What changed in this filing

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Item 1A. Risk Factors

2026-03-31 compared with 2025-03-31 · 16 added, 44 removed, 774 unchanged (7% of the section changed)

22 unchanged sentences

Our current business strategies include a plan to expand uses for VIVO, which will require additional clearances.

LockeT, a suture retention device, is a sterile, Class I product that was registered with the FDA in February 2023, at which time we began initial shipments to distributors.

In May 2023, Catheter submitted LockeT for CE Mark approval.

CE Mark approval is expected in the first half of 2025, at which time initial international shipments to distributors will begin.

LockeT, a suture retention device, is a sterile, Class I product that was registered with the FDA in February 2023.

CE Mark approval was received in April 2025, at which time initial international shipments to distributors began.

While we do generate revenue, we are currently operating at a loss, and there is no guarantee that we will be able to grow revenues enough to offset our costs and achieve profitability.

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Our current cash flows are not sufficient to fund our current operations, and we believe that we will need to complete additional financings within the next three to six months.

Additionally, please see Note 18, Subsequent Events in our audited consolidated financial statements included elsewhere in this Annual Report for additional information regarding certain financing which occurred in the first quarter of 2026.

Risks Related to Our Internal Controls

We have identified material weaknesses in our internal control over financial reporting.

These material weaknesses could adversely affect our ability to report our results of operations and financial condition accurately and in a timely manner.

Our management is responsible for establishing and maintaining adequate internal controls over financial reporting designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States of America (“U.S.

Our management is likewise required, on a quarterly basis, to evaluate the effectiveness of our disclosure controls and to disclose any material changes to our internal controls identified through such evaluation.

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected and corrected on a timely basis.

As described elsewhere in this Form 10-K and in our Quarterly Reports on Form 10-Q filed during 2024, we have identified material weaknesses in our internal control over financial reporting related to (1) the lack of segregation of duties, (2) the lack of designed and operating review controls with respect to oversight of the financial reporting process, and (3) review of work performed by service providers with regards to (i) management's provision of inputs for valuations to a third-party service provider and (ii) the Section 382 calculation in the tax provision in that the Company's provision did not reference the correct dates when determining ownership changes resulting in material changes in the amount of expiring net operating losses available to be utilized.

As a result of these material weaknesses, our management has concluded that our disclosure controls were not effective as of March 31, 2024, June 30, 2024, September 30, 2024, and December 31, 2024.

For a discussion of management’s consideration of the material weaknesses described above, see below “Part II, Item 9A.

Controls and Procedures:

of this Annual Report on Form 10-K, and “Part I, Item 4.

Controls and Procedures” included in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024.

As described below at “Part II, Item 9A.

Controls and Procedures” of this Annual Report on Form 10-K and “Part I, Item 4.

Controls and Procedures” included in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, we have concluded that our disclosure controls were not effective as of March 31, 2024, June 30, 2024, September 30, 2024, and December 31, 2024 because material weaknesses existed in our internal control over financial reporting.

We have formulated and are implementing a plan to remediate the material weaknesses described therein;

however, if we are unable to remediate our material weaknesses in a timely manner or we identify additional material weaknesses, we may be unable to provide required financial information in a timely or reliable manner and we may incorrectly report financial information.

Likewise, if our financial statements are not filed on a timely basis, we could be subject to sanctions or investigations by the stock exchange on which our common stock is listed, the SEC or other regulatory authorities.

In such a case, there could be a material adverse effect on our business.

The existence of material weaknesses or significant deficiencies in internal control over financial reporting could adversely affect our reputation or investor perceptions of us, which could have a negative effect on the trading price of our stock.

In addition, we may incur additional costs to remediate the material weaknesses in our internal control over financial reporting.

We can give no assurance that the measures we have taken and plan to take in the future will remediate the material weaknesses identified or that any additional material weaknesses or restatements of financial results will not arise in the future due to a failure to implement and maintain adequate internal control over financial reporting or circumvention of these controls or otherwise.

There may be additional undetected material weaknesses in our internal control over financial reporting, as a result of which we may not detect financial statement errors on a timely basis.

Further, to the extent we identify additional material weaknesses, we will not be able to fully assess whether corrective measures will remediate the material weakness in our internal control over financial reporting until we have completed our implementation efforts and sufficient time passes in order to evaluate their effectiveness.

In addition, if we identify additional errors that result in material weaknesses in our internal control over financial reporting, we may not detect errors on a timely basis and our financial statements may be materially misstated.

Moreover, in the future we may engage in additional business transactions, such as acquisitions, reorganizations or implementation of new information systems, any of which could negatively affect our internal control over financial reporting and result in material weaknesses.

If we identify additional material weaknesses in our internal control over financial reporting or if we continue to be unable to assert that our internal control over financial reporting is effective, we may again be late with the filing of our periodic reports, investors may lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock could be negatively affected.

As a result of any internal control failures, we could also become subject to investigations by the stock exchange on which our securities are listed, the SEC, or other regulatory authorities, and become subject to litigation from investors and stockholders, which could harm our reputation or divert financial and management resources from our core business, and which would have a material adverse effect on our business, financial condition and results of operations.

Compliance with Section 404 of the Sarbanes-Oxley Act could have a material adverse impact on our business.

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To date, we have met with reimbursement specialists and are working to determine the best strategy.

Develop new products, including potentially our PeriKard products.

Develop new products, including potentially our Cardionomix and KardioNav products.

In addition, our sales and marketing strategy for VIVO requires us to hire additional clinical support and sales representatives who are experienced in the EP field.

44 unchanged sentences

The agreements provide for the Noteholders to receive, in the aggregate, approximately 12% of the net sales, if any, of the Surgical Vessel Closing Pressure Device, commencing upon the first commercial sale through December 31, 2035.

On December 31, 2025, we entered into the Series J Exchange Agreement ("Royalty Right Exchange") with certain Noteholders to exchange future and accrued royalty rights of $2.7 million for an aggregate of 9,490 shares of the Company's newly designated Series J Convertible Preferred Stock, par value $0.0001 per share and stated value of $1,000 per share.

We derecognized $2.7 million of royalties payable due to related parties and recognized the fair value of the Series J Convertible Preferred Stock of $5.3 million in additional paid-in capital in the accompanying consolidated balance sheets included elsewhere in this Annual Report.

As a result, even if the Surgical Vessel Closing Pressure Device is successfully developed and marketed, our revenues from this device will be reduced by the amount of these royalties.

97 unchanged sentences

If any of our product candidates are approved but fail to achieve market acceptance or such market is smaller than anticipated, we may not be able to generate significant revenue and our business would suffer.

The recent coronavirus, or COVID-19, outbreak adversely affected our financial condition and results of operations, and we cannot provide any certainty as to whether there will be future impacts from COVID-19 or another pandemic.

The COVID-19 outbreak adversely affected our financial condition and results of operations.

The impact of the outbreak of COVID-19 on the businesses and the economy in the United States and the rest of the world was significant.

The extent to which the COVID-19 outbreak will continue to impact business and the economy is highly uncertain and cannot be predicted, and there can be no guarantee that a future pandemic will not have similar or worse impacts.

Accordingly, we cannot predict the extent to which our financial condition and results of operation will be affected.

A variety of risks associated with marketing our products internationally could materially adversely affect our business.

17 unchanged sentences

These and other risks associated with international operations may materially adversely affect our ability to attain or maintain profitable operations, which would have a material adverse effect on our business, financial condition, and results of operations.

The impact of the ongoing Russia-Ukraine and Israel-Gaza military conflicts, and other actions that have been and could be taken by other countries, including new and stricter sanctions and actions taken in response to such sanctions, have affected, and may continue to affect, our business and results of operations, including our supply chain.

The impact of the ongoing Russia-Ukraine, Israel-Gaza and Iran military conflicts, and other actions that have been and could be taken by other countries, including new and stricter sanctions and actions taken in response to such sanctions, have affected, and may continue to affect, our business and results of operations, including our supply chain.

On February 24, 2022, Russian forces launched significant military action against Ukraine, and sustained conflict and disruption in the region has occurred.

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We may suffer similar adverse effects from the Israel-Gaza conflict which has been ongoing since October 2023.

More recently, the Iran conflict in the middle east may also adversely effect our business.

We also cannot predict the impact of any heightened geopolitical instability or the results that may follow, including reductions in consumer confidence, heightened inflation, cyber disruptions or attacks, higher natural gas costs, higher manufacturing costs and higher supply chain costs.

437 unchanged sentences

Further, an inactive market may also impair our ability to raise capital by selling shares of our common stock and may impair our ability to enter into strategic partnerships or acquire companies or products by using shares of our common stock as consideration, which could have a material adverse effect on our business, financial condition, and results of operations.

In addition, the trading price of our common stock is likely to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume.

In addition, the trading price of our common stock has been and is likely to continue to be highly volatile and could be subject to wide fluctuations in response to various factors, some of which are beyond our control, including limited trading volume.

In addition to the factors discussed in this Risk Factors section and elsewhere in this Annual Report, these factors include:

40 unchanged sentences

If our stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market, the trading price of our common stock could decline.

As of March 17, 2025, we had 9,268,632 outstanding shares of our common stock and outstanding options to purchase up to 2,222,434 shares of our common stock, as well as 2,157,000 shares subject to pre-funded warrants, and 15,960,613 shares subject to outstanding warrants that are currently out of the money.

At our special meeting of stockholders held on March 21, 2023, our stockholders approved the conversion of 1,993.581 shares of our Series X Preferred Stock into 1,993,581 shares of our common stock.

The remaining 12,656 shares of Series X Preferred Stock may be convertible into 1,265,601 shares of our common stock on or after July 9, 2024, in the event that we meet the initial listing standards of the NYSE American or another securities exchange or have been delisted from the NYSE American.

As of March 20, 2026, we had 2,692,473 outstanding shares of our common stock and outstanding options to purchase up to 149,967 shares of our common stock, as well as 1,136,595 shares subject to outstanding warrants that are currently out of the money.

We also had 1,650.256 outstanding shares of our Series B Convertible Preferred stock convertible into approximately 916,997 shares of our commons stock, 3,470 outstanding shares of our Series C-1 Convertible Preferred stock convertible into approximately 2,426,573 shares of our common stock, and 9,489.488 outstanding shares of our Series J convertible Preferred stock convertible into approximately 6,083,005 shares of our common stock.

In addition, as of March 20, 2026, we had convertible promissory notes convertible into approximately 733,134 shares of our common stock.

In July 2023, we adopted the 2023 Equity Incentive Plan, or the 2023 Plan.

As of March 6, 2025, 796,615 shares were available for issuance as new awards under the 2023 Plan, options to purchase 1,681,000 shares were outstanding, and 66,667 shares of restricted stock awards had been authorized for future issuance.

As of March 20, 2026, 263,221 shares were available for issuance as new awards under the 2023 Plan, options to purchase 122,790 shares were outstanding.

The 2023 Equity Incentive Plan provides for quarterly increases in the number of shares authorized for issuance under the Plan based on a percentage of the increase in the number of shares outstanding during the quarter.

5 unchanged sentences

If we sell common stock, convertible securities or other equity securities, investors may be materially diluted by subsequent sales.

Such sales may also result in material dilution to our existing stockholders, and new investors could gain rights, preferences and privileges senior to the holders of our common stock.

Such sales may also result in material and substantial dilution to our existing stockholders, and new investors could gain rights, preferences and privileges senior to the holders of our common stock.

Anti- takeover provisions under our charter documents and Delaware law could delay or prevent a change of control which could limit the market price of our common stock and may prevent or frustrate attempts by our stockholders to replace or remove members of our board of directors or our current management and may adversely affect the market price of our common stock.

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In order to maintain our listing, we must maintain certain share prices, financial and share distribution targets, including maintaining a minimum amount of stockholders’ equity, minimum public float, and a minimum number of public stockholders.

In addition to these objective standards, the NYSE American may delist the securities of any issuer if, in its opinion, the issuer’s financial condition and/or operating results appear unsatisfactory;

In addition to these objective standards, the NYSE American may delist the securities of any issuer if, in the opinion of NYSE American, the issuer’s financial condition and/or operating results appear unsatisfactory;

if it appears that the extent of public distribution or the aggregate market value of the security has become so reduced as to make continued listing on the NYSE American inadvisable;

21 unchanged sentences

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