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These risk factors may be important to understanding other statements in this report.
−Removed: The following information should be carefully considered in addition to the other information set forth in this report, including the Management’s Discussion and Analysis of Financial Conditions and Results of Operations section and Consolidated Financial Statements and accompanying notes.
+Added: The following information should be carefully considered in addition to the other information set forth in this report, including the Management’s Discussion and Analysis of Financial Condition and Results of Operations section and Consolidated Financial Statements and accompanying notes.
If any of the risks or uncertainties described below actually occur or continue to occur, our business, reputation, financial condition, results of operations, future prospects and stock price could be materially and adversely affected.
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Industry Condition Risks
−Removed: • A prolonged downturn in macroeconomic conditions may materially adversely affect our business.
+Added: • A prolonged downturn in macroeconomic conditions may materially and adversely affect our business.
• Government and private payors may contain or reduce healthcare spending, including reimbursement for procedures that utilize our products.
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• We could face substantial penalties if we do not fully comply with federal, state and foreign regulations.
−Removed: • We may be subject to fines, injunctions and penalties if we fail to comply with extensive FDA regulations.
+Added: • We may be subject to fines, injunctions and penalties if we fail to comply with FDA regulations.
• Unless and until we obtain additional FDA approval for our products, we will not be able to promote them for treatment of Afib, prevention of stroke, or reduction of post-operative Afib, and our inability to maintain or grow our business could be harmed.
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failure to obtain such clearances or approvals where required could result in a recall of the modified products and limitation on future sales until cleared or approved.
−Removed: • If we or our third-party vendors fail to comply with extensive FDA regulations relating to the manufacturing of our products, we may be subject to fines, injunctions and penalties.
+Added: • If we or our third-party vendors fail to comply with FDA regulations relating to the manufacturing of our products, we may be subject to fines, injunctions and penalties.
• The use of products we sell may result in injuries or other adverse events that lead to product liability claims.
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• We are subject to various regulatory and other risks related to selling our products internationally which could harm our revenue.
+Added: • Changes in United States and international trade policies may adversely impact our business and operating results.
• Any allegation or determination of wrongdoing under the Foreign Corrupt Practices Act or other anti-corruption laws could have a material adverse effect on our business.
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• We are subject to credit risk from our accounts receivable related to our sales.
−Removed: • We may be unable to comply with the covenants of our Loan Agreement.
+Added: • We may be unable to comply with the covenants of our Credit Agreement.
Common Stock Risks
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• Our common stock may experience extreme fluctuations in the price and trading volume causing our stockholders to lose some or all of their investment.
−Removed: • The sale of material amounts of common stock could encourage short sales by third parties and depress the price of our common stock causing our stockholders to lose part or all of their investment.
+Added: • The sale of material amounts of common stock could encourage short sales by third parties and depress the price of our common stock, causing our stockholders to lose some or all of their investment.
• Stockholder ownership of our common stock may be diluted if we sell common stock in a capital raising transaction or issue shares in a future acquisition.
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In addition, acceptance of products for the treatment of Afib is dependent upon, among other factors, the level of awareness and education of the medical community about the surgical treatment of Afib and the existence, effectiveness and safety of our products.
−Removed: Market acceptance and adoption of our products for the treatment of Afib also depends on the level of health insurer (including Medicare) reimbursement to physicians and hospitals for procedures using our products.
+Added: Market acceptance and adoption of our products for the treatment of Afib also depend on the level of health insurer (including Medicare) reimbursement to physicians and hospitals for procedures using our products.
Negative publicity resulting from incidents involving our products, or similar products could have a significant adverse effect on the overall acceptance of our products.
−Removed: If we encounter difficulties growing the market for our products in the United States, we may not be able to increase our revenue enough to achieve or sustain profitability, and our business and operating results will be seriously harmed.
+Added: If we encounter difficulties growing market adoption of our products in the United States, we may not be able to increase our revenue enough to achieve or sustain profitability, and our business and operating results could be seriously harmed.
Competition from existing and new products and procedures may decrease our market share and may cause our revenue to decline, and could adversely affect our operating results.
−Removed: The medical device industry, including the market for the treatment of Afib, is highly competitive, is subject to rapid technological change and can be significantly affected by new product introductions and promotional activities.
+Added: The medical device industry, including the markets in which we operate, is highly competitive, is subject to rapid technological change and can be significantly affected by new product introductions and promotional activities.
There is no assurance that our products will compete effectively against drugs, catheter-based ablation, implantable devices, other surgical ablation devices, other products or techniques to occlude the left atrial appendage or other products and techniques to manage post-operative pain.
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In addition, other products may be sold at lower prices.
−Removed: Due to the size of our markets, we anticipate that new or existing competitors may develop competing products, procedures and/or clinical solutions.
−Removed: There are few barriers to prevent new entrants or existing competitors from developing products to compete directly with ours.
+Added: Due to the size of our markets, we anticipate that new or existing competitors may introduce competing products, procedures and/or clinical solutions.
+Added: There are few barriers to prevent new entrants or existing competitors from introducing products to compete directly with ours.
Companies also compete with us to attract qualified scientific, technical and commercial personnel as well as funding.
Most of our competitors and potential competitors have greater financial, manufacturing, marketing and research and development capabilities than we have, and may obtain FDA approval or clearance for their products.
−Removed: The introduction of new products, procedures or clinical solutions, or our competitors obtaining FDA approvals or clearances, may result in price reductions, reduced margins, loss of market share, or may render our products obsolete, which could adversely affect our revenue and future profitability.
+Added: The introduction of new products, procedures or clinical solutions, or our competitors obtaining FDA approvals or clearances, may result in price reductions, reduced margins, loss of market share, or may render our products obsolete, which could adversely affect our revenue and profitability.
Any clinical data that is generated regarding our products may not be positive, and our current and planned clinical trials may not satisfy the requirements of the FDA or other regulatory authorities.
−Removed: Our clinical trials are expensive to conduct, typically taking many years to complete and have uncertain outcomes.
+Added: Our clinical trials are expensive to conduct, typically take many years to complete and have uncertain outcomes.
Delays in patient enrollment or failure of patients to consent or continue to participate in a clinical trial may cause an increase in costs and delays in the approval and attempted commercialization of our products or result in the failure of the clinical trial.
Conducting successful clinical studies may require the enrollment of large numbers of clinical sites and patients, and suitable patients may be difficult to identify and recruit.
−Removed: Patient enrollment in clinical trials and completion of patient participation and follow-up depends on many factors, including the size of the patient population;
+Added: Patient enrollment in clinical trials and completion of patient participation and follow-up depend on many factors, including the size of the patient population;
the nature of the trial protocol;
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Industry Conditions Risks
−Removed: A prolonged downturn in macroeconomic conditions in which we operate may materially adversely affect our business.
−Removed: A prolonged economic downturn as a result of the collateral effects of inflationary pressures, increases in interest rates, slower economic activity, a future outbreak of COVID-19 or a similar infectious disease, among other factors, may adversely impact our business.
+Added: A prolonged downturn in macroeconomic conditions may materially and adversely affect our business.
+Added: A prolonged economic downturn as a result of the collateral effects of inflationary pressures, increases in interest rates, slower economic activity, a future outbreak of an infectious disease, among other factors, may adversely impact our business.
Specifically, impacts to procedure volumes and hospital staffing may result in reductions of our revenue and materially and adversely affect our results of operations and cash flows.
−Removed: Geopolitical issues around the world have impacted the global supply chain and could materially adversely affect global economic growth, disrupt discretionary spending habits and generally decrease demand for our products and services.
+Added: Geopolitical issues around the world have impacted the global supply chain and could materially and adversely affect global economic growth, disrupt discretionary spending habits and generally decrease demand for our products and services.
Our customers’ ability to borrow money from their existing lenders or to obtain credit from other sources to purchase our products may be impaired, resulting in a decrease in sales.
We may experience diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as our clinical trial sites.
−Removed: We may also encounter interruption or delays in
−Removed: the operations of FDA or other regulatory authorities, which may impact review and approval timelines.
+Added: We may also encounter interruption or delays in the operations
+Added: of FDA or other regulatory authorities, which may impact review and approval timelines.
We are unable to predict the extent to which current or future worldwide economic conditions may impact our business.
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FDA does not regulate the practice of medicine.
−Removed: Physicians may use our products in circumstances where they deem it medically appropriate, such as for the treatment Afib, prevention of stroke, or reduction of post-operative Afib, even though FDA may not have approved or cleared our products to be marketed specifically for those indications.
+Added: Physicians may use our products in circumstances where they deem it medically appropriate, such as for the treatment of Afib, prevention of stroke, or reduction of post-operative Afib, even though FDA may not have approved or cleared our products to be marketed specifically for those indications.
Some payors may deny coverage or payment for the use of our products for indications not specifically approved or cleared by FDA.
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We have significant concentrations with a limited number of vendors.
−Removed: It would be a time consuming and lengthy process to secure these products from an alternative supplier.
+Added: It would be a time-consuming and lengthy process to secure these products from alternative suppliers.
Additionally, our devices are sterilized prior to use using ethylene oxide at third-party sterilizers.
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In the future, we may experience difficulties in increasing production, including problems with production yields and quality control, component supply and shortages of qualified personnel.
−Removed: These problems could result in delays in product
−Removed: availability and increases in expenses.
+Added: These problems could result in delays in product availability and increases in expenses.
Any such delay or increased expense could adversely affect our ability to generate revenues and adversely impact our operating results.
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In order to manage our operations and growth, we will need to continue to improve our operational and management controls, reporting and information technology systems and financial internal control procedures.
+Added: For example, we may require further investments and enhancements to our enterprise resource planning software system that may impact our financial processes and operations.
If we are unable to manage our growth effectively, it may be difficult for us to execute our business strategy and our operating results and business could suffer.
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We also rely in part on information technology to store information, interface with customers, maintain financial accuracy, secure our data and accurately produce our financial statements.
−Removed: In addition, some of our software systems are cloud-based data management applications, hosted by third-party service providers whose security and information technology systems are subject to similar risks.
+Added: In addition, some of our software systems are
+Added: cloud-based data management applications, hosted by third-party service providers whose security and information technology systems are subject to similar risks.
The failure to protect either our or our service providers’ information technology infrastructure could disrupt our operations.
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The coverage provided by such insurance may not be adequate for claims we may make or may be contested by our insurance carriers.
−Removed: If our insurance is not adequate or available to pay liabilities associated with our operations, or if we are unable to purchase adequate insurance at reasonable rates in the future, our business, financial condition, results of operations or cash flows may be materially adversely impacted.
+Added: If our insurance is not adequate or available to pay liabilities associated with our operations, or if we are unable to purchase adequate insurance at reasonable rates in the future, our business, financial condition, results of operations or cash flows may be materially and adversely impacted.
Legal & Compliance Risks
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If there is a change in law, regulation or administrative or judicial interpretations, we may have to change our business practices or our existing business practices could be challenged as unlawful, which could have a material adverse effect on our business, financial condition and results of operations.
−Removed: Our manufacturing operations and research and development activities involve the use of biological materials and hazardous substances and are subject to a variety of federal, state and local environmental laws and regulations relating to the storage, use, discharge, disposal, remediation of and human exposure to hazardous substances.
+Added: Our manufacturing operations and research and development activities involve the use of biological materials and hazardous substances and are subject to a variety of federal, state and local environmental laws and regulations relating to
+Added: the storage, use, discharge, disposal, remediation of and human exposure to hazardous substances.
Our research and development and manufacturing operations may produce biological waste materials, such as animal tissues and certain chemical waste.
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FDA may not agree with our decisions regarding whether submissions were required.
−Removed: If FDA were to disagree with us and require us to submit a 510(k), PMA or a PMA supplement for then-existing modifications, we could be required to cease promoting or to recall the modified product until we obtain clearance or
+Added: If FDA were to disagree with us and require us to submit a 510(k), PMA or a PMA supplement for then-existing modifications, we could be required to cease promoting or to recall the modified product until we obtain clearance or approval.
In addition, we could be subject to significant regulatory fines or other penalties.
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If we or our third-party vendors fail to comply with extensive FDA regulations relating to the manufacturing of our products or component parts, we may be subject to fines, injunctions and penalties, and our ability to commercially distribute and sell our products may be hurt.
−Removed: Our manufacturing facilities and the manufacturing facilities of any of our third-party component manufacturers, critical suppliers or third-party sterilization facilities are required to comply with FDA’s QSR, which sets forth minimum standards for the procedures, execution and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of the products we sell.
−Removed: FDA may evaluate our compliance with the QSR, among other ways, through periodic announced or unannounced inspections which could disrupt our operations and interrupt our manufacturing.
−Removed: If in conducting an inspection of our manufacturing facilities or the manufacturing facilities of any of our third-party component manufacturers, critical suppliers or third-party sterilization facilities, an FDA investigator observes conditions or practices believed to violate the QSR, the investigator may document their observations on a Form FDA-483 that is issued at the conclusion of the inspection.
+Added: Our manufacturing facilities and the manufacturing facilities of any of our third-party component manufacturers, critical suppliers or third-party sterilization facilities are required to comply with FDA’s QMSR, which sets forth minimum standards for the procedures, execution and documentation of the design, testing, production, control, quality assurance, labeling, packaging, sterilization, storage and shipping of the products we sell.
+Added: FDA may evaluate our compliance with the QMSR, among other ways, through periodic announced or unannounced inspections which could disrupt our operations and interrupt our manufacturing.
+Added: If in conducting an inspection of our manufacturing facilities or the manufacturing facilities of any of our third-party component manufacturers, critical suppliers or third-party sterilization facilities, an FDA investigator observes conditions or practices believed to violate the QMSR, the investigator may document their observations on a Form FDA-483 that is issued at the conclusion of the inspection.
A manufacturer that receives an FDA-483 may respond in writing and explain any corrective actions taken in response to the inspection observations.
−Removed: FDA will typically review the facility’s written response and may re-inspect to determine the facility’s compliance with the QSR and other applicable regulatory requirements.
+Added: FDA will typically review the facility’s written response and may re-inspect to determine the facility’s compliance with the QMSR and other applicable regulatory requirements.
Failure to take adequate and timely corrective actions to remedy objectionable conditions listed on an FDA-483 could result in FDA taking administrative or enforcement actions.
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Our patent applications may not issue as patents at all or in a form that will be advantageous to us.
−Removed: Our issued patents and those that may be issued in the future may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products.
+Added: patents and those that may be issued in the future may be challenged, invalidated or circumvented, which could limit our ability to stop competitors from marketing related products.
Although we have taken steps to protect our intellectual property and proprietary technology, we cannot assure you that third parties will not be able to design around our patents or, if they do infringe upon our technology, that we will be successful in or will have sufficient resources to pursue a claim of infringement against those third parties.
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For example, our operations outside of the United States are subject to different regulatory requirements in each jurisdiction where we operate or have sales.
−Removed: Our failure, or the failure of our distributors, to comply with current or future
−Removed: foreign regulatory requirements, or the assertion by foreign authorities that we or our distributors have failed to comply, could result in adverse consequences, including enforcement actions, fines and penalties, recalls, cessation of sales, civil and criminal prosecution, and the consequences could be disproportionate to the relative contribution of our international operations to our results of operations.
−Removed: Moreover, if political or economic conditions deteriorate in these countries, or if any of these countries are affected by a natural disaster or other catastrophe, our ability to conduct our international operations or collect on international accounts receivable could be limited and our costs could be increased, which could negatively affect our operating results.
+Added: Our failure, or the failure of our distributors, to comply with current or future foreign regulatory requirements, or the assertion by foreign authorities that we or our distributors have failed to comply, could result in adverse consequences, including enforcement actions, fines and penalties, recalls, cessation of sales, civil and criminal prosecution, and the consequences could be disproportionate to the relative contribution of our international operations to our results of operations.
+Added: Moreover, if political or economic conditions deteriorate in these countries, or if any of these countries are affected by a natural disaster or other catastrophe, our ability to conduct our international operations or collect on international accounts receivable could be limited and our costs could be increased, which could negatively
+Added: affect our operating results.
Engaging in business outside of the United States inherently involves a number of other difficulties and risks, including, but not limited to:
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We cannot assure you that one or more of these factors will not harm our business.
+Added: Changes in United States and international trade policies may adversely impact our business and operating results.
+Added: The United States government has made statements and taken certain actions that may lead to potential changes to United States and international trade policies, including imposing tariffs or taxes.
+Added: Our products are manufactured in the United States, and a significant portion of our revenues are domestic.
+Added: Because some of revenues and direct and downstream suppliers of components for our products are located in foreign countries, we are exposed to potential supply chain disruptions or delays and increasing costs in the event of changes in policies, laws, rules and regulations of the United States or foreign governments.
+Added: Due to the global nature of our business, international results could be impacted.
+Added: Implementation of tariffs or other restrictive trade measures by the United States government and reciprocal measures potentially enacted by other countries subject to such tariffs remain highly uncertain and may cause material short-term or long-term fluctuations in our results.
+Added: These actions are unpredictable and could have a material adverse impact on our business, financial condition and results of operations.
Due to the global nature of our business, we may be exposed to liabilities under the Foreign Corrupt Practices Act and various other anti-corruption laws, and any allegation or determination that we violated these laws could have a material adverse effect on our business.
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Our net losses have resulted principally from costs and expenses relating to sales, training and promotional efforts, research and development, clinical trials, seeking regulatory clearances and approvals and general operating expenses.
−Removed: We expect to continue to incur substantial expenditures and to potentially incur additional operating losses in the future as we further develop and commercialize our products.
+Added: We expect to continue to incur substantial expenditures in the future as we further develop and commercialize our products.
If sales of our products do not continue to grow as we anticipate, we may not be able to achieve profitability.
Our expansion efforts may prove to be more expensive than we currently anticipate, and we may not succeed in increasing our revenue sufficiently to offset these higher expenses.
−Removed: Our losses have had, and are expected to continue to have, an adverse impact on our working capital, total assets and accumulated deficit.
+Added: Our losses have had, and may have, an adverse impact on our working capital, total assets and accumulated deficit.
Governmental authorities may challenge our intercompany transfer pricing policies or change their laws in a manner that could increase our effective tax rate or otherwise harm our business.
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If our goodwill becomes impaired, it could materially reduce the value of our assets and reduce our net income or increase our net loss for the year in which the impairment occurs.
−Removed: As of December 31, 2024, we had $234,781 in goodwill, which represents purchase price we paid in excess of the fair value of the net assets we acquired.
+Added: As of December 31, 2025, we had $234,781 in goodwill, which represents the purchase price we paid in excess of the fair value of the net assets we acquired.
The Financial Accounting Standards Board’s (FASB) Accounting Standards Codification (ASC) 350, “Goodwill and Other Intangible Assets” requires that goodwill be tested for impairment at least annually (absent any impairment indicators).
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Conversely, inadequate inventory levels may make it difficult for us to meet customer product demand, resulting in decreased revenue.
−Removed: An inability to forecast future revenue or estimated life cycles of products may result in inventory-related charges that would negatively affect our gross margins and results of operations and increase our accumulated deficit.
+Added: An inability to forecast future revenue or estimate life cycles of products may result in inventory-related charges that would negatively affect our gross margins and results of operations and increase our accumulated deficit.
We are subject to credit risk from our accounts receivable related to our sales, which include sales into countries outside the United States that may experience economic turmoil.
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Our accounts receivable outside the United States are primarily due from public and private hospitals and from independent distributors.
−Removed: Although our historical write-offs of accounts receivable have not been significant, we monitor the financial performance and credit worthiness of our customers so that we can properly assess and respond to changes in their credit profile.
+Added: Although our historical write-offs of accounts receivable have not been significant, we monitor the financial performance and creditworthiness of our customers so that we can properly assess and respond to changes in their credit profile.
Our independent distributors operate in certain countries where economic conditions continue to present challenges to their businesses, and, thus, could place the amounts due to us at risk.
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We may be unable to comply with the covenants of our Credit Agreement.
−Removed: The Credit Agreement entered into on January 5, 2024, contains specific financial covenants and a minimum liquidity requirement, along with other terms restricting indebtedness, liens, investments and acquisitions, asset dispositions, certain payments and other customary representations and warranties.
−Removed: The Credit Agreement contains mandatory prepayment provisions which require prepayment of amounts outstanding (i) upon the receipt of proceeds from the issuance of any non-permitted indebtedness and (ii) when there is an Availability shortfall, as defined.
+Added: Our Credit Agreement contains specific financial covenants, along with other terms restricting indebtedness, liens, investments and acquisitions, asset dispositions, certain payments and other customary representations and warranties.
+Added: The Credit Agreement contains mandatory prepayment provisions which require prepayment of amounts outstanding (i) upon the receipt of proceeds from the issuance of any non-permitted indebtedness and (ii) when there is an Availability shortfall, as defined in the Credit Agreement.
The occurrence of an event of default could result in an obligation to repay all obligations in full and a right by our lenders to exercise all remedies available to them.
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We provide financial guidance about our business and future operating results.
−Removed: In developing this guidance, our management makes certain assumptions and judgments about our future operating performance, including rate of adoption of our products, projected hiring to support our growth, continued increase of our market share, potential impact from competitive devices and therapies, and stability of the macro-economic environment in our key markets.
+Added: In developing this guidance, our management makes certain assumptions and judgments about our future operating performance, including rate of adoption of our products, projected hiring to support our growth, continued increase of our market share, potential impact from competitive devices and therapies, and stability of the macroeconomic environment in our key markets.
Furthermore, analysts and investors may develop and publish their own projections of our business, which may form a consensus about our future performance.
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Sales of common stock by us in a capital raising transaction or our issuances of shares in an acquisition may dilute stockholder ownership of common stock and cause a decline in the market price of our common stock.
−Removed: We may need to raise capital in the future to fund our operations or new initiatives or reduce or pay in full our indebtedness.
+Added: We may need to raise capital in the future to fund our operations or new initiatives or reduce or pay in full our borrowings and financing obligations.
If we raise funds by issuing equity securities, our stock price may decline and our existing stockholders may experience significant dilution.
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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.