Profusa (PFSA) FY2025 10-K Risk Factors: 77 New, 57 Dropped

What the changes say

Profusa completed its transition from a special purpose acquisition company to an operating medical device firm commercializing its Lumee Oxygen and Glucose Platform.
The risk profile shifted entirely from business combination mechanics to clinical trial progress, Nasdaq listing compliance, going concern doubts, and heavy operational losses.

What changed since the prior 10-K

New

New
There can be no assurance that our increased stock price following the Reverse Stock Split will remain at a price that will be sufficient in order to meet any continued requirements and policies of Nasdaq or that our Common Stock will remain listed on Nasdaq
Our stock price following the Reverse Stock Split may decline and jeopardize our continued listing on Nasdaq.
NewRisks Related to Our Business and Operations
We have a history of net losses, and we may not achieve or maintain profitability in the future
We reported a net loss of $35.8 million for 2025 and an accumulated deficit of $160.8 million, and expect operating costs to continue rising.
NewRisks Related to Our Business and Operations
We have substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain further financing
Our recurring operational losses raise substantial doubt about our ability to continue as a going concern.
NewRisks Related to Our Business and Operations
We have incurred significant losses in the past and will likely incur losses in the future
We have incurred significant historical losses from devoting substantial resources to the Lumee Oxygen and Glucose Platform and related clinical trials.
NewRisks Related to Our Business and Operations
The clinical trial process is lengthy and expensive with uncertain outcomes. Results of earlier studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such products
Our products require lengthy and expensive clinical trials with uncertain outcomes, and none are currently approved for commercial sale in the United States.
NewRisks Related to Our Business and Operations
Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates
Patient enrollment and follow-up in our clinical trials are subject to numerous delays and competition from other medical trials.
NewRisks Related to Our Business and Operations
Our products may not achieve or maintain market acceptance
Our continuous glucose monitoring systems and Lumee Oxygen Platform in the EU may fail to achieve or maintain market acceptance.
NewRisks Related to Our Business and Operations
We operate in a highly competitive market and face competition from large, well-established companies with significant resources, and, as a result, we may not be able to compete effectively
We face intense competition in the glucose monitoring market and our products could be rendered obsolete by technological breakthroughs.
NewRisks Related to Our Business and Operations
Medtronic and other third parties have developed or are developing insulin pumps integrated with CGM systems that provide, among other things, the ability to suspend insulin administration while the user’s glucose levels are low and to automate basal and bolus insulin dosing
Medtronic and other third parties have developed insulin pumps integrated with CGM systems, and non-traditional wellness companies are entering the space.
NewRisks Related to Our Business and Operations
Our Lumee Oxygen Platform primarily faces competition from Siemens Healthineers, Perimed AB, SenTec AG, Radiometer Medical, MESI, ATYS Medical, among other related companies
Our Lumee Oxygen Platform faces direct competition from well-established companies such as Siemens Healthineers, Perimed, SenTec, Radiometer Medical, MESI, and ATYS.
NewRisks Related to Our Business and Operations
The research and development efforts we undertake independently, and in some instances in connection with our collaborations with third parties, may not result in the development of commercially viable products, the generation of significant future revenues or adequate profitability
Our research and development efforts for next-generation products and strategic collaborations may not result in commercially viable products.
NewRisks Related to Our Business and Operations
Medical device development is costly and involves continual technological change, which may render our current or future products obsolete
Rapid technological change in the medical device market could render our current or future products obsolete if we lack sufficient financial resources to innovate.
NewRisks Related to Our Business and Operations
We may encounter significant competition across our existing and future planned products and services and in each market in which we sell or plan to sell our products and services from various companies, many of which have greater financial and marketing resources than we do
NewRisks Related to Our Business and Operations
If we are unable to successfully develop and effectively manage the introduction of new products, our business may be adversely affected
NewRisks Related to Our Business and Operations
If we are unable to establish and maintain adequate sales and marketing capabilities or enter into and maintain arrangements with third parties to sell and market our products, our business may be harmed
NewRisks Related to Our Business and Operations
We have limited experience in marketing and selling our products and related services, and if we are unable to successfully commercialize our products and related services, our business and operating results will be adversely affected
NewRisks Related to Our Business and Operations
We are subject to a variety of risks due to our international operations that could adversely affect our business, our operations or profitability and operating results
NewRisks Related to Our Business and Operations
Additionally, our international expansion efforts may not be successful and we may experience difficulties in scaling these functions from locations outside the United States and may not experience the expected cost efficiencies
NewRisks Related to Our Business and Operations
We expect the commercialization of the Lumee Oxygen Platform to generate nearly all our commercial revenue until we obtain regulatory approval for additional products
NewRisks Related to Our Business and Operations
Our business, financial condition and results of operations could be adversely affected by disruptions in the global economy caused by the ongoing war in Ukraine and the Middle East conflict
NewRisks Related to Our Business and Operations
We may face risks associated with acquisitions of companies, products and technologies and our business could be harmed if we are unable to address these risks
NewRisks Related to Our Business and Operations
Our success will depend on our ability to attract and retain our personnel and manage our human capital, while controlling labor costs
NewRisks Related to Our Business and Operations
We are subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulations
NewRisks Related to Our Business and Operations
Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liability
NewRisks Related to Our Business and Operations
If our manufacturing capabilities are insufficient to produce an adequate supply of product at appropriate quality levels, our growth could be limited and our business could be harmed
NewRisks Related to Our Business and Operations
We depend upon third-party suppliers and outsource to other parties, making us vulnerable to supply disruptions, suboptimal quality, noncompliance and/or price fluctuations, which could harm our business
NewRisks Related to Our Business and Operations
We will need to expand our organization, and we may experience difficulties in recruiting needed additional employees and consultants, which could disrupt our operations
NewRisks Related to Our Business and Operations
Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
NewRisks Related to Our Business and Operations
We may experience pricing pressures from contract suppliers or manufacturers on which we rely
NewRisks Related to Our Business and Operations
Manufacturing difficulties and/or any disruption at our facilities may adversely affect our manufacturing operations and related product sales, and increase our expenses
NewRisks Related to Our Business and Operations
Customer or third-party complaints or negative reviews or publicity about our company or our products could harm our reputation and brand
NewRisks Related to Our Business and Operations
The size and expected growth of our addressable market has not been established with precision, and may be smaller than we estimate
NewRisks Related to Our Business and Operations
If the actual number of consumers who would benefit from our products, the price at which we can sell future products or the addressable market for our products is smaller than we estimate, it could have a material adverse effect on our business, financial condition and results of operations
NewRisks Related to Our Business and Operations
Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide
NewRisks Related to Our Business and Operations
The cumulative effects of the factors discussed above could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningful
NewRisks Related to Our Business and Operations
If our financial performance fails to meet the expectations of investors and public market analysts, the market price of our Common Stock could decline
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our products, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
We conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could become subject to penalties, be excluded from participation in government programs, and/or be required to make significant changes to our operations
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support additional PMA, De Novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, which could impair our business, financial condition and operating results
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
Failure to obtain any required regulatory authorization in foreign jurisdictions will prevent us from marketing our products abroad
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
Potential long-term complications from our current or future products under development may not be revealed by our clinical experience to date
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
Quality problems could lead to recalls or safety alerts, reputational harm, and could have a material adverse effect on our business, results of operations, financial condition and cash flows
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the market
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
We may be subject to fines, penalties and injunctions if we are determined to be promoting the use of our products for unapproved or improper off-label uses or determined to have made claims that are untruthful or misleading or not adequately substantiated
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
Our current or future products may be subject to product recalls even after receiving FDA clearance or approval. A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products, could have a significant adverse impact on us
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
Health care policy changes, including U.S. health care reform legislation, may have a material adverse effect on our business
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
Changes to the regulatory landscape may impact our ability to obtain marketing authorization for future product developments
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
Our failure to comply with laws, regulations and contract requirements relating to reimbursement of health care goods and services may subject us to penalties and adversely impact our reputation, business, financial condition and cash flows
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
Security breaches and other disruptions that compromise our information and expose us to liability, could cause our business and reputation to suffer and could subject us to substantial liabilities
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
We are also subject to laws and regulations in foreign countries covering data privacy and other protection of health and employee information that may be more onerous than corresponding U.S. laws, including in particular the laws of Europe
NewRisks Related to Healthcare Industry Shifts and Changing Regulations
Failure to protect our information technology infrastructure against cyber-based attacks, network security breaches, service interruptions, or data corruption could significantly disrupt our operations and adversely affect our business and operating results
NewRisks Related to Intellectual Property Protection and Use
In addition, from time to time, we are subject to various claims, complaints and legal actions arising out of the ordinary course of business, including commercial insurance, product liability or employment-related matters
NewRisks Related to Intellectual Property Protection and Use
Our inability to adequately protect our intellectual property could allow our competitors and others to produce products based on our technology, which could substantially impair our ability to compete
NewRisks Related to Intellectual Property Protection and Use
We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful
NewRisks Related to Intellectual Property Protection and Use
We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets of their other clients or former employers to us, which could subject us to costly litigation
NewRisks Related to Intellectual Property Protection and Use
We may not be able to protect our intellectual property rights throughout the world, which could materially, negatively affect our business
NewRisks Related to Intellectual Property Protection and Use
If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business could be harmed
NewRisks Related to Intellectual Property Protection and Use
Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
NewRisks Related to Intellectual Property Protection and Use
We may need or may choose to obtain licenses from third parties to advance our research or allow commercialization of our current or future products, and we cannot provide any assurances that we would be able to obtain such licenses
NewRisks Related to Intellectual Property Protection and Use
If disputes over licensed intellectual property prevent or impair our ability to maintain the licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product, or the dispute may have an adverse effect on our results of operations
NewRisks Related to Intellectual Property Protection and Use
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
NewRisks Related to Intellectual Property Protection and Use
The measures that we use to protect the security of our intellectual property and other proprietary rights may not be adequate, which could result in the loss of legal protection for, and thereby diminish the value of, such intellectual property and other rights
NewRisks Related to Intellectual Property Protection and Use
Our issued patents could be found invalid or unenforceable if challenged in court, which could have a material adverse impact on our business
NewRisks Related to Intellectual Property Protection and Use
Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our products
NewRisks Related to Intellectual Property Protection and Use
Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submission, fee payment and other requirements imposed by government patent agencies and our patent protection could be reduced or eliminated for non-compliance with these requirements
NewRisks Related to Intellectual Property Protection and Use
Patent terms may be inadequate to protect our competitive position on products or product candidates for an adequate amount of time
NewRisks Related to Intellectual Property Protection and Use
If we do not obtain patent term extension and/or data exclusivity for any product candidates we decide to develop as drug product candidates, our business may be materially harmed
NewRisks Related to Intellectual Property Protection and Use
We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
NewRisks Related to Intellectual Property Protection and Use
Intellectual property rights do not necessarily address all potential threats
NewRisks Related to Intellectual Property Protection and Use
If we are unable to successfully remediate our existing material weaknesses and maintain effective internal control over financial reporting, investors may lose confidence in our reported financial information and our stock price and our business may be adversely impacted
NewRisks Related to Intellectual Property Protection and Use
Environmental, social and corporate governance (“ESG”) regulations, policies and provisions may make our supply chain more complex and may adversely affect our relationships with customers
NewRisks Related to Intellectual Property Protection and Use
Changes in financial accounting standards or practices or existing taxation rules or practices may cause adverse unexpected revenue and/or expense fluctuations and affect our reported results of operations
NewRisks Related to Intellectual Property Protection and Use
Climate change may have a long-term impact on our business
NewRisks Related to Intellectual Property Protection and Use
We face the risk of product liability claims and may be subject to damages, fines, penalties and injunctions, among other things
NewRisks Related to Intellectual Property Protection and Use
We incur increased costs and are subject to additional regulations and requirements as a result of becoming a public company, which could lower our profits or make it more difficult to run our business
NewRisks Related to Intellectual Property Protection and Use
We are an Emerging Growth Company
NewRisks Related to Intellectual Property Protection and Use
We will no longer qualify as an emerging growth company after December 31, 2026. References herein to “emerging growth company” have the meaning associated with it in the JOBS Act

Dropped

DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may not be able to complete the Business Combination pursuant to the Merger Agreement. If we are unable to do so, we will incur substantial costs associated with withdrawing from the transaction and may not be able to find additional sources of financing to cover those costs
Costs and financing risks associated with failing to complete the Business Combination pursuant to the Merger Agreement.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
Changes in the market for directors and officers liability insurance could make it more difficult and more expensive for us to negotiate and complete an initial business combination
Adverse changes in the market for directors and officers liability insurance for blank check companies.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may issue our shares to investors in connection with our initial business combination at a price that is less than the prevailing market price of our shares at that time
Risks of issuing shares to investors in private placement transactions at a discount to market price.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
If we seek stockholder approval of our initial business combination, our sponsor, officers and directors have agreed to vote in favor of such initial business combination, regardless of how our public stockholders vote
Sponsor, officer, and director agreements to vote founder shares in favor of the initial business combination.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
Your only opportunity to affect the investment decision regarding a potential business combination may be limited to the exercise of your right to redeem your shares from us for cash, unless we seek stockholder approval of the business combination
Limited opportunities for public stockholders to evaluate or vote on a potential business combination.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
The ability of our public stockholders to redeem their shares for cash may make our financial condition unattractive to potential business combination targets, which may make it difficult for us to enter into a business combination with a target
Net worth or minimum cash closing conditions impacted by public stockholder share redemptions.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
The ability of our public stockholders to exercise redemption rights with respect to a large number of our shares may not allow us to complete the most desirable business combination or optimize our capital structure
Uncertainties regarding how many stockholders may exercise redemption rights during a business combination.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
The ability of our public stockholders to exercise redemption rights with respect to a large number of our shares could increase the probability that our initial business combination would be unsuccessful and that you would have to wait for liquidation in order to redeem your stock
Increased probability of business combination failure and delayed trust account liquidation due to high share redemptions.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may not be able to complete our initial business combination within the prescribed time frame, in which case we would cease all operations except for the purpose of winding up and we would redeem our public shares and liquidate
Risks of failing to complete an initial business combination within the prescribed time frame.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
If a stockholder fails to receive notice of our offer to redeem our public shares in connection with our business combination, or fails to comply with the procedures for tendering its shares, such shares may not be redeemed
Stockholder failure to receive notice of redemption offers or comply with tender procedures.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
If the net proceeds of our initial public offering and the sale of the private placement warrants not being held in the trust account are insufficient to allow us to operate for at least the term of the combination period, we may be unable to complete our initial business combination
Insufficiency of net proceeds outside the trust account to operate through the combination period.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may seek acquisition opportunities in companies that may be outside of our management’s areas of expertise
Pursuing acquisition opportunities in companies outside of management's areas of expertise.
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We are not required to obtain an opinion from an independent investment banking firm or from an independent accounting firm, and consequently, you may have no assurance from an independent source that the price we are paying for the business is fair to our company from a financial point of view
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may have a limited ability to assess the management of a prospective target business and, as a result, may effect our initial business combination with a target business whose management may not have the skills, qualifications or abilities to manage a public company
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may engage in a business combination with one or more target businesses that have relationships with entities that may be affiliated with our sponsor, executive officers and directors which may raise potential conflicts of interest
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may attempt to simultaneously complete business combinations with multiple prospective targets, which may hinder our ability to complete our initial business combination and give rise to increased costs and risks that could negatively impact our operations and profitability
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may attempt to complete our initial business combination with a private company about which little information is available, which may result in a business combination with a company that is not as profitable as we suspected, if at all
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
Our management may not be able to maintain control of a target business after our initial business combination. We cannot provide assurance that, upon loss of control of a target business, new management will possess the skills, qualifications or abilities necessary to profitably operate such business
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may seek business combination opportunities with a high degree of complexity that require significant operational improvements, which could delay or prevent us from achieving our desired results
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
Any failure to meet the initial listing requirements of Nasdaq could result in an inability to list our common stock and warrants on Nasdaq and the obligation to comply with the “penny stock” rules and could affect the combined company’s cash position following the closing of an initial business combination
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We do not have a specified maximum redemption threshold. The absence of such a redemption threshold may make it possible for us to complete our initial business combination with which a substantial majority of our stockholders do not agree
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
We may be unable to obtain additional financing to complete our initial business combination or to fund the operations and growth of a target business, which could compel us to restructure or abandon a particular business combination
DroppedRisks Relating to Our Search For, Consummation of, or Inability to Consummate, a Business Combination
Because we must furnish our stockholders with target business financial statements, we may lose the ability to complete an otherwise advantageous initial business combination with some prospective target businesses
DroppedRisks Relating to the Post-Business Combination Company
Because we are not limited to a particular industry or any specific target businesses with which to pursue our initial business combination, you will be unable to ascertain the merits or risks of any particular target business’ operations
DroppedRisks Relating to the Post-Business Combination Company
We may issue notes or other debt securities, or otherwise incur substantial debt, to complete a business combination, which may adversely affect our leverage and financial condition and thus negatively impact the value of our stockholders’ investment in us
DroppedRisks Relating to the Post-Business Combination Company
If we effect our initial business combination with a company with operations or opportunities outside of the United States, we would be subject to a variety of additional risks that may negatively impact our operations
DroppedRisks Relating to our Management and Directors
Past performance by our management team may not be indicative of future performance of an investment in us
DroppedRisks Relating to our Management and Directors
We are dependent upon our executive officers and directors and their departure could adversely affect our ability to operate
DroppedRisks Relating to our Management and Directors
The officers and directors of an acquisition candidate may resign upon completion of our initial business combination. The loss of a business combination target’s key personnel could negatively impact the operations and profitability of our post-combination business
DroppedRisks Relating to our Management and Directors
Our executive officers and directors will allocate their time to other businesses thereby causing conflicts of interest in their determination as to how much time to devote to our affairs. This conflict of interest could have a negative impact on our ability to complete our initial business combination
DroppedRisks Relating to our Management and Directors
Our executive officers, directors, security holders and their respective affiliates may have competitive pecuniary interests that conflict with our interests
DroppedRisks Relating to our Management and Directors
Since our sponsor, executive officers and directors will not be eligible to be reimbursed for their out-of-pocket expenses if our business combination is not completed, a conflict of interest may arise in determining whether a particular business combination target is appropriate for our initial business combination
DroppedRisks Relating to our Management and Directors
Since our sponsor paid only approximately $0.005 per share for the founder shares, our officers and directors could potentially make a substantial profit even if we acquire a target business that subsequently declines in value
DroppedRisks Relating to Our Securities
You will not have any rights or interests in funds from the trust account, except under certain limited circumstances. To liquidate your investment, therefore, you may be forced to sell your public shares, rights, or warrants, potentially at a loss
DroppedRisks Relating to Our Securities
If third parties bring claims against us, the proceeds held in the trust account could be reduced and the per-share redemption amount received by stockholders may be less than $10.10 per share
DroppedRisks Relating to Our Securities
A provision of our warrant agreement may make it more difficult for us to consummate an initial business combination
DroppedRisks Relating to Our Securities
Our directors may decide not to enforce the indemnification obligations of our sponsor, resulting in a reduction in the amount of funds in the trust account available for distribution to our public stockholders
DroppedRisks Relating to Our Securities
Our stockholders may be held liable for claims by third parties against us to the extent of distributions received by them upon redemption of their shares
DroppedRisks Relating to Our Securities
We may not hold an annual meeting of stockholders until after our consummation of a business combination and you will not be entitled to any of the corporate protections provided by such a meeting
DroppedRisks Relating to Our Securities
The warrants may become exercisable and redeemable for a security other than the shares of our common stock, and you will not have any information regarding such other security at this time
DroppedRisks Relating to Our Securities
The grant of registration rights to our initial stockholders and holders of our private placement warrants may make it more difficult to complete our initial business combination, and the future exercise of such rights may adversely affect the market price of our common stock
DroppedRisks Relating to Our Securities
Our amended and restated certificate of incorporation authorizes the issuance of up to 100,000,000 shares of common stock, par value $0.0001 per share, and 1,000,000 shares of undesignated preferred stock, par value $0.0001 per share
DroppedRisks Relating to Our Securities
Certain agreements related to our initial public offering may be amended without stockholder approval
DroppedRisks Relating to Our Securities
Our initial stockholders control a substantial interest in us and thus may exert a substantial influence on actions requiring a stockholder vote, potentially in a manner that you do not support
DroppedRisks Relating to Our Securities
We may amend the terms of the rights in a manner that may be adverse to holders of rights with the approval by the holders of at least 65% of the then outstanding rights
DroppedRisks Relating to Our Securities
We may amend the terms of the warrants in a manner that may be adverse to holders of public warrants with the approval by the holders of at least 65% of the then outstanding public warrants
DroppedRisks Relating to Our Securities
We may redeem your unexpired warrants prior to their exercise at a time that is disadvantageous to you, thereby making your warrants worthless
DroppedRisks Relating to Our Securities
Our rights and warrants may have an adverse effect on the market price of our common stock and make it more difficult to effectuate our initial business combination
DroppedRisks Relating to Our Securities
Provisions in our amended and restated certificate of incorporation and Delaware law may inhibit a takeover of us, which could limit the price investors might be willing to pay in the future for our common stock and could entrench management
DroppedRisks Relating to Our Securities
Provisions in our amended and restated certificate of incorporation and Delaware law may have the effect of discouraging lawsuits against our directors and officers
DroppedRisks Relating to Our Securities
Our warrants are accounted for as warrant liabilities and recorded at fair value upon issuance with changes in fair value each period reported in earnings, which may make it more difficult for us to consummate an initial business combination
DroppedGeneral Risks
We are a newly formed company with no operating history and no revenues, and you have no basis on which to evaluate our ability to achieve our business objective
DroppedGeneral Risks
If we are deemed to be an investment company under the Investment Company Act, we may be required to institute burdensome compliance requirements and our activities may be restricted, which may make it difficult for us to complete our business combination
DroppedGeneral Risks
Changes in laws or regulations, or a failure to comply with any laws and regulations, may adversely affect our business, investments and results of operations
DroppedGeneral Risks
A market for our securities may not develop, which would adversely affect the liquidity and price of our securities
DroppedGeneral Risks
Compliance obligations under the Sarbanes-Oxley Act may make it more difficult for us to effectuate our initial business combination, require substantial financial and management resources, and increase the time and costs of completing an acquisition
DroppedGeneral Risks
Cyber incidents or attacks directed at us could result in information theft, data corruption, operational disruption and/or financial loss

Reworded

44% rewrittenRisks Related to Intellectual Property Protection and Use
As a public company, we are required to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act and make an ongoing, formal assessment of the effectiveness of our internal controls over financial reporting
The internal control risk factor heading was updated to explicitly reference compliance with SEC rules implementing Section 404 of the Sarbanes-Oxley Act.

All 78 risk factors

Headings as the filing states them, in filing order.

Other

01There can be no assurance that our increased stock price following the Reverse Stock Split will remain at a price that will be sufficient in order to meet any continued requirements and policies of Nasdaq or that our Common Stock will remain listed on NasdaqNew

Risks Related to Our Business and Operations

02We have a history of net losses, and we may not achieve or maintain profitability in the futureNew
03We have substantial doubt about our ability to continue as a going concern, which may hinder our ability to obtain further financingNew
04We have incurred significant losses in the past and will likely incur losses in the futureNew
05The clinical trial process is lengthy and expensive with uncertain outcomes. Results of earlier studies may not be predictive of future clinical trial results, or the safety or efficacy profile for such productsNew
06Any of these occurrences may significantly harm our business, financial condition and prospects. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidatesNew
07Our products may not achieve or maintain market acceptanceNew
08We operate in a highly competitive market and face competition from large, well-established companies with significant resources, and, as a result, we may not be able to compete effectivelyNew
09Medtronic and other third parties have developed or are developing insulin pumps integrated with CGM systems that provide, among other things, the ability to suspend insulin administration while the user’s glucose levels are low and to automate basal and bolus insulin dosingNew
10Our Lumee Oxygen Platform primarily faces competition from Siemens Healthineers, Perimed AB, SenTec AG, Radiometer Medical, MESI, ATYS Medical, among other related companiesNew
11The research and development efforts we undertake independently, and in some instances in connection with our collaborations with third parties, may not result in the development of commercially viable products, the generation of significant future revenues or adequate profitabilityNew
12Medical device development is costly and involves continual technological change, which may render our current or future products obsoleteNew
13We may encounter significant competition across our existing and future planned products and services and in each market in which we sell or plan to sell our products and services from various companies, many of which have greater financial and marketing resources than we doNew
14If we are unable to successfully develop and effectively manage the introduction of new products, our business may be adversely affectedNew
15If we are unable to establish and maintain adequate sales and marketing capabilities or enter into and maintain arrangements with third parties to sell and market our products, our business may be harmedNew
16We have limited experience in marketing and selling our products and related services, and if we are unable to successfully commercialize our products and related services, our business and operating results will be adversely affectedNew
17We are subject to a variety of risks due to our international operations that could adversely affect our business, our operations or profitability and operating resultsNew
18Additionally, our international expansion efforts may not be successful and we may experience difficulties in scaling these functions from locations outside the United States and may not experience the expected cost efficienciesNew
19We expect the commercialization of the Lumee Oxygen Platform to generate nearly all our commercial revenue until we obtain regulatory approval for additional productsNew
20Our business, financial condition and results of operations could be adversely affected by disruptions in the global economy caused by the ongoing war in Ukraine and the Middle East conflictNew
21We may face risks associated with acquisitions of companies, products and technologies and our business could be harmed if we are unable to address these risksNew
22Our success will depend on our ability to attract and retain our personnel and manage our human capital, while controlling labor costsNew
23We are subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulationsNew
24Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations which could subject our business to higher tax liabilityNew
25If our manufacturing capabilities are insufficient to produce an adequate supply of product at appropriate quality levels, our growth could be limited and our business could be harmedNew
26We depend upon third-party suppliers and outsource to other parties, making us vulnerable to supply disruptions, suboptimal quality, noncompliance and/or price fluctuations, which could harm our businessNew
27We will need to expand our organization, and we may experience difficulties in recruiting needed additional employees and consultants, which could disrupt our operationsNew
28Unfavorable global economic conditions could adversely affect our business, financial condition or results of operationsNew
29We may experience pricing pressures from contract suppliers or manufacturers on which we relyNew
30Manufacturing difficulties and/or any disruption at our facilities may adversely affect our manufacturing operations and related product sales, and increase our expensesNew
31Customer or third-party complaints or negative reviews or publicity about our company or our products could harm our reputation and brandNew
32The size and expected growth of our addressable market has not been established with precision, and may be smaller than we estimateNew
33If the actual number of consumers who would benefit from our products, the price at which we can sell future products or the addressable market for our products is smaller than we estimate, it could have a material adverse effect on our business, financial condition and results of operationsNew
34Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provideNew
35The cumulative effects of the factors discussed above could result in large fluctuations and unpredictability in our quarterly and annual operating results. As a result, comparing our operating results on a period-to-period basis may not be meaningfulNew
36If our financial performance fails to meet the expectations of investors and public market analysts, the market price of our Common Stock could declineNew

Risks Related to Healthcare Industry Shifts and Changing Regulations

37There is no guarantee that the FDA will grant 510(k) clearance or PMA approval of our products, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our businessNew
38We conduct business in a heavily regulated industry and if we fail to comply with applicable laws and government regulations, we could become subject to penalties, be excluded from participation in government programs, and/or be required to make significant changes to our operationsNew
39If we are unable to successfully complete the pre-clinical studies or clinical trials necessary to support additional PMA, De Novo, or 510(k) applications or supplements, we may be unable to commercialize our CGM systems under development, which could impair our business, financial condition and operating resultsNew
40Failure to obtain any required regulatory authorization in foreign jurisdictions will prevent us from marketing our products abroadNew
41Potential long-term complications from our current or future products under development may not be revealed by our clinical experience to dateNew
42Quality problems could lead to recalls or safety alerts, reputational harm, and could have a material adverse effect on our business, results of operations, financial condition and cash flowsNew
43If we or our suppliers or distributors fail to comply with ongoing regulatory requirements, or if we have unanticipated problems with our products, the products could be subject to restrictions or withdrawal from the marketNew
44We may be subject to fines, penalties and injunctions if we are determined to be promoting the use of our products for unapproved or improper off-label uses or determined to have made claims that are untruthful or misleading or not adequately substantiatedNew
45Our current or future products may be subject to product recalls even after receiving FDA clearance or approval. A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products, could have a significant adverse impact on usNew
46Health care policy changes, including U.S. health care reform legislation, may have a material adverse effect on our businessNew
47Changes to the regulatory landscape may impact our ability to obtain marketing authorization for future product developmentsNew
48Our failure to comply with laws, regulations and contract requirements relating to reimbursement of health care goods and services may subject us to penalties and adversely impact our reputation, business, financial condition and cash flowsNew
49Security breaches and other disruptions that compromise our information and expose us to liability, could cause our business and reputation to suffer and could subject us to substantial liabilitiesNew
50We are also subject to laws and regulations in foreign countries covering data privacy and other protection of health and employee information that may be more onerous than corresponding U.S. laws, including in particular the laws of EuropeNew
51Failure to protect our information technology infrastructure against cyber-based attacks, network security breaches, service interruptions, or data corruption could significantly disrupt our operations and adversely affect our business and operating resultsNew

Risks Related to Intellectual Property Protection and Use

52In addition, from time to time, we are subject to various claims, complaints and legal actions arising out of the ordinary course of business, including commercial insurance, product liability or employment-related mattersNew
53Our inability to adequately protect our intellectual property could allow our competitors and others to produce products based on our technology, which could substantially impair our ability to competeNew
54We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessfulNew
55We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets of their other clients or former employers to us, which could subject us to costly litigationNew
56We may not be able to protect our intellectual property rights throughout the world, which could materially, negatively affect our businessNew
57If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business could be harmedNew
58Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirementsNew
59We may need or may choose to obtain licenses from third parties to advance our research or allow commercialization of our current or future products, and we cannot provide any assurances that we would be able to obtain such licensesNew
60If disputes over licensed intellectual property prevent or impair our ability to maintain the licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product, or the dispute may have an adverse effect on our results of operationsNew
61If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affectedNew
62The measures that we use to protect the security of our intellectual property and other proprietary rights may not be adequate, which could result in the loss of legal protection for, and thereby diminish the value of, such intellectual property and other rightsNew
63Our issued patents could be found invalid or unenforceable if challenged in court, which could have a material adverse impact on our businessNew
64Changes in patent laws or patent jurisprudence could diminish the value of patents in general, thereby impairing our ability to protect our productsNew
65Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submission, fee payment and other requirements imposed by government patent agencies and our patent protection could be reduced or eliminated for non-compliance with these requirementsNew
66Patent terms may be inadequate to protect our competitive position on products or product candidates for an adequate amount of timeNew
67If we do not obtain patent term extension and/or data exclusivity for any product candidates we decide to develop as drug product candidates, our business may be materially harmedNew
68We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual propertyNew
69Intellectual property rights do not necessarily address all potential threatsNew
70If we are unable to successfully remediate our existing material weaknesses and maintain effective internal control over financial reporting, investors may lose confidence in our reported financial information and our stock price and our business may be adversely impactedNew
71Environmental, social and corporate governance (“ESG”) regulations, policies and provisions may make our supply chain more complex and may adversely affect our relationships with customersNew
72Changes in financial accounting standards or practices or existing taxation rules or practices may cause adverse unexpected revenue and/or expense fluctuations and affect our reported results of operationsNew
73Climate change may have a long-term impact on our businessNew
74We face the risk of product liability claims and may be subject to damages, fines, penalties and injunctions, among other thingsNew
75We incur increased costs and are subject to additional regulations and requirements as a result of becoming a public company, which could lower our profits or make it more difficult to run our businessNew
76We are an Emerging Growth CompanyNew
77We will no longer qualify as an emerging growth company after December 31, 2026. References herein to “emerging growth company” have the meaning associated with it in the JOBS ActNew
78As a public company, we are required to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act and make an ongoing, formal assessment of the effectiveness of our internal controls over financial reporting44% rewritten

Other Profusa 10-Ks

FY2024 10-K risk factors
58 risks
Profusa operates as a blank check company seeking an initial business combination, primarily in healthcare.
Filed Mar 31, 2025

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The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.