past practice. We will continue to apply our current business processes,
policies, policies,
systems, and controls to support recognition and disclosure. Our shipping policy is FOB Shipping Point. We recognize revenue
from sales
to stocking distributors when there is no right of returnreturn, other than for normal warranty claims. We have no ongoing obligations
related related
to product salessales, except for normal warranty obligations. We evaluated the requirement to disaggregate revenue and concluded that
substantially substantially
all of our revenue comes from multiple products within a line of medical devices. Our engineering service contracts are
billed on a time
and materials basis, and revenue is recognized over time as the services are performed. We record deferred revenue when
funds are received
prior to the recognition of the associated revenue. We record a contract liability to deferred revenue, which
includes customer prepayments
and is included in other accrued liabilities.
We recognize deferred income tax assets and liabilities
for the expected future income tax consequences, based on enacted tax laws, of temporary differences between the financial reporting and
tax bases of assets and liabilities. Deferred tax assets are then reduced, if deemed necessary, by a valuation allowance for the amount
of any tax benefits, which, more likely than notnot, based on current circumstances, are not expected to be realized. Should we maintain
sufficient, sufficient,
sustained income in the future, we may conclude that all or some of the valuation allowance should be reversed.
We amortize our patent costs over their estimated
useful lives, which is typically the remaining statutory life. From time to time, we may be required to adjust thethese useful lives of our
patents based on advances in technology, competitor actions, and the like. We review the recorded amounts of patents at each period end
to determine if their carrying amount is still recoverable based on our expectations regarding sales of related products. Such an assessment,
in the future, may result in a conclusion that the assets are impaired, with a corresponding charge against earnings.
We currently estimate forfeitures for stock-based
compensation expensesexpense related to employee stock options at 40% and evaluate the forfeiture rate quarterly. Other assumptions that are used
used in calculating stock-based compensation expense include risk-free interest rate, expected life, expected volatility, and expected
dividend.
ECIA insider buying and selling (Form 4)
Since 2026-04-11, insiders reported open-market purchases in 1 Form 4 filing (1 insider, 2 trade dates, 166,785 shares, about $24.0K) and open-market sales in 0 filings. Net open-market shares: 166,785 (purchases minus sales); net value about $24.0K.Totals add up every open-market (code P and S) line in those filings, using the prices reported in the filings. Awards, option exercises, tax withholding and gifts are listed below but not counted.
| Trade date | Insider | Transaction | Shares | Price | Value |
|---|---|---|---|---|---|
| 2026-04-16 | Fries Robert H |
Open-market purchase | 11,250 | $0.20 | $2.2K |
| 2026-04-15 | Fries Robert H |
Open-market purchase | 155,535 | $0.14 | $21.8K |
Well-known investors holding ECIA (13F)
None of the 59 investors we track reported a position in their latest 13F.