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1、2025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm1/153 As filed with the Securities and Exchange Commission on May 21,2025 Registration No.333-287229 UNITED STATESSECURITIES AND EXCHANGE CO

2、MMISSIONWashington,D.C.20549 FORM S-1/A(Amendment No.1)REGISTRATION STATEMENT UNDERTHE SECURITIES ACT OF 1933 IR-MED,INC.(Exact name of registrant as specified in its charter)Nevada 3845 84-4516398State or other jurisdiction Primary Standard Industrial(I.R.S.Employerincorporation or organization Cla

3、ssification Code Number)Identification Number)ZHR Industrial ZoneRosh Pina,Israel,1231400+972-4-655-5054(Address,including zip code,and telephone number,including area code,of principal executive offices)Nevada Agency and Transfer Company50 West Liberty Street,Suite 880Reno,Nevada 89501(Address,incl

4、uding zip code,and telephone number,including area code,of agent for service)with copies to Oded Har-Even,Esq.Sullivan and Worcester LLP1251 Avenue of the Americas,19th FloorNew York,NY 10020Tel:(212)660-3000 Approximate date of proposed sale to public:As soon as practicable on or after the effectiv

5、e date of this registration statement.If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the SecuritiesAct of 1933 check the following box.If this Form is filed to register additional securities for an offering pursuan

6、t to Rule 462(b)under the Securities Act,please check the following boxand 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(c)under the Securities Act,chec

7、k the following box and list the Securities Actregistration 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 Securities Act,check the following box and list the SecuritiesAct regis

8、tration 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,or a smaller reportingcompany.See definitions of“large accelerated filer,”“accelerate

9、d filer,”and“smaller reporting company”,and“emerging growth company”inRule 12b-2 of the Exchange Act.(Check one):Large accelerated filer Accelerated filer Non-accelerated filer Smaller reporting company Emerging growth company If an emerging growth company,indicate by checkmark if the registrant has

10、 elected not to use the extended transition period for complying withany new or revised financial accounting standards provided pursuant to Section 13(a)of the Exchange Act.2025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/183913

11、3/000164117225011913/forms-1a.htm2/153The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until theregistrant shall file a further amendment which specifically states that this registration statement shall thereafter become e

12、ffective inaccordance with section 8(a)of the Securities Act of 1933 or until the registration statement shall become effective on such date as theCommission acting pursuant to said section 8(a),may determine.2025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/ww

13、w.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm3/153 The information contained in this prospectus is not complete and may be changed.A registration statement relating to these securities has been filedwith the Securities and Exchange Commission and these securities may not be s

14、old until that registration statement becomes effective.Thisprospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer or sale is notpermitted.PRELIMINARY PROSPECTUSSUBJECT TO COMPLETION,DATED:MAY 21,2025 IR-MED INC.80,0

15、00,000 shares of Common Stock This prospectus relates to the resale,from time to time,of up to an aggregate of 80,000,000 shares(the“Shares”)of common stock,$0.001 parvalue per share(the“Common Stock”)of IR-Med Inc.,a Nevada corporation(the“Company”),to be offered by the selling stockholder,Williams

16、burg Venture Holdings,LLC(“Selling Stockholder”or“Williamsburg”)identified in this prospectus.We are registering the offer and saleof the Shares by the Selling Stockholder to satisfy registration rights we have granted to the Selling Stockholder under an equity purchaseagreement(the“Purchase Agreeme

17、nt”)and a registration rights agreement(the“Registration Rights Agreement”),each dated March 11,2025.The Selling Stockholder may sell the Shares of Common Stock described in this prospectus in a number of different ways and at varying prices.Weprovide more information about how the Selling Stockhold

18、er may sell its shares of Common Stock in the section titled“Plan of Distribution.”TheSelling Stockholder has informed us that it does not have any agreement or understanding,directly or indirectly,with any person to distribute theCommon Stock.All net proceeds from the sale or other disposition of t

19、he shares of Common Stock sold by the Selling Stockholder covered by this prospectus willgo to the Selling Stockholder.The Company will not realize any proceeds from sales by the Selling Stockholder.The Selling Stockholder is an underwriter within the meaning of the Securities Act of 1933,as amended

20、(the“Securities Act”),and any broker-dealers or agents that are involved in selling the Shares may be deemed to be underwriters within the meaning of the Securities Act in connectionwith such sales.In such event,any commissions received by such broker-dealers or agents and any profit on the resale o

21、f the Shares purchased bythem may be deemed to be underwriting commissions or discounts under the Securities Act.The Selling Stockholder will pay all underwritingdiscounts and selling commissions relating to the sale of these shares.We have agreed to pay the legal,accounting,printing,and other expen

22、sesrelated to the registration of the sale of the Shares.Our Common Stock is traded on the OTCQB Market,or OTCQB,under the symbol“IRME.”On May 20,2025,the last reported sale price of ourcommon stock as reported on the OTCQB was$0.12 per share.Investing in our Common Stock involves a high degree of r

23、isk.The trading volume in our stock has,been limited.Before making any investmentin our securities,you should read and carefully consider risks described in the“Risk Factors”section beginning on page 22 of thisprospectus.As of the date of this prospectus,the Company had 72,018,144 shares of common s

24、tock outstanding of which 28,248,769 shares were held byaffiliates.Therefore,the Companys public float is 43,769,375 shares and the number of shares being registered hereunder is approximately 182%of the public float.You should rely only on the information contained in this prospectus or any prospec

25、tus supplement or amendment thereto.We have not authorizedanyone to provide you with different information.NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES COMMISSION HAS APPROVEDOR DISAPPROVED OF THESE SECURITIES OR PASSED UPON THE ADEQUACY OR ACCURACY OF THIS PROSPECTUS.ANYR

26、EPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.The Company qualifies as an“emerging growth company”as defined in the Jumpstart Our Business Startups Act which became law in April 2012and will be subject to reduced public company reporting requirements.See Prospectus SummaryImplications of Being

27、 an Emerging GrowthCompany”on page 13 of this prospectus.Prospectus dated _,2025 2025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm4/153 TABLE OF CONTENTS Prospectus Summary3The Offering15Fi

28、nancial Data15Cautionary Note Regarding Forward Looking Statements20Selling Stockholder51Determination of the Offering Price51Use of Proceeds52Plan of Distribution53Market for our Common Stock and Dividend Policy54The Business and Business Plan55Managements Discussion and Analysis of Financial Condi

29、tion and Results of Operations73Management79Executive Compensation84Principal Stockholders91Certain Relationships and Related Transactions89Description of Securities92Material United States Federal Income Tax Considerations94Legal Matters98Experts98Where you Can Find More Information98Financial Stat

30、ementsF-1 You should rely only on information contained in this prospectus.We have not authorized anyone to provide you with information that isdifferent from that contained in this prospectus.The selling stockholder is not offering to sell or seeking offers to buy shares of commonstock in jurisdict

31、ions where offers and sales are not permitted.We are responsible for updating this prospectus to ensure that all materialinformation is included and will update this prospectus to the extent required by law.22025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www

32、.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm5/153 PROSPECTUS SUMMARY This summary highlights information contained elsewhere in this prospectus.This summary is not complete and does not contain all of theinformation you should consider in making your investment decision.Befor

33、e investing in our Common Stock,you should carefully read this entireprospectus,especially the sections titled“Risk Factors”and“Managements Discussion and Analysis of Financial Condition and Results ofOperations”and our financial statements and the related notes included elsewhere in this prospectus

34、.Unless the context otherwise requires,theterms“IR-Med,”“the Company,”“we,”“us,”“our”and similar references in this prospectus refer to IR-Med,Inc.a Nevada corporation.Overview We were incorporated in the State of Nevada in April 2007 under the name“Monster Motors,Inc.”We began operating the busines

35、s of IR.Med Ltd.,an Israeli company,through a reverse acquisition on December 24,2020.IR.Med Ltd.(an Israeli company which was founded in 2013)continues to operate as our operating subsidiary,and we are the sole stockholder of IR.Med Ltd.Our corporate headquarters and research facilities are located

36、 at ZHR Industrial Zone,Rosh Pina,Israel.Business Overview We are in the process of developing point-of-care decision support devices based on the patented cutting-edge infrared spectroscopy andartificial intelligence,or AI,analysis technology platform,as a basis for point-of-care decision support d

37、evices.The electrooptic visual and infraredspectroscopy technology platform allows harmless and non-invasive gathering of bio-information from a patients blood and tissue.Bioinformationis then analyzed using our AI-based algorithms to provide healthcare professionals with decision support in the ass

38、essment and monitoring ofvarious disease conditions.We plan to use our proceeds to continue development efforts of our products,while mainly focusing on the DiaSafedevice production and marketing of PressureSafe commercial units,and working capital.PressureSafe:Our first product based on this platfo

39、rm,is a handheld device designed to revolutionize the early assessment of pressureinjuries,or PIs,affecting the skin and underlying tissue.PIs in the U.S.alone account for$26.8 billion in healthcare spending and result in 60,000deaths annually.PressureSafe is expected to contribute to early assessme

40、nt of PIs,regardless of patient skin tone,which we believe will driveequitable healthcare and help reduce the toll and cost of PIs.We plan to launch PressureSafe as a decision support system,or DSS,tool forcaregivers in hospitals,nursing homes,and home-care companies.On April 9,2024,the PressureSafe

41、 decision support device received FDAlisting certification.PressureSafe is classified as a Class I device.We are currently working on completing the development of the commercialversion of the PressureSafe device,with initial sales planned during the second half of 2025,following the listing by the

42、FDA.DiaSafe:Similarities in the physiological development of PIs and diabetic foot ulcers,or DFU,under the skin surface allow the IRMEDPressureSafe device to be adopted to support the early assessment of DFU among diabetic patients at high risk of developing DFU.We areassessing and planning the deve

43、lopment of our second product,which is a handheld optical monitoring device that will support early assessment ofDFUs in lower limb skin and underlying tissue,primarily caused by prolonged pressure on the sole of diabetic patients,which sometimes isaccompanied by other comorbidities as lower limb ne

44、uropathy.Our novel technology platform will enable direct assessment of the development of a DFU before it becomes an open wound that may leadto limb amputation.The Israeli Innovation Authority,or IIA,has approved our plan to develop a diabetic foot ulcer device for early assessment ofDFU.On January

45、 25,2024,the IIA approved a program to develop a device for the early assessment of diabetic foot ulcers among diabetic patients,with a project budget of NIS 3,761,978(approximately US$1,030,000)which includes an amount equal to 50%grant of the total budget providedat the time of the grant,disbursed

46、 in installments over the course of 13 months,by the projects progress.In consideration for the grant by the IIA,the subsidiary is required to pay royalties at the rate of 3%-5%from the total sales until the repayment date of the full amount of the grant,plusannual interest at the SOFR rate.In addit

47、ion,the IIA must approve any arrangement whereby the Company seeks to transfer the technology relatingto the project,or its development,from Israel.Following the IIA grant we plan to commence a clinical trial in the center of Israels leading diabetesclinic.On July 15,2024,we announced that we receiv

48、ed a grant from the IIA in the amount of approximately$500,000,to develop our platformtechnology for a new indication,a decision support device for the early assessment of diabetic foot ulcers.The grants 13-month development wasfinalized,as we achieved the projects milestones.Computer simulations of

49、 infrared light reflectance from lesions under the skin surface have beencompleted.32025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm6/153 On April 6,2025,we received an amount of NIS 644,5

50、51(approximately$171,468),as an advance payment from the IIA to fund thedevelopment of a device for the assessment of diabetic foot ulcers before skin breakage among diabetic patients.The IIA awarded us a total amountof NIS 4,603,938(approximately$1,222,786),which includes a grant of 40%or NIS 1,841

51、,575(approximately$489,035).The IIA award will bedistributed in tranches based on specific milestones and the progress of product development,from January 1,2025,to December 31,2025.Theapproval of the research and development project by the IIA is subject to the provisions of the Encouragement of In

52、dustrial Research andDevelopment Law,5744-1984(the“Innovation Law”),as well as the rules,procedures,and guidelines established by the IIA.Pursuant to the termsof the grant,we are required to comply with all applicable regulatory and reporting obligations,including limitations relating to intellectua

53、lproperty and changes in ownership or control.In addition,the Company is obligated to pay royalties to the IIA for revenues generated in connectionwith the approved project,in accordance with the terms set forth in the grant approval and the Innovation Law.Future indication as part of our research a

54、nd development is an innovative otoscope,Nobiotics,to support physicians with an immediateindication as to whether mid-ear infection(otitis media),a common malady in children,is of a bacterial origin and thus requiring antibiotictreatment,or of a viral origin that consequently does not require antib

55、iotic treatment.Our technology platform utilizes AI.AI is a broad term generally used to describe conditions where a machine mimics“cognitive”functions associated with human intelligence,such as“learning”and“problem-solving.”Basic AI includes machine learning,where a machine usesalgorithms to parse

56、data,learn from it,and then suggest a determination or prediction about a given phenomenon.The machine is“trained”usinglarge amounts of data and algorithms that provide it with the ability to learn how to perform various tasks.The global diagnostics market is driven in large by solutions that can be

57、 applied in healthcare settings,as these tools will drive decisionsregarding specific treatments and the associated outlays.However,despite advances in medical imaging and other diagnostic tools,misdiagnosisremains a common occurrence.Our initial focus is on the development of decision support syste

58、m solutions utilizing our proprietary platform for the pre-emptivediagnosis of PIs,and diabetic foot ulcers.Our current business plan focuses on two principal medical devices:1.PressureSafe,a handheld skin-agnostic optical monitoring device that is being developed to support early assessment of PIs

59、to theskin and underlying tissue,primarily caused by prolonged pressure associated with bed confinement;and 2.DiaSafe,a handheld optical monitoring device that is being developed to support early assessment of DFUs in lower limb skin andunderlying tissue,primarily caused by prolonged pressure on the

60、 sole of diabetic patients,which sometimes is accompanied by othercomorbidities as lower limb neuropathy.42025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm7/153 Fig1.IRMED AI-Driven Point o

61、f Care Decisions technology platform Overview of Target Market and Our Solutions Pressure Injury Market Populations are aging due to improvements in healthcare.However,there are increased rates of obesity,diabetes and cardiovasculardiseases.This combination of an increasingly aging population and su

62、ch diseases has resulted in more people with decreased mobility needingassistance with activities of daily living.A major morbidity of decreased mobility is development of PIs.PIs develop as a result of a combination ofphysiologic events and external conditions.Along with localized,oedema,ischemia a

63、nd reperfusion hindering injury to tissues,impaired lymphaticdrainage and mechanical deformation of tissue cells have been shown to contribute to pressure injury.Compression prevents lymph fluid drainage and leads to deterioration in tissue cell normal activities,which causes increased interstitialf

64、luid and waste build up,contributing to the development of PIs.The time required to develop PIs depends on many factors,including the patientsphysiological medical background and the degree of pressure and sheer force placed on the tissue.PIs occur over predictable pressure points wherebony protuber

65、ances are more likely to compress tissues when the patient is in prolonged contact with hard surfaces.Studies show that the heel areais the second most frequent location for a pressure ulcer,with the most prevalent being the sacrum.The heel accounts for between 23%and 28%ofall pressure ulcers.1 Whil

66、e the overall number of Hospital Acquired Conditions,or HAC,have decreased by 8%,pressure injuries have resisted improvementefforts and continue to grow by 10%annually.PIs are both costly and deadly.The U.S.Agency for Healthcare Research and Quality,or AHRQ,reports that PIs add$10.2 billion to annua

67、l U.S.healthcare costs.Furthermore,these are associated with over 45%of the 63,619 HAC relateddeaths in the U.S.,making it the leading HAC related death.2 1 Smith,S.,Ashby,S.,Thomas,L.and Williams,F.,2017.Evaluation of a multifactorial approach to reduce the prevalence of pressure injuries inregiona

68、l Australian acute inpatient care settings.International Wound Journal,15(1),pp.95-105.2 AP News.2019.Pressure Ulcers Cost U.S.Healthcare$10.2 Billion and Contribute to Nearly 29,000 Hospital Deaths Each Year.52025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/w

69、ww.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm8/153 (AHRQ,2019).Source:https:/www.ahrq.gov/data/infographics/hac-rates_2019.html;AHRQ National Scorecard on Hospital-AcquiredConditions Final Results for 2014-2017(PDF,787 KB).PIs impose a tremendous healthcare burden.As stated

70、in the National Pressure Injury Advisory Panel fact sheet for 2023,60,000 patientsdie every year as a direct result of pressure injuries.Acute care attributable to hospital-acquired PIs reaches$26.8 billion,and 2.5 million patientsper year develop a PI.Patient care costs per PI range from$20,900 up

71、to$151,700.PIs are among one of the five most common harms experiencedby patients and the second most common claim for lawsuits,after wrongful death.More than 17,000 lawsuits arise due to PIs annually at anaverage settlement of$250,000.PIs occur across the healthcare industry,including in 10%of acut

72、e care patients,25%of long-term acute carepatients,12%of nursing home patients and 12%of rehabilitation center patients.3 The most common method used to detect early PIs is a visual assessment by a professional caregiver focusing on areas at high probabilityto develop PIs.This skin and tissue visual

73、 assessment is subjective,unreliable,untimely(as PIs often occur suddenly without visual cues),and onlyeffective to detect PIs once they are visible.Technology-based methods for detecting and monitoring have been developed,but as far as we know,none have succeeded in providing an effective solution.

74、Pressure injuries,especially HAPIs,are complex,difficult to treat,and at risk for re-occurrence.Pressure Injuries Background A pressure injury is caused when skin integrity is broken down by some type of unrelieved pressure,leading to the destruction of normalstructure and function.The National Pres

75、sure Injury Advisory Panel,or NPIAP,the preeminent U.S.professional organization dedicated toprevention and management of PIs,uses these four criteria to define a PI:A pressure injury is localized damage to the skin and underlying soft tissue,usually over a bony prominence.The injury can present as

76、intact skin or an open ulcer and may be painful.The injury occurs as a result of intense pressure,prolonged pressure,or pressure in combination with shear.The tolerance of soft tissue for pressure and shear may also be affected by microclimate,nutrition,perfusion,comorbidities and conditionof the so

77、ft tissue.Common places for PIs to develop include the back of the head,shoulders,elbows,buttocks,hips,ankles,and heels.3 National Pressure Injury Advisory Panel fact sheet for 2023 62025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/d

78、ata/1839133/000164117225011913/forms-1a.htm9/153 The 4 Stages of Pressure Injuries-PI Stage 1 Non-blanchable erythema of intact skin.Intact skin with a localized area of non-blanchable erythema,which may appear differently indarkly pigmented skin.Presence of blanchable erythema or changes in sensati

79、on,temperature or firmness may precede visual changes.Colorchanges do not include purple or maroon discoloration;these may indicate deep tissue pressure injury.Stage 1 in Darkly Pigmented Skin:Research indicates that people with darker skin tones are more likely to develop higher stage pressureinjur

80、ies,possibly because skin assessment protocols are less effective in identifying damage earlier.Pigmentation of the skin may preventvisualizing the reactive hyperemia in the pressure injury.4 Currently,PIs are discovered only as they begin to appear on the skin,after they have been festering underne

81、ath the skin layers.Nursesregularly assess patients at high risk by evaluating them according to accepted scores(e.g.,Braden or Norton Scales).Hospitals can then get thepatient onto a different type of mattress that wicks away moisture,changes patient support and reduces pressure and imposes orders

82、for theindividual to be turned every few hours,for example.The risk of a PI among acute care patients ranges between 2-40%of patients.Intrinsic risk factors such as diabetes,malnutrition and smoking also increase the overall risk for pressure injuries.The spinal cord injurypatient population is at t

83、he highest risk(25-66%)of developing a PI due to the combination of immobility and decreased sensation.A prospectivestudy of spinal cord patients not only found that sacral and ischial PIs were very common(43%and 15%,respectively),as might be expected,butalso noted that the second most common locati

84、on was on the heel(19%).5 Nursing home patients have PI prevalence of 11%6 and are most likely to develop PIs on the sacrum or heels.Nursing home patients werealso found to have contractures at a prevalence of 55%.Contractures are caused by decreased elasticity of the tissue surrounding major joints

85、,andthe resulting lack of full mobility in the affected extremities significantly increases the risk of PI information.A significant market is the home healthcare market,which is anticipated to be worth$645 billion by 2025(CAGR 8.7%).7 It is estimatedthat by 2030,seniors aged 65 and over will repres

86、ent 20%of the U.S.population,and over 19 million seniors are estimated to need homecareservices.Homecare companies have a strong incentive to prevent PIs as they are rated and carry part of the cost treating those patients.According to a survey published in 2000 by UCLA School of Medicine,8 in a tot

87、al sample of 3,048 patients,9.12%had PIs,and of these,37.4%had more than one PI,and 14%had three or more.Considering the worst PIs for each subject,40.3%had Stage II and 27%had Stage III orIV injuries.The Agency for Healthcare Research and Quality(AHRQ)has identified several basic principles for PI

88、prevention:(a)use a validated toolto assess risk such as the Braden Scale and Norton Scale;(b)implement a preventive plan for residents at risk,which should focus on avoidingfriction and sheer trauma to at-risk skin regions,as well as an individualized plan to reduce pressure,such as frequent reposi

89、tioning;and(c)dailyinspection of the skin for high-risk residents,as deep tissue damage can occur in as little as two hours.The most common method used to detectearly pressure injuries is a visual assessment by a professional caregiver focusing on areas where PIs most frequently develop.This visuala

90、ssessment is subjective,unreliable,untimely and ineffective as PIs develop under the skin before becoming visible to the naked eye.Technology-based methods for detecting and monitoring PIs have been developed,but none have succeeded in providing an effective solution.These includeulcer assessment ba

91、sed on skin conductivity which has relatively low resolution and is influenced by different topical skin conditions(e.g.,moisture,urine or feces).Other system solution methods such as electronic medical record programs,which prompt providers to document resultsof PI screening every shift or day,are

92、of great importance in diagnosing PIs early and preventing progression.Pads designed to specifically coverpressure points such as the sacrum and heels,as well as foam pads designed to wrap around at-risk body parts,are common products.However,it isimportant to note that some pads can actually be det

93、rimental;for example,supports with cut-outs can have increased pressure at their edges.Hospital-acquired PI rates are increasing while all other hospital-acquired conditions are decreasing(AHRQ,2019).4 Current Perspectives on Pressure Injuries in Persons with Dark Skin Tones from the National Pressu

94、re Injury Advisory Panel,Adv Skin WoundCare.2023 Sep 1;36(9):470-480.doi:10.1097/ASW.0000000000000032.Epub 2023 Aug 7.PMID:37590446.5 Delmore,B.,Lebovits,S.,Suggs,B.,Rolnitzky,L.and Ayello,E.,2015.Risk Factors Associated with Heel Pressure Ulcers in HospitalizedPatients.Journal of Wound,Ostomy&Conti

95、nence Nursing,42(3),pp.242-248.6 Palese,A.,Zammattio,E.,Zuttion,R.,Ferrario,B.,Ponta,S.,Gonella,S.and Comoretto,R.,2020.Avoidable and Unavoidable Pressure InjuriesAmong Residents Living in Nursing Homes.Journal of Wound,Ostomy&Continence Nursing,47(3),pp.230-235.7 Home Healthcare Market will grow at

96、 CAGR of 8.7%to hit$645.10 billion by 2025:Adroit Market Research.8 Ferrell,B.,Josephson,K.,Norvid,P.and Alcorn,H.,2000.Pressure Ulcers Among Patients Admitted to Home Care.Journal of the AmericanGeriatrics Society,48(9),pp.1042-1047.72025/5/22 10:19sec.gov/Archives/edgar/data/1839133/00016411722501

97、1913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm10/153 PressureSafe Since 2017,we have been designing and developing PressureSafe,a novel device that has the potential to provide a reliable method ofmonitoring and recording patients,providing additional

98、 bio information to healthcare providers as to where and when a pressure injury may occur.The technology platform is designed to record information relating to each patient.The core technologies underlying the PressureSafe device arepatent protected(US Patent No.US 10,709,365 and US Patent No.US10,7

99、72,541).Our technology platform is based on the fact that tissues of thehuman body absorb and reflect omitted light in different wave lengths(from the visual light to infra-red light),and the light is reflected andscattered back from different skin layers.During this process,the reflected and scatte

100、red light waves through a damaged area changes its propertiesin comparison to light reflection and scattering from normal healthy tissue.The PressureSafe device is being designed to capture,analyze andidentify tissue status to make early PI diagnoses using Spectrographic Analysis,while AI based algo

101、rithm is implemented to improve diagnosticaccuracy.The PressureSafe device illuminate the skin with a miniature set of LEDs less than a second in order to acquire the tissue fingerprint.The emitted light photons from the device will be absorbed,scattered,and reflected back.The device will then detec

102、t the absorption andreflectance,and by using algorithms,it will process the signals to identify and classify the scanned area.As all persons skin properties are unique,the diagnosing physician needs to use a device as the PressureSafe,which automaticallycalibrate the device to the specific patients

103、skin,a process that takes merely a few seconds and allows personalized diagnosis,improving physiciandiagnostic process effectiveness,as the PressureSafe device is designed to measure regardless of skin color.Our technology is being developed toenable the assessment of different subepidermal layers b

104、y scanning through these skin layers,thus assessing the subepidermal damaged tissue usingmulti-biomarker approach and assisting with additional information to allow better treatment.Assessing the subepidermal biomarkers has beendeveloped to“raise a flag”to allow the caregivers intervene and prevent

105、their opening(“skin breakage”).The biomarkers that our algorithm usesstarts from the early inflammatory process,as soon as local underlying tissue function is disturbed,ischemia and cells begin to be damaged.PressureSafe is a hand-held scanner designed to provide additional information as a DSS,to s

106、upport the care giver effectively with themain diagnostic ability to identify PIs and to differentiate between deep tissue PIs(before they become visible)and Stage 1 PIs.Deep tissue PIs areserious,deep PIs that form under intact skin,spread in deep tissues and eventually present themselves as full t

107、hickness wounds.The PressureSafeis composed of(a)a handheld optic probe device,which utilizes harmless infra-red light that is placed on the skin and has a disposable tip that ischanged between patients.The optic probe with its disposable cover is placed on suspected areas for performing measurement

108、s;(b)a disposableprobe tip component,changed between patients to avoid cross-contamination;(c)a software component containing machine learning algorithm foranalyzing the collected data;and(d)software for connectivity and downloading the collected data and measurements results to the EMR/EHRsystems u

109、sed by the medical center or homecare company.PressureSafe is a non-invasive real-time optical monitoring device to support early intervention in PI treatment prior to skin breakage.The device performs a reflectance spectroscopy scan to generate information for the decision maker,while collecting da

110、ta on epidermal andsubepidermal physiological changes together with other bio-signals typical of early formation of PIs in the main three skin layers,thus detecting theappearance of life-risking pressure injuries.PressureSafe is designed to detect changes deep in the skin,regardless of skin tone,by

111、measuring biomarkers.As soon as local subcutaneous tissue function is disturbed and cells begin to disintegrate by pressure exerted upon the body area,ourscanner is designed to be able to detect this very early inflammatory process and tissue structure changes.The technology will allow patientmonito

112、ring and immediate reading in a non-invasive way.It has the potential to help to reduce the number of PIs dramatically through accurateearly classification,making it attractive for public and private healthcare systems worldwide.82025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/

113、forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm11/153 PressureSafe Studies Our product candidates are in various stages of development and production.The PressureSafe device is in an advanced stage ofdevelopment and is planned to be our first go-to-market p

114、roduct.We have completed the development of the first generation PressureSafe prototype in the second quarter of 2022.In June 2022,IR.MedLtd.,our wholly owned subsidiary,entered into a study agreement with Beit Rivka,a large geriatric hospital in Israel associated with Clalit,thelargest Health Maint

115、enance Organization,or HMO,in Israel,to conduct a usability study of PressureSafe.On July 17,2023,we published our interim report of usability study performed in Israel in leading medical centers with the followingresults:PressureSafe demonstrated very high efficacy in noninvasively detecting the pr

116、esence and absence of PIs below the skins surface.PressureSafe accurately detected the presence of a PI in 96%of cases.In addition,PressureSafe correctly determined that no wound waspresent in 91%of cases.The study was conducted at two medical centers owned by Clalit,namely Beit Rivka Hospital and R

117、abin Medical Centerboth in Petah Tikva,where 370 PressureSafe scans were performed on 25 patients who had Stage 1 PIs or deep tissue injuries.No device relatedsafety issues were reported in the total of 44 patients evaluated for safety.On September 26,2023,we announced that we signed a Clinical Tria

118、l Agreement with the Methodist Healthcare System of San Antonio toconduct a useability study titled“Safety and Efficacy of the PressureSafe device for early assessment of Pressure Injury in People with VariousSkin Tones,Including Dark Skin Tones.”Methodist Healthcare is recognized as the most respec

119、ted healthcare provider in its region.With a networkof 85 hospitals,9 of which are acute care facilities,Methodist Healthcare employs more than 11,000 people,including 2,700 physicians.Based onour intended protocol,we plan to have 50%of the subjects for the upcoming study to have a dark skin tone,th

120、us producing comparative data onPressureSafes accuracy as a decision support device in detecting early-stage PIs in people of darker and lighter skin tones.Early-stage PIs can bemore difficult to see on dark skin tones with the current standard of care for the assessment of PIs,which is visual skin

121、inspection.On February 20,2024,we reported 92%efficacy for PressureSafe.Data from the study conducted at two medical centers owned byClalit,namely Beit Rivka Hospital and Rabin Medical Center,presented at the NPIAP 2024 Annual Conference on February 16 and 17,2024 in SanAntonio,Texas.The 14-day effi

122、cacy portion of the single arm,bi-center study evaluated 38 patients at high risk of pressure injury development.Atotal of 924 scans were conducted on 154 body locations.Nurses conducting the scans were blinded to PressureSafes results,which wereencrypted.PressureSafe detected Stage 1 pressure injur

123、ies with 92%sensitivity and 88%specificity.Additional portions of the study evaluatedsafety,as well as device calibration and validation.Total data from 66 patients was obtained for safety analysis and no safety signals were identifiedin 1,493 scans.Based on these data,the study concluded that Press

124、ureSafe is a safe,efficient,and valuable method for early assessment ofpressure injuries.On May 22,2024,we published a poster presentation on our website titled“Near Infra-Red Spectroscopy scanner for earlyassessment of stage 1 pressure injury and deep tissue injury clinical study results”,which inc

125、ludes data that was presented at the NPIAP 2024Annual Conference in San Antonio,Texas.On April 9,2024,the PressureSafe decision support device received an FDA listing certification.PressureSafe is classified as a ClassI device and is exempt from 510(k)premarket submission.We are currently working on

126、 completing larger scale production of the commercialversion of the PressureSafe device,with initial sales planned during the second half of 2025,following the listing under the FDA.On September 10,2024,we announced the start of a usability study PressureSafe,at San Antonio,Texas based Methodist Hea

127、lthcare.The study,titled“Safety and Efficacy of the PressureSafe Device for Early Assessment of Pressure Injury in People with Various Skin Tones,Including Dark Skin Tones,”has received approval from Methodist Healthcare and has commenced patient enrollment and monitoring.MethodistHealthcare is wide

128、ly regarded as one of the most respected healthcare providers in its region.With a growing network of care locations includinghospitals,surgery centers,ERs,and family health clinics,each year Methodist Healthcare serves 608,000 patients,including 11,000 births,and330,000 ER visits.The study aims to

129、improve the early assessment and prevention of pressure injuries among all patients.Importantly,the studyaims to address the substantial challenge of healthcare inequality in the assessment of pressure injuries in people of dark skin tones who are morethan twice as likely to suffer from pressure inj

130、uries than those with lighter skin tone,according to a 5-year study published in Wounds.The currentstandard of care relies on visual inspection of the skin,which can be less effective for early assessment in individuals with darker skin tones.Up to104 people will be enrolled in the study,approximate

131、ly half with dark skin tones.Registered nurses specialized in wound care,or WOCN,will betrained in using PressureSafe.Sensitivity and specificity will be assessed and compared to standard of care visual skin assessment done by theWOCN nurses.92025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164

132、117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm12/153 DiaSafe We are now in the development stages of Software/Hardware,algorithms and optics to allow early assessment of incipient DFU in thelower limbs,the DiaSafe.DiaSafe is an adjustment to t

133、he PressureSafe proven technology allows us to reduce the development period andapproach the relevant markets faster.We plan to initiate a clinical study in Israel,to train the developed algorithm and test patients.DFU Background Diabetic foot ulcer are an increasing problem among diabetic patients.

134、Diabetic foot ulcers are one of several serious complications ofdiabetes progression.Major contributing causes to diabetic foot ulcers are peripheral neuropathy,peripheral arterial disease,andimmunosuppression.Up to 15%of patients with diabetes have diabetic foot ulcers,and these ulcers lead to more

135、 than 80,000 amputations per yearin the United States.The lifetime risk of diabetic foot ulcers for patients with diabetes may reach up to 68 per 1,000 people as reported by somestudies.As a diabetic foot ulcer progresses,the patients risk for amputation increases;in nearly 84%of patients who have a

136、 lower limb amputationsecondary to diabetes,the amputation is preceded by a diabetic foot ulcer.Peripheral neuropathy secondary to diabetes is an etiologic factor ofdiabetic foot ulcers and is estimated to affect 5.5 million people in the United States.These collective findings indicate that diabeti

137、c foot ulcers lead to serious disability,serious reduction in patient quality of life,and highfinancial costs for society.With increased vigilance on risk assessment,diagnosis,and management of diabetic foot ulcers,clinicians can improvepatient outcomes and reduce healthcare costs.There are a few es

138、tablished methods for diagnosing DFU.These methods assess side effects of diabetic related symptoms as PeripheralArtery Disease diabetic neuropathy(mono-filament test tuning fork test),skin temperature,BP,heart rate,skin dryness etc.The suggestedDiaSafe device measures actual dermal and subdermal ch

139、anges of injured skin tissue structure caused directly the development of diabetic footulcers.The optical platform developed by IR-MED allows direct assessment and measurement of changes in skin structure(including blood flowchanges).9 Market Prevalence:The percentage of Americans aged 65 and older

140、diagnosed with diabetes remains high,at 29.2%,or 16.5 million seniors(diagnosed and undiagnosed).Diabetic foot ulcers are wounds on the feet that develop in patients with type 1 or type 2 diabetes.About one-third of people with diabetesdevelop a foot ulcer during their lifetime.Diabetic foot ulcers

141、affect about 18.6 million people worldwide and 1.6 million in the U.S.annually.Treatment of infection in a diabetic ulcer is difficult and expensive.Patients usually need to take long-term medications or become hospitalizedfor an extended period of time DFU treatment is expensive.On average,the trea

142、tment cost for wounds with Wagner grade I in fiveindustrialized countries was$3,096 in 2010.However,if the wound becomes complicated and amputated,the cost will rise to almost$107,900.10 Average in-hospital costs were$10,827(range:$702$82,880)per DFU episode.Primary healed DFUs costs on average$4,83

143、0,single minor amputations on average$13,580,multiple minor amputations on average$31,835 and major amputations on average$73,813 perepisode.11 9 Tuttolomondo A,Maida C,Pinto A.Diabetic foot syndrome:Immune-inflammatory features as possible cardiovascular markers in diabetes.World J Orthop.2015 Jan

144、18;6(1):62-76.doi:10.5312/wjo.v6.i1.62.PMID:25621212;PMCID:PMC4303791.10 https:/ https:/www.ncbi.nlm.nih.gov/pmc/articles/PMC3634178/Iraj B,Khorvash F,Ebneshahidi A,Askari G.Prevention of diabetic foot ulcer.Int JPrev Med.2013;4(3):373-376,https:/ https:/ 10:19sec.gov/Archives/edgar/data/1839133/000

145、164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm13/153 All the diabetic patients should undergo comprehensive foot exam once a year.The goal of this examination is to determine the risk factorsthat may result in a foot ulcer and consequently

146、amputation of the affected organ.The physical examination contains observation,palpation of thepulses in the lower extremities,including the posterior tibial and dorsalis pedis pulses.The physical examination also includes neurological tests.Atleast two neurologic tests are performed and one of the

147、tests should measure the protective sensation in which a 10 g monofilament is used.Vibration sensation using a 128 Hz diapason.The DiaSafe device as the PressureSafe device is being designed to capture,analyze and identify tissue status to make early DFUassessment and classification using Spectrogra

148、phic Analysis,while AI based algorithm is implemented to improve provided diagnostic accuracy.The DiaSafe device illuminates the skin with a miniature set of LEDs less than a second in order to acquire the tissue fingerprint.The emittedlight photons from the device will be absorbed,scattered and ref

149、lected back.The device will then detect the absorption and reflectance,and byusing algorithms,it will process the signals to identify and classify the scanned area or DFU.As all persons skin properties are unique,the diagnosing physician needs to use a device as the DiaSafe,which automatically calib

150、ratethe device to the specific patients skin,a process that takes merely a few seconds and allows personalized diagnosis,improving physiciandiagnostic process effectiveness,as the DiaSafe device is designed to measure regardless of skin color.Our technology is being developed toenable the assessment

151、 of different subepidermal layers by scanning through these skin layers,thus improving the identification of the damage,assessing the subepidermal damaged tissue volume and assisting with additional information to allow better treatment efficacy.Measuring thedifferences of subepidermal biomarker is

152、being developed to detect early formation of DFUs and to“raise a flag”to allow the caregivers interveneand prevent their appearance.The biomarkers that our algorithm detects start from the early inflammatory process,as soon as local underlyingtissue function is disturbed,and cells begin to be damage

153、d.DiaSafe is a hand-held scanner designed to provide additional information as a DSS,to support the care giver effectively with the maindiagnostic ability to identify DFUs and to differentiate between DFUs under different skin conditions(before they become visible.The DiaSafe iscomposed of:(a)a hand

154、held optic probe device,which utilizes harmless infra-red light that is placed on the skin and has a disposable tip which ischanged between patients.The optic probe with its disposable cover is placed on suspected areas for performing measurements;(b)a disposableprobe tip component,changed between p

155、atients to avoid cross-contamination;(c)a software component containing machine learning algorithm foranalyzing the collected data;and(d)software for connectivity and downloading the collected data and measurements results to the EMR/EHRsystems used by the medical center or homecare company.DiaeSafe

156、 is a non-invasive real-time optical monitoring device to support early intervention in DFU treatment prior to skin breakage.The device performs a reflectance spectroscopy scan to generate information for the decision maker,while collecting data on epidermal andsubepidermal physiological changes tog

157、ether with other bio-signals typical of early formation of PIs in the main three skin layers,thus detecting theappearance of life risking pressure DiaSafe is designed to detect changes deep in the skin,regardless of skin tone,by measuring bio markers.Assoon as local subcutaneous tissue function is d

158、isturbed and cells begin to disintegrate by pressure exerted upon the body area,our scanner isdesigned to be able to detect this very early inflammatory process and tissue structure changes.The technology will allow patient monitoring andimmediate reading in a non-invasive way.It has the potential t

159、o help to reduce the number of DFUs dramatically through accurate earlyclassification,making it attractive for public and private healthcare systems worldwide.112025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/0001641172

160、25011913/forms-1a.htm14/153 Recent Developments Equity Purchase Agreement and Registration Rights Agreement with Williamsburg On March 11,2025,we entered into an Equity Purchase Agreement(the“Purchase Agreement”)with Williamsburg,pursuant to whichWilliamsburg agreed to purchase up to Fifteen Million

161、 Dollars($15,000,000)of our Comon Stock(“Maximum Commitment Amount”)bydelivering put notices(each,a“Put Notice”).The Purchase Agreement provides that we will sell the shares of Common Stock(the“Put Shares”)toWilliamsburg pursuant to applicable Put Notices from time to time over a 24-month period(unl

162、ess otherwise determined therein)in accordancewith the terms and conditions the Purchase Agreement,commencing on March 11,2025,and ending on the earlier of(i)the date on which theWilliamsburg shall have purchased Put Shares pursuant to this Agreement equal to the Maximum Commitment Amount,(ii)March

163、11,2027,or(iii)written notice of termination us to Williamsburg(which shall not occur at any time that Williamsburg holds any of the Put Shares)(the“Commitment Period”).Each Put Notice shall state the number of shares of the Common Stock Williamsburg is required to purchase,at such priceas determine

164、d in accordance with the Purchase Agreement.The per share purchase price for the Put Shares shall be equal to 90%of the marketprice defined as the average of the two(2)lowest Volume-Weighted Average Price(“VWAP”)for the five(5)consecutive trading days immediatelypreceding the relevant clearing date,

165、as reported by Bloomberg Finance L.P.or other reputable source.Pursuant to the Purchase Agreement,Williamsburg may not acquire at any point,more than 9.99%of our outstanding common stock.Pursuant to the terms of the Purchase Agreement,Williamsburg agreed to accept a Put Notice of up to$500,000 upon

166、a registration statement being declared effective by the SEC.As stated in the Purchase Agreement,the“Principal Market”includes any of the national exchanges(i.e.NYSE,NYSE AMEX,NASDAQ),or principal quotation systems(i.e.OTCQX,OTCQB,OTC Pink,the OTC Bulletin Board),or other principal exchange or recog

167、nizedquotation system which is at the time the principal trading platform or market for the Companys Common Stock.As consideration for its commitment to purchase Put Shares pursuant to the Purchase Agreement,the Company issued to Williamsburg1,000,000 shares of Common Stock(the“Commitment Shares”)fo

168、llowing the execution of the Purchase Agreement.The shares of Common Stockthat may be issued to Williamsburg under the Purchase Agreement,including the Commitment Shares,were issued and will be issued pursuant toan exemption from registration under the Securities Act.Our ability to require Williamsb

169、urg to purchase the Shares under the Purchase Agreement is subject to various limitations and conditions,including but not limited to the following:The Company shall promptly secure the listing of all Put Shares and Commitment Shares to be issued to Williamsburg hereunder on thePrincipal Market(subj

170、ect to official notice of issuance)and shall use commercially reasonable best efforts to maintain,so long as anyshares of Common Stock shall be so listed,the listing of all such Put Shares and Commitment Shares from time to time issuablehereunder.The Company shall have performed,satisfied and compli

171、ed in all material respects with all covenants,agreements and conditions requiredby this Agreement to be performed,satisfied or complied with by the Company.The trading of the Common Stock shall not have been suspended by the SEC,the Principal Market or FINRA,or otherwise halted for anyreason,and th

172、e Common Stock shall have been approved for listing or quotation on and shall not have been delisted from the PrincipalMarket.So long as the Purchase Agreement remains in effect,the Company shall not and will not enter into any other equity line of creditagreement with any other party,without Willia

173、msburgs prior written consent,which consent may be granted or withheld inWilliamsburgs sole and absolute discretion.122025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm15/153 The Registratio

174、n Statement,and any amendment or supplement thereto,which includes this prospectus covering the Put Shares and theCommitment Shares,shall be and remain effective for the resale and shall not be suspended withdrawn and neither the Company norWilliamsburg shall receive the notice that the SEC has issu

175、ed or intends to issue a stop order with respect to such Registration Statementor that the SEC otherwise has suspended or withdrawn the effectiveness of such Registration Statement,either temporarily or permanently.The number of Put Shares to be purchased by Williamsburg,when aggregated with all oth

176、er shares of Common Stock beneficially ownedby Williamsburg would not exceed 9.99%of the number of shares of the Common Stock outstanding immediately after giving effect tothe issuance of shares of Common Stock.The Companys Common Stock must be DWAC eligible and not subject to a“DTC chill.”Selling S

177、tockholder shall have received an opinion from our outside legal counsel in the form previously agreed to.There is no guarantee that we will be able to meet the foregoing conditions or any other conditions under the Purchase Agreement or that wewill be able to draw down any portion of the amounts av

178、ailable under the Purchase Agreement.We also entered into the Registration Rights Agreement with Williamsburg,pursuant to which,we have filed a registration statement,whichincludes this prospectus,with the SEC relating to Williamsburgs resale of any shares of Common Stock it purchased under the Purc

179、haseAgreement,including the Commitment Shares we issued to the Selling Stockholder on March 11,2025.The effectiveness of this RegistrationStatement is a condition precedent to our ability to sell shares of our Common Stock to Williamsburg under the Purchase Agreement.If all 80,000,000 shares offered

180、 pursuant to this prospectus were sold,they would represent approximately 52%of the total number of shares ofour Common Stock outstanding and approximately 65%of the total number of outstanding shares of our Common Stock held by nonaffiliates as ofthe date of this prospectus.Issuance of the shares i

181、n this offering will not affect the rights or privileges of our existing stockholders except that theeconomic and voting interests of each of our existing stockholders will be diluted as a result of any such issuances.Although the number of sharesof our Common Stock that our existing stockholders ow

182、n will not decrease,the shares owned by our existing stockholders will represent a smallerpercentage of our total outstanding shares after any issuances of shares of our Common Stock to the Selling Stockholder.Corporate Information IR-Med,Inc.was incorporated in the state of Nevada on April 20,2007,

183、under the name“Monster Motors,Inc.”On June 24,2009,thecorporate name was changed to Eco2 Forests,Inc.During September 2012,Eco2 Forests,Inc.,accepted a court ordered receiver who authorized areduction of the authorized shares from 900,000,000 to 500,000,000 and in November 2012 effectuated a 16,000

184、to 1 stock split.In February 2013,the Company underwent a change of control.On March 25,2013,Eco2 Forests,Inc.,effectuated a 4-to-1 reverse stock split in addition to changingthe corporate name to International Display Advertising,Inc.IR-Med,Inc.began operating the business of IR.Med Ltd.An Israeli

185、company,through a reverse acquisition on December 24,2020(the“Acquisition”).IR.Med Ltd.(an Israeli company which was founded in 2013)continuesas an operating subsidiary of IR-Med,Inc.;IR-Med,Inc.is the sole stockholder of IR.Med Ltd.IR-Med,Inc.s corporate headquarters and IR.MedLtd.s research facili

186、ties are located at ZHR Industrial Zone,Rosh Pina,Israel.Implications of Being an Emerging Growth Company We qualify as an“emerging growth company”as defined in the Jumpstart Our Business Startups Act of 2012,or the JOBS Act.As anemerging growth company,we may take advantage of specified reduced dis

187、closure and other requirements that are otherwise applicable generallyto public companies.These provisions include:132025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm16/153 a requirement to

188、 provide only two years of audited financial statements in addition to any required unaudited interim financialstatements with correspondingly reduced“Managements Discussion and Analysis of Financial Condition and Results of Operations”disclosure;reduced disclosure about executive compensation arran

189、gements;no non-binding advisory votes on executive compensation or golden parachute arrangements;and an exemption from the auditor attestation requirement in the assessment of internal control over financial reporting.We may take advantage of these provisions for up to five years or such earlier tim

190、e that we are no longer an emerging growth company.We would cease to be an emerging growth company on the date that is the earliest of(i)the last day of the fiscal year in which we had total annualgross revenues of$1.07 billion or more;(ii)the last day of the year following the fifth anniversary of

191、the date of the completion of our initial publicoffering;(iii)the date on which we had issued more than$1 billion in nonconvertible debt during the previous three years;or(iv)the date on whichwe are deemed to be a large accelerated filer under the rules of the SEC.To the extent that we continue to q

192、ualify as a“smaller reporting company,”as such term is defined in Rule 12b-2 under the SecuritiesExchange Act of 1934(the“Exchange Act”),after we cease to qualify as an emerging growth company,certain of the exemptions available to us asan emerging growth company may continue to be available to us a

193、s a smaller reporting company,including:(1)not being required to comply withthe auditor attestation requirements of Section 404(b)of the Sarbanes Oxley Act;(2)scaled executive compensation disclosures;and(3)therequirement to provide only two years of audited financial statements,instead of three yea

194、rs.142025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm17/153 THE OFFERING Issuer:IR-Med,Inc.Securities Being Offered by the SellingStockholder:Up to 80,000,000 shares of our Common Stock.Of

195、fering Price:The Selling Stockholder may offer,sell,or distribute all or a portion of the Shares registeredhereby either through public or private transactions at prevailing market prices or at negotiatedprices.See“Plan of Distribution.”Common stock outstanding before thisoffering:72,018,144 shares

196、Common stock outstanding after theoffering:152,018,144 shares.Assumes that the Selling Stockholder sells all of the Shares offered pursuantto this prospectus.Terms of the offering:The Selling Stockholder will determine when and how it sells the Shares offered in thisProspectus as described in“Plan o

197、f Distribution.”Use of proceeds:We will not receive any proceeds from the sale of the Shares by the Selling Stockholder.We haveagreed to bear the expenses relating to the registration of the Shares.See“Use of Proceeds.”Risk factors:See“Risk Factors”and the other information included in this prospect

198、us for a discussion offactors you should carefully consider before deciding to invest in our Common Stock.Market Information Our shares of Common Stock are traded on the OTCQB under the symbol“IRME.”152025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.go

199、v/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm18/153 FINANCIAL DATA The following tables set forth our summary consolidated statements of operations and consolidated balance sheet data.The summaryconsolidated statements of operations data for the years ended December 31,2024 and 2023

200、and the consolidated balance sheet data as ofDecember 31,2024 and 2023 are derived from our audited consolidated financial statements appearing elsewhere in this prospectus.The summaryof the interim unaudited consolidated statements of operations data for the three months ended March 31,2025 and 202

201、4 and the balance sheet dataas of March 31,2025,are derived from our interim unaudited consolidated financial statements appearing elsewhere in this prospectus.Ourhistorical results are not necessarily indicative of the results that may be expected for any period in the future and our interim result

202、s are notnecessarily indicative of our expected results for the year ending December 31,2025.You should read the following summary consolidatedfinancial data together with the section titled“Managements Discussion and Analysis of Financial Condition and Results of Operations”and ourconsolidated fina

203、ncial statements and the related notes included elsewhere in this prospectus.Consolidated Balance Sheets as of December 31 2024 2023 US Dollars(In thousands)Assets Current assets Cash and cash equivalents 129 767 Accounts receivable 76 81 Total current assets 205 848 Non-current assets Long term res

204、tricted deposits 11 11 Right of use assets -84 Property and equipment,net 35 56 Total non-current assets 46 151 Total assets 251 999 Liabilities and stockholders equity(deficit)Current liabilities Trade and other payables 388 473 Stockholders loans 157 -Total current liabilities 545 473 Non-current

205、liabilities Stockholders loans -161 Total non-current liabilities -161 Total liabilities 545 634 Stockholders equity(deficit)Common stock,par value$0.001 per share,600,000,000 shares authorized:71,008,144 and 69,931,056 issued and outstanding as of December 31,2024and 2023,respectively 70 69 Additio

206、nal paid-in capital 16,374 15,135 Accumulated deficit (16,738)(14,839)Total stockholders equity(deficit)(294)365 Total liabilities and stockholders equity 251 999 162025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164

207、117225011913/forms-1a.htm19/153 Consolidated Statements of Operations For the year For the year ended ended December 31,December 31,2024 2023 US Dollars(In thousands)Research and development expenses Expenses incurred 1,178 2,061 Less-government grants (468)-Research and development expenses,net 710

208、 2,061 Marketing expenses 220 822 General and administrative expenses 1,011 2,028 Total operating loss 1,941 4,911 Other income (48)-Financial expenses(income),net 6 (2)Loss for the year 1,899 4,909 Loss per share Basic and dilutive loss per common stock(in U.S.dollars)(0.03)(0.07)172025/5/22 10:19s

209、ec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm20/153 Interim Unaudited Condensed Consolidated Balance Sheets March 31 2025 December 31 2024 USD thousands USD thousands Assets Current assets Cash and cas

210、h equivalents 51 129 Accounts receivable 30 76 Total current assets 81 205 Non-current assets Long term restricted deposits 11 11 Property and equipment,net 32 35 Total non-current assets 43 46 Total assets 124 251 Liabilities and stockholders deficit Current liabilities Trade and other payables 428

211、 388 Stockholders loans 158 157 Convertible loans of related parties 31 -Total Current Liabilities 617 545 Total liabilities 617 545 Stockholders deficit Common Stock,par value$0.001 per share,600,000,000,sharesauthorized.As of March 31,2025,and December 31,2024,72,008,144and 71,008,144 shares were

212、issued and outstanding,respectively.72 70 Additional paid-in capital 16,946 16,374 Accumulated deficit (17,511)(16,738)Total Stockholders deficit (493)(294)Total liabilities and stockholders deficit 124 251 182025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/ww

213、w.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm21/153 Interim Unaudited Condensed Consolidated Statements of Operations For the three-monthsperiod ended March 31 2025 2024 U.S dollars(in thousands)Research and development expenses:Expenses incurred 64 375 Less-government partic

214、ipation (41)(180)Research and development expenses,net 23 195 Marketing expenses 2 168 General and administrative expenses 228 295 Total operating loss 253 658 Financial(income)expense,net 520 (1)Loss for the period 773 657 Basic and dilutive loss per common stock(in dollars)(0.01)(0.01)Weighted-ave

215、rage number of shares in the loss per share computation for the three months ended March 31,2025 and three months endedMarch 31,2024 were 71,258,144 and 69,931,056,respectively.192025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/

216、1839133/000164117225011913/forms-1a.htm22/153 CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This prospectus may contain“forward-looking statements”(within the meaning of Section 27A of the Securities Act and Section 21E ofthe Securities and Exchange Act of 1934,as amended,or the Exchange Act.

217、All statements other than statements of historical facts contained in thisprospectus,including statements regarding the timing of our clinical trials,our strategy,future operations,future financial position,future revenue,projected costs,prospects,plans,objectives of management and expected market g

218、rowth are forward-looking statements.These statements involveknown and unknown risks,uncertainties and other important factors that may cause our actual results,performance or achievements to bematerially different from any future results,performance or achievements expressed or implied by the forwa

219、rd-looking statements.The words or phrases“will likely result”,“will be”,“will”,“are expected to”,“will continue to”,“is anticipated”,“estimate”,“project”orsimilar expressions identify“forward-looking statements”within the meaning of the Private Securities Litigation Reform Act of 1995.Suchstatement

220、s are subject to certain risks and uncertainties that could cause actual results to differ materially from historical earnings and thosepresently anticipated or projected.Readers are cautioned not to place undue reliance on any such forward-looking statements,which speak only asof the date made.Thes

221、e forward-looking statements include,among other things,statements about:the accuracy of our estimates regarding expenses,future revenues,uses of cash,capital requirements and the need for additionalfinancing;the initiation,cost,timing,progress and results of our development activities,usability stu

222、dies,preclinical studies and any clinical trialsthat we may be required to undertake;the timing of and our ability to obtain and maintain regulatory approval of our existing product candidates,any product candidates thatwe may develop,and any related restrictions and/or limitations;our plans to rese

223、arch,develop and commercialize our current and future product candidates;our ability to attract collaborators with development,regulatory and commercialization expertise;our ability to obtain and maintain intellectual property protection for our product candidates;our ability to successfully commerc

224、ialize our product candidates;the size and growth of the markets for our product candidates and our ability to serve those markets;the rate and degree of market acceptance of any future products;the success of competing devices that are or may become available;regulatory developments in the United S

225、tates and other countries;the performance of our third-party suppliers and manufacturers and our ability to obtain alternative sources of raw materials;the impact of global inflationary pressures;our ability to obtain additional financing;our use of the proceeds from our securities offerings;any res

226、trictions on our ability to use our net operating loss carry-forwards;202025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm23/153 the impact of Israels multi-front war on our results,includin

227、g potential economic restrictions imposed on and political and militaryinstability in Israel;and our ability to attract and retain key personnel.Moreover,we operate in a very competitive and rapidly changing environment.New risks emerge from time to time,and it is neitherpossible for us to predict a

228、ll risk factors nor address the impact of all factors on our business or the extent to which any factor,or combination offactors,may cause our actual results to differ materially from those contained in any forward-looking statements.Actual results could differmaterially from our forward-looking sta

229、tements due to a number of factors,including the early stage of our product candidates presently underdevelopment;our ability to obtain and,if obtained,maintain regulatory approval of our current product candidates and any of our other futureproduct candidates;our need for substantial additional fun

230、ds in order to continue our operations and the uncertainty of whether we will be able toobtain the funding we need;our future financial performance;our ability to retain or hire key scientific or management personnel;our ability toprotect our intellectual property rights that are valuable to our bus

231、iness,including patent and other intellectual property rights;our dependence onthird-party manufacturers,suppliers,research organizations,testing laboratories and other potential collaborators;the success of our collaborationswith third parties;the size and growth of the potential markets for any of

232、 our approved product candidates and the rate and degree of marketacceptance of any of our approved product candidates;competition in our industry;regulatory developments in the United States and foreigncountries,including the U.S.Food and Drug Administration,or FDA;and the expected impact of new ac

233、counting standards.You should not place undue reliance on any forward-looking statement,each of which applies only as of the date of this prospectus.Beforeyou invest in our securities,you should be aware that the occurrence of the events described in the section entitled“Risk Factors”and elsewhere i

234、nthis prospectus could negatively affect our business,operating results,financial condition and stock price.All forward-looking statements includedin this document are based on information available to us on the date hereof,and except as required by law,we undertake no obligation to update orrevise

235、publicly any of the forward-looking statements after the date of this prospectus to conform our statements to actual results or changedexpectations.212025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/fo

236、rms-1a.htm24/153 RISK FACTORS Investing in our Common Stock involves a high degree of risk.Before investing in our Common Stock,you should carefully consider therisks described below,as well as the other information in this prospectus,Investors should consider carefully the following information abo

237、ut theserisks,together with the other information contained in this prospectus,including our consolidated financial statements and the related notes.If anyof the following risks actually occur,the business,financial condition or results of operations of the Company could be materially adverselyaffec

238、ted,the market price of the Common Stock would likely decline,and investors could lose all or a portion of their investment.Summary of Risk Factors Below is a summary of the principal factors that make an investment in our common stock speculative or risky.This summary does notaddress all of the ris

239、ks that we face.Additional discussion of the risks summarized in this risk factor summary,and other risks that we face,can befound below under the heading“Risk Factors”and should be carefully considered,together with other information in our Annual Report on Form10-K and our other filings with the S

240、EC,before making an investment decision regarding our common stock.We are a development stage medical device company and have a history of significant operating losses;we expect to continue to incuroperating losses,and we may never achieve or maintain profitability.We will need substantial additiona

241、l funding to continue our operations,which could result in significant dilution or restrictions on our businessactivities.We may not be able to raise capital when needed,if at all,which would force us to delay,reduce or eliminate our productdevelopment programs or commercialization efforts and could

242、 cause our business to fail.Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concernin its report on our audited financial statements included in this report.Our audited financial statements on December 31,2024,wer

243、e preparedassuming that we will continue as a going concern.Medical device development involves a lengthy and expensive process with an uncertain outcome.We may incur additional costs or experiencedelays in completing,or ultimately be unable to complete,the development and commercialization of any p

244、roduct.The size and future growth in the market for our planned devices under development has not been established with precision and may besmaller than we estimate,possibly materially.If our estimates and projections overestimate the size of this market,our sales growth may beadversely affected.222

245、025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm25/153 Any product candidates we may advance into clinical trials(assuming the FDA so requires)may be subject to extensive regulation,which c

246、anbe costly and time consuming,cause unanticipated delays or prevent the receipt of the required approvals to commercialize our productcandidates,all of which can adversely affect our business We may be subject to numerous and varying privacy and security laws,and our failure to comply could result

247、in penalties and reputationaldamage.If we are unable to establish sales and marketing capabilities or fail to enter into agreements with third parties to market and sell any productswe may successfully develop,we may not be able to effectively market and sell any such products and generate product r

248、evenue.Failure to manage our growth effectively could increase our expenses,decrease our revenue and prevent us from implementing our businessstrategy.Failure to secure or retain coverage or adequate reimbursement for our planned products in development by third-party payors could adverselyaffect ou

249、r business,financial condition and operating results.If we are unable to protect our intellectual property rights or if our intellectual property rights are inadequate to protect our technology,ourcompetitors could develop and commercialize technology similar to ours,and our competitive position cou

250、ld be harmed.Our technology development is headquartered in Israel and,therefore,our results may be adversely affected by economic restrictions imposedon,and political and military instability in Israel,including Israels multi-front war.Risk Factors An investment in our common stock involves a numbe

251、r of very significant risks.You should carefully consider the following risks anduncertainties in addition to other information in this report in evaluating our company and its business before purchasing shares of our companyscommon stock.Our business,operating results and financial condition could

252、be seriously harmed due to any of the following risks.You could loseall or part of your investment due to any of these risks.Risks Related to Our Business,Financial Position,Capital Requirements,Managing our Growth and Other Legal Compliance Matters We are a development stage medical device company

253、and have a history of significant operating losses;we expect to continue to incuroperating losses,and we may never achieve or maintain profitability.As a development stage company,we do not currently have revenues to generate cash flows to cover operating expenses.Since ourinception,we have incurred

254、 operating losses in each year due to costs incurred in connection with research and development activities,marketingand general and administrative expenses associated with our operations.For the years ended December 31,2024,and 2023,we incurred net lossesof approximately$1,899,000 and$4,909,000,res

255、pectively.As of December 31,2024,and 2023,we had an accumulated deficit of$16,738,000 and$14,839,000,respectively.We expect to incur losses for the foreseeable future as we continue the development of,and seek regulatory clearance and approvals for,our devices in development(for pre-emptive diagnosi

256、s of PIs on the skin surface),DiaSafe and thereafter,for the Nobiotics device(for detectingthe ear infections in children).If we fail to generate revenue and eventually become profitable,or if we are unable to fund our continuing losses,ourshareholders could lose all or a substantial part of their i

257、nvestment.We will need substantial additional funding to complete subsequent phases of our medical devices and to operate our business and suchfunding may not be available or,if it is available,such financing is likely to substantially dilute our existing shareholders.232025/5/22 10:19sec.gov/Archiv

258、es/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm26/153 The discovery,development and commercialization of new medical devices(such as our PressureSafe and DiaSafe devices)entailssignificant costs.As we are in the earl

259、y stage of the engineering,electronics,algorithm and mechanical aspects of our devices and prototypes,westill must develop,modify,refine and finalize them.To enable us to accomplish these and other related items and continue to operate our business,we will need to raise substantial additional capita

260、l or enter into strategic partnerships to enable us to:fund clinical studies and seek regulatory approvals/clearance prior to performing clinical trials(if needed);build or access manufacturing and commercialization capabilities;develop,test and receive regulatory commercial sale approval to market

261、our products;acquire or license additional internal systems and other infrastructure;and hire and support additional management,engineering and scientific personnel.We will need substantial additional funding to continue our operations,which could result in significant dilution or restrictions on ou

262、rbusiness activities.We may not be able to raise capital when needed,if at all,which would force us to delay,reduce or eliminate our productdevelopment programs or commercialization efforts and could cause our business to fail.Our operations have consumed substantial amounts of cash since inception.

263、We expect to need substantial additional funding to pursue theclinical development of our drug candidates and launch and commercialize any drug candidates for which we receive regulatory approval.In 2022 and 2023,we raised aggregate gross proceeds of$3,625,000 and$1,000,000,respectively,from sales o

264、f our equity and equitylinked securities.On June 4,2024,and July 4,2024,we raised aggregate proceeds of$755,000 from sales of our shares of common stock andwarrants to purchase shares of common stock.Nonetheless,we will require additional capital for the further development and commercialization of

265、our three product candidates(whichare in various stages of design and development)and may need to raise additional funds sooner if we choose to and are able to expand more rapidlythan we currently anticipate.Further,we expect our expenses to increase in connection with our ongoing activities.In addi

266、tion,if we obtainregulatory approval for any of our product candidates,we expect to incur significant commercialization expenses related to regulatoryrequirements,product manufacturing,marketing,sales and distribution.Furthermore,we expect to incur additional costs associated with operating as a pub

267、lic company.We may also encounter unforeseenexpenses,difficulties,complications,delays and other unknown factors that may increase our capital needs and/or cause us to spend our cashresources faster than we expect.Accordingly,we will need to obtain substantial additional funding in order to continue

268、 our operations.To date,we have financed our operations through a mix of equity investments from private investors,the incurrence of debt,grant fundingand technology licensing revenues,and we expect to continue to utilize such means of financing for the foreseeable future.Additional funding fromthos

269、e or other sources may not be available when or in the amounts needed,on acceptable terms,or at all.If we raise capital through the sale of equity,or securities convertible into equity,it will result in dilution to our then existing stockholders,which could be significant depending on the price at w

270、hich we may be able to sell our securities.If we raise additional capital through the incurrence of indebtedness,we may become subject to covenants restricting our businessactivities,and holders of debt instruments may have rights and privileges senior to those of our equity investors.In addition,se

271、rvicing the interestand principal repayment obligations under debt facilities could divert funds that would otherwise be available to support research and developmentor commercialization activities.242025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov

272、/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm27/153 If we are unable to raise capital when needed on commercially reasonable terms,we could be forced to delay,reduce or eliminate ourresearch and development for our product candidates or any future commercialization efforts or ultimate

273、ly cease operations.Any of these eventscould significantly harm our business,financial condition and prospects.Until we can generate a sufficient amount of product revenue to finance our cash requirements,which we may never achieve,we expect tofinance our cash needs primarily through public or priva

274、te equity offerings,debt financings or through the establishment of possible strategicalliances.We cannot be certain that additional funding will be available on acceptable terms,or at all.If we are not able to secure additional equityfunding when needed,we may have to delay,reduce the scope of,or e

275、liminate one or more of our clinical studies,development programs or futurecommercialization initiatives.In addition,any additional equity funding that we do obtain will dilute the ownership held by our existing security holders.The amount ofthis dilution may be substantially increased if the tradin

276、g price of our common stock is lower at the time of any financing.Regardless,the economicdilution to shareholders will be significant if our stock price does not increase significantly,or if the effective price of any sale is below the pricepaid by a particular shareholder.Any debt financing that we

277、 obtain in the future could involve substantial restrictions on activities and creditorscould seek a pledge of some or all of our assets.We have not identified potential sources for such financing that we will require,and we do not havecommitments from any third parties to provide any future debt fi

278、nancing.If we fail to obtain funding as needed,we may be forced to cease or scaleback operations,and our results,financial condition and stock price would be adversely affected.Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue

279、 as agoing concern in its report on our audited financial statements included in this prospectus.Our audited financial statements on December 31,2024,were prepared assuming that we will continue as a going concern.Primarily as a result of our losses and limited cash balances and cash flows,the repor

280、t of our independent registered public accounting firmfor the fiscal year ended December 31,2024,contains an explanatory paragraph on our financial statements stating that the Company has sufferedrecurring losses from operations and has accumulated deficit that raise substantial doubt about the Comp

281、anys ability to continue as a goingconcern.While we raised proceeds of$755,000 during the year ended December 31,2024,by way of private placement offerings to accreditedinvestors,we do not believe our resources will be sufficient to meet our operating and capital needs beyond the second quarter of 2

282、025.We expectwe will require additional capital to fully implement the scope of our proposed business operations,which raises substantial doubt about our abilityto continue as a going concern.We will have to continue to rely on equity and debt financing,and/or continued support from our officers and

283、directors.There can be no assurance that financing,whether debt or equity,will be available to us in the amount required at any particular time orfor any particular period or,if available,that it can be obtained on favorable terms.If we are unable to secure additional capital,we may be required to c

284、urtail our clinical and research and development initiatives and takeadditional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations.Thesemeasures could cause significant delays in our clinical and regulatory efforts,which is cri

285、tical to the realization of our business plan.Theaccompanying financial statements do not include any adjustments that may be necessary should we be unable to continue as a going concern.It isnot possible for us to predict at this time the potential success of our business.The revenue and income pot

286、ential of our proposed business andoperations are currently unknown.If we cannot continue as a viable entity,you may lose some or all of your investment.Our limited operating history as a development stage company may hinder our ability to successfully meet our objectives.We were formed in 2013,and

287、since that time our focus has been on our two leading product candidates,which are the PressureSafedevice,DiaSafe device.We have limited experience with development stage operations,including manufacturing and have not yet demonstratedan ability to successfully overcome many of the risks and uncerta

288、inties frequently encountered by companies in new and rapidly evolving fields,particularly in the medical device support systems arena.In addition,the early-stage nature of our development operations can only provide limitedoperating results upon which investors can evaluate our business and prospec

289、ts.252025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm28/153 Our limited operating history may adversely affect our ability to implement our business strategy and achieve our business goals

290、,whichinclude,among others,the following activities:developing our product candidates using unproven technologies;undertaking preclinical development and clinical trials as well as formulating and manufacturing products;obtaining the human,financial and other resources necessary to develop,test,manu

291、facture,commercialize and market our product candidates;engaging collaborators to assist in developing,testing,manufacturing and marketing our product candidates;continuing to build and maintain an intellectual property portfolio covering our technology and product candidates;achieving acceptance an

292、d use by the medical community of our Anticalin platform and drug candidates after they receive regulatory approvals;maintaining,growing and managing our internal teams as and to the extent we increase our operations and develop new segments of ourbusiness;developing and maintaining successful colla

293、boration,strategic and other relationships for the development and commercialization of ourproduct candidates that receive regulatory approvals with existing and new partners;and managing our cash flows and any growth we may experience in an environment where costs and expenses relating to clinical

294、studies,regulatory approvals and commercialization continue to increase.If we are unsuccessful in accomplishing any or all of these objectives,we may not be able to raise capital,expand our business,developour drug candidates or continue our operations.We may never achieve profitability.Because of t

295、he numerous risks and uncertainties associated with the development and commercialization of medical device solutions,weare unable to accurately predict the timing or amount of future revenue or expenses or when,or if,we will be able to achieve profitability.We havefinanced our operations primarily

296、through issuance and sale of equity and equity linked securities.The size of our future net losses will depend,inpart,on the rate of growth or contraction of our expenses and the level and rate of growth,if any,of our revenues.We expect to continue to expendsubstantial financial and other resources

297、on,among other things:investments to expand and enhance our platform and technology infrastructure,make improvements to the scalability,availability and securityof our platform,and develop new products;sales and marketing,including expanding our indirect sales organization and marketing programs;pla

298、nning and conducting clinical trials to obtain regulatory approval/clearance for the commercialization of our products;expansion of our operations and infrastructure,both domestically and internationally;and general administration,including legal,accounting and other expenses related to being a publ

299、ic company.If we are unable to successfully commercialize our products or if revenue from any of our products that receives marketing approval isinsufficient,we will not achieve profitability.Furthermore,even if we successfully commercialize our products,our planned investments may notresult in incr

300、eased revenue or growth of our business.We may not be able to generate net revenues sufficient to offset our expected cost increasesand planned investments in our business and platform.As a result,we may incur significant losses for the foreseeable future,and may not be able toachieve and sustain pr

301、ofitability.If we fail to achieve and sustain profitability,then we may not be able to achieve our business plan,fund ourbusiness or continue as a going concern.262025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/00016411

302、7225011913/forms-1a.htm29/153 Our quarterly results may fluctuate significantly,and period-to-period comparisons of our results may not be meaningful.Our quarterly results,including the levels of future revenue,if any,our operating expenses and other costs,and our operating margins,mayfluctuate sign

303、ificantly in the future,and period-to-period comparisons of our results may not be meaningful.This may be especially true to theextent that we do not successfully establish our business model.Accordingly,the results of any one period should not be relied upon as anindication of our future performanc

304、e.In addition,our quarterly results may not fully reflect the underlying performance of our business.Factors thatmay cause fluctuations in our quarterly results include,but are not limited to:the timing of regulatory commercial sale approvals for our products in various stages of development;the tim

305、ing of regulatory commercial sale approvals for our products in various stages of development;our ability to successfully establish our business model;our ability to attract and retain distribution networks,customers and to expand our business;enacted or pending legislation effecting the healthcare

306、industry;changes in our pricing policies or those of our competitors;the timing of our recognition of revenue and the mix of our revenues during the period;the amount and timing of operating expenses and other costs related to the maintenance and expansion of our business,infrastructure andoperation

307、s;the amount and timing of operating expenses and other costs related to the development or acquisition of businesses,services,technologies orintellectual property rights;the timing and costs associated with legal or regulatory actions;changes in the competitive dynamics of our industry,including co

308、nsolidation among competitors or customers;loss of our executive officers or other key employees industry conditions and trends that are specific to the vertical markets in which we sell or intend to sell our devices;and general economic and market conditions.Fluctuations in quarterly results may ne

309、gatively impact the value of our common stock,regardless of whether they impact or reflect theoverall performance of our business.If our quarterly results fall below the expectations of investors or any securities analysts who follow ourshares,or below any guidance we may provide,the price of our or

310、dinary shares could decline substantially.272025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm30/153 Currency exchange rate fluctuations affect our results of operations,as reported in our f

311、inancial statements.We incur expenses in U.S.Dollars and in NIS,but our functional currency is the U.S.dollar.However,a significant portion of ourheadcount-related expenses,consisting principally of salaries and related personnel expenses as well as R&D consulting services,leases and certainother op

312、erating expenses,are denominated in NIS.This foreign currency exposure gives rise to market risk associated with exchange ratemovements of the U.S.dollar against the NIS.Furthermore,we anticipate that a material portion of our expenses will continue to be denominated inNIS.In addition,increased inte

313、rnational sales in the future may result in greater foreign currency denominated sales,increasing our foreigncurrency risk.If we are not able to successfully hedge against the risks associated with currency fluctuations,our financial condition and results ofoperations could be adversely affected.Med

314、ical device development involves a lengthy and expensive process with an uncertain outcome.We may incur additional costs orexperience delays in completing,or ultimately be unable to complete,the development and commercialization of any product.Before the DiaSafe and the Nobiotics medical devices can

315、 be available for commercial sale the United States and in other countries,wemust complete all regulatory requirements necessitated by the FDA and foreign health regulatory authorities and demonstrate the performance andsafety of our technology.These activities will include performing clinical useab

316、ility studies.While we currently plan to pursue 510(k)approvalwhich does not require clinical trials,the FDA may require clinical trials in order to approve our product candidates.Clinical Trials are expensive,difficult to design and implement,can take years to complete and are inherently uncertain

317、as to outcome.A failure of one or more clinical trials canoccur at any stage of testing.Further,the outcomes of completed clinical trials may not be predictive of the success of later clinical trials,andinterim results of a clinical trial do not necessarily predict final results.Clinical data is oft

318、en susceptible to varying interpretations and analyses,andmany companies that have believed their products performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval.We have limited resources to complete the expensive process of medical device development,and cl

319、inical trials,putting us at a disadvantage,particularly compared to some of our larger and established competitors,and we may not have sufficient resources to commercialize our productsunder development in a timely fashion,if ever.We may experience numerous unforeseen events during or as a result of

320、 clinical trials that we may be required to perform that could delayor prevent our ability to receive marketing approval or commercialize our products,including:regulators may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;t

321、he failure to successfully complete clinical trials testing requirements required by the FDA and foreign health regulatory authorities;we may experience delays in reaching agreement(or fail in reaching agreement)on acceptable clinical trial contracts with third parties oracceptable clinical trial pr

322、otocols with prospective trial sites,the terms of which can be subject to extensive negotiation and may varysignificantly among trial sites;clinical trials of the technology underlying PressureSafe,DiaSafe s devices may produce negative or inconclusive results,including failureto demonstrate statist

323、ical significance,and we may decide,or regulators may require us,to conduct additional clinical trials or abandon ourdevelopment programs;the number of people with the necessary disorders required for clinical trials may be larger than we anticipate.Enrollment in these clinicaltrials may be slower t

324、han we anticipate.People may drop out of these clinical trials or fail to return for follow-up at a higher rate than weanticipate;our third-party contractors conducting the clinical trials may fail to comply with regulatory requirements or meet their contractual obligationsto us in a timely manner,o

325、r at all;the cost of clinical trials of our products may be greater than we anticipate;282025/5/22 10:19sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htmhttps:/www.sec.gov/Archives/edgar/data/1839133/000164117225011913/forms-1a.htm31/153 the supply or quality of our products or oth

326、er materials necessary to conduct clinical trials of our products may be insufficient or inadequate;and delays from our suppliers and manufacturers could impact clinical trial completion and impact future revenue.If we are required to conduct clinical trials or other testing of our proposed devices

327、under development beyond those that we contemplateor if the results of these trials or tests are not favorable or if there are safety concerns,we may:not obtain commercial sale approvals at all;be delayed in obtaining commercial sale approvals for our planned products under development in a jurisdic

328、tion;or be subject to additional testing requirements.Our development costs will also increase if we experience delays in testing or commercial sale approval from regulatory authorities.We donot know whether any of our clinical trials will begin as planned,will need to be restructured or will be com

329、pleted on schedule,or at all.Significantclinical trial delays also could allow our competitors to bring innovative products to market before we do and impair our ability to successfullycommercialize our products.Changes in the configuration of the technology underlying our devices under development

330、may result in additional costs or delay.As products are developed towards approval and commercialization,it is common that various aspects of the development program,suchas manufacturing methods and configuration,are altered along the way in an effort to optimize processes and results.Any changes we

331、 make carrythe risk that they will not achieve the intended objectives.Any of these changes could cause our products under development to perform differentlyand affect the results of planned clinical trials or other future clinical trials conducted with the altered device.Such changes may also requi

332、readditional testing,regulatory notification or regulatory approval.This could delay the completion of clinical trials,increase costs,delay approval ofour future products and jeopardize our ability to commence sales and generate revenue.We currently have one product that is approved for commercial s

333、ale.However,we are unable to predict if our additional products willreceive commercial sale approval from regulatory authorities as applicable.If we experience significant delays in doing so,our business will beadversely affected.We currently have one product that is approved for commercial sale.On April 9,2024,the PressureSafe decision support devicereceived an FDA listing certification.PressureS