SeaStar Medical Holding Corp
For the period ended Dec 31, 2024. Filed Mar 27, 2025.
View on SEC.govAbout this filing
A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2024 · Filed Mar 27, 2025
ICU$1.88-2.1%Stored close · as of Nov 6, 2026
What changed in Risk Factors?
Read the current filingPrevious report: 10-K
Period ended 2023-12-31; filed 2024-04-16.
0000950170-24-044855
Item 1A. Risk FactorsCurrent report: 10-K
Period ended 2024-12-31; filed 2025-03-27.
0000950170-25-046200
Item 1A. Risk FactorsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 347 previous paragraphs and 333 current paragraphs.
69 unchanged; 215 reworded; 40 added; 54 removed; 9 previous and 9 current paragraphs rearranged.
Tables are not compared: 0 previous and 0 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (40)
Current report
We may become a defendant in one or more stockholder derivative, class-action, and other litigation.
Current report
We may face challenges in obtaining additional FDA approvals to market our product.
Current report
The United States could change tariff, trade, or tax provisions related to the manufacturing and sales of our products in ways that we currently cannot predict.
Current report
Changing priorities within the U.S. government resulting in the loss of government grant funding could adversely impact our future growth plans.
Current report
commercializing our pediatric SCD, including securing adoption and increasing awareness;
Current report
obtaining regulatory approval for our adult SCD, including the PMA from the FDA;
Current report
We may become a defendant in one or more stockholder derivative, class-action, and other litigation, and any such lawsuits may adversely affect our business, financial condition, results of operations and cash flows.
Current report
We may in the future become defendants in one or more stockholder derivative actions or other class-action lawsuits. For example, certain former directors have threatened litigation for purported harm to us in connection with certain allegations made by the former directors against other members of our Board of Directors and management. The former directors have also made demands in connection with certain alleged contractual rights and purported agreements with us. We and the Board of Directors dispute these allegations and believe they are unfounded.
Current report
In addition, on July 5, 2024, Forrest A K Wells (the “Plaintiff”), a purported stockholder of ours, filed a putative class action complaint in the United States District Court for the State of Colorado (the “Class Action”), alleging that we and our management members made material misstatements or omissions regarding our business and operations, including disclosures relating to FDA approval of our product candidates, allegedly culminating in the restatement of our consolidated financial statements as disclosed in the Form 8-K filed on March 27, 2024. The Class Action asserts claims under Section 10(b) of the Exchange Act against us, our Chief Executive Officer and former Chief Financial Officer (collectively, the “Defendants”), as well as claims under Section 20(a) of the Exchange Act against the
Current report
Defendants. Among other remedies, the Class Action seeks to recover compensatory and other damages. On March 4, 2025, the Plaintiff filed an amended complaint. We intend to vigorously defend the action.
Current report
On December 13, 2024, Jose Lazo, a purported stockholder of ours, filed a putative stockholder derivative action complaint in the United States District Court for the District of Colorado (the “Derivative Action”). The factual allegations of the Derivative Action are substantially similar to the Class Action. On January 30, 2025, upon joint motion of the parties, the Court stayed the Derivative Action pending the Court’s resolution of an anticipated motion to dismiss to be filed in the Class Action.
Current report
Any such lawsuit could divert our management’s attention and resources from our ordinary business operations, and we would likely incur significant expenses associated with their defense (including, without limitation, substantial attorneys’ fees and other fees of professional advisors and potential obligations to indemnify current and former officers and directors who are or may become parties to such actions). In connection with these lawsuits, we may be required to pay material damages, consent to injunctions on future conduct and/or suffer other penalties, remedies or sanctions, or issue additional shares upon the exercise of certain warrants, which may cause additional dilution. In addition, any such future lawsuits could adversely impact our reputation and/or ability to launch and commercialize our products, thereby harming our ability to generate revenue. Accordingly, the ultimate resolution of these matters and any future matters could have a material adverse effect on our business, financial condition, results of operations and cash flow and, consequently, could negatively impact the trading price of our common stock.
Current report
We may face challenges in obtaining additional FDA approvals to market our products in the United States or abroad.
Current report
The United States could change tariff, trade, or tax provisions related to the manufacturing and sales of our products in ways that we currently cannot predict.
Current report
Our business benefits from free trade agreements, and we also rely on various U.S. corporate tax provisions related to international commerce as we develop, market and sell our products within the U.S. and globally. The U.S. presidential administration has instituted or proposed changes in trade policies that include the imposition of higher tariffs on imports into the U.S., economic sanctions on individuals, corporations or countries, and other government regulations affecting trade between the U.S. and other countries where we conduct business. The new tariffs and other changes in U.S. trade policy could trigger retaliatory actions by affected countries, and certain foreign governments have instituted or are considering imposing trade sanctions on certain U.S. goods. The U.S. presidential administration has indicated a focus on policy reforms that discourage corporations from outsourcing manufacturing and production activities to foreign jurisdictions, including through tariffs or penalties on goods manufactured outside the U.S., which may require us to change the way we conduct business. These changes in U.S. and foreign laws and policies have the potential to adversely impact the U.S. economy or certain sectors thereof, our industry and the demand for our products, and as a result, could have a material adverse effect on our business, financial condition and results of operations. As of March 27, 2025, we do not import materials from Canada or China, but we do source tubing sets from Medtronic that is manufactured in Mexico. Tariffs and other trade restrictions could adversely affect our ability to obtain such materials on a timely basis or cause such components to become more expensive, which could adversely affect our business.
Current report
We may pursue government funding in the future. Changing priorities within the U.S. government resulting in the loss of government grant funding could adversely impact our future growth plans.
Current report
As a commercial-stage medical device company, there are grants and other funding provided by the U.S. government that we could apply for and receive. However, the current U.S. presidential administration has indicated that there will not only be a pause on government funding, but there will also be a change in who is eligible to receive it and for what purpose. These changes are not predictable and may impact our ability to receive government funding in the future. An inability to receive government funding could adversely impact our future growth plans.
Current report
Additionally, use of the SCD in the hospital setting requires the administration of RCA and calcium replacement into CRRT circuitry for safe and effective use. Both components are IV solutions which are commonly stocked by hospital systems. However, there are limited manufacturers/suppliers of these IV solutions nationwide, and any supply chain disruptions may have detrimental effects to the utilization of CRRT, and subsequently use of commercial QUELIMMUNE or the adult SCD in clinical studies.
Current report
For example, in December 2022, we entered into the Distribution Agreement with Nuwellis, pursuant to which we appointed Nuwellis as our exclusive distributor for the sale and distribution of our pediatric SCD product throughout the United States once we receive from the FDA a written authorization to market such product for pediatric use pursuant to our HDE application. In the event of a material breach if such breach is not cured within ninety (90) days after written notice, we have the right to terminate the Distribution Agreement in accordance with the terms set forth in the Distribution Agreement. In May 2024, we provided notice to Nuwellis that Nuwellis had breached the Distribution Agreement. Nuwellis disputed the validity of the termination and on October 20, 2024, we entered into a confidential settlement agreement and release with Nuwellis, pursuant to which we paid Nuwellis an aggregate of $900,000 payable in three installments through December 31, 2024.
Current report
For example, on June 24, 2024, we received a written notification from the Listing Qualifications staff of The Nasdaq Stock Market (“Nasdaq”) that we were not in compliance with the requirement to maintain a minimum market value of listed securities of $35 million, as set forth in Nasdaq Listing Rule 5550(b)(2) (the “Rule”), because the market value of our listed securities (the “Securities”) had been below $35 million for 30 consecutive business days. We had an initial 180 days, or until December 23, 2024, to regain compliance with the MVLS Requirement.
Current report
On December 24, 2024, we received written notification (the “Notification”) from Nasdaq stating that we had not regained compliance with the Rule. Pursuant to the Notification, the Securities were subject to delisting from Nasdaq on January 3, 2025, unless we requested a hearing before the Nasdaq Hearings Panel (the “Panel”) by December 31, 2024.
Current report
We requested a hearing before the Panel by December 31, 2024. As disclosed to Form 8-K on March 13, 2025, on March 11, 2025, we received a decision letter (the “Letter”) from the Nasdaq Hearings Panel (the “Panel”), granting our request to continue listing our common stock on The Nasdaq Stock Market (“Nasdaq”), subject to certain conditions. The Panel’s decision provides us with an exception until June 22, 2025, to demonstrate compliance with Nasdaq Listing Rule 5550(b)(2) (the “MVLS Rule”), which requires a Market Value of Listed Securities of at least $35 million. The Panel reviewed our compliance plan, which includes the continuation of fundraising efforts that began in 2024 and strategies for achieving long-term compliance with the MVLS Rule. As part of the conditions outlined in the Panel’s decision, we are required to, on or before June 22, 2025:
Current report
file a public disclosure describing the transactions undertaken to increase our equity and providing an indication of our equity following those transactions, and
Current report
provide the Panel with an update on our fundraising plans and updated income projections for the next 12 months, with all underlying assumptions clearly stated.
Current report
We are taking steps to address the conditions outlined.
Current report
There can be no assurance that we will be successful or that we will be able to regain compliance with the MLVS Rule or maintain compliance with other Nasdaq listing requirements. If we fail to regain compliance with Nasdaq’s continued listing standards during any period granted by the Panel, the Securities could be subject to delisting from Nasdaq, unless another exception is granted by Nasdaq.
Current report
In response to the material weaknesses, we have identified and documented all relevant processes, conducted a corporate-wide risk assessment to address emerging risks, and implemented new entity-level, process-level, and monitoring controls. Additionally, we upgraded IT systems and general controls to mitigate segregation of duty risks.
Current report
As a result of these efforts, our management concluded that, as of December 31, 2024, the material weaknesses has been remediated. While these material weaknesses have been remediated, other weaknesses in our disclosure controls and procedures and internal control over financial reporting may be discovered in the future.
Current report
As a public company, we are subject to the reporting requirements of the Exchange Act, the Sarbanes-Oxley Act of 2002 (“the Sarbanes-Oxley Act”), and the rules and regulations of the applicable listing standards of Nasdaq. We expect that the requirements of these rules and regulations will continue to increase our legal, accounting, and financial compliance costs, make some activities more difficult, time-consuming, and costly, and place significant strain on our personnel, systems, and resources.
Current report
The Sarbanes-Oxley Act requires, among other things, that we maintain effective disclosure controls and procedures and internal control over financial reporting. However, as an emerging growth company, an attestation of an independent registered public accounting firm will initially not be required. We are continuing to develop and refine our disclosure controls and other procedures. We are also continuing to improve our internal control over financial reporting. In order to maintain and improve the effectiveness of our disclosure controls and procedures and internal control over financial reporting, we have expended, and anticipate that we will continue to expend, significant resources, including accounting-related costs, and significant management oversight. Our current controls and any new controls that we develop may become inadequate because of changes in conditions in our business. We may need to upgrade our legacy information technology systems; implement additional financial and management controls, reporting systems and procedures; and hire additional accounting and finance staff. If we are unable to hire the additional accounting and finance staff necessary to comply with these requirements, we may need to retain additional outside consultants. If we or, if required, our independent registered public accounting firm, are unable to conclude that our internal control over financial reporting is effective, investors may lose confidence in our financial reporting, which could negatively impact the price of our securities.
Current report
Our management and other personnel will need to devote a substantial amount of time to compliance initiatives applicable to public companies, including compliance with Section 404 and the evaluation of the effectiveness of our internal controls over financial reporting within the prescribed timeframe. We cannot assure you that there will not be additional material weaknesses in our internal control over financial reporting now or in the future and we may discover additional deficiencies in existing systems and controls that we may not be able to remediate in an efficient or timely manner. In the event that we identify additional deficiencies, we may be required to further restate our financial statements and our results of operations and financial condition could be negatively affected.
Current report
Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows. If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines that we have a material weakness in our internal control over financial reporting, investors may lose confidence in the accuracy and completeness of our financial reports, the market price of our securities could decline, and we could be subject to sanctions or investigations by Nasdaq, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to the capital markets.
Removed paragraphs (54)
Previous report
The Company may not use its net operating losses to offset future taxable income Risks Related to the Company’s Business Operations.
Previous report
The Company may not receive approval from the FDA to market its product.
Previous report
The Company is subject to certain risks relating to pursuing an FDA approval process.
Previous report
The Company may not be able to manage its growth effectively.
Previous report
The Company’s forecasted operating and financial results may not be accurate
Previous report
Intellectual property rights do not necessarily address all potential threats to the Company’s competitive advantage.
Previous report
The Company identified a material weakness in its internal control over financial reporting, which may result in restatements of financial statements.
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Risks Relating to the Company’s Financial Condition
Previous report
The Company has incurred significant losses since its inception and anticipates that it will continue to incur significant losses for the foreseeable future.
Previous report
The Company is a medical technology company focused primarily on developing and commercializing its lead product candidate, the SCD, for pediatric and adult AKI indications. The Company applied for a HDE for SCD in June 2022 for the treatment of pediatric patients with AKI on CRRT. On September 29, 2023, the Company received a correspondence from the FDA indicating that this HDE is approvable for use in children weighing 10 kilograms or more with AKI and sepsis or a septic condition requiring CRRT in the hospital ICU. On October 30, 2023, the Company announced that it received the approvable letter from the FDA, which outlined remaining administrative steps that must be finalized before the HDE can be approved and active for commercialization. On February 22, 2024, the Company announced the receipt of the approval order from the FDA. The Company believes the approval of its HDE will confirm SCD and its technology as an effective tool to treat hyperinflammation related diseases, which will enable us to successfully execute our business and growth strategies.
Previous report
In addition, on February 9, 2023, the Company received approval from the FDA of its IDE application to conduct a pivotal study evaluating the effectiveness of its SCD in reducing hyperinflammation in adults with AKI requiring CRRT. The Company began enrollment in June 2023 and expects to generate interim study results by mid-2024 and topline study results and submission of a PMA application by the end of 2024, and the Company is targeting FDA approval by the end of 2025. However, there is no guarantee that the Company will complete any planned clinical trial in a timely manner, or at all, nor will there be any assurance that positive data will be generated from such a trial. Even if the Company is able to generate positive results from this trial, the FDA and other regulatory agencies may require the Company to conduct additional trials to support the study or disagree with the design of the trial and request changes or improvements to such design.
Previous report
obtaining regulatory approval for its SCD for the designated indication, including the HDE in pediatrics and PMA for adults;
Previous report
On August 23, 2022, LMF and the Predecessor entered into a Common Stock Purchase Agreement (the “Purchase Agreement”) with Tumim for the purchase of up to $100.0 million in shares of the common stock (“Common Stock") after the consummation of the Business Combination. There were certain conditions and limitations on the Company’s ability to utilize the $100.0 million equity line with Tumim. The Company was required to satisfy various conditions, which include, among others: (1) delivery of a compliance certificate; (2) filing of an initial registration statement; and (3) customary bring-down opinions and negative assurances, in order to commence the selling of Common Stock to Tumim under the Purchase Agreement. Once such conditions were satisfied, Tumim’s purchases were subject to various restrictions and other limitations, including a cap on the number of shares of
Previous report
Common Stock that we could sell based on the trading volume of our Common Stock, as well as certain beneficial ownership restrictions of Tumim. The Company has received a total of $1.9 million from the Purchase Agreement through February 15, 2024, when the Purchase Agreement was terminated by mutual consent of the parties thereto pursuant to its terms.
Previous report
In March 2023, the Company entered into a securities purchase agreement with an 3i (as amended from time to time, the “March 2023 SPA”) for the purchase and sale of convertible notes and warrants (together with the March 2023 SPA, the “Note Documents”). The Note Documents include various restrictions and covenants, including an optional redemption provision that provides such investor the right to require the Company to use up to 20% of the proceeds of any subsequent financing, including this offering, to repay outstanding balance of the notes (the “Optional Redemption Rights”). In connection with this offering, the institutional investor agreed to waive its Optional Redemption Rights and any event of default that may arise thereunder with respect to this offering and suspend the Optional Redemption Rights for a period of sixty (60) days following the closing of this offering (the “Suspension Period”), and the Company granted the institutional investor a right to redeem all or a portion of the then outstanding Conversion Amount (as defined in the Note Documents) within three (3) trading days after the Suspension Period at an amount equal to 200% of the Conversion Amount. As of the date of this Form 10-K, the aggregate Conversion Amount under the Note Documents is approximately $1.0 million. Failure to meet the restrictions, obligations, and limitations under the Notes Documents or the securities issued thereunder may result in an event of default in accordance with the terms of the convertible notes issued thereunder. An event of default would, among other things, provide the noteholder with the right to increase the outstanding balance by 15%. Additionally, upon an event of default, the noteholder may consider the convertible note immediately due and payable. Furthermore, upon an event of default, the interest rate may also be increased to 12% per annum
Previous report
significantly delay, scale back or discontinue the development or commercialization of its product candidates;
Previous report
relinquish or license on unfavorable terms, its rights to technologies or product candidates that it otherwise would seek to develop or commercialize itself;
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Risks Related to the Company’s Business Operations
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The Company has not received, and may never receive, approval from the FDA to market its product in the United States or abroad.
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The Company is required to submit a substantial amount of supporting documentation for its HDE application to demonstrate the eligibility of the SCD to treat pediatric patients. The Company submitted an application for a HDE for SCD in June 2022 for the treatment of pediatric patients with AKI on CRRT. On September 29, 2023, the Company received correspondence from the FDA indicating that this HDE is approvable for use in children weighing 10 kilograms or more with AKI and sepsis or a septic condition requiring CRRT in the hospital ICU. On October 30, 2023, the Company announced that it received the approvable letter from the FDA. On February 22, 2024, the Company announced the receipt of the approval order from the FDA. The Company believes the approval of its HDE will confirm SCD and its technology as an effective tool to treat hyperinflammation related diseases, which will enable us to successfully execute our business and growth strategies.
Previous report
The Company is subject to certain risks relating to pursuing an FDA approval via the HDE pathway, including limitations on the ability to profit from sales of the product.
Previous report
Except in certain circumstances, products approved under an HDE cannot be sold for an amount that exceeds the costs of the research and development, fabrication, and distribution of the device (i.e., for profit). Currently, under section 520(m)(6)(A)(i) of the Food, Drug, and Cosmetic Act, as amended (the “FD&C Act”) by the Food and Drug Administration Safety and Innovation Act, a Humanitarian Use Device (“HUD”) is only eligible to be sold for profit after receiving HDE approval if the device (1) is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or (2) is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe. If an HDE-approved device does not meet this eligibility criteria, the device cannot be sold for profit. With enactment of the FDA Reauthorization Act of 2017, Congress provided that the exemption for the HUD/HDE profitability is available as long as the request for an exemption is submitted on or before October 1, 2022. Not receiving an exemption for the HUD/HDE profitability would have a material adverse effect on the Company’s business, results of operations and financial condition.
Previous report
In addition, if the FDA subsequently approves a PMA or clears a 510(k) for the HUD or another comparable device with the same indication, the FDA may withdraw the HDE. Once a comparable device becomes legally marketed through PMA approval or 510(k) clearance to treat or diagnose the disease or condition in question, there may no longer be a need for the HUD and so the HUD may no longer meet the requirements of section 520(m)(2)(B) of the FD&C Act.
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global viruses and pandemics, including the current COVID-19 pandemic.
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If a clinical research organization that the Company utilizes is unable to allocate sufficient qualified personnel to its studies in a timely manner or if the work performed by it does not fully satisfy the requirements of the FDA or other regulatory agencies, the Company may encounter substantial delays and increased costs in completing its development efforts. Any manufacturer of the Company’s products may encounter difficulties in the manufacturing of enough new product to meet demand, including problems with product yields, product stability or shelf life, quality control, adequacy of control procedures and policies, compliance with FDA regulations and the need for FDA approval of new manufacturing processes and facilities. If any of these occur, the development and commercialization of the Company’s product candidates could be delayed, curtailed, or terminated because the Company may not have sufficient financial resources or capabilities to continue such development and commercialization on its own.
Previous report
For example, in the United States, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (collectively, the “ACA”), among other things, reduced and/or limited Medicare reimbursement to certain providers. However, on December 14, 2018, a Texas United States District Court Judge ruled that the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress as part of legislation enacted in 2017, informally titled the Tax Cuts and Jobs Act of 2017. Additionally, on June 17, 2021, the United States Supreme Court dismissed a challenge on procedural grounds that argued the ACA is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Thus, the ACA remains in effect without the “individual mandate.”
Previous report
Further, prior to the United States Supreme Court ruling, on January 28, 2021, President Biden issued an executive order that initiated a special enrollment period for purposes of obtaining health insurance coverage through the ACA marketplace, which began on February 15, 2021 and remained open through August 15, 2021. The executive order also instructed certain governmental agencies to review and reconsider their existing policies and rules that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access to health insurance coverage through Medicaid or the ACA. It is possible that the ACA will be subject to judicial or Congressional challenges in the future. It is unclear how any such challenges and litigation, and the healthcare reform measures of the Biden administration will impact the ACA and the Company’s business. The Budget Control Act of 2011, as amended by subsequent legislation, further reduces Medicare’s payments to providers by 2% through fiscal year 2031. However, COVID-19 relief legislation suspended the 2% Medicare sequester from May 1, 2020 through March 31, 2022. Under current legislation, the actual reduction in Medicare payments will vary from 1% in 2022 to up to 3% in the final fiscal year of this sequester. These reductions may reduce providers’ revenues or profits, which could affect their ability to purchase new technologies.
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the interruption of, or delays in receiving, supplies of its product candidates from its contract manufacturing organizations due to staffing shortages, production slowdowns or stoppages and disruptions in delivery systems;
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limitations on employee resources that would otherwise be focused on the conduct of its clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
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A small number of the Company’s stockholders, including its major stockholders, the Dow Pension Funds, could significantly influence its business.
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The Company has a few significant stockholders who own a substantial percentage of its outstanding shares of Common Stock, including Dow Employees’ Pension Plan Trust and Union Carbide Employees’ Pension Plan Trust. These few significant shareholders, either individually or acting together, may be able to exercise significant influence over matters requiring shareholder approval, including the election of directors and approval of significant corporate transactions, such as a merger or other sale of the Company or its assets. This concentration of ownership may make it more difficult for other shareholders to effect substantial changes in the Company, may have the effect of delaying, preventing or expediting, as the case may be, a change in control of the Company and may adversely affect the market price of the Common Stock. Further, the possibility that one or more of these significant shareholders may sell all or a large portion of their Common Stock in a short period of time could adversely affect the trading price of our Common Stock.
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whether the Company can manage relationships with key suppliers;
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Risks Relating to the Company’s Intellectual Property
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the extent to which the Company’s technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
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the sublicensing of patent and other rights under any collaboration relationships the Company might enter into in the future;
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the Company’s diligence obligations under the license agreement and what activities satisfy those diligence obligations;
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Intellectual property rights do not necessarily address all potential threats to the Company’s competitive advantage.
Showing the first 40 of 54 passages. Open the source sections for the rest.
Reworded paragraphs (215)
Previous wording
The Company has incurred significant losses since its inception and may continue to incur significant losses for the foreseeable future.
Current wording
We have not generated revenue sufficient for positive operating cash flows, have incurred significant losses since our inception and may continue to incur significant losses for the foreseeable future.
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If the Company fails to obtain additional financing, it would be forced to delay, reduce or eliminate its product development program.
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If we fail to obtain additional financing, we would be forced to delay, reduce or eliminate our product development program.
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The Company’s ability to use its net operating losses to offset future taxable income may be subject to certain limitations.
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We may not be able to use our net operating losses to offset future taxable income.
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The Company will initially depend on revenue generated from a single product.
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We will initially depend on revenue generated from a single product.
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The Company may fail to comply with extensive regulations of United States and foreign regulatory agencies.
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We may fail to comply with extensive regulations of United States and foreign regulatory agencies.
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Delays in successfully completing the Company’s planned clinical trials could jeopardize its ability to obtain regulatory approval.
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Delays in successfully completing our planned clinical trials could jeopardize our ability to obtain regulatory approval.
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Delays, interruptions, or the cessation of production by its third-party suppliers of important materials or delays in qualifying new materials, may prevent or delay the Company’s ability to manufacture or process its SCD device.
Current wording
Delays, interruptions, or the cessation of production by our third-party suppliers of important materials or delays in qualifying new materials, may prevent or delay our ability to manufacture or process our SCD device.
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The Company has limited experience in identifying and working with large-scale contracts with medical device manufacturers.
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We have limited experience in identifying and working with large-scale contracts with medical device manufacturers.
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Difficulties in manufacturing the Company’s SCD could have an adverse effect upon its revenue and expenses.
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Difficulties in manufacturing our SCD could have an adverse effect upon our revenue and expenses.
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The Company faces intense competition in the medical device industry.
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We face intense competition in the medical device industry and our SCD technology may become obsolete.
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The Company outsources many of its operational and development activities for which it may not have full control.
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We outsource many of our operational and development activities for which we may not have full control.
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Should the Company’s products be approved for commercialization, a lack of third-party coverage and reimbursement for the Company’s devices could delay or limit their adoption.
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A lack of third-party coverage and reimbursement for our devices could delay or limit their adoption.
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Should any of its future products, including the SCD, be approved for commercialization, adverse changes in reimbursement policies and procedures by payors may impact the Company’s ability to market and sell its products.
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Adverse changes in reimbursement policies and procedures by payors may impact our ability to market and sell our products.
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The Company may be subject to enforcement action if it engages in improper marketing or promotion of its products.
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We may be subject to enforcement action if we engage in improper marketing or promotion of our products.
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The Company is and will be exposed to product liability risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon it should it be sued.
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We are and will be exposed to product liability risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon us should we be sued.
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United States legislative or FDA regulatory reforms may make it more difficult and costly for the Company to obtain regulatory approval of its product candidates and to manufacture, market and distribute its products after approval is obtained.
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United States legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained.
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The Company is subject to stringent and changing privacy laws, regulations and standards
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We are subject to stringent and changing privacy laws, regulations and standards
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The Company’s business operations will be adversely affected if its security measures, or those maintained on its behalf, are compromised, limited or fails.
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Our business operations will be adversely affected if our security measures, or those maintained on our behalf, are compromised, limited or fails.
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The Company depends on key personnel and its inability to attract and retain qualified personnel could impede its ability to achieve its business objectives.
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We depend on key personnel and our inability to attract and retain qualified personnel could impede our ability to achieve our business objectives.
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The Company’s products may in the future be subject to product recalls.
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Our products may in the future be subject to product recalls.
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The Company’s estimates of market opportunity, industry projections and forecasts of market growth may prove to be inaccurate.
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Our estimates of market opportunity, industry projections and forecasts of operating and financial results and market growth may prove to be inaccurate.
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The Company relies upon exclusively licensed patent rights from third parties which are subject to termination or expiration.
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We rely upon exclusively licensed patent rights from third parties which are subject to termination or expiration.
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If the Company is unable to obtain and maintain sufficient patent protection for its products, the Company’s ability to commercialize such products successfully may be adversely affected.
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If we are unable to obtain and maintain sufficient patent protection for our products, our ability to commercialize such products successfully may be adversely affected.
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The Company may not be able to obtain protection under the Hatch-Waxman Act and similar non-United States legislation for extending the term of patents covering its products
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We may not be able to obtain protection under the Hatch-Waxman Act and similar non-United States legislation for extending the term of patents covering our products.
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Issued patents covering one or more of the Company’s products could be found invalid or unenforceable if challenged in patent office proceedings, or in court.
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Issued patents covering one or more of our products could be found invalid or unenforceable if challenged in patent office proceedings, or in court.
Previous wording
If the Company is unable to protect the confidentiality of its trade secrets, the value of its technology could be adversely and materially affected, and its business could be harmed.
Current wording
If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be adversely and materially affected, and our business could be harmed.
Previous wording
The United States government may exercise certain rights with regard to the Company’s inventions, or licensors’ inventions, developed using federal government funding.
Current wording
The United States government may exercise certain rights with regard to our inventions, or licensors’ inventions, developed using federal government funding.
Previous wording
Changes to the patent law in the United States and other jurisdictions could diminish the value of patents in general, thereby impairing the Company’s ability to protect its products.
Current wording
Changes to the patent law in the United States and other jurisdictions could diminish the value of our patents in general, thereby impairing our ability to protect our products.
Previous wording
Obtaining and maintaining the Company’s patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and its patent protection could be reduced or eliminated for noncompliance with these requirements.
Current wording
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies.
Previous wording
The Company may obtain only limited geographical protection with respect to certain patent rights,
Current wording
We may obtain only limited geographical protection with respect to certain patent rights,
Previous wording
The Company does not have long-term experience operating as a United States public company.
Current wording
We do not have long-term experience operating as a United States public company.
Previous wording
Our Common Stock may be delisted from Nasdaq if we do not maintain compliance with Nasdaq’s continued listing requirements. If our Common Stock is delisted, it could negatively impact the Company.
Current wording
Our Common Stock may be delisted from Nasdaq if we do not maintain compliance with Nasdaq’s continued listing requirements. If our Common Stock is delisted, it could negatively impact us.
Previous wording
To date, the Company has not obtained regulatory approval to commercialize or sell any of its SCD product candidates, and it does not expect to generate any significant revenue for the foreseeable future. The Company has incurred significant net losses since its inception and had an accumulated deficit of $106.1 million and $69. million as of December 31, 2023 and 2022, respectively.
Current wording
We have incurred significant net losses since our inception and had an accumulated deficit of $139.6 million and $114.7 million as of December 31, 2024 and 2023, respectively.
Previous wording
The Company has devoted most of its financial resources to research and development, including clinical trials and non-clinical development activities, and to obtain regulatory approval of its SCD product candidates. Since the completion of the Business Combination, the Company relied primarily on the sales of securities to fund its operations and are limited as the Company needs to meet certain conditions before such funding becomes available. The size of its future net losses will depend, in part, on the rate of future expenditures and its ability to generate revenues. To date, none of its product candidates have generated revenue, and if its product candidates are not successfully developed or commercialized, or if revenues are insufficient following marketing approval, it will not achieve profitability and its business may fail. Even if the Company successfully obtains regulatory approval to market its product candidates in the United States, its revenues are also dependent upon the size of the markets outside of the United States, regulatory approval outside of the United States, and its ability to obtain market approval and achieve commercial success.
Current wording
We have devoted most of our financial resources to research and development, including clinical trials and non-clinical development activities, and obtaining regulatory approval of our SCD product candidates. Since the completion of the Business Combination, we relied primarily on the sales of securities to fund our operations and are limited as we need to meet certain conditions before such funding becomes available. The size of our future net losses will depend, in part, on the rate of future expenditures and our ability to generate revenues. If our product candidates are not successfully developed or commercialized, or if revenues are insufficient following marketing approval, it will not achieve profitability and our business may fail. Even if we successfully obtain regulatory approval to market our product candidates in the United States, our revenues are also dependent upon the size of the markets outside of the United States, regulatory approval outside of the United States, and our ability to obtain market approval and achieve commercial success.
Previous wording
The Company expects to continue to incur substantial and increased expenses as it expands research and development activities and advances clinical programs through the regulatory approval process. The Company also expects an increase in its expenses associated with preparing for the potential commercialization of its products and creating additional infrastructure to support operations as a public company. As a result of the foregoing, it expects to continue to incur significant and increasing losses and negative cash flows for the foreseeable future.
Current wording
We expect to continue to incur substantial and increased expenses as we expand research and development activities and advances clinical programs through the regulatory approval process. We also expect an increase in our expenses associated with commercialization of our products and creating additional infrastructure to support operations as a public company. As a result of the foregoing, we expect to continue to incur significant and increasing losses and negative cash flows for the foreseeable future.
Previous wording
The Company has not generated any significant revenue and may never be profitable.
Current wording
We have not generated any significant revenue and may never be profitable.
Previous wording
The Company’s ability to generate revenue and achieve profitability depends on its ability, alone or with collaborators, to successfully complete the development, obtain the necessary regulatory approvals of and commercialize its lead product candidate, the SCD. It does not anticipate generating revenues from its product candidates’ sales for the foreseeable future. Its ability to generate future revenues from product sales depends heavily on its success with the following items:
Current wording
Our ability to generate sustainable revenue and achieve profitability depends on our ability, alone or with collaborators, to successfully commercialize our approved pediatric SCD and complete the development, obtain the necessary regulatory approvals of and commercialize our adult SCD. We do not anticipate generating substantial revenue for the foreseeable future. Our ability to generate meaningful future revenue from product sales depends heavily on our success with the following items:
Previous wording
completing the clinical development of its SCD, initially for the treatment of adult AKI in the hospital setting;
Current wording
completing the clinical development of our adult SCD;
Previous wording
launching and commercializing its SCD, including building a hospital-directed sales force and collaborating with third parties;
Current wording
scaling our commercial operations, including building a hospital-directed sales force and collaborating with third parties;
Previous wording
entering into collaboration agreement and partnerships to commercialize its products.
Current wording
entering into collaboration agreements and partnerships to commercialize our products.
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Rearranged current paragraphs (9)
Current report — wording carried from elsewhere
We may suffer from a lack of availability of future funds.
Current report — wording carried from elsewhere
If our products, or the malfunction of our products, cause or contribute to a death or a serious injury, we will be subject to medical device reporting regulations.
Current report — wording carried from elsewhere
Delays, interruptions, or the cessation of production by our third-party suppliers of important materials or delays in qualifying new materials, may prevent or delay our ability to manufacture or process our SCD device.
Current report — wording carried from elsewhere
A lack of third-party coverage and reimbursement for our devices could delay or limit their adoption.
Current report — wording carried from elsewhere
Adverse changes in reimbursement policies and procedures by payors may impact our ability to market and sell our products.
Current report — wording carried from elsewhere
We are and will be exposed to product liability risks, and clinical and preclinical liability risks, which could place a substantial financial burden upon us should we be sued.
Current report — wording carried from elsewhere
United States legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain regulatory approval of our product candidates and to manufacture, market and distribute our products after approval is obtained.
Current report — wording carried from elsewhere
Our business operations will be adversely affected if our security measures, or those maintained on our behalf, are compromised, limited or fail.
Current report — wording carried from elsewhere
The United States government may exercise certain rights with regard to our inventions, or licensors’ inventions, developed using federal government funding.
Rearranged previous paragraphs (9)
Previous report — wording carried elsewhere
The Company could become involved in intellectual property litigation that could be costly, result in the diversion of management’s time and efforts.
Previous report — wording carried elsewhere
Changes to the patent law in the United States and other jurisdictions could diminish the value of the Company’s patents in general, thereby impairing the Company’s ability to protect its products.
Previous report — wording carried elsewhere
We have not paid cash dividends in the past and do not expect to pay dividends in the future
Previous report — wording carried elsewhere
The Company has not generated any significant revenue and may never be profitable.
Previous report — wording carried elsewhere
The Company has a limited operating history, which makes it difficult to forecast its future results of operations.
Previous report — wording carried elsewhere
The Company has not received approval from the FDA and other regulatory authorities to sell its SCD product candidates and therefore it has a limited commercial operating history. According, the Company’s ability to accurately forecast future results of its operations is limited and subject to a number of uncertainties and risks, including its ability to plan for and model future growth. If the Company receives regulatory approval to market and sell its SCD product candidates, its revenue growth could slow in the future, or its revenue could decline or fluctuate for a number of reasons, including slowing demand for its products, increasing competition, changing demand in the markets, new scientific or technological developments, a decrease in the growth of its overall market, its failure to attract more customers, the inability to obtain reimbursement for its products by government agencies and insurers, or its failure, for any reason, to continue to take advantage of growth opportunities. If its assumptions regarding these risks and uncertainties and its future revenue growth are incorrect or change, or if it does not address these risks successfully or forecast its results accurately, the Company’s operating and financial results could differ materially from its expectations, and its business could suffer.
Previous report — wording carried elsewhere
In both the United States and international markets, the use and success of medical devices is dependent in part on the availability of reimbursement from third-party payors, such as government and private insurance plans.
Previous report — wording carried elsewhere
The Company’s business is subject to risks arising from future pandemics.
Previous report — wording carried elsewhere
An adverse outcome in a litigation or proceeding involving the Company’s patents could limit its ability to assert its patents against those other parties and other competitors, which may curtail or preclude its ability to exclude third parties from selling similar products. Any of these occurrences could adversely and materially affect the Company’s business, results of operations and financial condition.