UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

MARK ONE

☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

for the Quarterly Period ended September 30, 2021; or

☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

for the transition period from ________ to ________

Commission File Number: 333-255894

IR-Med, Inc.

(Exact name of registrant as specified in its charter)

+ 972-4-655-5054

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 15, 2021, 64,601,649 shares of the registrant’s common stock, par value $0.001 per share, were outstanding.

IR-MED, INC.

Form 10-Q

September 30, 2021

IR-MED, INC.

Interim Unaudited Condensed Consolidated Balance Sheets

The accompanying notes are an integral part of these interim unaudited condensed financial statements.

IR-MED, INC.

Interim Unaudited Condensed Consolidated Statements of Operations

The accompanying notes are an integral part of these interim unaudited condensed financial statements.

IR-MED, INC.

Interim Unaudited Condensed Consolidated Statements of Changes in Stockholders’ Equity (Deficit)

The accompanying notes are an integral part of these interim unaudited condensed financial statements.

IR-MED, INC.

Interim Unaudited Condensed Consolidated Statements of Changes in Equity (Deficit)

The accompanying notes are an integral part of these interim unaudited condensed financial statements.

IR-MED, INC.

The accompanying notes are an integral part of these interim unaudited condensed financial statements.

IR-MED, INC.

Notes to the Interim Unaudited Condensed Consolidated Financial Statements

Forward-looking Statements

This Quarterly Report on Form 10-Q contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws, and is subject to the safe-harbor created by such Act and laws. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential” or “continue,” the negative of such terms, or other variations thereon or comparable terminology. The statements herein and their implications are merely predictions and therefore inherently subject to known and unknown risks, uncertainties, assumptions and other factors that may cause actual results, performance levels of activity, or our achievements, or industry results to be materially different from those contemplated by the forward-looking statements. Except as required by law, we undertake no obligation to release publicly the result of any revision to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. Further information on potential factors that could affect our business is described under the heading “Risk Factors” in our registration statement on Form S-1 as filed with the Securities and Exchange Commission, or the SEC, on October 28, 2021As used in this quarterly report, the terms “we”, “us”, “our”, the “Company” and “IR-Med” mean IR-Med, Inc.. and our wholly-owned subsidiary IR. Med Ltd. unless otherwise indicated or as otherwise required by the context.

Overview

Through its subsidiary IR-Med Ltd, the Company is an innovative development stage medical device company that utilizes Infra-Red light spectroscopy (IR) combined with Artificial Intelligence (AI) technologies to address currently unmet medical needs. Our initial product candidates which are currently in various stages of development are non-invasive, user friendly and designed to address the medical needs of large and growing target patient groups by offering earlier and more accurate detection, reducing healthcare expenses and reducing the widespread reliance on antibiotics, optimizing the delivery of the targeted medical services and, as a result, improving the efficacy and safety of administered treatments.

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 uses algorithms to parse data, learn from it, and then make a determination or prediction about a given phenomenon. The machine is “trained” using large amounts of data and algorithms that provide it with the ability to learn how to perform the task.

The global diagnostics market is driven in large part by solutions that can be applied in healthcare settings, as these tools will drive decisions regarding specific treatments and the associated outlays. However, despite advances in medical imaging and other diagnostic tools, misdiagnosis remains a common occurrence. We believe that improved diagnoses and outcomes are achievable through the adoption of AI-based decision support tools.

Our initial focus is on the development of diagnostic supporting solutions utilizing our proprietary platform for the pre-emptive diagnosis of pressure injuries (PI) and of mid-ear infections detection Our current business plan focuses on two principal medical devices currently in development:

1. PressureSafe — a handheld optical monitoring device that is being developed to support early detection of pressure injuries (PI) to the skin and underlying tissue, primarily caused by prolonged pressure associated with bed confinement; and

2. Nobiotics, an innovative otoscope, being designed to support physicians with an immediate indication as to whether mid-ear infection (Otitis Media), a common malady in children, is of a bacterial origin and thus requiring antibiotic treatment, or of a viral origin and does not require antibiotic treatment.

Our product candidates are in various stages of development.

We are currently working on completing the development of first preliminary prototype of the PressureSafe device, incorporating a more advanced technology platform. We expect to complete the development of the PressureSafe prototype in the second quarter of 2022.

The Nobiotics device is planned to be an otoscope for supporting noninvasive detection of otitis media (ear infection). The device is in initial stages of development as an ear examination device.

Background on Pressure Injuries

PI is a significant challenge to care providers throughout the world. Failure to identify and treat PI is potentially fatal, with an estimated 60,000 mortalities from PI in the United States each year²⁴. Prevention of PI is a measure of quality in all healthcare settings. There are three main healthcare setting most prone to high frequency of PI - hospital settings, nursing homes and long term homecare.

To address the preemptive diagnosis of PI, we are developing a proprietary, user-friendly, non-invasive and real-time optical monitoring device combined with an AI based capabilities for pre-emptive detection of PI and for enhanced management of PI in different settings. The device is being designed to address the main diagnostic problems of identifying PI and differentiating between two main groups of PIs— Deep Tissue Injury (DTI) and Stage 1 PI (the first stage is most difficult to detect) three to four days before the PI becomes visible to the naked eye. The device is being designed to operate regardless of the skin type and skin complexion of the patient, which is a critical advantage. The device is being designed to include a disposable component, which will be attached to the tip of the device, where the infra-red light source and light collector are located, which is intended to come into contact with the individual’s skin surface. The disposable unit will be specific to each individual; hence any potential for cross infection of individuals is avoided. The disposable will be designed using high clarity polymer, to allow high light visibility through the disposable.

Preliminary clinical studies of PressureSafe proof of concept (POC) unit have been carried out in Israel and additional clinical useability studies with PressureSafe prototype are expected in the first half of 2022.

Ear Infection Background

An ear infection is an inflammation of the middle ear, usually caused by bacteria or a virus, which occurs together with fluid builds up behind the eardrum. Three out of four children will have at least one ear infection by their third birthday²⁵. In fact, ear infections are the most common reason parents bring their child to a doctor.

The presence of middle ear fluid is the key diagnostic marker for the two most common pediatric ear diseases, acute otitis media (AOM) and otitis media with effusion (OME)²⁶.

AOM, known commonly as an “ear infection” is characterized by the presence of infected fluid in the middle ear and results in symptoms of fever and ear pain. It is a leading cause of pediatric healthcare visits, and although many cases can resolve without antibiotics, complications may include eardrum perforation, mastoiditis, facial nerve palsy, or meningitis.

OME is the presence of middle ear fluid without signs of an acute infection and affects up to 80% of children. Although OME has few overt symptoms, making diagnosis more difficult, it is associated with speech delay, sleep disruption, poor school performance, balance issues, and a higher likelihood of developing AOM.

The simplest way for a doctor to diagnose an ear infection is by using an otoscope, a lighted instrument, to view and assess the eardrum. A red, bulging eardrum indicates an infection.

²⁴ Market Research Future, 2020. Global Ear Infection Treatment Market: Information By Type (Middle Ear, Outer Ear, Inner Ear), By Pathogen (Bacteria, Virus), By Treatment (Surgery, Medication), By End User (Hospitals, ENT Clinics) and Region (Americas, Europe, Asia-Pacific and the Middle East & Africa) - Forecast till 2027.

²⁵ Thomas, J., Berner, R., Zahnert, T. and Dazert, S., 2014. Acute Otitis Media. Deutsches Aerzteblatt Online,.

26 Thomas, J., Berner, R., Zahnert, T. and Dazert, S., 2014. Acute Otitis Media. Deutsches Aerzteblatt Online,.

Other methods a doctor can use include: (i) Pneumatic otoscope, which blows a puff of air into the ear canal, this allows the doctor to observe the eardrum movement. A normal eardrum will move back and forth more easily than an eardrum with fluid behind it; and (ii) Tympanometry, this is soft plug that contains a miniature microphone and speaker as well as a device that varies air pressure in the ear, measuring how flexible the eardrum is at different pressures.

Many doctors will prescribe an antibiotic, such as amoxicillin, to be taken over seven to 10 days. The doctor also may recommend over-the-counter pain relievers such as acetaminophen or ibuprofen, also as eardrops, to help with fever and pain.

If the doctor is not able to make a definite diagnosis of OME and the child does not have severe ear pain or a fever, the doctor may suggest waiting a day or so to see if the earache goes away. Today, when a child has ear pain, the doctor will check the ear but unless there is a clear visible need, he/she will probably not give any treatment beside pain relief - due to simple fact that he/she cannot determine if the infection is Viral – which no antibiotic should be given or Bacterial which will require antibiotic treatment.

Nobiotics

The Nobiotics device is planned to be an otoscope for supporting noninvasive detection of otitis media (ear infection). The device is in initial stages of development as an ear examination device that will give the physician an immediate indication if the infection is from a Viral or Bacterial source. The device works on a similar IR-spectrographic analysis method as being developed in the PressureSafe device. The Nobiotics otoscope is based on infrared light reflection and absorption by the effluents behind the ear drum. Reflected (and absorbed infrared light) is compared continuously to the emitted light. Light changes as it penetrated and reflected through different tissues.

Otoscopes are considered a required device by any physicians performing physical diagnoses. Target customers for the Nobiotics device are general practitioners (GPs), pediatricians and ear nose and throat (ENT) specialists.

Recent Developments

Reverse Merger

On September 3, 2020, IR-Med Inc. and IR-Med Ltd. and the former stockholders of IR-Med Ltd. entered into a Securities Exchange Agreement (the “Acquisition”) pursuant to which the stockholders of IR-Med Ltd. contributed all of their equity interests in IR-Med Ltd. to IR-Med Inc. in exchange for shares of IR-Med common stock, which resulted in IR-Med Ltd. becoming a wholly owned subsidiary of IR-Med Inc., which we refer to as the Acquisition. The Acquisition closed on December 24, 2020.

Private Placement

In connection with the Acquisition, we held on December 24, 2020, an initial closing on a private placement of our securities with certain accredited investors providing for the issuance and sale to such investors of units of our securities (the “2020 Private Placement”), with each unit comprised of (i) two (2) shares of our common stock, par value $0.001 per share (the “Common Stock”) and (ii) one (1) common stock purchase warrant to purchase an additional share of Common Stock (the “Warrant”), at a per unit purchase price of $0.64. The Warrant is exercisable through December 28, 2023 at a per share exercise price of $0.64. At the initial closing of the 2020 Private Placement, we raised aggregate gross proceeds of $2,306,000, prior to payment of offering related expenses of $161,000.

Between January and April 10, 2021, we raised additional approximate gross proceeds to the Company from the 2020 Private Placement of $3,525,000.

Comparison of the Three and Nine Months Ended September 30, 2021 to the Three and Nine Months Ended September 30, 2020

Revenues. We have not recorded any revenues to date.

Research and Development Expenses, Research and development expenses increased from $46,000 and $192,000 for the three and nine months ended September 30, 2020, respectively, to $374,000 and $869,000, respectively, for the corresponding periods in 2021. The increase in each of the three and nine months periods resulted primarily from the recruitment of employees, increased use of third party contractors for further research and development activities and the recording of non-cash expenses resulting stock based compensation to employees and service providers awarded in June 2021.

Marketing Expenses -During the nine months ended September 2021 we started to expend efforts to develop the marketing strategy for PressureSafe. In connection therewith, we recorded $61,000 and $824,000 for the three and nine months ended September 2021, respectively, which includes non-cash expenses attributable to stock based compensation to employees and service providers awarded in June 2021.

General and Administrative Expenses. General and administrative expenses increased from $34,000 and $145,000 for the three and nine months ended September 30, 2020, respectively, to $287,000 and $977,000 for the corresponding periods in 2021. The increase is primarily due to the increased resulted primarily from recruitment of new employees, patent registration in the U.S. accounting/audit related expenses and the recording of non-cash expenses due to stock based compensation to employees and service providers awarded in June 2021.

Loss. Loss for the three months and nine months ended September 30, 2021 was $730,000 and $2,696,000, respectively, and is primarily attributable to research and development, marketing activities, general and administrative expenses and the recording of non-cash expenses attributable to stock based compensation to employees and service providers awarded in June 2021.

Liquidity and Capital Resources

From inception, we have funded our operations from a combination of loans and sales of equity instruments. Between December 24, 2020 and April 10, 2021, we raised aggregate gross proceeds in the approximate amount of $5.83 million.

As of September 30, 2021, we had a total of $3,550,000 in cash resources and approximately $408,000 of liabilities, consisting of $238,000 of current liabilities from operations. ,

We have experienced operating losses since its inception and had a total accumulated deficit of $4,176,000 as of September 30, 2021. We expect to incur additional costs and require additional capital. We have incurred losses in nearly every year since inception and in the nine months ended September 30, 2021. These losses have resulted in significant cash used in operations. During the nine months ended September 30, 2020 and 2021, our cash used in operations was approximately $279,000, and $1,660,000, respectively. We need to continue and intensify our research and development efforts for our product candidates (which are in various stages of development), strengthen our patent portfolio, establish operations processes and pursue FDA clearance and international regulatory approvals. As we continue to conduct these activities, we expect the cash needed to fund operations to increase significantly over the next several years.

At the initial closing of the 2020 Private Placement, we entered into a securities purchase agreement with certain accredited investors providing for the issuance and sale to such investors of an aggregate of 7,206,250 shares of our Common Stock and warrants for an additional 3,603,125 shares of our Common Stock, exercisable through December 28, 2023, at a per share exercise price of $0.64. After deducting for offering related expenses, the aggregate net proceeds from the initial closing of the 2020 Private Placement were approximately $2.14 million. Between January and April 2021, we raised an additional $3,525,000 in gross proceeds from the 2020 Private Placement.

Even after giving effect to the proceeds of the 2020 Private Placement, we will need to obtain additional funding in order to pursue our business plans. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

We expect that our existing cash and cash equivalents will enable us to fund our operations and capital expenditure requirements for the next twelve months. Our requirements for additional capital during this period will depend on many factors, including the following:

We cannot be sure that future funding will be available to us on acceptable terms, or at all. Due to often volatile nature of the financial markets, equity and debt financing may be difficult to obtain.

We may seek to raise any necessary additional capital through a combination of private or public equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements and other marketing and distribution arrangements. To the extent that we raise additional capital through marketing and distribution arrangements or other collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights, future revenue streams, or product candidates or to grant licenses on terms that may not be favorable to us. If we raise additional capital through private or public equity offerings, the ownership interest of our existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.

Off-Balance Sheet Arrangements

We do not have any off-balance sheet arrangements.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

Not Applicable.

ITEM 4. CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

As of September 30,. 2021, we conducted an evaluation under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, regarding the effectiveness of the design and operation of our disclosure controls and procedures as defined in Rule 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934 (the “Exchange Act”). The term “disclosure controls and procedures” means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the requisite time periods and that such disclosure controls and procedures were effective to ensure that information required to be disclosed by the company in the reports that it files or submits under the Exchange Act is accumulated and communicated to its management, including its principal executive and principal accounting officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. Based on the evaluation of our disclosure controls and procedures as of September 30, 2021, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were not effective at reasonable assurance level due to a material weakness in internal control over financial reporting, as further described below.

Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis. The limitation of our internal control over financial reporting was due to the applied risk-based approach which is indicative of many small companies with limited number of staff in corporate functions implying:

Our management believes the weaknesses identified above have not had any material effect on our financial results.

We are committed to maintaining a strong internal control environment and are exploring appropriate remediation options to address the identified material weaknesses.

Changes in Internal Control Over Financial Reporting

Except for the material weakness, during the quarter ended September 30, 2021, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II—OTHER INFORMATION

From time to time we may become involved in various legal proceedings that arise in the ordinary course of business, including actions related to our intellectual property. Although the outcomes of these legal proceedings cannot be predicted with certainty, we are currently not aware of any such legal proceedings that arise in the ordinary course of business, including actions related to our intellectual property. Although the outcomes of these legal proceedings cannot be predicted with certainty, we are currently not aware of any such legal proceedings or claims that we believe, either individually or in the aggregate, will have a material adverse effect on our business, financial condition, or results of operations.

An investment in the Company’s Common Stock involves a number of very significant risks. You should carefully consider the risk factors included in the “Risk Factors” section of our Registration Statement on Form S-1, as filed with the SEC on October 28, 2021, in addition to other information contained in our reports and in this quarterly report in evaluating the Company and its business before purchasing shares of our Common Stock. There have been no material changes to our risk factors contained in such registration statement.

None.

None.

None.

None

Exhibit Index:

* Filed herewith

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

IR-Med, Inc.

(Registrant)