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1、2025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm1/223REGISTRATION STATEMENT As filed with the Securities and Exchange Commission on May 19,2025Registration No.333-U

2、NITED STATESSECURITIES AND EXCHANGE COMMISSIONWashington,D.C.20549 FORM S-1REGISTRATION STATEMENTUNDERTHE SECURITIES ACT OF 1933 SeaStar Medical Holding Corporation(Exact Name of Registrant as Specified in Its Charter)Delaware 3841 85-3681132(State or Other Jurisdiction ofIncorporation or Organizati

3、on)(Primary Standard IndustrialClassification Code Number)(I.R.S.EmployerIdentification No.3513 Brighton Blvd,Suite 410Denver,CO 80216(844)427-8100(Address,Including Zip Code,and Telephone Number,Including Area Code,of Registrants Principal Executive Offices)Eric SchlorffChief Executive Officer3513

4、Brighton Blvd,Suite 410Denver,CO 80216(Name,Address,Including Zip Code,and Telephone Number,Including Area Code,of Agent for Service)Copies to:Joshua EreksonDaniel LymanDorsey&Whitney LLP111 South Main Street,Suite 2100Salt Lake City,UT 84111(801)933-7360 Approximate date of commencement of proposed

5、 sale to the public:From time to time after the effective date of thisregistration statement.If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule415 under the Securities Act of 1933,please check the following box.If this Form is f

6、iled to register additional securities for an offering pursuant to Rule 462(b)under the Securities Act,please check the following box and list the Securities Act registration statement number of the earlier effective registrationstatement for the same offering.If this Form is a post-effective amendm

7、ent filed pursuant to Rule 462(c)under the Securities Act,check the followingbox and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.If this Form is a post-effective amendment filed pursuant to Rule 462(d)under the Securitie

8、s Act,check the followingbox and list the Securities Act registration statement number of the earlier effective registration statement for the same offering.Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,asmaller reporting comp

9、any,or an emerging growth company.See the definitions of“large accelerated filer,”“accelerated filer,”“smaller reporting company”and“emerging growth company”in Rule 12b-2 under the Securities Exchange Act of 1934:Large accelerated filerAccelerated filerNon-accelerated filerSmaller reporting company

10、Emerging growth company 2025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm2/223If an emerging growth company,indicate by check mark if the registrant has elected not

11、to use the extended transitionperiod for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B)of theSecurities Act.The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effectivedate until th

12、e Registrant shall file a further amendment which specifically states that this Registration Statement shallthereafter become effective in accordance with Section 8(a)of the Securities Act of 1933 or until the Registration Statementshall become effective on such date as the Commission,acting pursuan

13、t to said Section 8(a),may determine.2025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm3/223 The information in this preliminary prospectus is not complete and may be

14、 changed.These securities may not be sold untilthe registration statement filed with the Securities and Exchange Commission is effective.This preliminary prospectus isnot an offer to sell nor does it seek an offer to buy these securities in any jurisdiction where the offer or sale is notpermitted.PR

15、ELIMINARY PROSPECTUS(Subject to Completion)Dated May 19,2025 Up to 4,736,406 Shares Common Stock SeaStar Medical Holding Corporation This prospectus relates to the resale,from time to time,of up to 4,736,406 shares of our common stock,par value$0.0001 pershare(“Common Stock”),by Lincoln Park Capital

16、 Fund,LLC(“Lincoln Park”or the“selling stockholder”).The shares of Common Stock being offered by the selling stockholder have been or may be purchased pursuant to the purchaseagreement,dated April 25,2025,that we entered into with Lincoln Park(the“Purchase Agreement”).See“The Lincoln ParkTransaction

17、”for a description of the Purchase Agreement and“Selling Stockholder”for additional information regarding LincolnPark.The prices at which Lincoln Park may sell the shares will be determined by the prevailing market price for the shares or innegotiated transactions.We are not selling any securities u

18、nder this prospectus and will not receive any of the proceeds from thesale of shares of Common Stock by the selling stockholder.We have not yet sold any shares of Common Stock to Lincoln Parkunder the Purchase Agreement.Subject to the Exchange Cap(as defined herein),we may receive up to$15.0 million

19、 aggregategross proceeds(subject to certain limitations)under the Purchase Agreement from any sales we make to Lincoln Park pursuant tothe Purchase Agreement after the date of this prospectus.The selling stockholder may sell or otherwise dispose of the shares of Common Stock described in this prospe

20、ctus in a numberof different ways and at varying prices.See“Plan of Distribution”for more information about how the selling stockholder may sellor otherwise dispose of the shares of Common Stock being registered pursuant to this prospectus.The selling stockholder is an“underwriter”within the meaning

21、 of Section 2(a)(11)of the Securities Act of 1933,as amended.The selling stockholder will pay all brokerage fees and commissions and similar expenses.We will pay the expenses(exceptbrokerage fees and commissions and similar expenses)incurred in registering the shares,including legal and accounting f

22、ees.See“Plan of Distribution.”We are a“smaller reporting company”under the federal securities laws and,as such,are subject to reduced public companyreporting requirements.See“Implications of Being a Smaller Reporting Company.”We are an“emerging growth company”under the federal securities laws and,as

23、 such,are subject to reduced public companyreporting requirements.See“Implications of Being an Emerging Growth Company.”Our Common Stock and warrants exercisable for one share of Common Stock for$11.50 per share(the“Listed Warrants”)aretraded on the Nasdaq Stock Market under the symbols“ICU”and“ICUC

24、W,”respectively.On May 13,2025,the closing price ofour Common Stock was$1.27 per share,and the closing price of our Listed Warrants,was$0.321 per warrant.2025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/00012

25、1390025045463/ea0242384-s1_seastar.htm4/223 On June 7,2024,we effected a 1-for-25 reverse stock split of the Common Stock(the“Reverse Split”)of our issued andoutstanding shares of Common Stock,and our shares of Common Stock began trading on a split-adjusted basis on the NasdaqCapital Market on June

26、10,2024 under the same symbol“ICU”.All of our stock options and warrants outstanding immediatelyprior to the Reverse Split were proportionally adjusted except for the Listed Warrants and the private placement warrants that wereissued as part of the SPAC transaction,which total 16,788,000 outstanding

27、 warrants in the aggregate(the“Unadjusted Warrants”).The Unadjusted Warrants retain an$11.50 exercise price each and require the exercise of 25 warrants to purchase one share ofCommon Stock.Unless otherwise indicated,all other share and per share prices in this prospectus have been adjusted to refle

28、ct theReverse Split.On June 24,2024,we received a written notification from the Listing Qualifications staff of The Nasdaq Stock Market(“Nasdaq”)that we were not in compliance with the requirement to maintain a minimum market value of listed securities of$35million(the“MVLS Requirement”),as set fort

29、h in Nasdaq Listing Rule 5550(b)(2)(the“MVLS Rule”),because the market valueof our listed securities(the“Securities”)had been below$35 million for 30 consecutive business days.We had an initial 180 days,or until December 23,2024,to regain compliance with the MVLS Requirement.On December 24,2024,we r

30、eceived written notification(the“Notification”)from Nasdaq stating that we had not regainedcompliance with the MVLS Requirement.Pursuant to the Notification,the Securities were subject to delisting from Nasdaq onJanuary 3,2025,unless we requested a hearing before the Nasdaq Hearings Panel(the“Panel”

31、)by December 31,2024.On March 11,2025,we received a decision letter(the“Letter”)from the Panel,granting our request to continue its listing onNasdaq,subject to certain conditions.The Panels decision provides us with an exception until June 22,2025,to demonstratecompliance with the MVLS Requirement.I

32、nvesting in our securities involves a high degree of risk.You should read“Risk Factors”beginning on page 6 of thisprospectus,and under similar headings in the documents incorporated by reference in this prospectus,as well as in anyamendments or supplements to this prospectus,to read about factors to

33、 consider before purchasing our securities.Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved ofthese securities or determined if this prospectus is truthful or complete.Any representation to the contrary is a criminaloffense.The date of th

34、is prospectus is ,2025.2025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm5/223 TABLE OF CONTENTS ABOUT THIS PROSPECTUS ii CAUTIONARY NOTE REGARDING FORWARD-LOOKING ST

35、ATEMENTS iii SUMMARY 1 THE OFFERING 5 RISK FACTORS 6 OUR AGREEMENTS WITH LINCOLN PARK 41 USE OF PROCEEDS 46 SELLING STOCKHOLDER 47 DILUTION 48 PLAN OF DISTRIBUTION 49 MATERIAL U.S.FEDERAL INCOME TAX CONSIDERATIONS 51 DESCRIPTION OF SECURITIES 54 BUSINESS 61 MANAGEMENTS DISCUSSION AND ANALYSIS OF FIN

36、ANCIAL CONDITION AND RESULTS OFOPERATIONS 88 DIRECTORS AND EXECUTIVE OFFICERS 102 CORPORATE GOVERNANCE 105 COMMITTEES OF THE BOARD 108 EXECUTIVE COMPENSATION 110 SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 117 CERTAIN RELATIONSHIPS AND RELATED PERSON TRANSACTIONS 119 LEGAL MATTERS

37、 122 EXPERTS 122 WHERE YOU CAN FIND MORE INFORMATION 122 INDEX TO FINANCIAL STATEMENTS F-1 i2025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm6/223 ABOUT THIS PROSPEC

38、TUS We have not,and the selling stockholder has not,authorized anyone to provide you with information different from thatcontained in this prospectus or any accompanying prospectus supplement or free writing prospectus,and neither we nor the sellingstockholder take any responsibility for any other i

39、nformation that others may give you.We and the selling stockholder are offeringto sell these securities and seeking offers to buy these securities only in jurisdictions where offers and sales are permitted.Thisprospectus and any accompanying supplement to this prospectus do not constitute an offer t

40、o sell or the solicitation of an offer tobuy any securities other than the registered securities to which they relate.You should not assume that the information contained in this prospectus or any prospectus supplement or free writingprospectus is accurate as of any date other than the date on the f

41、ront cover of those documents,regardless of the time of delivery ofthis prospectus or any sale of a security.Our business,financial condition,results of operations and prospects may have changedsince those dates.This prospectus relates to the offering of our Common Stock.Before buying any of our Com

42、mon Stock,you should carefullyread this prospectus,any supplement to this prospectus,and the additional information under the heading“Where You Can FindMore Information.”These documents contain important information that you should consider when making your investmentdecision.Unless the context indi

43、cates otherwise,references to the“Company,”“we,”“us”and“our”refer to the business ofSeaStar Medical Holding Corporation,a Delaware corporation,and its consolidated subsidiaries following the BusinessCombination.“LMAO”refers to LMF Acquisition Opportunities,Inc.prior to the Business Combination.ii202

44、5/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm7/223 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This prospectus contains forward-looking statements within t

45、he meaning of Section 27A of the Securities Act of 1933,asamended(the“Securities Act”)and Section 21E of the Exchange Act of 1934,as amended(the“Exchange Act”).These statementsare based on our managements current beliefs,expectations and assumptions about future events,conditions and results and oni

46、nformation currently available to us.Discussions containing these forward-looking statements may be found,among other places,in the sections titled“Business,”“Risk Factors”and“Managements Discussion and Analysis of Financial Condition and Results ofOperations.”Any statements in this prospectus about

47、 our expectations,beliefs,plans,objectives,assumptions or future events orperformance are not historical facts and are forward-looking statements.Within the meaning of Section 27A of the Securities Actand Section 21E of the Exchange Act,these forward-looking statements may include,but are not limite

48、d to,statements regarding:our future capital requirements and sources and uses of cash;our ability to obtain funding or raise capital for our operations and future growth;any delays or challenges in obtaining U.S.Food and Drug Administration approval of our SCD product candidates;economic downturns

49、and the possibility of rapid change in the highly competitive industry in which we operate;the ability to develop and commercialize our products or services following regulatory approval of our product candidates;the failure of third-party suppliers and manufacturers to fully and timely meet their o

50、bligations;product liability or regulatory lawsuits or proceedings relating to our products and services;inability to secure or protect our intellectual property;dispute or deterioration of relationship with our major partners and collaborators;the ability to maintain the listing of our Common Stock

51、 on the Nasdaq Capital Market;the ability to recognize the anticipated benefits of the Business Combination,which may be affected by,among otherthings,competition,and the ability to grow and manage growth profitably;and other risks and uncertainties indicated in this prospectus,including those under

52、“Risk Factors”herein,and other filingsthat have been made or will be made with the SEC.In some cases,you can identify forward-looking statements by terminology such as“anticipate,”“believe,”“continue,”“could,”“estimate,”“expects,”“intend,”“may,”“might,”“plan,”“potential,”“predict,”“project,”“should,

53、”“will,”“would”or thenegative or plural of those terms,and similar expressions intended to identify statements about the future,although not all forward-looking statements contain these words.These statements involve known and unknown risks,uncertainties and other factors thatmay cause our actual re

54、sults,levels of activity,performance or achievements to be materially different from the informationexpressed or implied by these forward-looking statements.In addition,statements that“we believe”and similar statements reflectour beliefs and opinions on the relevant subject.These statements are base

55、d upon information available to us as of the date of thisprospectus,and while we believe such information forms a reasonable basis for such statements,such information may be limitedor incomplete,and our statements should not be read to indicate that we have conducted an exhaustive inquiry into,or r

56、eview of,all potentially available relevant information.These statements are inherently uncertain and investors are cautioned not to undulyrely upon these statements.iii2025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/dat

57、a/1831868/000121390025045463/ea0242384-s1_seastar.htm8/223 SUMMARY This summary highlights selected information appearing elsewhere in this prospectus.Because it is a summary,it may notcontain all of the information that may be important to you.To understand this offering fully,you should read this

58、entireprospectus and,the registration statement of which this prospectus is a part carefully,including the information set forth underthe heading“Risk Factors”and our financial statements.Business Summary Company Overview We are a commercial-stage healthcare company focused on transforming treatment

59、s for critically ill patients facing organfailure and potential loss of life.Our Selective Cytopheretic Device(“SCD”),is designed as a disease-modifying device thatneutralizes over-active immune cells and stops the cytokine storm that yields destructive hyperinflammation and creates acascade of even

60、ts that wreak havoc in the patients body.It has broad potential applications for patients suffering from bothacute and chronic kidney disease as well as cardiovascular and other serious inflammatory diseases.We received Food and Drug Administration(“FDA”)approval on February 21,2024,under a Humanita

61、rian DeviceExemption(“HDE”)for our pediatric SCD therapy.It is the only FDA approved product for use in pediatric patients with acutekidney injury(“AKI”)due to sepsis or a septic condition requiring kidney replacement therapy.We shipped our firstcommercial pediatric SCD(QUELIMMUNE)in July 2024.In ad

62、dition,we are currently conducting a pivotal clinical trial toassess the safety and efficacy of the SCD therapy in critically ill adult patients with AKI requiring continuous renal replacementtherapy(“CRRT”).Our SCD therapy has been awarded Breakthrough Device Designation(“BDD”)for six therapeutic i

63、ndications by the FDA,including the use of the SCD therapy for adult patients with AKI,patients with cardiorenal syndrome awaiting left ventricularassist device(“LVAD”)implantation,patients with hepatorenal syndrome,patients with end stage renal disease(“ESRD”)andadult and pediatric patients undergo

64、ing cardiac surgery.The BDD enables the potential for a speedier pathway to approval andthe ability to have more frequent and flexible meetings with the FDA.The inflammatory response is essential to the healing process of critical organs;however,the overactivation ofinflammatory cells,which can be t

65、riggered by many different bodily insults such as trauma,surgery or infection,can send thebody into shock and cause severe damage to a variety of critical organs such as the heart,lungs and kidney.Central toinflammation are the cells within blood and lymph circulatory systems,called white blood cell

66、s(primarily neutrophils andmonocytes).In a normal inflammatory response,neutrophils are the first immune cells to arrive at the site and are key to theentire immune response that kills pathogens and promotes tissue repair.These inflammatory cells release chemicals(cytokines)that trigger the immune s

67、ystem to eliminate foreign pathogens or damaged tissue,enhancing the immune response.If the inflammatory response becomes excessive and dysregulated(referred to as proinflammatory),the inflammatory cellswill continue to produce cytokines and other damaging molecules,further enhancing the dysregulate

68、d immune response,andaltering feedback mechanisms that regulate the immune system.This results in damaging hyperinflammation spreadinguncontrollably to other parts of the body,often leading to acute chronic solid organ dysfunction or failure,including the heart,lung,kidney,liver,and even death.This

69、hyperinflammatory response is also known as the“cytokine storm,”referring to thebodys reaction to the category of small-secreted proteins released by hyperinflammatory cells that affect communicationbetween cells.Currently,there are no therapeutic options that specifically neutralize the white blood

70、 cells that are primarily responsible forthe destructive hyperinflammatory response.Clinicians typically address hyperinflammation with therapies that are eitherimmunosuppressive or that target one cytokine,both of which are generally suboptimal in the treatment of hyperinflammation.We believe our t

71、echnology has the potential to overcome limitations in existing anti-inflammatory treatments and address thechallenge of selectively targeting activated neutrophils and monocytes.We are leveraging our patent protected and scalable SCD technology platform to develop proprietary therapies that areorga

72、n agnostic and target both acute and chronic indications.Preclinically,our SCD was tested in various animal models,whichinclude acute myocardial infarction,intracranial hemorrhage,chronic heart failure,sepsis,and acute respiratory distresssyndrome.The animal models demonstrated the inflammatory resp

73、onse and how it was modified by our SCD.We will continueto explore the application of our SCD technology across a broad range of markets and indications where proinflammatoryactivated neutrophils and monocytes may contribute to disease progression or severity in both acute and chronic indications.20

74、25/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm9/22312025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov

75、/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm10/223 We are using our SCD initially to clinically validate several acute organ injury indications,including kidneys and lungs.Our investigational SCD for adults is an extracorporeal synthetic membrane device that is currently

76、being evaluated in a pivotalclinical trial in the U.S.for premarket clearance by the FDA.The SCD for adults is designed to be easily integrated into existingCRRT systems that are commonly installed in hospitals,including in intensive care units throughout the United States.Similarto our pediatric SC

77、D,once approved and commercialized,our adult SCD is expected to initially target acute kidney injury inadults on CRRT.In addition,we are developing our SCD to address inflammation associated with liver disease,acuterespiratory distress syndrome,chronic dialysis and chronic heart failure in adult pop

78、ulations.There is substantial clinical demand for safe and effective control of hyperinflammation.The use of our SCD to reverse thecytokine storm in pediatric and adult patients with acute kidney injury on CRRT in clinical studies with more than 150 patientsreduced mortality rates by 50%,and,of thos

79、e patients who survive 60 days,none have required dialysis.On October 28,2022,we completed a business combination with LMAO,pursuant to that certain Agreement and Plan ofMerger,dated as of April 21,2022(the“Merger Agreement”),by and among LMAO,LMF Merger Sub,Inc.,a Delawarecorporation and direct who

80、lly owned subsidiary of LMAO(“Merger Sub”),and SeaStar Medical,Inc.,a Delaware corporation(“SeaStar Medical,Inc.”).As contemplated by the Merger Agreement,SeaStar Medical,Inc.merged with and into Merger Sub,with SeaStar Medical,Inc.continuing as the surviving entity in the merger as a wholly owned s

81、ubsidiary of LMAO(the“Business Combination”).In connection with the closing of the Business Combination,LMAO changed its name to“SeaStarMedical Holding Corporation.”Corporate Information Our principal executive offices are located at 3513 Brighton Boulevard,Suite 410,Denver,Colorado 80216,and our ph

82、onenumber is 844-427-8100.Implications of Being a Smaller Reporting Company We are a“smaller reporting company,”meaning that the market value of our Common Stock held by non-affiliates is lessthan$250.0 million measured on the last business day of our most recent second fiscal quarter or our annual

83、revenue was lessthan$100.0 million during the most recent completed fiscal year and the market value of our Common Stock held by non-affiliates was less than$700.0 million measured on the last business day of our most recent second fiscal quarter.Accordingly,we may provide less public disclosure tha

84、n larger public companies,including the inclusion of only two years of auditedfinancial statements and only two years of managements discussion and analysis of financial condition and results of operationsdisclosure.As a result,the information that we provide to our stockholders may be different tha

85、n what you might receive fromother public reporting companies in which you hold equity interests.Implications of Being an Emerging Growth Company We are an“emerging growth company,”as defined in the Jumpstart Our Business Startups Act of 2012(the“JOBS Act”)and may remain an emerging growth company f

86、or up to five years.For so long as we remain an emerging growth company,weare permitted and intend to rely on exemptions from certain disclosure requirements that are applicable to other publiccompanies that are not applicable to emerging growth companies.These exemptions include:reduced disclosure

87、about our executive compensation arrangements;no non-binding stockholder advisory votes on executive compensation or golden parachute arrangements;and exemption from the auditor attestation requirement in the assessment of our internal control over financial reporting.22025/5/20 10:49sec.gov/Archive

88、s/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm11/223 We have taken advantage of reduced reporting requirements in this prospectus and may continue to do so until such timethat we are no longer

89、 an emerging growth company.We will remain an“emerging growth company”until the earliest of(a)thelast day of the fiscal year in which we have total annual gross revenues of$1.235 billion or more,(b)the last day of our firstfiscal year following the fifth anniversary of the closing of the Business Co

90、mbination,(c)the date on which we have issuedmore than$1.0 billion in nonconvertible debt during the previous three years or(d)the date on which we are deemed to be alarge accelerated filer under the rules of the SEC.Section 107 of the JOBS Act provides that an emerging growth company cantake advant

91、age of the extended transition period for complying with new or revised accounting standards.Recent Developments Nasdaq Listing On June 24,2024,we received a written notification from the Listing Qualifications staff of Nasdaq that we were not incompliance with the requirement to maintain a minimum

92、market value of listed securities of$35 million,as set forth in theMVLS Rule,because the market value of our listed securities had been below$35 million for 30 consecutive business days.Wehad an initial 180 days,or until December 23,2024,to regain compliance with the MVLS Requirement.On December 24,

93、2024,we received the Notification from Nasdaq stating that we had not regained compliance with theMVLS Requirement.Pursuant to the Notification,the Securities were subject to delisting from Nasdaq on January 3,2025,unless we requested a hearing before the Panel by December 31,2024.On March 11,2025,w

94、e received the Letter from the Panel,granting our request to continue its listing on Nasdaq,subject tocertain conditions.The Panels decision provides us with an exception until June 22,2025,to demonstrate compliance with theMVLS Requirement.The Purchase Agreement with Lincoln Park On April 25,2025,w

95、e entered into a purchase agreement with Lincoln Park,which we refer to in this prospectus as thePurchase Agreement,pursuant to which Lincoln Park agreed to purchase from us up to an aggregate of$15.0 million of ourCommon Stock(subject to certain limitations)from time to time over the term of the Pu

96、rchase Agreement.Also on April 25,2025,we entered into a registration rights agreement with Lincoln Park,which we refer to in this prospectus as the RegistrationRights Agreement,pursuant to which we filed with the SEC the registration statement of which this prospectus forms a part toregister for re

97、sale under the Securities Act of 1933,as amended,or the Securities Act,the shares of Common Stock that havebeen or may be issued to Lincoln Park under the Purchase Agreement.We do not have the right to commence any sales of our Common Stock to Lincoln Park under the Purchase Agreement untilthe condi

98、tions set forth in the Purchase Agreement,all of which are outside of Lincoln Parks control,have been satisfied,including that the SEC has declared effective the registration statement of which this prospectus forms a part,which time werefer to in this prospectus as the Commencement.From time to tim

99、e after the Commencement,at our sole discretion,on anybusiness day selected by us on which the closing sale price of our Common Stock is not below$0.25 per share,we may directLincoln Park to purchase up to 40,000 shares of our Common Stock(each,a“Regular Purchase”);provided that the shareamount unde

100、r a Regular Purchase may be increased to up to 50,000 shares,up to 60,000 shares or up to 75,000 shares if theclosing sale price of our Common Stock is not below$1.00,$1.75 or$2.50,respectively,on the business day on which weinitiate the purchase,subject to adjustment for any reorganization,recapita

101、lization,non-cash dividend,stock split,reverse stocksplit or other similar transaction as provided in the Purchase Agreement.However,Lincoln Parks maximum commitment inany single Regular Purchase may not exceed$500,000.The purchase price per share for each Regular Purchase will be 97%ofthe lower of(

102、i)the lowest sale price of our Common Stock on the business day on which we initiate the Regular Purchase and(ii)the average of the three lowest closing sale prices of our Common Stock during the 10-business day period immediatelypreceding the business day on which we initiate the Regular Purchase.I

103、n addition to Regular Purchases,we may also directLincoln Park to purchase other amounts of Common Stock as accelerated purchases and as additional accelerated purchases,subject to limits specified in the Purchase Agreement,at a purchase price per share calculated as specified in the PurchaseAgreeme

104、nt,but in no case lower than the minimum price per share we stipulate in our notice to Lincoln Park initiating thesepurchases.We will control the timing and amount of any sales of our Common Stock to Lincoln Park.32025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_sea

105、star.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm12/223 On April 25,2025,in consideration for its commitment to purchase shares of our Common Stock under the PurchaseAgreement,we issued 236,406 shares of our Common Stock to Lincoln Park,which we refer

106、 to in this prospectus as the“Commitment Shares.”We may terminate the Purchase Agreement at any time after the date of Commencement,at no penalty or cost,other thanthe Commitment Shares.There are no restrictions on future financings,rights of first refusal,participation rights,penalties orliquidated

107、 damages in the Purchase Agreement or Registration Rights Agreement,other than a prohibition on our issuing,orentering into any agreement to effect the issuance of,shares of our Common Stock or common stock equivalents involving atransaction that is defined in the Purchase Agreement as a“Variable Ra

108、te Transaction,”other than with Lincoln Park.LincolnPark may not assign or transfer its rights and obligations under the Purchase Agreement.As of May 13,2025,there were 10,355,041 shares of our Common Stock outstanding,excluding the Commitment Shares,of which 10,242,033 shares were held by non-affil

109、iates.Although the Purchase Agreement provides that we may sell up to$15.0 million of our Common Stock to Lincoln Park,only 4,736,406 shares of our Common Stock are being offered under thisprospectus,which represents the Commitment Shares and up to 4,500,000 shares which may be issued to Lincoln Par

110、k in thefuture under the Purchase Agreement,if and when we sell shares to Lincoln Park under the Purchase Agreement.If all of the4,736,406 shares offered by Lincoln Park under this prospectus were issued and outstanding,such shares would representapproximately 30.9%of the total number of shares of o

111、ur Common Stock outstanding and approximately 31.1%of the totalnumber of outstanding shares held by non-affiliates,in each case as of May 13,2025.Depending on the price per share at whichwe sell shares to Lincoln Park under the Purchase Agreement,we may need to sell more shares to Lincoln Park than

112、are offeredunder this prospectus to receive aggregate gross proceeds equal to the$15.0 million total commitment of Lincoln Park under thePurchase Agreement,in which case we must first register for resale under the Securities Act additional shares of our CommonStock.The number of shares ultimately of

113、fered for resale by Lincoln Park will depend upon the number of shares we elect tosell to Lincoln Park under the Purchase Agreement.Sales of our Common Stock to Lincoln Park by us under the PurchaseAgreement could result in substantial dilution to our stockholders.Under applicable rules of The Nasda

114、q Stock Market,in no event may we issue or sell to Lincoln Park under the PurchaseAgreement more than 19.99%of the shares of our Common Stock outstanding immediately prior to the execution of thePurchase Agreement,which is 1,981,163 shares based on 9,910,775 shares outstanding immediately prior to t

115、he execution of thePurchase Agreement(the“Exchange Cap”),unless(i)we obtain stockholder approval to issue shares in excess of the ExchangeCap or(ii)the average price of all applicable sales of our Common Stock to Lincoln Park under the Purchase Agreement equalsor exceeds$1.25 per share(which represe

116、nts the lower of(A)the official closing price of our Common Stock on Nasdaqimmediately preceding the signing of the Purchase Agreement and(B)the average official closing price of our Common Stockon Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date

117、of the PurchaseAgreement),such that issuances and sales of Common Stock to Lincoln Park under the Purchase Agreement would not besubject to the Exchange Cap under applicable Nasdaq rules.In any event,the Purchase Agreement specifically provides that wemay not issue or sell any shares of our Common S

118、tock under the Purchase Agreement if such issuance or sale would breach anyapplicable Nasdaq rules.The Purchase Agreement also prohibits us from directing Lincoln Park to purchase any shares of Common Stock if thoseshares,when aggregated with all other shares of our Common Stock then beneficially ow

119、ned by Lincoln Park and its affiliates,would result in Lincoln Park and its affiliates having beneficial ownership,at any single point in time,of more than 4.99%ofthe then total outstanding shares of our Common Stock,as calculated pursuant to Section 13(d)of the Securities Exchange Actof 1934,as ame

120、nded,or the Exchange Act,and Rule 13d-3 thereunder,which limitation we refer to as the Beneficial OwnershipCap.Lincoln Park,upon written notice to us,may increase the Beneficial Ownership Cap to up to 9.99%.Any increase in theBeneficial Ownership Cap will not be effective until the 61st day after su

121、ch written notice is delivered to us.Issuances of our Common Stock to Lincoln Park will not affect the rights or privileges of our existing stockholders,exceptthat the economic and voting interests of each of our existing stockholders will be diluted as a result of any such issuance.Although the num

122、ber of shares of Common Stock that our existing stockholders own will not decrease,the shares owned by ourexisting stockholders will represent a smaller percentage of our total outstanding shares after any such issuance to Lincoln Park.42025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025

123、045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm13/223 THE OFFERING This prospectus relates to the resale by Lincoln Park Capital Fund,LLC,the selling stockholder identified in thisprospectus,of shares of our Common Stock,par v

124、alue$0.0001 per share,as follows:Common Stock offered by theselling stockholder Up to 4,736,406 shares consisting of:236,406 shares issued to Lincoln Park in consideration for its commitment to purchaseshares of our Common Stock under the Purchase Agreement;and 4,500,000 shares we may sell to Lincol

125、n Park under the Purchase Agreement fromtime to time after the date of this prospectus.Common Stock outstanding priorto this offering(which excludesthe 236,406 shares issued toLincoln Park described above)10,355,041 Common Stock to be outstandingafter giving effect to the issuanceof 4,736,406 shares

126、 under thePurchase Agreement registeredhereunder 15,091,447 Use of Proceeds We will receive no proceeds from the sale of shares of Common Stock by Lincoln Park inthis offering.We may receive up to$15.0 million in aggregate gross proceeds under thePurchase Agreement from any sales we make to Lincoln

127、Park pursuant to the PurchaseAgreement after the date of this prospectus.Any such proceeds we receive will be used forworking capital and general corporate purposes.See“Use of Proceeds”on page 46 of thisprospectus.Risk Factors Investment in our Common Stock involves a high degree of risk.See“Risk Fa

128、ctors”beginning on page 6 of this prospectus,as well as the other information included in thisprospectus,for a discussion of risks you should carefully consider before investing in ourCommon Stock.Nasdaq Capital Market symbol Our Common Stock and Listed Warrants are listed for trading on Nasdaq unde

129、r thesymbols“ICU”and“ICUCW,”respectively.The actual number of shares of our Common Stock outstanding after this offering will vary depending on the actual numberof shares we sell to Lincoln Park under the Purchase Agreement.The number of shares of our Common Stock outstanding priorto and after this

130、offering in the table above is based on shares of our Common Stock outstanding as of May 13,2025,andexcludes(in each case as of May 13,2025):236,406 shares issued to Lincoln Park on April 25,2025 in consideration for its commitment to purchase shares underthe Purchase Agreement;29,838 shares of Comm

131、on Stock issued subsequent to May 13,2025;21,931 shares of Common Stock issuable upon the exercise of stock options,with a weighted-average exercise price of$45.32 per share;322,554 shares of Common Stock issuable upon the settlement of outstanding restricted stock units;6,480,300 shares of Common S

132、tock issuable upon the exercise of outstanding warrants,with a weighted-averageexercise price of$32.80 per share;and 147,251 additional shares of Common Stock reserved for future issuance under our 2022 Omnibus Equity IncentivePlan.2025/5/20 10:49sec.gov/Archives/edgar/data/1831868/00012139002504546

133、3/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm14/22352025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seas

134、tar.htm15/223 RISK FACTORS An investment in our Common Stock involves a high degree of risk.Before making an investment decision,you should carefullyconsider the risks described below.The impacts of the contingencies contemplated by these risks could materially adversely affectour business,financial

135、 condition or results of operations.The risks described in these documents are not the only ones we face,butthose that we consider to be material.Additional risks not presently known to us or that we currently believe are immaterial mayalso significantly impair our business operations and financial

136、condition.Please also read carefully the section titled“CautionaryNote Regarding Forward-Looking Statements,”where we describe additional uncertainties associated with our business and theforward-looking statements included in this prospectus.Risk Factor Summary The sale of our Common Stock to Linco

137、ln Park may dilute stockholders,and the sale or perceived sale of those sharescould lower our stock price.It is not possible to predict the number of shares we will sell to Lincoln Park or the gross proceeds from those sales.Investors may pay varying prices for our shares,and Lincoln Parks sales cou

138、ld further drive down our stock price.We may not access the full amount available under the Lincoln Park agreement and could require additional financing tocontinue operations.Future financings may negatively impact holders of our securities.Our management has broad discretion over the use of the ne

139、t proceeds from Lincoln Park sales,and the proceeds may notbe used effectively or as investors prefer.Stockholders would be diluted if we raise capital through Common Stock,and actual or anticipated sales could decreaseour stock price.We have not generated revenue sufficient for positive operating c

140、ash flows,have incurred significant losses since ourinception and may continue to incur significant losses for the foreseeable future.If we fail to obtain additional financing,we would be forced to delay,reduce or eliminate our product developmentprogram.We have a limited operating history.We may no

141、t be able to use our net operating losses to offset future taxable income.We may face challenges in obtaining additional FDA approvals to market our product.The United States could change tariff,trade,or tax provisions related to the manufacturing and sales of our products inways that we currently c

142、annot predict.We may not be able to manage our growth effectively.Changing priorities within the U.S.government resulting in the loss of government grant funding could adversely impactour future growth plans.We will initially depend on revenue generated from a single product.62025/5/20 10:49sec.gov/

143、Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm16/223 We may fail to comply with extensive regulations of United States and foreign regulatory agencies.Delays in successfully completing

144、our clinical trials could jeopardize our ability to obtain regulatory approval.We have limited experience in identifying and working with large-scale contracts with medical device manufacturers.We face intense competition in the medical device industry and our SCD technology may become obsolete.We o

145、utsource many of our operational and development activities for which we may not have full control.A lack of third-party coverage and reimbursement for our devices could delay or limit their adoption.Adverse changes in reimbursement policies and procedures by payors may impact our ability to market

146、and sell ourproducts.We are and will be exposed to product liability risks,and clinical and preclinical liability risks,which could place asubstantial financial burden upon us should we be sued.United States legislative or FDA regulatory reforms may make it more difficult and costly for us to obtain

147、 regulatoryapproval of our product candidates and to manufacture,market and distribute our products after approval is obtained.We are subject to stringent and changing privacy laws,regulations and standards Our business operations will be adversely affected if our security measures,or those maintain

148、ed on our behalf,arecompromised,limited or fails.We depend on key personnel and our inability to attract and retain qualified personnel could impede our ability to achieveour business objectives.Our estimates of market opportunity,industry projections and forecasts of operating and financial results

149、 and marketgrowth may prove to be inaccurate.We rely upon exclusively licensed patent rights from third parties which are subject to termination or expiration.If we are unable to obtain and maintain sufficient patent protection for our products,our ability to commercialize suchproducts successfully

150、may be adversely affected.If we are unable to protect the confidentiality of our trade secrets,the value of our technology could be adversely andmaterially affected,and our business could be harmed.The United States government may exercise certain rights with regard to our inventions,or licensors in

151、ventions,developed using federal government funding.Intellectual property rights do not necessarily address all potential threats to our competitive advantage.Our Common Stock may be delisted from Nasdaq if we do not maintain compliance with Nasdaqs continued listingrequirements.If our Common Stock

152、is delisted,it could negatively impact us.The trading price of our Common Stock has been volatile and is likely to be volatile in the future.Future sales,or the possibility of future sales,of a substantial number of shares of our Common Stock could adverselyaffect the price of the shares and dilute

153、stockholders.72025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm17/223 Risks Related to this Offering The sale of our Common Stock to Lincoln Park may cause dilution

154、and the subsequent sale of the shares of Common Stockacquired by Lincoln Park,or the perception that such sales may occur,could cause the price of our Common Stock to fall.On April 25,2025,we entered into the Purchase Agreement with Lincoln Park,pursuant to which Lincoln Park committed topurchase up

155、 to$15.0 million of our Common Stock,and we issued the Commitment Shares.Other than the Commitment Shares,the shares of our Common Stock that may be issued under the Purchase Agreement may be sold by us to Lincoln Park from time totime at our discretion over a 36-month period commencing on the date

156、that the conditions set forth in the Purchase Agreement aresatisfied,including that the registration statement of which this prospectus forms a part is declared effective by the SEC.Thepurchase price for the shares that we may sell to Lincoln Park under the Purchase Agreement will vary based on the

157、price of ourCommon Stock at the time we initiate the sale.Depending on market liquidity at the time,sales of such shares may cause thetrading price of our Common Stock to fall.We generally have the right to control the timing and amount of any future sales of our shares to Lincoln Park.Sales of shar

158、esof our Common Stock to Lincoln Park under the Purchase Agreement,if any,will depend upon market conditions and other factorsto be determined by us.We may ultimately decide to sell to Lincoln Park all,some or none of the shares of our Common Stock thatmay be available for us to sell pursuant to the

159、 Purchase Agreement.If and when we do sell shares to Lincoln Park,after LincolnPark has acquired the shares,Lincoln Park may resell all,some or none of those shares at any time or from time to time in itsdiscretion.Therefore,sales to Lincoln Park by us could result in substantial dilution to the int

160、erests of other holders of ourCommon Stock.Additionally,the sale of a substantial number of shares of our Common Stock to Lincoln Park,or the anticipationof such sales,could make it more difficult for us to sell equity or equity-related securities in the future at a time and at a price thatwe might

161、otherwise wish to effect sales.See also,“The sale of our Common Stock in ATM offerings may cause substantial dilutionto our existing stockholders,and such sales,or the anticipation of such sales,may cause the price of our Common Stock todecline,”below.It is not possible to predict the actual number

162、of shares of Common Stock we may sell to Lincoln Park under the PurchaseAgreement,or the actual gross proceeds resulting from those sales.Because the purchase price per share to be paid by Lincoln Park for the shares of Common Stock that we may elect to sell toLincoln Park under the Purchase Agreeme

163、nt,if any,will fluctuate based on the market prices of our Common Stock at the time weelect to sell shares to Lincoln Park pursuant to the Purchase Agreement,if any,it is not possible for us to predict,as of the date ofthis prospectus and prior to any such sales,the number of shares of Common Stock

164、that we will sell to Lincoln Park under thePurchase Agreement,the purchase price per share that Lincoln Park will pay for shares purchased from us under the PurchaseAgreement,or the aggregate gross proceeds that we will receive from those purchases by Lincoln Park under the PurchaseAgreement.Moreove

165、r,although the Purchase Agreement provides that we may sell up to an aggregate of$15.0 million of our CommonStock to Lincoln Park,only 4,736,406 shares of Common Stock are being registered under the Securities Act for resale by LincolnPark under the registration statement of which this prospectus fo

166、rms a part,consisting of(i)the 236,406 Commitment Shares thatwe issued to Lincoln Park as consideration for its commitment to purchase shares of our Common Stock under the PurchaseAgreement and(ii)up to 4,500,000 shares of our Common Stock that we may elect to sell to Lincoln Park,in our sole discre

167、tion,from time to time from and after the Commencement under the Purchase Agreement.If after the Commencement we elect to sell to the selling stockholder all of the 4,736,406 shares of Common Stock beingregistered for resale by Lincoln Park under this prospectus that are available for sale by us to

168、the selling stockholder under thePurchase Agreement,depending on the market prices of our Common Stock at the time of such sales,the actual gross proceedsfrom the sale of all such shares of Common Stock by us to Lincoln Park may be substantially less than the$15.0 million totalpurchase commitment av

169、ailable to us under the Purchase Agreement,which could materially adversely affect our liquidity.82025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm18/223 If it becom

170、es necessary for us to issue and sell to Lincoln Park shares of Common Stock in excess of the Exchange Cap underthe Purchase Agreement in order to receive aggregate gross proceeds equal to$15.0 million under the Purchase Agreement,thenfor so long as the Exchange Cap continues to apply to issuances a

171、nd sales of Common Stock under the Purchase Agreement,wemust first obtain stockholder approval to issue shares of Common Stock in excess of the Exchange Cap in accordance withapplicable Nasdaq listing rules.Furthermore,if we elect to issue and sell to Lincoln Park more than the 4,736,406 shares of o

172、ur Common Stock that we mayelect to issue and sell to Lincoln Park under the Purchase Agreement that are being registered for resale by Lincoln Park hereunder,which we have the right,but not the obligation,to do,we must first file with the SEC one or more additional registration statementsto registe

173、r under the Securities Act for resale by Lincoln Park such additional shares of our Common Stock we wish to sell fromtime to time under the Purchase Agreement,which the SEC must declare effective,in each case before we may elect to sell anyadditional shares of our Common Stock to Lincoln Park under

174、the Purchase Agreement.Any issuance and sale by us under thePurchase Agreement of a substantial amount of shares of Common Stock in addition to the 4,736,406 shares of Common Stock thatwe may elect to issue and sell to Lincoln Park under the Purchase Agreement that are being registered for resale by

175、 Lincoln Parkhereunder could cause additional substantial dilution to our stockholders.The number of shares of our Common Stock ultimatelyoffered for sale by Lincoln Park is dependent upon the number of shares of Common Stock,if any,we ultimately sell to LincolnPark under the Purchase Agreement,and

176、the sale of Common Stock under the Purchase Agreement may cause the trading price ofour Common Stock to decline.Investors who buy shares at different times will likely pay different prices,and the sale of the shares of Common Stock acquiredby Lincoln Park could cause the price of our Common Stock to

177、 decline.Pursuant to the Purchase Agreement,we will have discretion,subject to market demand,to vary the timing,prices,andnumbers of shares sold to Lincoln Park.If and when we do elect to sell shares of our Common Stock to Lincoln Park pursuant tothe Purchase Agreement,after Lincoln Park has acquire

178、d such shares,Lincoln Park may resell all,some or none of such shares atany time or from time to time in its discretion and at different prices.As a result,investors who purchase shares from Lincoln Parkin this offering at different times will likely pay different prices for those shares,and so may

179、experience different levels of dilutionand in some cases substantial dilution and different outcomes in their investment results.Investors may experience a decline in thevalue of the shares they purchase from Lincoln Park in this offering as a result of future sales made by us to Lincoln Park at pri

180、ceslower than the prices such investors paid for their shares in this offering.Further,the sale of a substantial number of shares of ourCommon Stock by Lincoln Park,or anticipation of such sales,could cause the trading price of our Common Stock to decline ormake it more difficult for us to sell equi

181、ty or equity-related securities in the future at a time and at a price that we might otherwisedesire.We may not have access to the full amount available under the Purchase Agreement with Lincoln Park.We may requireadditional financing to sustain our operations,without which we may not be able to con

182、tinue operations.We may direct Lincoln Park to purchase up to$15.0 million worth of shares of our Common Stock in a Regular Purchase fromtime to time under the Purchase Agreement over a 36-month period generally in amounts up to 40,000 shares of our CommonStock,which may be increased to up to 75,000

183、 shares of our Common Stock depending on the closing sale price of our CommonStock at the time of sale,provided that Lincoln Parks maximum purchase obligation under any single Regular Purchase shall notexceed$500,000.Moreover,under certain circumstances as set forth in the Purchase Agreement,we may,

184、in our sole discretion,also direct Lincoln Park to purchase additional shares of Common Stock in“accelerated purchases,”and“additional acceleratedpurchases”as set forth in the Purchase Agreement.Depending on the prevailing market price of our Common Stock,we may not be able to sell shares to Lincoln

185、 Park for themaximum$15.0 million over the term of the Purchase Agreement.We will need to seek stockholder approval before issuing morethan the Exchange Cap limit of 1,981,163 shares of Common Stock under the Purchase Agreement,unless the average price pershare of Common Stock for all shares of Comm

186、on Stock sold by us to Lincoln Park under the Purchase Agreement equals orexceeds$1.25 per share(which represents the lower of(A)the official closing price of our Common Stock on Nasdaq immediatelypreceding the signing of the Purchase Agreement and(B)the average official closing price of our Common

187、Stock on Nasdaq forthe five consecutive trading days ending on the trading day immediately preceding the date of the Purchase Agreement),such thatthe Exchange Cap limitation would no longer apply to issuances and sales of Common Stock by us to Lincoln Park under thePurchase Agreement under applicabl

188、e Nasdaq listing rules.In addition,Lincoln Park will not be required to purchase any shares ofour Common Stock if such sale would result in Lincoln Parks beneficial ownership of our Common Stock exceeding theBeneficial Ownership Cap.Our inability to access a portion or the full amount available unde

189、r the Purchase Agreement,in theabsence of any other financing sources,could have a material adverse effect on our business.92025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_sea

190、star.htm19/223 The extent we rely on Lincoln Park as a source of funding will depend on a number of factors including the prevailing marketprice of our Common Stock and the extent to which we are able to raise capital from other sources.Assuming a purchase price of$1.27 per share(which represents th

191、e closing price of our Common Stock on May 13,2025),the purchase by Lincoln Park of theentire 4,500,000 shares of Common Stock issuable under the Purchase Agreement being registered for resale by Lincoln Parkhereunder(which excludes the Commitment Shares that we issued to Lincoln Park for which we w

192、ill receive no cash proceeds)would result in gross proceeds to us of approximately$5.72 million.If obtaining sufficient funding from Lincoln Park were toprove unavailable or prohibitively dilutive,we will need to secure another source of capital in order to satisfy our working capitalneeds.Even if w

193、e sell all$15.0 million of shares of our Common Stock to Lincoln Park under the Purchase Agreement,we willneed to raise substantial additional capital to continue to fund our operations and execute our current business strategy.Terms of subsequent financings may adversely impact holders of our secur

194、ities.In order to finance our future production plans and working capital needs,we may have to raise funds through the issuance ofequity or debt securities.Depending on the type and the terms of any financing we pursue,holders of our securities rights and thevalue of their investment in our Common S

195、tock could be reduced.A financing could involve one or more types of securitiesincluding Common Stock,convertible debt or warrants to acquire Common Stock.These securities could be issued at or below thethen prevailing market price for our Common Stock.We currently have no authorized preferred stock

196、.In addition,if we issuesecured debt securities,the holders of the debt would have a claim to our assets that would be senior to the rights of holders of ourother securities until the debt is paid.Interest on these debt securities would increase financing and interest costs and couldnegatively our i

197、mpact our operating results.If the issuance of new securities results in diminished rights to holders of our CommonStock,the market price of our Common Stock could be negatively impacted.Our management will have broad discretion over the use of the net proceeds,if any,from sales of shares of our Com

198、mon Stockto Lincoln Park,you may not agree with how we use the proceeds and the proceeds may not be used effectively.This prospectus relates to shares of our Common Stock that may be offered and sold from time to time by Lincoln Park.Wewill not receive any proceeds upon the sale of shares by Lincoln

199、 Park.However,we may receive gross proceeds of up to$15.0million from the sale of shares under the Purchase Agreement to Lincoln Park.The anticipated use of net proceeds from the sale ofour Common Stock to Lincoln Park under the Purchase Agreement represents our intentions based upon our current pla

200、ns andbusiness conditions.Because we have not designated the amount of net proceeds from the sale of shares under the PurchaseAgreement to be used for any particular purpose,our management will have broad discretion as to the use of the net proceeds fromour sale of shares of Common Stock to Lincoln

201、Park.Accordingly,you will be relying on the judgment of our management withregard to the use of those net proceeds,and you will not have the opportunity,as part of your investment decision,to assesswhether the proceeds are being used appropriately.It is possible that,pending their use,we may invest

202、those net proceeds in a waythat does not yield a favorable,or any,return for us.Further,our management may use the net proceeds for corporate purposes thatmay not improve our financial condition or market value.The failure of our management to use such funds effectively could have amaterial adverse

203、effect on our business,financial condition,operating results and cash flows.102025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm20/223 The sale of our Common Stock in

204、 ATM offerings may cause substantial dilution to our existing stockholders,and such sales,orthe anticipation of such sales,may cause the price of our Common Stock to decline.We have used at-the-market,or ATM,offerings to fund a significant portion of our operations in prior years,and we maycontinue

205、to use ATM offerings to raise additional capital in the future.For example,in 2024,we sold an aggregate ofapproximately 1.78 million shares of our Common Stock for net proceeds of approximately$4.5 million under our At-the-Marketoffering program.While sales of shares of our Common Stock in ATM offer

206、ings may enable us to raise capital at a lower costcompared with other types of equity financing transactions;such sales may result in dilution to our existing stockholders,and suchsales,or the anticipation of such sales,may cause the trading price of our Common Stock to decline.Stockholders would b

207、e diluted if we use Common Stock to raise capital,and the perception that such sales may occur,couldcause the price of our Common Stock to decrease.We plan to seek additional capital to carry out our business plan.This financing could involve one or more types of securitiesincluding Common Stock,con

208、vertible debt or warrants to acquire Common Stock.These securities could be issued at or below thethen prevailing market price for our Common Stock.Any issuance of additional shares of our Common Stock could be dilutive toexisting holders of our securities and could adversely affect the market price

209、 of our Common Stock.The trading price of our Common Stock has been volatile and is likely to be volatile in the future.Our Common Stock could be subject to wide fluctuation in response to many risk factors listed in this section,and othersbeyond our control,including:market acceptance and commercia

210、lization of our products;our being able to timely demonstrate achievement of milestones,including those related to revenue generation,costcontrol,cost effective source supply and regulatory approvals;regulatory developments or enforcements in the United States and non-U.S.countries with respect to o

211、ur products or ourcompetitors products;failure to achieve pricing acceptable to the market;actual or anticipated fluctuations in our financial condition and operating results,or our continuing to sustain operatinglosses;competition from existing products or new products that may emerge;announcements

212、 by us or our competitors of significant acquisitions,strategic partnerships,joint ventures,collaborations orcapital commitments;issuance of new or updated research or reports by securities analysts;announcement or expectation of additional financing efforts,particularly if our cash available for op

213、erations significantlydecreases;fluctuations in the valuation of companies perceived by investors to be comparable to us;share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;additions or departures of key management personnel;disputes or other developm

214、ents related to proprietary rights,including patents,litigation matters and our ability to obtainpatent protection for our technologies;112025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea

215、0242384-s1_seastar.htm21/223 entry by us into any material litigation or other proceedings;sales of our Common Stock by us,our insiders,or our other stockholders;market conditions for stocks in general;and general economic and market conditions unrelated to our performance.Furthermore,the stock mark

216、ets have experienced extreme price and volume fluctuations that have affected and continue toaffect the market prices of equity securities of many companies.These fluctuations often have been unrelated or disproportionate tothe operating performance of those companies.These broad market and industry

217、 fluctuations,as well as general economic,political,and market conditions such as recessions,interest rate changes or international currency fluctuations,may negativelyimpact the market price of shares of our Common Stock.In addition,such fluctuations could subject us to securities class actionlitig

218、ation,which could result in substantial costs and divert our managements attention from other business concerns,which couldseriously harm our business.If the market price of shares of our Common Stock after this offering does not exceed the price atwhich you obtain shares of our Common Stock,you may

219、 not realize any return on your investment in us and may lose some or allyour investment.If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business,ourstock price and trading volume could decline.The trading market for our Common Stock

220、 is impacted by the research and reports that securities or industry analysts publishabout us or our business.We do not have any control over these analysts.We cannot assure that analysts will continue to cover usor provide favorable coverage.If one or more of the analysts who cover us downgrade our

221、 stock or change their opinions of ourstock,our share price would likely decline.If one or more of these analysts cease coverage of us or fail to regularly publish reportson us,we could lose visibility in the financial markets,which could cause our stock price or trading volume to decline.Future sal

222、es,or the possibility of future sales,of a substantial number of shares of our Common Stock could adversely affectthe price of the shares and dilute stockholders.Future sales of a substantial number of shares of our Common Stock,or the perception that such sales will occur,could cause adecline in th

223、e market price of our Common Stock.This is particularly true if we sell our stock at a discount.If our stockholders sellsubstantial amounts of Common Stock in the public market,or the market perceives that such sales may occur,the market price ofour Common Stock and our ability to raise capital thro

224、ugh an issue of equity securities in the future could be adversely affected.In addition,in the future,we may issue additional shares of Common Stock or other equity or debt securities convertible intoCommon Stock in connection with financing,acquisition,litigation settlement,employee arrangements or

225、 otherwise.Any suchissuance could result in substantial dilution to our existing stockholders and could cause the market price of our Common Stock todecline.We have not paid cash dividends in the past and do not expect to pay dividends in the future.Any return on investment may belimited to the valu

226、e of our Common Stock.We have never paid cash dividends on our Common Stock and do not anticipate doing so in the foreseeable future.Thepayment of dividends on our Common Stock will depend on earnings,financial condition and other business and economic factorsaffecting us at such time as our board o

227、f directors(the“Board”)may consider relevant.Further,the agreements governing ourindebtedness limit our ability to make dividends on our Common Stock.If we do not pay dividends,our Common Stock may beless valuable because a return on your investment will only occur if our stock price appreciates.122

228、025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm22/223 We are an“emerging growth company”as that term is used in the Jumpstart Our Business Startups Act of 2012 and

229、we intendto continue to take advantage of reduced disclosure and governance requirements applicable to emerging growth companies,which could result in our Common Stock being less attractive to investors and adversely affect the market price of our CommonStock or make it more difficult to raise capit

230、al as and when we need it.We are an“emerging growth company”as that term is used in the JOBS Act,and we intend to continue to take advantage ofcertain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growthcompanies including,but not

231、limited to,not being required to comply with the auditor attestation requirements of Section 404 ofthe Sarbanes-Oxley Act of 2002,reduced disclosure obligations regarding executive compensation in our periodic reports andproxy statements,exemptions from the requirements of holding a non-binding advi

232、sory vote on executive compensation andstockholder approval of any golden parachute payments not previously approved,and exemptions from any rules that the PublicCompany Accounting Oversight Board may adopt requiring mandatory audit firm rotation or a supplement to the auditors reporton the financia

233、l statements.We currently take advantage of some,but not all,of the reduced regulatory and reporting requirementsthat are available to us under the JOBS Act and intend to continue to do so if we qualify as an“emerging growth company.”Forexample,so long as we qualify as an“emerging growth company,”we

234、 may elect not to provide you with certain information,including certain financial information and certain information regarding compensation of our executive officers,that we wouldhave otherwise been required to provide in filings we make with the SEC,which may make it more difficult for investors

235、andsecurities analysts to evaluate us.We cannot predict if investors will find our Common Stock less attractive because we will rely on these exemptions.If someinvestors find our Common Stock less attractive as a result,there may be a less active trading market for our Common Stock andour stock pric

236、e may be more volatile.We may take advantage of these reporting exemptions until we are no longer an emerginggrowth company,which in certain circumstances could be for up to five years.Because of the exemptions from various reporting requirements provided to us as an“emerging growth company,”we may

237、beless attractive to investors,and it may be difficult for us to raise additional capital as and when we need it.Investors may be unableto compare our business with other companies in our industry if they believe that our financial accounting is not as transparent asother companies in our industry.I

238、f we are unable to raise additional capital as and when we need it,our business,results ofoperations,financial condition and cash flows,and prospects may be materially and adversely affected.Risks Relating to Our Financial Condition We have incurred significant losses since our inception and anticip

239、ate that we will continue to incur significant losses for theforeseeable future.We have incurred significant net losses since our inception and had an accumulated deficit of$143.3 million and$139.6million as of March 31,2025 and December 31,2024,respectively.We have devoted most of our financial res

240、ources to research and development,including clinical trials and non-clinicaldevelopment activities,and obtaining regulatory approval of our SCD product candidates.Since the completion of the BusinessCombination,we relied primarily on the sales of securities to fund our operations and are limited as

241、 we need to meet certainconditions before such funding becomes available.The size of our future net losses will depend,in part,on the rate of futureexpenditures and our ability to generate revenues.If our product candidates are not successfully developed or commercialized,or ifrevenues are insuffici

242、ent following marketing approval,it will not achieve profitability and our business may fail.Even if wesuccessfully obtain regulatory approval to market our product candidates in the United States,our revenues are also dependentupon the size of the markets outside of the United States,regulatory app

243、roval outside of the United States,and our ability to obtainmarket approval and achieve commercial success.We expect to continue to incur substantial and increased expenses as we expand research and development activities andadvance clinical programs through the regulatory approval process.We also e

244、xpect an increase in our expenses associated withcommercialization of our products and creating additional infrastructure to support operations as a public company.As a result ofthe foregoing,we expect to continue to incur significant and increasing losses and negative cash flows for the foreseeable

245、 future.132025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm23/223 We have not generated any significant revenue and may never be profitable.Our ability to generate s

246、ustainable revenue and achieve profitability depends on our ability,alone or with collaborators,tosuccessfully commercialize our approved pediatric SCD and complete the development,obtain the necessary regulatory approvalsof and commercialize our adult SCD.We do not anticipate generating substantial

247、 revenue for the foreseeable future.Our ability togenerate meaningful future revenue from product sales depends heavily on our success with the following items:commercializing our pediatric SCD,including securing adoption and increasing awareness;completing the clinical development of our adult SCD;

248、obtaining regulatory approval for our adult SCD,including the PMA from the FDA;scaling our commercial operations,including building a hospital-directed sales force and collaborating with third parties;obtaining third-party reimbursement status from government agencies and insurance carriers;and ente

249、ring into collaboration agreements and partnerships to commercialize our products.Because of the numerous risks and uncertainties associated with medical device commercialization and product development,we are unable to predict the timing or amount of increased expenses,when,or if,we will be able to

250、 achieve or maintainprofitability.In addition,our expenses could increase beyond expectations if it is required by the FDA to perform additional,unanticipated studies.Even if our product candidates are approved for commercial sale,we anticipate incurring significant costs associated withcommercializ

251、ing any approved product candidate.In the case of our SCD product candidate for the treatment of pediatric AKI,wewill be limited in our ability to sell and distribute our SCD units due to certain restrictions under the HDE requirements that limitthe number of units that can be sold on an annual basi

252、s,which will further limit the amount of revenue that could be generated byus.Even if we successfully expand sales of our products,we may not become profitable and may need to obtain additional fundingto continue operations.We may suffer from lack of availability of additional funds.We expect to hav

253、e ongoing needs for working capital in order to fund operations,continue to expand our operations and recruitexperienced personnel.To that end,we will be required to raise additional funds through equity or debt financing.However,therecan be no assurance that we will be successful in securing additi

254、onal capital on favorable terms,if at all.If we are successful,whether the terms are favorable or unfavorable,there is a potential that we will fail to comply with the terms of such financing,which could result in severe liability for us.If we are unsuccessful,we may need to(a)initiate cost reductio

255、ns;(b)forego businessdevelopment opportunities;(c)seek extensions of time to fund liabilities,or(d)seek protection from creditors.In addition,anyfuture sale of our equity securities would dilute the ownership and control of your shares and could be at prices substantially belowprices at which our sh

256、ares currently trade.Our inability to raise capital could require us to significantly curtail or terminate ouroperations altogether.We may seek to increase our cash reserves through the sale of additional equity or debt securities.The sale ofconvertible debt securities or additional equity securitie

257、s could result in additional and potentially substantial dilution to ourshareholders.The incurrence of indebtedness would result in increased debt service obligations and could result in operating andfinancing covenants that would restrict our operations and liquidity.In addition,our ability to obta

258、in additional capital onacceptable terms is subject to a variety of uncertainties.In addition,if we are unable to generate adequate cash from operations,and if we are unable to find sources of funding,it maybe necessary for us to sell all or a portion of our assets,enter into a business combination,

259、or reduce or eliminate operations.Thesepossibilities,to the extent available,may be on terms that result in significant dilution to our shareholders or that result in ourshareholders losing all of their investment in us.142025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea024238

260、4-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm24/223 If we fail to obtain additional financing,we would be forced to delay,reduce or eliminate our product development program,which may result in the cessation of our operations.Developing me

261、dical device products,including conducting preclinical studies and clinical trials,is expensive.We expect ourresearch and development expenses to increase in connection with our ongoing activities,particularly as we advance our clinicalprograms.As of March 31,2025 and December 31,2024,we had negativ

262、e working capital of$0.2 million and$3.0 million,respectively.We currently do not have sufficient capital to support our operations and complete our planned regulatory approvalprocess.We will need to secure additional capital to continue our operations,and such funding may not be available on accept

263、ableterms,or at all.Even if we receive sufficient capital in the future,we will be required to raise additional funds to support our operations andcomplete our planned regulatory approval process,and such funding may not be available in sufficient amounts or on acceptableterms to us,or at all.If we

264、are unable to raise additional capital when required or on acceptable terms,we may be required to:significantly delay,scale back or discontinue the development or commercialization of our product candidates;seek corporate partners on terms that are less favorable than might otherwise be available;or

265、 relinquish or license on unfavorable terms our rights to technologies or product candidates that we otherwise would seekto develop or commercialize ourselves;If we are unable to raise additional capital in sufficient amounts or on acceptable terms,we will be prevented from pursuingdevelopment and c

266、ommercialization efforts,including completing the clinical trials and regulatory approval process for our SCDproduct candidates,which would have a material adverse impact on our business,results of operations and financial condition.We have a limited operating history,which makes it difficult to for

267、ecast our future results of operations.We received HDE approval from the FDA for our pediatric SCD in February 2024 and shipped our first commercialQUELIMMUNE units in July 2024.As a result,we have a limited commercial operating history,making it difficult to accuratelyforecast future results of our

268、 operations and subject to a number of uncertainties and risks,including our ability to plan for andmodel future growth.Even if we receive regulatory approval to market and sell our other SCD product candidates,our revenuegrowth could slow in the future,or our revenue could decline or fluctuate for

269、a number of reasons,including slowing demand forour products,increasing competition,changing demand in the markets,new scientific or technological developments,a decrease inthe growth of our overall market,our failure to attract more customers,the inability to obtain reimbursement for our products b

270、ygovernment agencies and insurers,or our failure,for any reason,to continue to take advantage of growth opportunities.If ourassumptions regarding these risks and uncertainties and our future revenue growth are incorrect or change,or if we do not addressthese risks successfully or forecast our result

271、s accurately,our operating and financial results could differ materially from ourexpectations,and our business could suffer.Our ability to use our net operating losses to offset future taxable income may be subject to certain limitations.As of December 31,2024,we had net operating loss(“NOL”)carryfo

272、rwards for federal and state income tax purposes of$108.2 million and$36.3 million,respectively,which may be available to offset taxable income in the future.Under the Tax Cutsand Jobs Act of 2017,as modified by the Coronavirus Aid,Relief,and Economic Security Act,federal NOLs incurred in tax yearsb

273、eginning after December 31,2017 may be carried forward indefinitely,but the deductibility of such federal net operating losses intax years beginning after December 31,2020,is limited to 80 percent of taxable income.Federal NOLs incurred before 2018 maybe carried forward 20 years but are not subject

274、to the taxable income limitation.Under current law,California NOLs generally maybe carried forward 20 years(with a limited extension for California NOLs incurred in 2020-2021)without a taxable incomelimitation.Our federal NOLs include$55.6 million that can also be carried forward indefinitely,and th

275、e remaining$52.8 million offederal NOLs expire in various years beginning in 2027 for federal purposes.The California NOLs expire beginning in 2039 if notutilized.A lack of future taxable income would adversely affect our ability to utilize these NOLs before they expire.152025/5/20 10:49sec.gov/Arch

276、ives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm25/223 In general,under Section 382 of the Internal Revenue Code of 1986,as amended,or the Code,a corporation that undergoes an“ownership chang

277、e”(as defined in Section 382 of the Code and applicable Treasury Regulations)is subject to limitations on itsability to utilize its pre-change NOLs to offset future taxable income.We may experience a future ownership change under Section382 of the Code that could affect our ability to utilize the NO

278、Ls to offset our income.We have not completed an ownership changeanalysis pursuant to IRC Section 382.If ownership changes within the meaning of IRC Section 382 are identified as havingoccurred,the amount of NOL and research tax credit carryforwards available to offset future taxable income and inco

279、me taxliabilities in future years may be significantly restricted or eliminated.Further,deferred tax assets associated with such NOLs,andresearch tax credits could be significantly reduced upon realization of an ownership change within the meaning of IRC Section382.Furthermore,our ability to utilize

280、 NOLs of companies that we may acquire in the future may be subject to limitations.There isalso a risk that due to legislative or regulatory changes,such as suspensions on the use of NOLs or other unforeseen reasons,ourexisting NOLs could expire or otherwise be unavailable to reduce future income ta

281、x liabilities,including for state tax purposes.Forthese reasons,we may not be able to utilize a material portion of the NOLs reflected on our balance sheet,even if we attainprofitability,which could potentially result in increased future tax liability to us and could adversely affect our business,re

282、sults ofoperations and financial condition.We may become a defendant in one or more stockholder derivative,class-action,and other litigation,and any such lawsuits mayadversely affect our business,financial condition,results of operations and cash flows.We may in the future become defendants in one o

283、r more stockholder derivative actions or other class-action lawsuits.Forexample,certain former directors have threatened litigation for purported harm to us in connection with certain allegations made bythe former directors against other members of our Board of Directors and management.The former di

284、rectors have also madedemands in connection with certain alleged contractual rights and purported agreements with us.We and the Board of Directorsdispute these allegations and believe they are unfounded.In addition,on July 5,2024,Forrest A K Wells(the“Plaintiff”),a purported stockholder of ours,file

285、d a putative class actioncomplaint in the United States District Court for the State of Colorado(the“Class Action”),alleging that we and our managementmembers made material misstatements or omissions regarding our business and operations,including disclosures relating to FDAapproval of our product c

286、andidates,allegedly culminating in the restatement of our consolidated financial statements as disclosedin the Form 8-K filed on March 27,2024.The Class Action asserts claims under Section 10(b)of the Exchange Act against us,ourChief Executive Officer and former Chief Financial Officer(collectively,

287、the“Defendants”),as well as claims under Section 20(a)of the Exchange Act against the Defendants.Among other remedies,the Class Action seeks to recover compensatory and otherdamages.On March 4,2025,the Plaintiff filed an amended complaint.We intend to vigorously defend the action.On December 13,2024

288、,Jose Lazo,a purported stockholder of ours,filed a putative stockholder derivative action complaint inthe United States District Court for the District of Colorado(the“Derivative Action”).The factual allegations of the DerivativeAction are substantially similar to the Class Action.On January 30,2025

289、,upon joint motion of the parties,the Court stayed theDerivative Action pending the Courts resolution of an anticipated motion to dismiss to be filed in the Class Action.Any such lawsuit could divert our managements attention and resources from our ordinary business operations,and we wouldlikely inc

290、ur significant expenses associated with their defense(including,without limitation,substantial attorneys fees and otherfees of professional advisors and potential obligations to indemnify current and former officers and directors who are or maybecome parties to such actions).In connection with these

291、 lawsuits,we may be required to pay material damages,consent toinjunctions on future conduct and/or suffer other penalties,remedies or sanctions,or issue additional shares upon the exercise ofcertain warrants,which may cause additional dilution.In addition,any such future lawsuits could adversely im

292、pact our reputationand/or ability to launch and commercialize our products,thereby harming our ability to generate revenue.Accordingly,the ultimateresolution of these matters and any future matters could have a material adverse effect on our business,financial condition,resultsof operations and cash

293、 flow and,consequently,could negatively impact the trading price of our Common Stock.162025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm26/223 Risks Related to Our B

294、usiness Operations We may face challenges in obtaining additional FDA approvals to market our products in the United States or abroad.We may encounter various challenges and difficulties in our application to seek approval from the FDA to sell and market ourSCD product candidates,including the pivot

295、al trial for adult AKI indication.On November 6,2024,we received BDD for our patented and cell-directed SCD to treat chronic systemic inflammation inend-stage renal disease(ESRD)patients who require chronic hemodialysis,also known as chronic dialysis.While we expect theBDD to expedite the clinical d

296、evelopment and regulatory review of the SCD program for use in this patient population,there is noguarantee that we will be able to expedite the clinical development or obtain regulatory approval.While we recently obtained approval from the FDA to conduct the AKI adult pivotal trial for SCD,there is

297、 no guarantee thatwe will be able to complete such trial in a timely manner,or at all,nor will there be any assurance that positive data will begenerated from such trials.Even if we are able to generate positive results from this trial,the FDA and other regulatory agenciesmay require us to conduct a

298、dditional trials to support the study or disagree with the design of the trial and request changes orimprovements to such design.We are also subject to numerous other risks relating to the regulatory approval process,whichinclude but are not limited to:an inability to secure and obtain support and r

299、eferences from collaborators and suppliers required by the FDA;a disagreement with the FDA regarding the design of the trial,including the number of clinical study subjects and otherdata,which may require us to conduct additional testing or increase the size and complexity of our pivotal study;a fai

300、lure to obtain a sufficient supply of cartridges to conduct our trial;an inability to enroll a sufficient number of subjects;a shortage of necessary raw materials,such as calcium;and delays and failures to train qualified personnel to operate the SCD therapy.Even if we obtain approval,the FDA or oth

301、er regulatory authorities may require expensive or burdensome post-market testingor controls.Any delay in,or failure to receive or maintain,clearance or approval for our future products could prevent us fromgenerating revenue from these products or achieving profitability.Additionally,the FDA and ot

302、her regulatory authorities havebroad enforcement powers.Regulatory enforcement or inquiries,or other increased scrutiny on us,could dissuade some physiciansfrom using our products and adversely affect our reputation and the perceived safety and efficacy of our products.Delays or rejections may occur

303、 based on changes in governmental policies for medical devices during the period of productdevelopment.The FDA can delay,limit or deny approval of a PMA application for many reasons,including:our inability to demonstrate the safety or effectiveness of the SCD or any other product we develop to the F

304、DAssatisfaction;insufficient data from our preclinical studies and clinical trials,including for our SCD,to support approval;failure of the facilities of our third-party manufacturers or suppliers to meet applicable requirements;inadequate compliance with preclinical,clinical or other regulations;ou

305、r failure to meet the FDAs statistical requirements for approval;and changes in the FDAs approval policies,or the adoption of new regulations that require additional data or additionalclinical studies.172025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhtt

306、ps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htm27/223 If we are not able to obtain regulatory approval of our other product candidates in a timely manner or at all,we may not beable to continue to operate our business and may be forced to shut down our operati

307、ons.The United States could change tariff,trade,or tax provisions related to the manufacturing and sales of our products in waysthat we currently cannot predict.Our business benefits from free trade agreements,and we also rely on various U.S.corporate tax provisions related tointernational commerce

308、as we develop,market and sell our products within the U.S.and globally.The U.S.presidentialadministration has instituted or proposed changes in trade policies that include the imposition of higher tariffs on imports into theU.S.,economic sanctions on individuals,corporations or countries,and other g

309、overnment regulations affecting trade between theU.S.and other countries where we conduct business.The new tariffs and other changes in U.S.trade policy could trigger retaliatoryactions by affected countries,and certain foreign governments have instituted or are considering imposing trade sanctions

310、oncertain U.S.goods.The U.S.presidential administration has indicated a focus on policy reforms that discourage corporations fromoutsourcing manufacturing and production activities to foreign jurisdictions,including through tariffs or penalties on goodsmanufactured outside the U.S.,which may require

311、 us to change the way we conduct business.These changes in U.S.and foreignlaws and policies have the potential to adversely impact the U.S.economy or certain sectors thereof,our industry and the demandfor our products,and as a result,could have a material adverse effect on our business,financial con

312、dition and results of operations.As of March 27,2025,we do not import materials from Canada or China,but we do source tubing sets from Medtronic that ismanufactured in Mexico.Tariffs and other trade restrictions could adversely affect our ability to obtain such materials on a timelybasis or cause su

313、ch components to become more expensive,which could adversely affect our business.We plan to expand our operations and we may not be able to manage our growth effectively,which could strain our resourcesand delay or derail implementation of our business objectives.We will need to significantly expand

314、 our operations to implement our longer-term business plan and growth strategies,including building and expanding our internal organizational infrastructure to complete the regulatory approval process with theFDA.We will also be required to manage and form new relationships with various strategic pa

315、rtners,technology licensors,customers,manufacturers and suppliers,consultants and other third parties.This expansion and these new relationships will requireus to significantly improve or replace our existing managerial,operational and financial systems,and procedures and controls;toimprove the coor

316、dination between our various corporate functions;and to manage,train,motivate and maintain a growingemployee base.The time and costs to effectuate these steps may place a significant strain on our management personnel,systemsand resources,particularly if there are limited financial resources and ski

317、lled employees available at the time.We cannot assure thatwe will institute,in a timely manner or at all,the improvements to our managerial,operational and financial systems,proceduresand controls necessary to support our anticipated increased levels of operations and to coordinate our various corpo

318、rate functions,or that we will be able to properly manage,train,motivate and retain our anticipated increased employee base.If we cannotmanage our growth initiatives,we will be unable to commercialize our products on a large scale in a timely manner,if at all,andour business could fail.We may pursue

319、 government funding in the future.Changing priorities within the U.S.government resulting in the loss ofgovernment grant funding could adversely impact our future growth plans.As a commercial-stage medical device company,there are grants and other funding provided by the U.S.government that wecould

320、apply for and receive.However,the current U.S.presidential administration has indicated that there will not only be a pauseon government funding,but there will also be a change in who is eligible to receive it and for what purpose.These changes are notpredictable and may impact our ability to receiv

321、e government funding in the future.An inability to receive government fundingcould adversely impact our future growth plans.We will initially depend on revenue generated from a single product and in the foreseeable future will be significantlydependent on a limited number of products.We will initial

322、ly depend on revenue generated from our pediatric SCD and,if approved,our SCD product candidate forpediatric and adult patients with AKI.Given that,for the foreseeable future,our business will depend on a single or limited numberof products,to the extent a particular product is not well-received by

323、the market,our sales volume,prospects,business,results ofoperations and financial condition could be materially and adversely affected.182025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0

324、242384-s1_seastar.htm28/223 If we fail to comply with extensive regulations of United States and foreign regulatory agencies,the commercialization of ourproducts could be delayed or prevented entirely.Our SCD product candidate and research and development activities are subject to extensive governme

325、nt regulations related toits development,testing,manufacturing and commercialization in the United States and other countries.The determination of whenand whether a product is ready for large-scale purchase and potential use in the United States will be made by the United Statesgovernment through co

326、nsultation with a number of governmental agencies,including the FDA,the National Institutes of Healthand the Centers for Disease Control and Prevention.We have received approval for our pediatric SCD,but the product has notreceived regulatory approval from the FDA,or any foreign regulatory agencies,

327、for use with adult patients.The process ofobtaining and complying with FDA and other governmental regulatory approvals and regulations in the United States and inforeign countries is costly,time-consuming,uncertain and subject to unanticipated delays.Obtaining such regulatory approvals,ifany,can tak

328、e several years.Despite the time and expense exerted,regulatory approval is never guaranteed.We are also subject tothe following risks and obligations,among others:the FDA may refuse to approve an application if it believes that applicable regulatory criteria are not satisfied;the FDA may require ad

329、ditional testing for safety and effectiveness;the FDA may interpret data from pre-clinical testing and clinical trials in different ways than we interpret them;if regulatory approval of a product is granted,the approval may be limited to specific indications or limited with respect toits distributio

330、n;and the FDA may change its approval policies and/or adopt new regulations.Failure to comply with these or other regulatory requirements of the FDA may subject us to administrative or judiciallyimposed sanctions,including:warning letters,untitled letters or other written notice of violations;civil

331、penalties;criminal penalties;injunctions;product seizure or detention;product recalls;and total or partial suspension of production.192025/5/20 10:49sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242384-s1_seastar.htmhttps:/www.sec.gov/Archives/edgar/data/1831868/000121390025045463/ea0242

332、384-s1_seastar.htm29/223 Delays in successfully completing our planned clinical trials could jeopardize our ability to obtain regulatory approval.Our business prospects will depend on our ability to complete studies,clinical trials,including our planned pivotal trials of ourSCD for adult AKI indicat

333、ion,obtain satisfactory results,obtain required regulatory approvals and successfully commercialize ourSCD product candidate.The completion of our clinical trials,the announcement of results of the trials and our ability to obtainregulatory approvals could be delayed for a variety of reasons,including:slow patient enrollment;insufficient hospital supplies or staffing;serious adverse events related