What changed in this filing

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Item 1A. Risk Factors

2026-03-19 compared with 2025-03-20 · 69 added, 66 removed, 1223 unchanged (10% of the section changed)

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all of our revenues have been derived from sales and royalties from sales of IB-Stim, and we expect to develop, market, and sell other

neuromodulation therapy devices for the treatment of chronic and debilitating conditions in children.

The commercial success of our products

and our ability to generate and maintain revenues from the sale of our products will depend on a number of factors, including:

neuromodulation therapy devices for the treatment of chronic and debilitating conditions in children and adults.

The commercial success

of our products and our ability to generate and maintain revenues from the sale of our products will depend on a number of factors, including:

ability to develop and obtain additional regulatory clearances and further commercialize our products for additional indications;

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by enrolled subjects;

and delays in clinical studies that may occur as a result of the COVID-19 pandemic;

ability to obtain IRB approval at clinical study locations;

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and other patients may forego our products for financial, privacy, cosmetic, visibility or mobility reasons;

patient compliance may be difficult because the recommended use of our products is 120 hours per week for three (3) consecutive weeks,

and not to exceed four (4) weeks, which to some extent restricts physical mobility because our products cannot be worn in all circumstances,

patient compliance may be difficult because the recommended use of our products is 120 hours per week for four (4) consecutive weeks,

which to some extent restricts physical mobility because our products cannot be worn in all circumstances,

and the patient or a caregiver must ensure that it remains continuously operable and this may also impact the pool of patients to

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services attendant to our products .

payers, healthcare systems, government agencies or other groups often issue reimbursement codes to facilitate billing for products and

physician services used in the delivery of healthcare.

Our IB-STIM technology specific CAT III CPT Code (0720T) was published on December

30, 2021 and effective on July 1, 2022.

In September of 2024, the AMA’s CPT Editorial Panel accepted addition of Category I CPT

Code (placeholder 64X11) for PENFS and deletion of Category III CPT Code 0720T.

The finalized Category I CPT Code for PENFS, and associated

valuations, will be announced publicly in Q4 of 2025.

The new code will become effective for utilization on January 1, 2026.

RED is billable

under Category I CPT Code 91120.

We may not be able to maintain the CPT code for physician services related to our products.

revenues and results may be affected by the absence of CPT codes, as physicians may be less likely to prescribe the therapy when there

is no certainty that adequate reimbursement will be available for the time, effort, skill, practice expense and malpractice costs required

to provide the therapy to patients.

payers, healthcare systems, government agencies or other groups often issue reimbursement codes to facilitate billing for products

and physician services used in the delivery of healthcare.

Our IB-Stim technology-specific CAT III CPT Code (0720T) was published on

December 30, 2021 and effective on July 1, 2022.

In September of 2024, the AMA’s CPT Editorial Panel accepted the addition of

Category I CPT Code (64567) for PENFS and deletion of Category III CPT Code 0720T.

The finalized Category I CPT Code for PENFS, and

associated valuations, were announced publicly in Q4 of 2025.

The new code became effective for utilization on January 1, 2026.

CAT I CPT codes changed on January 1, 2026.

We may not be able to maintain the CPT code for physician services related to

our products.

Our future revenues and results may be affected by the absence of CPT codes, as physicians may be less likely to

prescribe the therapy when there is no certainty that adequate reimbursement will be available for the time, effort, skill, practice

expense and malpractice costs required to provide the therapy to patients.

the U.S., we have not secured codes to describe our products or to document physician services related to the delivery of therapy using

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for an extended period of time, which would materially adversely affect our business, prospects, financial condition and results of operations.

currently do not own a manufacturing facility and rely on a sole manufacturer for the production of our product .

Any significant

disruption to the sole manufacturer’s operations or facilities could have a material adverse effect on our business, financial

condition and results of operations .

rely on a sole manufacturer for the production of our products.

currently do not own a manufacturing facility and rely on contract manufacturers for the production of our product s.

significant disruption to the contract manufacturer’s operations or facilities could have a material adverse effect on our business,

financial condition and results of operations .

rely on two manufacturers for the production of our products.

We do not have control over the operations of the facilities of the third-party

manufacturer that we use.

A significant disruption to our manufacturer could have a material adverse effect on our business, financial

manufacturers that we use.

A significant disruption to our manufacturers could have a material adverse effect on our business, financial

condition and results of operations.

Our reliance on our manufacturer poses a number of risks, including lack of control over the manufacturing

Our reliance on our manufacturers poses a number of risks, including lack of control over the manufacturing

process and ultimately over the quality and timing of delivery of our product.

A change in our relationship with our manufacturer could

A change in our relationship with our manufacturers could

result in a material adverse effect on our business, financial condition and results of operations.

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these assumptions and estimates may not be correct.

In addition, the statements in this prospectus relating to, among other things, the

expected growth in the market for our IB-Stim are based on a number of internal and third-party data, estimates and assumptions, and

may prove to be inaccurate.

In addition, the statements in this document relating to, among other things, the

expected growth in the market for IB-Stim are based on a number of internal and third-party data, estimates and assumptions, and may

prove to be inaccurate.

If the actual number of consumers who would benefit from our products, the price at which we can sell future

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or third-party complaints or negative reviews or publicity about our company or our products could harm our reputation and brand.

are heavily dependent on customers who use our IB-Stim device to provide good reviews and word-of-mouth recommendations to contribute

to our growth.

are heavily dependent on customers who use IB-Stim to provide good reviews and word-of-mouth recommendations to contribute to our growth.

Customers who are dissatisfied with their experiences with our products or services may post negative reviews.

also be the subject of blog, forum or other media postings that include inaccurate statements and/or create negative publicity.

any negative news regarding similar products may adversely impact our business.

Any negative reviews or publicity, whether real or perceived,

disseminated by word-of-mouth, by the general media, by electronic or social networking means or by other methods, could harm our reputation

and brand and could severely diminish consumer confidence in our products.

We may also be the subject

of blog, forum or other media postings that include inaccurate statements and/or create negative publicity.

In addition, any negative

news regarding similar products may adversely impact our business.

Any negative reviews or publicity, whether real or perceived, disseminated

by word-of-mouth, by the general media, by electronic or social networking means or by other methods, could harm our reputation and brand

and could severely diminish consumer confidence in our products.

global economic conditions could have a negative effect on our business, results of operations and financial condition and liquidity.

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of new patients, and other delays or losses of materials and results.

A pandemic could materially adversely impact our business .

pandemic could materially adversely impact our business .

pandemic could disruption and impact our business and clinical studies, which could include:

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in shipping that may affect the transport of active patient and clinical study materials;

in local regulations as part of a response to a pandemic that may require us to change the ways in which our clinical

studies are conducted, which may result in unexpected costs, or to discontinue the clinical studies altogether;

in local regulations as part of a response to a pandemic that may require us to change the ways in which our clinical studies are

conducted, which may result in unexpected costs, or to discontinue the clinical studies altogether;

in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations

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for clinical study and active patient care needs;

consequences of a pandemic on the economy in general, such as an increase in bankruptcies of our key suppliers, or the

inability of our third-party payers to meet their obligations reimburse us in a timely fashion or at all;

consequences of a pandemic on the economy in general, such as an increase in bankruptcies of our key suppliers, or the inability

of our third-party payers to meet their obligations reimburse us in a timely fashion or at all;

postponements

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the use of our products or disqualify the patient from participating in a given study.

The extent to which a pandemic may

impact our business and clinical studies will depend on future developments, which are highly uncertain and cannot be predicted with

confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel restrictions and social distancing

guidelines, business closures or business disruptions and the effectiveness of actions taken to contain and treat the disease.

to a pandemic may result in permanent changes to the environment in which we operate as described above in ways we are unable to predict.

extent to which a pandemic may impact our business and clinical studies will depend on future developments, which are highly uncertain

and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the pandemic, travel

restrictions and social distancing guidelines, business closures or business disruptions and the effectiveness of actions taken to contain

and treat the disease.

The response to a pandemic may result in permanent changes to the environment in which we operate as described

above in ways we are unable to predict.

A pandemic may also have the effect of heightening many of the other risks described herein.

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unremediated as of December 31, 2025.

If we fail to establish and maintain proper and effective internal control over financial

reporting, our operating results and our ability to operate our business could be harmed.

If we fail to establish and maintain proper and effective internal control over financial reporting,

our operating results and our ability to operate our business could be harmed.

that we have adequate internal financial and accounting controls and procedures in place so that we can produce accurate financial statements

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and reputation with investors may be harmed.

has developed, documented and implemented controls over each of the Company’s material weaknesses and successfully tested the

design and operating effectiveness of three deficiencies during the year ended December 31, 2025.

However, the material weaknesses

were not considered remediated as of December 31, 2025, because the new controls were not operational for a sustained period of a

full financial reporting cycle.

These remediation efforts are subject to ongoing management evaluation and will continue into

fiscal year 2026.

Related to Legal and Regulatory Matters

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with continuing regulations, we could lose these clearances and the sale of any of our approved commercial products could be suspended.

as we received regulatory clearance to market the IB-Stim, the manufacturing, labeling, packaging, adverse event reporting, storage,

advertising, promotion, and record keeping related to IB-Stim will remain subject to extensive regulatory requirements.

If we fail to

comply with the regulatory requirements of the FDA and other applicable domestic and foreign regulatory authorities or discover any previously

unknown problems with any approved product, manufacturer, or manufacturing process, we could be subject to administrative or judicially

imposed sanctions, including:

as we received regulatory clearance to market IB-Stim, the manufacturing, labeling, packaging, adverse event reporting, storage, advertising,

promotion, and record keeping related to IB-Stim will remain subject to extensive regulatory requirements.

If we fail to comply with

the regulatory requirements of the FDA and other applicable domestic and foreign regulatory authorities or discover any previously unknown

problems with any approved product, manufacturer, or manufacturing process, we could be subject to administrative or judicially imposed

sanctions, including:

on the products, manufacturers, or manufacturing processes;

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securities, and holders may be unable to sell their securities on favorable terms or at all.

securities industry analysts do not publish research reports on us, or publish unfavorable reports on us, then the market price and market

trading volume of our common stock could be negatively affected.

securities industry analysts publish unfavorable reports on us, then the market price and market trading volume of our common stock could

be negatively affected.

trading market for our common stock may be influenced in part by any research reports that securities industry analysts publish about

We do not currently have and may never obtain research coverage by securities industry analysts.

If no securities industry analysts

commence coverage of us, the market price and market trading volume of our common stock could be negatively affected.

In the event we

are covered by analysts, and one or more of such analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues

coverage of us, the market price and market trading volume of our common stock could be negatively affected.

If one or more of security analysts downgrade our securities, or otherwise reports on us unfavorably, or discontinues coverage of

us, the market price and market trading volume of our common stock could be negatively affected.

issuances of our common stock or securities convertible into, or exercisable or exchangeable for, our common stock, or the expiration

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

What changed 10-K

Item 1A. Risk Factors