What changed in this filing

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Item 1. Business

2023-03-30 compared with 2022-04-06 · 806 added, 159 removed, 0 unchanged (100% of the section changed)

In this Annual Report on Form 10-K (this “Annual Report”), references to the “Company” and to “we,” “us,” and “our” refer to LMF Acquisition Opportunities, Inc.

We are a blank check company incorporated in Delaware in October 2020 for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization, or similar business combination with one or more businesses, which we refer to throughout this Annual Report on Form 10-K as our initial business combination.

As of December 31, 2021, the Company had not yet commenced any operations.

All activity for the period from October 28, 2020 (inception) through December 31, 2021 relates to the Company's formation and the initial public offering ("IPO") described below.

The Company will not generate any operating revenues until after the completion of its initial business combination, at the earliest.

The Company will generate non-operating income in the form of interest income on cash and cash equivalents from the proceeds derived from the IPO and unrealized gains or losses from the revaluation of the warrant liability.

The registration statement for the Company’s IPO was declared effective on January 25, 2021 (the “Effective Date”).

On January 28, 2021, the Company consummated the IPO of 10,350,000 units (the “Units” and, with respect to the shares of Class A common stock included in the Units sold, the “Public Shares”), at $10.00 per Unit, generating gross proceeds of $103,500,000, which is described in Note 2.

Simultaneously with the closing of the IPO, the Company consummated the sale of 5,738,000 warrants (the “Private Placement Warrants”) at a price of $1.00 per Private Placement Warrant in a private placement to LMFAO Sponsor LLC, a Florida limited liability company (the “Sponsor”), generating gross proceeds of $5,738,000.

Transaction costs for the IPO amounted to $6,211,902 consisting of $2,070,000 of underwriting discount, $3,622,500 of deferred underwriting fee, the fair value of the shares issued to the underwriters of $1,000 deemed as underwriters’ compensation, and $518,402 of other offering costs.

In addition, $974,009 of cash was held outside of the Trust Account (as defined below) as of the date of the IPO and became available for working capital purposes at such time.

Following the closing of the IPO on January 28, 2021, an amount of $105,570,000 ($10.20 per Unit) from the net proceeds of the sale of the Units in the IPO and the sale of the Private Placement Warrants was placed in a trust account (“Trust Account”) and was invested in U.S.

government securities, within the meaning set forth in Section 2(a)(16) of the Investment Company Act, with a maturity of 185 days or less or in any open-ended investment company that holds itself out as a money market fund meeting the conditions of Rule 2a-7 of the Investment Company Act, as determined by the Company.

Except with respect to interest earned on the funds held in the Trust Account that may be released to the Company to pay its franchise and income tax obligations (less up to $100,000 of interest to pay dissolution expenses), the proceeds from the IPO and the sale of the Private Placement Warrants will not be released from the Trust Account until the earliest of (a) the completion of the Company’s initial business combination, (b) the redemption of any Public Shares properly submitted in connection with a stockholder vote to amend the Company’s amended and restated certificate of incorporation, and (c) the redemption of the Company’s Public Shares if the Company is unable to complete the initial business combination within 18 months from the closing of the IPO (or up to 21 months from the closing of the IPO if the Company extends the period of time to consummate a business combination, as described in more detail in the prospectus for the IPO), subject to applicable law.

The proceeds deposited in the Trust Account could become subject to the claims of the Company’s creditors, if any, which could have priority over the claims of the Company’s public stockholders.

We have not selected any specific business combination target and we have not, nor has anyone on our behalf, initiated any substantive discussions, directly or indirectly, with any business combination target.

We may pursue an initial business combination target in any industry or sector, but we expect to focus on acquiring a business combination target within the financial services industry and related sectors, including potentially the FinTech sector, with an enterprise value of approximately $100 million to $950 million.

Our management believes that this relative size of target opportunities will enable us to pursue companies that are the most attractive from a return standpoint and are less pursued by larger, more established sources of capital .

We intend to capitalize on the seasoned operating experience of our management team, including Bruce Rodgers, our President and Chief Executive Officer, and Richard Russell, our Chief Financial Officer, Treasurer, Secretary, and a director.

Our management team has extensive experience in leadership roles and financial services-related entrepreneurship, venture capital, and private equity.

Rodgers spent several years as a business transactions lawyer for several prominent firms and businesses, including in management positions, and he has a background in engineering as well as military service in the United States Navy.

Russell serves and has served in several executive management positions, including CEO and CFO

positions, as well as corporate boards, leveraging his advanced degrees and certifications in tax and accounting.

While we may pursue an initial business combination target in any industry, our investment strategy will focus our efforts in the financial services industry, specifically within alternative lending, asset management, business process outsourcing, housing and commercial real estate finance, insurance , and tech-enabled business opportunities.

Our sponsor, LMFAO Sponsor, LLC, is a majority-owned and controlled subsidiary of LM Funding America, Inc.

LMFA is a specialty finance company that provides funding to nonprofit community associations primarily located in the state of Florida.

Past performance by the members of our management team in their other endeavors or the other entities with which they are or have been affiliated is not a guarantee of future success.

We cannot assure you that we will be able to locate a suitable candidate for our initial business combination or that any business combination we consummate will be successful.

You should not rely on the historical record of our management team’s performance, or the performance of any other entities with which our management team is or has been affiliated, as indicative of our future performance or how an investment in our company will perform or the returns our company will, or is likely to, generate going forward.

Business Strategy

Our initial business combination and value creation strategy will be to identify, acquire and, after our initial business combination, implement an operating strategy with a view of creating value for our stockholders through operational improvements, capital infusion, or future acquisitions.

We intend to source initial business combination opportunities through our management team’s broad network of investors in the financial services industry, board members, company executives, lawyers, accountants, and brokers.

With respect to our investment strategy, we intend to focus our efforts on assets and businesses with the following aspects, or within the following sectors, of the financial services industry, in search of value-oriented and opportunistic transaction opportunities:

Asset Management :

non-correlated asset classes and non-traditional asset management models;

innovative manufacturers of financial assets;

administrators, servicers, and special servicers;

Bankruptcy and Distressed Real Estate :

businesses that are either in financial distress or have completed and emerged from a financial restructuring, which may have included a Chapter 11 bankruptcy court protection filing;

fundamentally sound businesses handling or investing in real estate that have become distressed, including due to COVID-19’s impact on the economy or due to pre-existing financial troubles, which can often occur through excessive leverage, challenging industry conditions, material litigation, regulatory shifts, macroeconomic events, performance disruptions, lack of management execution, or any combination thereof;

Commercial Real Estate Tech and Services :

fee-based services creating efficiency to the burdensome and expensive transaction life cycle;

businesses focused on property management, operational efficiency, and tenant experience;

Consumer and Business Lending :

businesses with advanced capabilities in data modeling, risk management, and asset management;

differentiated and defendable customer acquisition and risk management strategies;

consumer finance and commercial finance businesses with responsible lending models;

FinTech and Business Process Outsourcing :

businesses providing critical workflow to financial institutions, including data aggregation and analytics, risk management, and compliance, as well as open banking, including third-party providers and account service information providers;

“InsurTech” and Insurance Services :

business models with unique products and/or customer acquisition strategies, including, but not limited to, businesses with specialized product design focused on regulatory capital arbitrage, with roll-up opportunities among niche brokerage and agencies;

Mortgage Origination, Housing Services, and Technology :

businesses with disruptive and scalable mortgage platforms, with competitive advantages in customer acquisition, origination, and servicing cost;

businesses providing housing-related lead generation, alternative home ownership and rental models, and community association property management (and other ancillary services providers to community associations);

businesses leveraging technology to offer contemporary and cutting-edge home-purchase and home-sale options, such as iBuyer investment models, as well as other opportunities for equity monetization;

Regulated Industries :

businesses in certain regulated industries that may presently have less, or no, options for lending or financial services, including the cannabis industry .

Business Combination Criteria

Our business combination criteria will not be limited to a particular industry or geographic sector, but given the experience of our management team, we expect to focus on acquiring a business combination target within the financial services industry, like the FinTech sector or a related sector, with an enterprise value of approximately $250 million to $500 million.

Our management team will look to identify business combination targets which are in need of strategic growth capital, will benefit from becoming a publicly listed company, may require creative business approaches to unlock additional value, or may need to repurchase debt, target strategic acquisitions or require working capital.

Aligned with our business and investment strategies, we have identified the following criteria that we believe are important and that we intend to use in evaluating initial business combination opportunities.

While we intend to utilize these criteria in evaluating business combination opportunities, we expect that no individual criterion will entirely determine a decision to pursue a particular opportunity.

Further, any particular initial business combination opportunity that we ultimately determine to pursue may not meet one or more of these criteria.

In assessing prospective target companies, we may consider various criteria, including whether such prospects:

are fundamentally sound businesses that have a sustainable business model with the ability to successfully navigate the ebbs and flows of an economic downturn, and changes in the industry landscape and regulatory environment;

can benefit from the vast network, experience, and guidance of our management team;

have a defensible market position and demonstrate differentiated competitive advantages with high barriers to entry against new competitors;

have recurring, predictable revenues and the history of, or the near-term potential to, generate stable and sustainable free cash flow;

exhibit unrecognized value, desirable returns on capital, and a need for capital to achieve the company’s growth strategy;

are able to structure around or ring fence exposure to legacy assets to the extent desirable to enhance stockholder returns or reduce volatility of such returns;

have the potential for strong and continued growth both organically and through add-on acquisitions;

are at an inflection point and would benefit from a catalyst such as incremental capital, innovation through new operational practices, and application of innovative FinTech, product creation, or additional management expertise;

have publicly traded comparable companies that operate in a similar industry sector or which have similar operating metrics which may help establish that the valuation of our initial business combination is attractive relative to such public peers;

are positioned to be publicly traded and can benefit from being publicly traded, with access to broader and more efficient capital markets, to drive improved financial performance and achieve key business strategies.

These criteria are not intended to be exhaustive.

Any evaluation relating to the merits of a particular initial business combination may be based, to the extent relevant, on these general guidelines as well as other considerations, factors, and criteria that our management may deem relevant.

In the event that we decide to enter into our initial business combination with a target business that does not meet the above criteria and guidelines, we will disclose that the target business does not meet the above criteria in our stockholder communications related to our initial business combination, which, as discussed in this Annual Report, would be in the form of proxy solicitation materials or tender offer documents that we would file with the U.S.

Securities and Exchange Commission (the “SEC”).

Competitive Strengths

We believe the sourcing, valuation, diligence, and execution capabilities of our management team will provide us with a significant pipeline of opportunities from which to evaluate and select a business that will benefit from our expertise.

Strong Management Team .

We will leverage the extensive experience of our management team, all of whom have been involved at various levels in acquisitions, financings, and advisory transactions, totaling millions in transaction value, and have significant experience investing in a variety of economic cycles, with a track record of identifying high-quality assets with opportunities for optimization.

We believe our management team’s ability to originate, effectively diligence, and creatively and thoughtfully structure transactions will generate attractive risk-adjusted returns for investors.

We believe we will benefit from our management team’s successful track record in corporate finance, including Mr.

Rodgers’s and Mr.

Russell’s experiences serving as corporate executives and board members for various companies, both public and private, as well as their respective backgrounds in transactional law practice and tax and accounting practice.

Broad Sourcing Channels and Leading Industry Relationships .

We believe the capabilities and relationships associated with our management team will provide us with a differentiated pipeline of attractive business combination opportunities that would be difficult for other market participants to replicate.

Underwriting, Execution, and Structuring Capabilities .

Our management team will apply to our acquisition targets a rigorous analytical review and diligence process that its individual members apply or have applied in their current or past professional experiences.

The sensitivity of financial and operational drivers to external factors is a key component of evaluating investment opportunities and pricing risk.

Our investment discipline will allow us to identify opportunities where our management team can create stockholder value, which may include operational or capital structure improvements, as well as the introduction of new technologies and/or products to drive growth.

Public Company Operating Expertise.

As a result of serving as executive officers and directors of publicly traded companies, our management team has substantial experience in navigating the challenges of operating as a public company.

In addition, Mr.

Rodgers is a former business lawyer who has the ability to guide issuers through the “going public” process.

We anticipate that one or more members of our management team or board, would remain on the board of the company post business combination.

In addition, some of the potential acquisition targets we consider may operate within a regulated industry.

We believe that the expertise within our management team around regulated financial services industries will be advantageous when evaluating certain acquisition targets.

Initial Business Combination

Nasdaq rules require that we must complete one or more business combinations having an aggregate fair market value of at least 80% of the value of the assets held in the trust account (excluding the deferred underwriting commissions and taxes payable on the interest earned on the trust account) at the time of our signing a definitive agreement in connection with our initial business combination.

Our board of directors will make the determination as to the fair market value of our initial business combination.

If our board of directors is not able to independently determine the fair market value of our initial business combination, we will obtain an opinion from an independent investment banking firm that is a member of FINRA or an independent accounting firm with respect to the satisfaction of such criteria.

While we consider it unlikely that our board of directors will not be able to make an independent determination of the fair market value of our initial business combination, it may be unable to do so if it is less familiar or experienced with the business of a particular target or if there is a significant amount of uncertainty as to the value of a target’s assets or prospects.

Additionally, pursuant to Nasdaq rules, any initial business combination must be approved by a majority of our independent directors.

We will have until 18 months from the closing of our offering to consummate an initial business combination.

However, if we anticipate that we may not be able to consummate our initial business combination within 18 months, we will, by resolution of our board if requested by our sponsor, extend the period of time to consummate a business combination by an additional three months (for a total of 21 months to complete a business combination), subject to the sponsor depositing additional funds into the trust account as set out below.

Pursuant to the terms of our certificate of incorporation and the trust agreement to be entered into between us and Continental Stock Transfer & Trust Company on the date of this prospectus, in order to extend the time available for us to consummate our initial business combination, our sponsor or its affiliates or designees must deposit into the trust account $900,000, or up to $1,035,000 if the underwriters’ over-allotment option is exercised in full ($0.10 per share in either case) on or prior to the date of the deadline.

We will issue a press release

announcing the extension, at least three days prior to the deadline.

In addition, we will issue a press release the day after the deadline, announcing whether the funds have been timely deposited.

Our sponsor and its affiliates or designees are obligated to fund the trust account in order to extend the time for us to complete our initial business combination, but our sponsor will not be obligated to extend such time.

We anticipate structuring our initial business combination either:

(i) in such a way so that the post-transaction company in which our public stockholders own shares will own or acquire 100% of the equity interests or assets of the target business or businesses;

or (ii) in such a way so that the post-transaction company owns or acquires less than 100% of such interests or assets of the target business in order to meet certain objectives of the target management team or stockholders, or for other reasons.

However, we will only complete an initial business combination if the post-transaction company owns or acquires 50% or more of the outstanding voting securities of the target or otherwise acquires a controlling interest in the target sufficient for it not to be required to register as an investment company under the Investment Company Act of 1940, as amended, or the “Investment Company Act.” Even if the post-transaction company owns or acquires 50% or more of the voting securities of the target, our stockholders prior to the initial business combination may collectively own a minority interest in the post-transaction company, depending on valuations ascribed to the target and us in the initial business combination.

For example, we could pursue a transaction in which we issue a substantial number of new shares in exchange for all of the outstanding capital stock of a target.

In this case, we would acquire a 100% controlling interest in the target.

However, as a result of the issuance of a substantial number of new shares, our stockholders immediately prior to our initial business combination could own less than a majority of our outstanding shares subsequent to our initial business combination.

If less than 100% of the equity interests or assets of a target business or businesses are owned or acquired by the post-transaction company, the portion of such business or businesses that is owned or acquired is what will be taken into account for purposes of Nasdaq’s 80% of net assets test.

If the initial business combination involves more than one target business, the 80% of net assets test will be based on the aggregate value of all of the transactions and we will treat the target businesses together as the initial business combination for purposes of a tender offer or for seeking stockholder approval, as applicable.

Our Initial Business Combination Process

In evaluating prospective business combinations, we expect to conduct a thorough due diligence review process that will encompass, among other things, a review of historical and projected financial and operating data, meetings with management and their advisors (if applicable), on-site inspection of facilities and assets, discussion with customers and suppliers, legal reviews and other reviews as we deem appropriate.

We are not prohibited from pursuing an initial business combination with a company that is affiliated with our sponsor, officers or directors.

In the event we seek to complete our initial business combination with a company that is affiliated with our sponsor, officers or directors, we, or a committee of independent directors, will obtain an opinion from an independent investment banking firm that is a member of FINRA or an independent accounting firm that our initial business combination is fair to our company from a financial point of view.

Members of our management team will directly or indirectly own founder shares and/or private placement warrants following our offering and, accordingly, may have a conflict of interest in determining whether a particular target business is an appropriate business with which to effectuate our initial business combination.

Further, each of our officers and directors may have a conflict of interest with respect to evaluating a particular business combination if the retention or resignation of any such officers and directors were to be included by a target business as a condition to any agreement with respect to our initial business combination.

Members of our management team are employed by or otherwise work with our sponsor or with entities affiliated with it or with other entities.

Our sponsor and these other entities and their respective affiliates are continuously made aware of potential business opportunities, one or more of which we may desire to pursue for an initial business combination;

we have not, however, selected any specific business combination target and we have not, nor has anyone on our behalf, initiated any substantive discussions, directly or indirectly, with any business combination target.

Our sponsor and each of our officers and directors presently have, and any of them in the future may have additional, fiduciary or contractual obligations to other entities pursuant to which such officer or director is or will be required to present a business combination opportunity.

Accordingly, if any of our officers or directors becomes aware of a business combination opportunity which is suitable for an entity to which he or she has then-current fiduciary or contractual obligations, he or she will honor his or her fiduciary or contractual obligations to present such business combination opportunity to such other entity.

We do not believe, however, that any fiduciary duties or contractual obligations of our sponsor and our officers or directors will materially affect our ability to complete our initial business combination.

Our certificate of incorporation provides that we renounce our interest in any corporate opportunity offered to any director or officer unless such opportunity is expressly offered to such person solely in his or her capacity as a director or officer of our company and such opportunity is one we are legally and contractually permitted to undertake and would otherwise be

reasonable for us to pursue, and to the extent the director or officer is permitted to refer that opportunity to us without violating another legal obligation.

Please see the section of this Annual Report entitled “Management—Conflicts of Interest” for additional information.

COVID-19 Update

Although COVID-19 is currently not material to our results of operations, there is uncertainty relating to the potential future impact on our business.

While our employees currently have the ability and are encouraged to work remotely, such measures have and may continue to have an impact on employee attendance or productivity, which, along with the possibility of employees’ illness, may adversely affect our operations.

In addition to encouraging employees to work remotely, the Company has increased sanitation of its offices, provided hand gel and masks to its employees and has closed the offices during identified periods of high contagion.

The extent to which COVID-19 impacts our operations, or our ability to obtain financing should we require it, will depend on future developments which are uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and the actions taken by governments and private businesses to contain COVID-19 to treat its impact, among others.

If the disruptions posed by COVID-19 continue for an extended period of time, financial markets may not be available to the Company for raising capital in order to fund future growth.

Should the Company not be able to obtain financing when required, in the amounts necessary or under terms which are economically feasible, we may be required to reduce planned future growth and/or the scope of our operations.

In identifying, evaluating and selecting a target business for our initial business combination, we may encounter intense competition from other entities having a business objective similar to ours, including other blank check companies, private equity groups and leveraged buyout funds, and operating businesses seeking strategic business combinations.

Many of these entities are well established and have extensive experience identifying and effecting business combinations directly or through affiliates.

Moreover, many of these competitors possess greater financial, technical, human and other resources than we do.

Our ability to acquire larger target businesses will be limited by our available financial resources.

This inherent limitation gives others an advantage in pursuing the initial business combination of a target business.

Furthermore, our obligation to pay cash in connection with our public stockholders who exercise their redemption rights may reduce the resources available to us for our initial business combination and our outstanding warrants, and the future dilution they potentially represent, may not be viewed favorably by certain target businesses.

Either of these factors may place us at a competitive disadvantage in successfully negotiating an initial business combination

We currently have two officers.

These individuals are not obligated to devote any specific number of hours to our matters but they intend to devote as much of their time as they deem necessary to our affairs until we have completed our initial business combination.

The amount of time they will devote in any time period will vary based on whether a target business has been selected for our initial business combination and the stage of the initial business combination process we are in.

We do not intend to have any full time employees prior to the completion of our initial business combination.

Where you can Find More Information

We are required to file annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other information, including our proxy statement, with the Securities and Exchange Commission (“SEC”).

The public can obtain copies of these materials by accessing the SEC’s website at http://www.sec.gov.

In addition, as soon as reasonably practicable after these materials are filed with or furnished to the SEC, we will make copies available to the public free of charge through our website, https://www.lmfacquisitions.com.

The information on our website is not incorporated into, and is not part of, this Annual Report on Form 10-K or our other filings with the SEC.

Unless the context otherwise requires, all references in this section to "SeaStar Medical," the “Company,”

“we,”

“us”

or “our”

refer to SeaStar Medical Holding Corporation and its consolidated subsidiaries following the Business Combination (as defined herein), other than certain historical information that refers to the business of SeaStar Medical prior t0o the consummation of the Business Combination.

We are a medical technology company developing a platform therapy to reduce the consequences of hyperinflammation on vital organs.

The inflammatory response is critical to fend off infections and repair damaged tissue in the body.

Central to inflammation are the cells within blood and lymph circulatory systems, called white blood cells (primarily neutrophils and monocytes) or also referred to commonly as “pus”

In a normal inflammatory response, neutrophils are the first immune cells to arrive at the site and are key to the entire immune response that kills pathogens and promotes tissue repair.

These inflammatory cell release chemicals (cytokines) which trigger the immune system to eliminate the foreign pathogens or damaged tissue, enhancing the immune response.

If the inflammatory response becomes excessive and dysregulated (referred as proinflammatory), normal neutrophil die off (“apoptosis”) may be delayed, allowing the inflammatory cells to continue to produce cytokines further enhancing the dysregulated immune response, altering feedback mechanisms that regulate the immune system.

This results in damaging hyperinflammation spreading uncontrollably to other parts of the body, often leading to acute chronic solid organ dysfunction or failure, including heart, lung, kidney and liver diseases.

This hyperinflammatory response is also known as the “cytokine storm,”

referring to the body’s reaction to the category of small-secreted proteins released by hyperinflammatory cells that affect communication between cells.

The cytokine storm, when left uncontrolled, can lead to organ damage and even death.

Based on clinical and preclinical studies conducted over the last 15 years, the Company’s technology has shown promise in modulating the degree of activity of proinflammatory cells to help reduce tissue damage and speed the repair and recovery of organ function.

We believe this approach, if successful, will transform the ability of clinicians to treat acute organ failure in the intensive care unit (“ICU”) and to improve organ function in hospitalized patients.

Currently few therapeutics are available to clinicians to address the issue of hyperinflammation and for those options that do exist, such options are either immunosuppressive or only target one cytokine.

We believe our technology has the potential to overcome limitations in existing anti-inflammatory treatments and address the challenge in selectively targeting activated neutrophils and monocytes.

We are leveraging our patent protected and scalable technology platform to develop proprietary therapies that are organ agnostic and target both acute and chronic indications.

We are using our proprietary Selective Cytopheretic Device ("SCD") technology platform initially to clinically validate several acute organ injury indications, including kidneys and lungs.

Our investigational SCD is an extracorporeal synthetic membrane device designed to be easily integrated into existing continuous renal replacement therapy ("CRRT") systems that are commonly installed in hospitals, including in ICUs throughout the United States.

Once approved and commercialized, our SCD would initially target acute kidney injury in both the pediatric CRRT population as well as adults on CRRT.

In addition, we are developing our SCD to address inflammation associated with chronic dialysis and chronic heart failure.

Preclinically, our SCD was tested in various animal models, which include acute myocardial infarction, intracranial hemorrhage, chronic heart failure, sepsis and acute respiratory distress syndrome.

The animal models showed the inflammatory response and how it was modified by our SCD.

We will continue to explore the application of our SCD technology across a broad range of markets and indications where proinflammatory activated neutrophils and monocytes may contribute to disease progression or severity in both acute and chronic indications.

There is substantial clinical demand for safe and effective control of hyperinflammation.

Existing treatment options in hyperinflammation include the use of corticosteroids (immunosuppression) and absorbent technologies that either directly absorb cytokines, viruses, bacteria or endotoxins and pharmaceuticals that target cytokines and the immune cascade.

None selectively addresses activated neutrophils or monocytes.

The use of our SCD to reverse the cytokine storm in pediatric and adult patients with acute kidney injury on CRRT in clinical studies with more than 140

patients reduced mortality rates by 50%, and, of those patients who survive 60 days, none have required dialysis.

The unique mechanism of action (modulation of neutrophils and monocytes) has exhibited consistent clinical outcomes in both adults as well as children.

Given the clinical advantages of our SCD, we believe our SCD has the potential to become a preferred course of treatment by clinicians for hyperinflammatory indications based on its potential to improve patient outcomes, increase survival rates, reduce dialysis dependence, and ultimately lower healthcare costs.

As of December 31, 2022, our SCD has been used in approximately 170 adult and pediatric patients on an investigational basis.

In June 2022, we submitted a humanitarian device exemption ("HDE") application with the U.S.

Food & Drug Administration ("FDA") for pediatric patients with acute kidney injury ("AKI") on CRRT.

Based on the current timeline of the HDE application, we expect the FDA to complete its substantive review of our HDE application during the first half of 2023;

however, there is no guarantee that the FDA will approve our HDE application.

In addition, on February 9, 2023, we received approval from the FDA of our investigational device exemption ("IDE") application to conduct a pivotal study evaluating the effectiveness of SCD in reducing hyperinflammation in adults with AKI requiring CRRT.

The Company plans to begin enrollment in Q2 2023 and expect to generate interim study results during the fourth quarter of 2023 and topline study results and submission of a Pre-market Approval ("PMA") application in the second half of 2024.

On April 29, 2022, we received a Breakthrough Device Designation ("BDD") for the use of our SCD in the treatment of immunomodulatory dysregulation in adult patients (18 and older) with AKI, which is expected to accelerate the regulatory approval process for such trial.

There is no guarantee that we will complete the AKI adult trial in a timely manner, or at all, nor will there be any assurance that positive data will be generated from such trial.

Even if we are able to generate positive results from these trials, the FDA may require us to conduct additional trials to support the study, or disagree with the design of the trials and request changes or improvements to such design.

We believe that our novel therapeutic device is readily applicable for use in other indications, which will require additional clinical studies and FDA approval.

As we continue our work to expand indications, we believe we will have the ability to take advantage of economies of scale to reduce costs of production.

We believe our scalable manufacturing process demonstrates a significant competitive advantage in the hyperinflammatory market.

We have pursued patent protection for our SCD technology as well as other technologies, which consists of 40 patents and 10 pending patent applications in the U.S.

and certain foreign jurisdictions.

Of these patents and patent applications 33 are owned exclusively by us, and 17 are co-owned with the University of Michigan ("UOM").

UOM has granted to us an exclusive worldwide, royalty bearing license to UOM’s interest in all of the co-owned patents and applications.

This license permits us to commercialize our SCD in all human therapeutic indications.

For more information, see “

Intellectual Property ”

We intend to continue to shape our commercial and distribution strategy by expanding indications and pursue collaborations with partners in markets where such partners provide strategic capabilities in launching our product candidates and enabling access to specific patient populations.

On December 27, 2022, we entered into a license and distribution agreement (the “Distribution Agreement”) with Nuwellis, Inc.

(“Nuwellis”), pursuant to which we appointed Nuwellis as our exclusive distributor for the sale and distribution of 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.

Pursuant to the Distribution Agreement, we received an upfront payment, and will receive milestone payments upon achievement of certain milestones and royalties on gross sales of the SCD product.

The Distribution Agreement has an initial term commencing on December 27, 2022 and shall end on the three (3) year anniversary from the date that is the earlier of (a) ninety (90) days after we receive FDA authorization to market such SCD product for pediatric use and (b) the first commercial sale of the SCD product.

The term of the Distribution Agreement may be automatically extended for additional terms of one (1) year and for a total of two (2) extensions.

Each party has the right to terminate the Distribution Agreement for material breach if such breach is not cured within ninety (90) days after written notice and we have additional rights to terminate the Distribution Agreement in accordance with other terms set forth in the Distribution Agreement.

Our senior management team and Board have an average of more than 19 years of experience in the healthcare industry, including expertise in medical affairs, commercialization and distribution in our initial therapeutic priority areas.

We are also supported by a group of well-respected scientific advisors who are experts in the development of our technology and products.

Corporate History

SeaStar Medical, Inc.

was initially incorporated under the name Nephrion, Inc.

on June 6, 2007.

On August 3, 2007, we amended our corporate name to CytoPherx, Inc.

On June 19, 2019, we amended our corporate name to SeaStar Medical, Inc.

On October 28, 2022, LMF Acquisition Opportunities, Inc.

(“LMAO”), a Delaware corporation, consummated a series of transactions that resulted in the combination of LMF Merger Sub, Inc., a Delaware corporation and a wholly-owned subsidiary of LMAO (“Merger Sub”), and SeaStar Medical, Inc., a Delaware corporation, pursuant to an Agreement and Plan of Merger, dated April 21, 2022 (the “Merger Agreement”), by and among LMAO, Merger Sub and SeaStar Medical, Inc.

(the "Closing").

Pursuant to the terms of the Merger Agreement, a business combination between LMAO and SeaStar Medical, Inc.

was affected through the merger of Merger Sub with and into SeaStar Medical, Inc., with SeaStar Medical, Inc.

surviving the merger as a wholly-owned subsidiary of LMAO (the “Business Combination”).

Following the consummation of the Business Combination, LMAO was renamed “SeaStar Medical Holding Corporation”

(the “Company”).

The acute inflammatory response occurs in a well-defined coordinated sequential response.

Neutrophils are the first responders followed by monocytes.

The monocytes, as they egress into tissue also follow another sequence of differentiation into tissue macrophages.

The first are proinflammatory macrophages, followed by patrolling, reparative macrophages.

This complex tightly coordinated process is critical for host defense and tissue repair but needs to be tightly regulated by the body’s inflammatory signaling and cellular apoptosis.

If not, further tissue destruction may occur when uncontrolled hyperinflammation leads to degradative reparative processes with worsening tissue or organ function.

If this excessive systemic inflammation is severe and prolonged, multi-organ failure, including cardiovascular, respiratory, kidney, liver and neurologic dysfunction may occur, resulting in poor clinical outcomes.

Prior therapeutic approaches to block soluble mediator targets, such as a cytokines or free radicals have not proven successful.

We believe that our SCD approach, which targets activated cells, is a potentially transformative, if not disruptive, therapeutic approach to a range of acute and chronic inflammatory disorders.

Our SCD is an extracorporeal synthetic membrane device designed to bind activated leukocytes (neutrophils and monocytes) as part of a CRRT extracorporeal circuit.

When added to the circuit and release of a standard CRRT system (using regional citrate anticoagulation) immediately following a standard hemofilter cartridge, blood within

the standard hemofilter cartridge enters our SCD and disperses among the fibers of the device.

Upon exiting our SCD under a low calcium environment, the blood is returned to the patient’s body.

Our SCD delivers its therapeutic benefit by attenuating the excessive inflammatory response of activated neutrophils and monocytes.

Uninterrupted, the excessive inflammatory response progresses to multi-organ failure (“MOF”), with documented increases in both morbidity and mortality in critically ill patients.

Our initial lead product is focused on critically ill AKI pediatric and adult patients on CRRT.

Our SCD leverages the existing footprint of CRRT pump systems in ICUs today, as well as the growing use and adoption of regional citrate as an anticoagulant.

Citrate is used to bind the free ionized calcium within the extracorporeal circuit which is needed to impact the neutrophils and monocytes.

A recent study in the Journal of the American Medical Association in 2020 demonstrated that while the use of regional citrate anticoagulation has the same mortality profile as heparin, regional citrate anticoagulation now showed to be more effective in preserving filter life as used to create the low calcium environment for our SCD, which impacts the white cells interaction with the SCD membrane leading to the reduction in inflammation.

Mechanism of Action

The mechanism of action of our SCD consists of two steps:

1) binding activated neutrophils and monocytes on our SCD biomimetic membrane and 2) deactivating the activated neutrophils by maintaining a specified ionized calcium level within our SCD.

Our SCD utilizes clinically approved regional citrate anticoagulation protocols to lower the ionized calcium level, which prevents blood clogging within the circuit and immuno-modulates the activated

neutrophils, which are then returned to the patient.

Calcium is then infused into the blood returning to the patient from the SCD, thereby maintaining normal calcium levels in the patient throughout the process.

Our SCD and Neutrophils

Calcium plays a critical role in many biological processes.

In the case of neutrophils, calcium can have a profound effect on their activity.

It has been shown that lowering calcium levels in neutrophils can lead to higher levels of neutrophil apoptosis (deactivation).

Our SCD is designed to selectively bind the most highly activated neutrophils (associated with hyperinflammation) and in a low iCa environment, the activated neutrophils are deactivated, which has the effect of reducing hyperinflammation.

When neutrophils are in homeostasis, the normal half-life is six to eight hours, but in a hyperinflammatory state, neutrophil apoptosis is delayed leading to increased numbers of activated neutrophils in circulation.

Through clinical and preclinical studies, our SCD has been shown to selectively sequester and deactivate the most highly activated neutrophils, allowing the body to restore neutrophil homeostasis.

Our SCD and Monocytes

We believe the role of circulating monocytes in systemic inflammation and organ specific injury is becoming more appreciated by healthcare professionals.

Calcium also has an important influence on monocyte activity.

A high percentage of the circulating monocyte subtypes (M1 proinflammatory versus M2 patrolling, reparative) has been shown to influence the degree of acute organ injury and chronic organ dysfunction.

In vitro, our SCD membranes in a low iCa perfusion circuit binds the proinflammatory monocytes within the blood more selectively.

This selective binding has been shown in clinical trials and results in less proinflammatory circulating monocytes in inflammatory disorders.

It is important to note that our SCD does not sequester 100% of these monocytes as they are important to maintaining immune homeostasis.

Histological evaluation of our SCD

Microscopy of our SCD after being used for patient treatment demonstrated the binding of leukocytes on the outer surface of the membranes of the cartridge along the blood flow path within the extracorporeal circuit.

The bound leukocytes were dominated by neutrophils and monocytes (see Figure 1 below).

The ability of neutrophils and monocytes to bind to the outer walls of the hollow fiber membranes (figure below) rather than the inner walls, which is the conventional blood flow path, is due to the difference in shear forces of blood flow.

The sheer force of our SCD is similar to capillary flow providing a microenvironment for the neutrophils and monocytes, enabling the cells to catch and release.

Our Market Opportunity

We are a therapeutic medical device company with clinical data collected and available to support a HDE submission to the FDA to request the use of our SCD in pediatric patients with AKI and additional clinical data intended to support the initiation of a pivotal PMA study in adult AKI.

In the long term, we intend to pursue the application of our SCD technology to additional indications, including, but not limited to, acute respiratory distress syndrome, chronic dialysis, cardiorenal syndrome and hepatorenal syndrome.

Our Initial Market Opportunity in Acute Kidney Injury

We believe AKI has increasingly received the attention of healthcare professionals and academic publications that reveal the devastating clinical and financial impact of what is most-often a multi-organ syndrome.

A 2017 study by Samuel A.

Silver and Glenn M Chertow titled “The Economic Consequences of Acute Kidney Injury”

stated hospital costs associated with AKI in the U.S.

are between $5.4 billion and $20 billion per year.

The kidneys are a silent killer within medical triage.

They do not present clear symptoms or tell the body they are suffering like other major organs such as the heart or lungs.

For example, one does not feel pain with a “kidney attack”

and symptoms are delayed until irreversible damage may have already occurred.

Kidneys also refrain from revealing the impact to the rest of body and organs (and vice-versa) and often are not considered systemically for co-treatment.

Globally consistent criteria for diagnosing AKI have recently emerged with Risk, Injury, Failure, Loss of kidney function, and End-stage kidney disease ("RIFLE"), an international consensus classification for AKI staging and diagnosing guidelines introduced in 2004, the Acute Kidney Injury Network ("AKIN") staging system in 2007, and finally the Kidney Disease:

Improving Global Outcomes, AKI Staging and Diagnosing Guidelines published in 2012.

These sources have helped clinicians to both improve recognition, staging, diagnosing and subsequent documentation of less obvious cases of AKI secondary diagnoses.

While our initial market is focused on AKI patients on CRRT, future indications will likely benefit from improved characterization and diagnosis of patients.

As a result, demand for ICU renal replacement therapy is growing.

CRRT is the newest of AKI dialysis modality in the market, first becoming available in 1997, and according to Fortune Business Insights, it is estimated that it has grown to a $986 million global market ($354 million market in the U.S.) as of 2019.

The two largest operators in the CRRT market by revenue are Fresenius Medical Care Holdings, Inc.

and Baxter International, which represent over 80% of the market today in the U.S.

Since 2010, a significant amount of data has been published to quantify the clinical and financial impact of AKI, resulting in a broadening AKI treatment “boom”

beyond dialysis to areas of diagnostics, complimentary therapies, and pharmacologics.

As hospital administrators and government officials’

understanding of the impact and burden of AKI increases, we believe that attention will only continue to grow.

According to Hobson in his article titled “Cost and Mortality Associated with Postoperative Acute Kidney Injury,”

a 2015 study of 50,314 patients (over 11 years) found that upon greater scrutiny, AKI was found in 39% of post-surgical patients, and 19% of patients had stage 2 or 3 AKI with an average incremental cost of $29,800 per patient.

Additionally, with historical mortality rates approximately 50%, treating AKI is increasingly of interest to clinicians, hospitals, and product manufacturers alike.

The AKI patient population is growing on average 6.9% per year according to the Healthcare Cost and Utilization Project commissioned by the Agency for Healthcare Research and Quality, a U.S.

federal agency.

According to Massicotte and Azarniouch in their 2015 work titled “Acute Kidney Injury in the Intensive Care Unit:

Risk Factors and Outcomes of Physician Recognition Compared with KDIGO Classification,”

around 80% of moderate or severe cases of AKI are not diagnosed and documented, suggesting the U.S.

AKI patient population is higher than the estimated 6 million patients annually.

The pediatric population for AKI patients on CRRT is estimated to be less than 8,000 patients per year, which is a substantially small sub-set of the 6 million AKI patient population.

The AKI market needs new and effective solutions, and hospitals continue to search and evaluate new products.

For a product to succeed in the AKI space, it must demonstrate and achieve clear and significant clinical benefit to patients, while providing positive financial incentives for hospitals to generate revenue and profitability.

Our Growth Strategies

Key elements of our growth strategy include innovating and expand our applications through clinical trials;

differentiation through medical education;

business development and out-licensing activities and scaling production with manufacturing partners.

We expect to employ several core growth strategies:

Execute on the clinical plan through key relationships:

Our initial focus on the treatment of AKI in adults and pediatrics is supported by our long and established relationship with UOM, which licenses to us certain key technology underpinning our novel immunomodulatory therapy, as well as other leading academic hospitals and institutions throughout the U.S.

Such relationships enable us to expand and refine the design and execution of our clinical plans with a more targeted outcome and objectives.

In addition, we have submitted the HDE for the pediatric AKI indication in June 2022.

In February 2023, the Company received FDA IDE approval for the adult AKI indication.

This indication has received the FDA BDD for our SCD therapy targeting AKI adult patients, is expected to accelerate and streamline the regulatory approval process prior to the commercial launch of our product candidates.

Differentiation through medical education:

We intend to dedicate resources to educate physicians, hospital clinicians and other decision makers in the medical communities on the role of neutrophils and monocytes in both acute and chronic indications, and therapeutic benefit of controlling and modulating excessive inflammatory response.

We intend to focus our marketing strategies not only on the therapeutic capabilities of our technology, but also the economic consequences of hyper-inflammation in the current standard of care and treatment infrastructure and highlight the differentiating factors of our SCD product candidates that can provide a cost effective solution.

Business development and out-licensing activities:

We intend to explore and pursue business development opportunities with major medical and pharmaceutical companies to establish partnerships, including outbound licensing arrangements.

We believe that our clinical experience and depth, combined with our understanding of the scientific mechanism of our SCD and our regulatory submissions around the world, can drive value for our partners and reduce their market risk.

We believe our partners will benefit from insight in other SCD trials around the world as well as data generation that is being conducted by our trials.

We believe that our SCD therapy has the potential to apply to multiple indications.

By pursuing and establishing business relationships with partners who may have strong capabilities beyond AKI, such as the markets for respiratory distress syndrome, we may be able to expand our solutions to the chronic disease setting.

Scaling production with manufacturing partners:

As we progress through our planned clinical trials and anticipate the potential commercial launch of our SCD product candidates if FDA approval is received, we are focused on identifying and securing various suppliers and manufacturing partners to scale production in response to the expected demand for our solutions.

We continue to negotiate with suppliers of raw materials, including filters, tubing and other components, to establish redundancies and alternative sources to mitigate interruptions in the supply chain in the future.

In addition, we may also explore strategic relationships with partners who can provide sources of raw materials while collaborating with us on the marketing and distribution of our product candidates.

Our Clinical Stage Product Candidates

The following disclosure summarizes our SCD product candidates in clinical stages and other clinical studies.

All trials and studies below are conducted under IDEs approved by the FDA.

We submitted an HDE application for SCD for the treatment of pediatric patients with acute kidney injury undergoing CRRT with the FDA in June 2022.

We expect the FDA to complete substantive review of the HDE application by the first half of 2023.

Clinical Progression

SCD 006 Pivotal Study (“SCD 006”) Design

We are in the process of initiating a pivotal clinical trial of the SCD for the treatment of AKI in adults under the recent grant of BDD by the FDA.

This trial ("SCD 006") is a 200 patient, pivotal, prospective, multi-center, open

label, randomized, two-arm comparative study conducted in the United States.

The SCD 006 trial is designed to assess a composite endpoint of both mortality and dialysis dependency at Day 60.

Our target population will be adults with AKI in ICUs in hospital settings and has an estimated 60-day mortality rate of 40% to 50% and for those who survive, the probability of requiring dialysis at Day 60 will be 25%.

Current Trial Status

We submitted the SCD 006 IDE Protocol to the FDA on January 6, 2023.

We anticipate the trial to begin enrollment late in the second quarter of 2023 and is anticipated to complete enrollment in 15 to 18 months.

On April 29, 2022, we received a BDD for the use of our SCD in the treatment of immunomodulatory dysregulation in adult patients (18 and older) with AKI, which should accelerate the regulatory review and approval process for such trial.

We currently anticipate generating interim results from this trial in late 2023 and topline study results and submission of a PMA application in the second half of 2024.

Additional clinical studies under IDEs include cardiorenal syndrome in congested heart failure, myocardial stunning in end-stage renal disease, and hepatorenal syndrome.

We are conducting exploratory clinical research at the University of Michigan to define the patient population for potential treatment with SCD product candidates, and any future studies will be based upon initial clinical data collected in these studies.

Clinical Studies

With the exception of our SCD 003, all of our clinical studies to date have not had a randomized control arm.

AKI Safety, Mortality and Device Integrity Study (CHINA) (ASAIO Journal 57:426-432,2011)

(January 2009 to April 2010)

A study of the SCD was conducted by SeaStar Medical in collaboration with Huashan Hospital in Shanghai, China titled:

An Exploratory Clinical Study to Assess Safety and Efficacy of the Double Hemofiltration Cartridge Device (DCD) in Patients with Acute Renal Failure .

This study was a prospective, non-randomized, interventional study designed to evaluate the effect of treatment with the SCD on in-hospital mortality in the acute renal failure population being treated with CRRT with regional citrate anticoagulation (“RCA”).

Up to seven days of therapy were allowed.

All subjects received standard intensive care treatment for patients undergoing CRRT in addition to the SCD treatment.

In this nine-patient study, the SCD treatment was demonstrated to reduce the mortality rates of ICU patients with AKI in hospitals compared with case-matched controls from a national dataset, based on deaths resulting from all causes in the hospital setting.

The study showed a 22% mortality rates in the SCD treatment arm versus a mortality rate of 78% in the case-matched control group.

This improved survival rate was demonstrated to be independent of age and Sequential Organ Failure Assessment (“SOFA”) Score, which is a scoring system used to predict ICU mortality based on lab results and clinical data.

The results from this study indicated that treatment with SCD was well tolerated, without significant effects on hematological parameters, including white blood cell and platelet counts, and with an adverse event profile that was expected for a seriously ill population in the ICU with AKI.

In the nine subjects analyzed on SCD treatment, no neutropenic events were reported, and no serious adverse events (“SAEs”) were reported.

Adverse events noted included hypercalcemia (8), hypocalcemia (1), hypophosphatemia (2), hypernatremia (1) and thrombocytopenia (1).

A multi-center pilot study to assess the safety and efficacy of a SCD in Patients with Acute Renal Failure (ARF 002) (Seminars in Dialysis Vol 26, Issue 5 :616-623,2013) (May 2010 to January 2011)

This pilot study of the SCD device (ARF-002 Clinical Trial) was sponsored by SeaStar Medical with the support of a third-party contract research organization.

The study was designed to evaluate the safety and efficacy of the SCD treatment after up to seven consecutive 24-hour SCD treatments.

Outcomes were compared to historical data on in-hospital mortality based on all causes of deaths at day 28 and day 60 in the AKI population being treated with CRRT with RCA.

The study enrolled 35 adult subjects.

The mean age was 56.3 and 71.4% of the subjects were Caucasian, 22.9% were Black and 5.7% were Hispanic.

The average SOFA score was 11.3.

The mortality rate from any cause at Day 60 was 31.4% with SCD versus 50% with the historical standard of care based on literature.

Renal recovery, defined as dialysis independence, was observed in all the surviving subjects at Day 60.

Based on the significantly lower mortality rate, the results of this pilot study indicate a potential for a substantial improvement in patient outcomes over historical standard of care therapy.

A total of 199 adverse events (“AEs”) were observed in 33 of the 35 subjects.

Of these 199 AEs, 12 were deemed to be possibly related and one was deemed related (as determined by the investigator) to the study therapy.

These included a worsening coagulation defect, hypotension, neutropenia, disseminated intravascular coagulation (“DIC”), thrombocytopenia, recurrent renal failure, hypophosphatemia, hypercalcemia, anemia, and cardiogenic shock.

Of the 199 total adverse events, 34.7% were deemed to be mild and were experienced by 60% of the subjects, 51.8% were moderate and experienced by 71% of the subjects and 13.6% were severe, experienced by 54% of the subjects.

The AEs observed were those that were expected for a critically ill patient population with acute renal failure and/or in an ICU setting.

Twenty-eight SAEs were observed in 23 subjects (which included death).

There were no unanticipated adverse device effects.

Of these 28 SAEs, two were deemed to be possibly related to treatment (i.e., DIC and cardiogenic shock) and were severe in intensity.

Of the SAEs, seven of the 28, or 25%, were deemed to be moderate and were experienced by 20% of the 35 subjects, and 21 (75%) were deemed to be severe, experienced by 51% of the 35 subjects.

The following table lists all SAEs encountered during the study by category and the assessment of each SAE:

Study Related

List of Serious Adverse Events

Definitely Not

Blood and lymphatic system disorders

Cardiac Disorders

Gastrointestinal Disorders

General disorders and administration site conditions

Infections and infestations

Injury, poisoning and procedural complications

Metabolism and nutrition disorders

Musculoskeletal and connective tissue disorders

Nervous system disorders

Renal and Urinary Disorders

Respiratory, thoracic and mediastinal disorders

Vascular Disorders

This was a controlled, randomized, and multicenter clinical trial that was initiated in September 2011 and terminated in September 2013 under an FDA approved IDE.

For this trial, the control group received standard CRRT with RCA and the SCD-treated group received up to seven days of SCD therapy.

The study was sponsored by SeaStar Medical with the support of a third-party contract research organization.

The primary objective of the study was to determine if the SCD, when used in conjunction with CRRT, results in clinical and statistical improvement in mortality rate based on all causes through Day 60.

Secondary objectives included an assessment of renal replacement therapy dependency at Day 60, mortality at Day 28, the number of ventilator free days at Day 28, and the mortality of the subset of patients with severe sepsis at Day 60.

A total of 134 patients were enrolled in 21 United States medical centers.

Patients receiving care in the ICU of each participating hospital were randomized to intensive care treatment for patients undergoing CRRT or CRRT + SCD.

Each participating clinical site used their established RCA protocol for the CRRT + SCD circuits (treatment group) and for the CRRT only (control group).

The recommended calcium (iCal) level (measured post SCD) in the CRRT

and SCD blood circuit was specified to be between 0.25 and 0.4 mmol/L.

Inclusion and exclusion criteria were similar to the previous IDE multicenter pilot clinical study except for an age range of 8-80 years and body weight of over 135 kilograms.

Once the patient met all eligibility criteria, including being on CRRT for a minimum of four hours, but no longer than 24 hours, and had signed an informed consent, the subject was randomized in a 1:1 allocation utilizing a random permuted block design into either the control or treatment group, stratified by study center and the presence of severe sepsis.

An overall two-sided 0.05 level of significance at 80% power was used to calculate a sample size of 344 patients, assuming a mortality rate of 50% for the control group and 35% for the treatment group.

Adaptive design and interim analysis were planned at the mid-point of enrollment (i.e., 172 patients).

Several exploratory biomarkers were also compared between the control and treatment groups, including urine output, serum levels of elastase, cytokines, and total absolute white blood cell, neutrophil and platelet counts throughout treatment.

During the second quarter of the enrollment period, a national calcium shortage occurred in the United States due to certain FDA-related quality manufacturing issues at major U.S.

Due to the reliance of the SCD on a narrow intra-circuit iCa range for functional efficacy and the concern that patients randomized to the SCD were not receiving effective therapy due to insufficient iCa levels, the interim analysis was performed early after enrollment of 134 patients.

Enrollment was paused on May 24, 2013 to assess the clinical impact of the calcium shortage on study endpoints.

The shortage of calcium infusion solutions resulted in a tendency to minimize citrate infusion rates.

Accordingly, the iCa levels within the blood circuit tended to be above the recommended range of 0.25 to 0.40 mmol/L.

No significant differences were noted between the control and treatment groups in terms of baseline characteristics.

Of the 134 patients in the analysis, 69 received CRRT alone and 65 received SCD therapy.

No statistically significant difference was found between the treated and control patients with a 60-day mortality of 39% (27/69) and 36% (21/59), respectively.

No statistically significant difference was found between the SAEs of the control and treatment groups.

Furthermore, none of the SAEs were considered ‘definitely’

device related per the principal investigator.

The amount of time patients in both the control and treatment group were maintained in the recommended iCa range (0.23 - 0.40 mmol/L), as specified in the study protocol, was substantially lower than expected.

Of the 134 patients enrolled in the SCD-003 protocol at the time of the interim analysis, 19 SCD patients (CRRT + SCD) and 31 control patients (CRRT alone) were maintained in the protocol’s recommended range for greater or equal to 90% of the therapy time.

The study was subsequently terminated.

No statistically significant difference was found between the SAEs of the control and treatment groups.

The study reported 71 SAEs in the control group (40 of the 63 patients) and 80 SAEs in the SCD treatment group (45 of the 69 patients).

The most frequent categories of SAEs were infections and infestations as well as cardiac, respiratory, thoracic and mediastinal disorders.

Furthermore, none of the SAEs were considered “definitely”

related to the SCD device per the principal investigator.

Overall adverse events did not differ between the treatment and control groups in the intent to treat analysis.

The following table lists all SAEs encountered during the study by category and the assessment of each SAE:

Study Related

List of Serious Adverse Events

Definitely Not

Blood and lymphatic system disorders

Cardiac Disorders

Gastrointestinal Disorders

General disorders and administration site conditions

Infections and infestations

Injury, poisoning and procedural complications

Metabolism and nutrition disorders

Musculoskeletal and connective tissue disorders

Nervous system disorders

Renal and Urinary Disorders

Respiratory, thoracic and mediastinal disorders

Vascular Disorders

When the iCa treated and control subgroups were compared for a composite index of 60-day mortality and dialysis dependency, the percentage of the SCD treated subjects was 16% versus 58% in the control subjects.

The incidence of serious adverse events did not differ between the treated and control groups.

A new IDE was FDA approved on February 12, 2014 for a pivotal trial of 122 patients in up to 30 sites utilizing this primary composite endpoint.

If this trial met safety and effectiveness criteria, the FDA stated that a premarket approval and clearance was supportable.

This clinical trial was not initiated in 2014 due to continuing injectable calcium shortages, and the company limited the clinical focus to the pediatric indications, where less calcium was needed due to size of study (pediatric study had 15% of the patients compared to pivotal trial of 122 patients).

Safety and early efficacy trial of our SCD therapy in pediatric patients with AKI requiring CRRT (December 2016 and February 2020)

A multi-center, prospective pilot study was undertaken to assess the safety and efficacy of our SCD in pediatric patients with AKI being treated with continuous kidney replacement therapy with RCA.

The primary objective of the study was to evaluate the safety of up to seven consecutive 24-hour treatments of our SCD.

The secondary objective was to evaluate the efficacy of up to seven consecutive 24-hour SCD treatments on all-cause mortality and dialysis dependency at day 28 and day 60.

This study was sponsored by SeaStar Medical with the support of a third-party contract research organization.

Sixteen patients (eight male and eight female) were enrolled in the study at four United States pediatric medical centers, which ran from December 2016 through February 2020.

The most common diagnosis leading to ICU admission was septic shock followed by, in diminishing order, pneumonia, rhabdomyolysis, pulmonary hypertension, hemolytic uremic syndrome, encephalomyelitis, disseminated adenoviral infection, cardiac arrest, acute respiratory failure and acute liver failure.

Twelve of the 16 patients survived (75%) to hospital discharge (versus historical control of 50%) and none of the 12 patients required dialysis at 60 days (versus historical control of 15% to 20%).

There were 14 SAEs that occurred in fourteen patients in the study.

None of the SAEs were device related.

There were 47 adverse events that occurred in 14 subjects in the study.

The following table lists all SAEs encountered during the study by category and the assessment of each SAE:

Study Related

List of Serious Adverse Events

Definitely Not

Cardiac Disorders

Gastrointestinal Disorders

Infections and infestations

Metabolism and nutrition disorders

Nervous system disorders

Renal and Urinary Disorders

Respiratory, thoracic and mediastinal disorders

Surgical and medical procedures

Vascular Disorders

A Multi-Center Pilot Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients Developing AKI or Acute Respiratory Distress Syndrome Associated with COVID-19

(September 2020 to July 2021).

Critical Care Exploration

Twenty-two subjects were enrolled in this pilot study at two leading medical centers.

All enrolled patients were treated with corticosteroids, either dexamethasone or hydrocortisone.

The majority of enrolled patients also received remdesivir.

Sixteen patients were included in the contemporaneous control.

Sixteen of the intent to treat (“ITT”) patients received greater than 96 hours of our SCD treatment per protocol (“PP”) since the inclusion criteria required

an intent to treat for at least 96 hours.

This study was sponsored by SeaStar Medical with the support of a third-party contract research organization.

The mortality rate of the ITT group at 60 days post-initiation of our SCD treatment was 50% and was 31% for the PP group.

The control group had a mortality rate of 81%, which was higher than both the ITT and PP treated groups.

The patients in the control group on Extracorporeal Membrane Oxygenation treatment did not survive, while 44% survived in the ITT group.

For dialysis dependency at 60 days, 60% of the survivors had not recovered renal function in the ITT group;

however, a post-hoc follow up at 90 days demonstrated that only 30% of the survivors still required dialytic support.

Fifty SAEs occurred in 18 subjects.

Of note, 22 nosocomial and opportunistic infections were reported in 12 subjects during the entire 60-day follow-up period.

Sixteen of the 22 infections occurred after SCD treatment.

None of these SAEs were device-related as determined by the site clinical investigators and the independent safety review committee.

No RCA-related adverse events were observed with greater than 90% of measured circuit ionized calcium (iCa) values less than 0.4 mmol/L.

Systemic iCa values were within the normal ranges required by the clinical protocol.

Two circuit clotting events were reported;

clotting was initiated in the hemodialysis catheter in one instance and in the hemofilter in the other.

No SCD clotting episodes were reported.

No episodes of thrombocytopenia, neutropenia, or leukopenia were observed.

The following table lists all SAEs encountered during the study by category and the assessment of each SAE:

Study Related

List of Serious Adverse Events

Definitely Not

Blood and lymphatic system disorders

Cardiac Disorders

Gastrointestinal Disorders

General disorders and administration site conditions

Hepatobiliary disorders

Infections and infestations

Injury, poisoning and procedural complications

Metabolism and nutrition disorders

Musculoskeletal and connective tissue disorders

Nervous system disorders

Renal and Urinary Disorders

Respiratory, thoracic and mediastinal disorders

Vascular Disorders

SeaStar Medical and the principal investigators of SCD-005 COVID-19 clinical study have recently been accepted and were recently published in Critical Care Exploration;

a peer reviewed academic journal.

Chronic Applications

Pilot Feasibility Trial of SCD Therapy in ESRD Patients (May 2012 to April 2013)

Our SCD therapy was evaluated in a more stable end stage renal disease (“ESRD”) patient cohort on chronic hemodialysis.

Fifteen ESRD patients were enrolled to assess the safety and early efficacy signals on inflammatory biomarkers.

Our SCD therapy promoted a monocyte shift from predominant proinflammatory to reparative phenotype.

Very few adverse events or SAEs were observed during SCD treatment and RCA.

SCD treatment and RCA was associated with adverse events in four of the 13 patients.

The adverse events were comprised of one episode each of

fever, chills, headache, itching, coughing, dizziness, muscle cramps, nausea, vomiting, and chest pain.

These adverse events are frequently experienced by patients undergoing standard hemodialysis treatment.

No adverse events were definitively related to SCD therapy.

SCD treatment and heparin anticoagulation, however, resulted in symptomatic and biochemical events.

The initial two patients (Pt1 and Pt2) of this cohort, treated with SCD and heparin anticoagulation, demonstrated a large rise in C-reactive protein levels from 22 to 38 (Pt1) and 51–132 (Pt2) mg/L after four hours of SCD treatment.

C-reactive protein levels continued to be elevated at 93 (Pt1) and 147 (Pt2) mg/L on day 1 post-SCD treatment.

Because of these events, no further patients were recruited for SCD treatment and heparin anticoagulation.

The following table lists all SAEs encountered during the study by category and the assessment of each SAE:

Study Related

List of Serious Adverse Events

Definitely Not

General disorders and administration site conditions

Additional Indications with Preclinical Data

The initial research and translation of our SCD into clinical studies was targeted to treat the acute dysregulated systemic inflammation associated with AKI and MOF.

Due to the broad applications of immunomodulatory therapy, preclinical models were developed to evaluate the efficacy of our SCD to ameliorate single organ tissue injury.

A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of A Selective Cytopheretic Device in Patients with Acute Kidney Injury (SCD-003 –

IDEG090189) (September 2011 to May 2013)

Clinical Studies

Additional Indications with Preclinical Data

The initial research and translation of our SCD into clinical studies was targeted to treat the acute dysregulated systemic inflammation associated with AKI and Multi Organ Failure.

Due to the broad applications of immunomodulatory therapy, preclinical models were developed to evaluate the efficacy of our SCD to ameliorate single organ tissue injury.

Chronic Inflammatory Disorders

Chronic Heart Failure

Prior preclinical and clinical evaluations of our SCD therapy have focused on acute inflammatory conditions related to organ dysfunction and failure.

Extensions of the immunomodulatory approach to improve organ dysfunction related to chronic inflammation would be transformative.

Over the past decade, a number of novel pharmacologic approaches have failed to prove clinical efficacy, accentuating the need to discover new, safe approaches to treat chronic heart failure (“CHF”).

In this regard, our SCD was evaluated in a preclinical model of CHF to dampen the cardio-depressant effects of the chronic proinflammatory state of CHF.

Chronic heart failure and acute decompensated heart failure have been increasingly recognized as associated with chronic systemic inflammation.

Monocytes have been identified as critical sources of systemic inflammation in CHF and may cause a decrease in cardiac myocyte contractility.

Cardiorenal Syndrome

Cardiorenal syndrome (“CRS”) is a clinical disorder in which therapy to relieve the congestive symptoms of chronic heart failure is limited by a decline in renal function.

Up to one-third of patients with acute decompensated chronic heart failure present with this disorder;

this condition is increasing in incidence with an estimated one million hospital admissions annually in the United States.

Once hospitalized, these patients are treated with high dose intravenous diuretics to relieve the persistent congestion.

The use of diuretics, however, frequently results in worsening renal function, progression of heart failure and death.

Immune dysregulation plays a key role in cardiorenal syndrome.

Myocardial Ischemia in End-Stage Renal Disease Patients on Chronic Hemodialysis

A major cause of death in patients on chronic dialysis is due to cardiovascular disease.

Novel interventions need to be identified and tested to ameliorate the high morbidity and mortality of myocardial disease in these patients.

Multiple hemodynamic and inflammatory factors contribute to the elevated risk of cardiac disease in the chronic hemodialysis patient populations.

Hemodialysis treatment is associated with repetitive ischemic events, or myocardial stunning, and is identified with regional wall motion abnormalities on echocardiograms.

This repetitive ischemic stress results in progressive damage resulting in declines in left ventricular ejection fraction and risk for sudden cardiac death.

Both acute and chronic inflammation and its cellular immunologic effector, the activated monocyte, are central to the accelerated cardiovascular disease in patients with chronic end-stage renal disease.

Studies at the University of Michigan

Cardiorenal Syndrome Clinical Trial

The CRS clinical trial is a safety and efficacy dose escalation study in 10 patients that was designed to evaluate whether ultrafiltration therapy in CRS, a disease with a dismal prognosis and currently ineffective therapy, with use of the SCD therapy will improve cardiac and renal (production of urine) functions.

In the study, an improvement of cardiac function is measured by the rate of ejection fraction, which is the percentage of blood leaving the heart each time it contracts.

An improvement of renal function is measured by the serum creatinine and blood urine nitrogen (two common biomarkers to assess renal function).

In addition, a variety of other biomarkers will also be measured.

The successful completion of this study is expected to demonstrate proof-of-concept for an innovative approach to the treatment of CRS.

Initial results will provide important feasibility data for a follow-on study to undertake a controlled randomized clinical trial to evaluate the clinical efficacy of our SCD in CRS patients that have failed ultrafiltration therapy.

Myocardial Ischemia in End-Stage Renal Disease Patients on Chronic Hemodialysis Clinical Trial

Pilot safety and efficacy study in 10 patients to evaluate the reduction in myocardial stunning events in hemodialysis patients.

The primary outcome will measure the change in regional wall abnormalities identified on an echocardiogram.

Initial results will provide important feasibility data for a follow-on study to undertake a controlled randomized clinical trial to evaluate the clinical efficacy of the SCD in myocardial stunning hemodialysis patients.

Clinical Study

Product Development

Our first generation SCD has been based upon the design of a synthetic hemofilter due to the reduced regulatory risk of an FDA approved polysulfone hollow fiber cartridge.

Second generation prototypes will include flat end caps to allow consistent implementation of the therapy, which we expect is more suitable as we scale up our operations.

We are currently evaluating altered configuration for differing clinical indication, so that pricing decisions can be made based upon unmet medical need and product specifications.

We source critical components from vendors that have been approved and qualified through our vendor management program.

Fresenius Medical Care North America (“FMCNA”) is the current supplier of the filter used in our pediatric acute kidney injury indication.

In March 2022, we entered into a supply agreement (the “Supply Agreement”) with an FMCNA affiliate, Fresenius USA Marketing, Inc.

(“FUSA”), to supply certain filters at an agreed amount per case for use in our SCD product in our upcoming clinical trial and any additional clinical trials.

We may resell the filters as part of the SCD system in both an Emergency Use Authorization application as well as a future PMA-approved product.

The initial term of the Supply Agreement is for three years commencing on March 31, 2022.

Either party may terminate the Supply Agreement for uncured material breach or for the insolvency of the other party.

In addition, either party may terminate the Supply Agreement if in the reasonable opinion of legal counsel for either party, any future changes in federal or state law or regulations make any portion of the Supply

Agreement invalid or illegal and the parties are not able to agree on mutually acceptable addendum to the Supply Agreement.

We have agreed to indemnify FUSA against certain third-party claims.

We are in the process of developing a second source for the adult and pediatric filters, which will enable us to better manage any supply disruptions.

In addition, we have secured a supplier to provide the tubing set required to assemble the SCD device, although we are able to identify and secure additional sources of supplies for the tubing set as it is readily available in the market.

The Supply Agreement contains a provision granting FUSA a first right of refusal for the first three years after regulatory approval of our SCD product candidate to distribute the pediatric and adult products in the United States.

If during such period, SeaStar Medical elects to promote and sell the SCD through distributors, SeaStar Medical will be required to provide FUSA with a right of first refusal to be SeaStar Medical’s exclusive distributor of the SCD in the United States and its territories, provided that the SCD is not promoted or sold in a manner that is incompatible with any devices manufactured and/or sold by FUSA or its affiliates.

On December 27, 2022, we entered into a license and distribution agreement with Nuwellis.

We appointed Nuwellis as our exclusive distributor for the sale and distribution of SCD product throughout the United States once we receive written authorization from the FDA to market our SCD for pediatric use pursuant to our HDE application.

Third-Party Reimbursement

We anticipate that coverage and reimbursement by Centers for Medicare and Medicaid Services (" CMS") and private payors will be essential for most patients and health care providers to afford our treatments, particularly in the applications of continuous renal replacement therapy for dialysis access and the treatment of hyperinflammatory conditions, including AKI.

Accordingly, future sales of our products will depend substantially, both domestically and abroad, on reimbursement by government authorities, private health coverage insurers and other third-party payors.

Our strategy around reimbursement focuses on achieving alignment and agreement from CMS on coding and payment pathways;

both are critical to influencing and achieving optimal reimbursement payment from private payor sources.

Therefore, we continue to develop a comprehensive reimbursement strategy including CMS, private payors and other key stakeholders to ensure a clear and sustainable reimbursement path for all SCD product opportunities.

We are pursuing a regulatory reimbursement strategy to ensure separate Medicare payment for our SCD at an appropriate price.

The regulatory strategy includes engaging CMS political and career staff directly on coverage, payment and coding followed by submission of formal applications in these areas once FDA approval is obtained.

It is difficult to predict what CMS will decide with respect to coverage and reimbursement for fundamentally novel products.

Risk Factors —

Risks Related to the Company’s Business Operations —

Should the Company’s products be approved for commercialization, lack of third-party coverage and reimbursement for the Company’s devices could delay or limit their adoption .”

Intellectual Property

We strive to protect the proprietary technologies that we believe are important to our business.

We have and will continue to seek patent protection for our SCD product and related technologies, as well for any future products.

In addition to seeking patent protection, we also rely on trade secrets to protect aspects of our business that are not amenable to, or that we do not consider appropriate for, patent protection.

We also rely on know-how, confidentiality agreements, license agreements and other agreements to establish and protect our proprietary rights.

Our success depends in large part on our ability to protect our proprietary technology, including our SCD technologies, and to operate without infringing the proprietary rights of third parties.

The term of individual patents depends on the legal term of the patents in the countries in which they are obtained.

In most countries in which we file, the patent term is 20 years from the earliest date of filing a non-provisional patent application.

In the United States, a patent’s term may be lengthened by patent term adjustment, which

compensates a patentee for administrative delays by the U.S.

Patent and Trademark Office in granting a patent.

patent term may be shortened, if a patent is terminally disclaimed by its owner, over another patent.

The Company currently has 18 issued U.S.

patents and 5 pending U.S.

patent applications.

The Company also has 22 issued foreign patents and has 5 pending foreign patent applications.

The Company’s issued patents begin to expire in 2028, with the last of these patents expiring in 2034, although terminal disclaimers, patent term extension or patent term adjustment can shorten or lengthen the patent term.

The following table summarizes the number of our patents and patent applications as of December 31, 2022:

Granted Patents

Pending Applications

SCD Technology (Patent Families 1-5)

Other Technology (Patent Families 6-10)

With respect to our SCD technologies, we own patents and patent applications in five patent families.

The patents and applications in Patent Family 1 are co-owned by the Company and UOM.

The patents and applications in Patent Families 2-5 are solely owned by the Company.

The inventions disclosed in Patent Families 1-4 were developed with U.S.

government funding and are subject to the obligations under the Bayh-Dole Act.

Patent Family 1 contains nine U.S.

patents and one pending U.S.

patent application directed to systems and methods for processing leukocytes and for treating subjects with various inflammatory conditions using a SCD cartridge, and to a SCD cartridge.

These patents will expire from 2028-2031, and the pending application, if granted, will expire in 2028, assuming that the required maintenance fees are paid.

We also co-own with UOM counterpart patents granted in Canada, Japan and New Zealand, and one patent application pending in Europe.

These counterpart patents, and applications, if granted, will expire in 2028, assuming that the required maintenance fees are paid.

The patents and applications in Patent Family 1 are as follows:

Patent Family 1

Subject Matter

United States

Methods for processing leukocytes and methods for treating subjects having inflammatory conditions using such methods

United States

Methods for treating subjects undergoing a cardiopulmonary bypass

United States

Methods for treating subjects with end-stage renal disease

United States

Methods for treating subjects with acute renal failure

United States

Methods for treating subject with sepsis

United States

A device that processes activated leukocytes and platelets

United States

Methods for treating acute lung injury and acute respiratory distress syndrome

United States

Systems for treating activated platelets

United States

Systems for treating activated leukocytes

United States

Systems for treating leukocytes and platelets and methods

for treating subject having inflammatory conditions by

processing leukocytes or platelets

Systems and methods for processing leukocytes and

platelets and systems for treating inflammatory conditions

A device for processing activated leukocytes and platelets

A device and methods for treating leukocytes

A device for processing activated leukocytes

Systems and methods for processing leukocytes and

platelets and for treating inflammatory conditions

A device that processes platelets or leukocytes

Expiration date if application is granted.

This patent family was developed with U.S.

federal government funding and is subject to obligations under the Bayh-Dole Act.

Pursuant to a license agreement with UOM (as amended, the “UOM License Agreement”), UOM has granted us a worldwide, royalty bearing, exclusive license to their interest in the co-owned patents and applications in Patent Family 1 in the field of medical devices for human therapeutics for certain technologies used in the SCD technology platform, including composition of matter and methods of use patents.

In consideration for such exclusive license, during the term of the UOM License Agreement, we agreed to pay UOM a royalty fee equal to 1% of net sales and reimbursement of patent costs.

To date, we have not paid and do not owe any royalty payments under the UOM License Agreement.

We have paid approximately $124 thousand in patent costs reimbursement since January 1, 2020.

The UOM License Agreement also imposes certain diligence obligations on us and requires us to achieve specified milestone events by a certain date.

Under the UOM License Agreement, UOM’s liability is limited and we agreed to indemnify and hold UOM harmless in connection with the use of the licensed technology and activities related to the products created using such licensed patents and/or technology.

The UOM License Agreement will remain in effect, unless earlier terminated, until the latter of (i) the expiration of all licensed patents, (ii) the tenth anniversary of the Effective Date (as defined therein) or (iii) the seventh anniversary of the date of the First Commercial Sale (as defined therein).

Either party may terminate the UOM License Agreement for the other party’s material breach of any covenant or promise therein that remains uncured for 90 days.

We may also terminate the agreement by giving UOM 90-day advanced notice.

In addition to the co-owned patents and patent applications in Family 1, we also solely own four additional patent families (Families 2-5).

Patent Family 2 includes one U.S.

patent and one pending U.S.

patent application directed to a second generation of the SCD cartridge and methods for using our SCD cartridge to process leukocytes.

The patent will expire in 2032, and the application, if granted, will expire in 2031, assuming that the required maintenance fees are paid.

Counterpart patents have been granted in Australia, Europe, and Japan with the European patent having been validated in France, Germany, Italy, Spain, and the United Kingdom, and a patent application is pending in

These patents, and the application, if granted, will expire in 2031, assuming that the required maintenance fees are paid.

The patents and the application in Patent Family 2 are as follows:

Patent Family 2

Subject Matter

United States

Cartridge for treating leukocytes or platelets

United States

Methods for processing leukocytes or platelets and for treating a subject with an inflammatory condition

Cartridge for treating leukocytes or platelets and methods for treating a subject with an inflammatory condition

Germany, Italy,

Cartridge for sequestering leukocytes or platelets

Cartridge for processing leukocytes or platelets

Cartridge for treating leukocytes or platelets

Expiration date if application is granted.

This patent family was developed with U.S.

federal government funding and is subject to obligations under the Bayh-Dole Act.

Patent Family 3 includes one U.S.

patent directed to methods of treating chronic heart failure using a SCD cartridge, which will expire in 2032, assuming that the required maintenance fees are paid.

A counterpart patent has been granted in Japan, that will expire in 2032, assuming that the required maintenance fees are paid.

The patents and applications in Patent Family 3 are as follows:

Patent Family 3

Subject Matter

United States

Methods for treating chronic heart failure

Device for use in treating chronic heart failure

This patent family was developed with U.S.

federal government funding and is subject to obligations under the Bayh-Dole Act.

Patent Family 4 includes two U.S.

patents directed to methods of treating chronic heart failure and acute decompensated heart failure using a SCD cartridge.

These patents will expire in 2032, assuming that the required maintenance fees are paid.

Counterpart patents have been granted in Australia, and patent applications are pending in Canada and Europe.

These patents, and patent applications, if granted, will expire in 2032, assuming that the required maintenance fees are paid.

The patents and applications in Patent Family 4 are as follows:

Patent Family 4

Subject Matter

United States

Methods for increasing myocardial function in subject with acute decompensated heart failure

United States

Methods for increasing myocardial function in subject with chronic heart failure

Methods for increasing myocardial function in a subject with acute chronic heart failure or chronic heart failure

Methods, cartridges, and systems for improving myocardial function and treating inflammation associated with acute decompensated heart failure and chronic heart failure

Devices for use in treating subjects with chronic heart failure and acute decompensated heart failure

Devices for use in treating subjects with chronic heart failure or acute decompensated heart failure

Expiration date if application is granted.

This patent family was developed with U.S.

federal government funding and is subject to obligations under the Bayh-Dole Act.

Patent Family 5 includes three U.S.

design patents, three European Community design patents, and three United Kingdom design patents directed to a medical device connector as follows:

Patent Family 5

Subject Matter

United States