NUMD 10-K
Nu-Med Plus, Inc. (NUMD)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
[
For the fiscal year ended
For the transition period from ________ to __________
Commission File Number:
(Exact name of registrant as specified in charter)
| (State or other jurisdiction of Incorporation or organization) | (I.R.S. Employer I.D. No.) |
| (Address of principal executive offices | (Zip Code) |
Issuer's telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Securities registered under Section 12(g) of the Act: Common Stock
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
Yes [ ]
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act.
Yes [ ]
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 past 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.
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
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required to submit and post such files).
Indicate by check mark if disclosure of delinquent filers in response to Item 405 of Regulation S-K is not contained herein, and not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ]
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 definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer [ ] | Accelerated filer [ ] |
| Smaller reporting company [ | |
| Emerging Growth company [ |
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 checkmark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to §240.10D-1(b). [ ]
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes [ ] No [
State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, or the average bid and asked prices of such common equity, as of the last business day of the registrant’s most recently completed second fiscal quarter: At June 30, 2025, the Company’s last sale price of its stock was $0.0740 resulting in an aggregate market value of our common stock held by non-affiliates of $
Applicable Only to Issuers Involved in Bankruptcy Proceedings During the Preceding Five Years:
Indicate by check mark whether the Registrant has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.
Not applicable.
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Applicable Only to Corporate Issuers:
Indicate the number of shares outstanding of each of the Registrant’s classes of common equity, as of the latest practicable date.
Class | Outstanding as of April 15, 2026 |
| Common Stock |
Documents incorporated by reference:
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TABLE OF CONTENTS
PART I
| Item 1. | Business | 5 |
| Item 1A. | Risk Factors | 13 |
| Item 1C. | Cybersecurity | 17 |
| Item 2. | Properties | 18 |
| Item 3. | Legal Proceedings | 18 |
| Item 4. | Mine Safety Disclosure | 18 |
PART II
| Item 5. | Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 18 |
| Item 6. | [Reserved] | 18 |
| Item 7. | Management's Discussion and Analysis of Financial Condition and Results of Operations | 19 |
| Item 8. | Financial Statements and Supplementary Data | 20 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 20 |
| Item 9A. | Controls and Procedures | 20 |
| Item 9B. | Other Information | 21 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions that Prevent Inspections | 21 |
PART III
| Item 10. | Directors, Executive Officers and Corporate Governance | 22 |
| Item 11. | Executive Compensation | 23 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 25 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 26 |
| Item 14. | Principal Accounting Fees and Services | 27 |
PART IV
| Item 15. | Exhibits, Financial Statement Schedules | 27 |
| Signatures | 29 | |
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PART I
ITEM 1. BUSINESS
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Certain statements in this Report constitute “forward-looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that might cause such a difference include, among others, uncertainties relating to general economic and business conditions; industry trends; changes in demand for our products and services; uncertainties relating to customer plans and commitments and the timing of orders received from customers; announcements or changes in our pricing policies or that of our competitors; unanticipated delays in the development, market acceptance or installation of our products and services; changes in government regulations; availability of management and other key personnel; availability, terms and deployment of capital; relationships with third-party equipment suppliers; and worldwide political stability and economic growth. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date the statement was made.
Corporate History
NU-MED PLUS, INC., a Utah corporation (“NU-MED” or the “Company”) was incorporated in October 2011 in the state of Utah to develop, manufacture and market new technologies utilizing nitric oxide in the medical device field, primarily through the creation of a nitric oxide generating compound formulation and delivery systems. To date we have developed a hospital nitric oxide delivery system, a clinical nitric oxide delivery system, a mobile rechargeable device to deliver nitric oxide gas, and a nitric oxide system that can be used for research applications. NU-MED is headquartered in Salt Lake City, Utah.
EMERGING GROWTH COMPANY STATUS
As part of the Jumpstart Startups Act of 2012 (“JOBS ACT”), companies with less than $1.0 billion in gross revenue can qualify as an “emerging growth company.” We will qualify as an emerging growth company as defined in the JOBS Act, and, as such, we are eligible to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, (i) not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002, (ii) reduced disclosure obligations regarding executive compensation in our periodic and annual reports, (iii) not being required to comply with certain new requirements adopted by the Public Company Accounting Oversight Board, or the PCAOB, and (iv) not being required to obtain stockholder approval of any golden parachute payments not previously approved. We intend to take advantage of the reduced disclosure obligations. Additionally, we qualify as a “Smaller Reporting Company” and also have the advantage of not being required to provide the same level of disclosure as larger companies. Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in the Securities Act for complying with new or revised accounting standards. In other words, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(2) of the Jobs Act, that allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, our financial statements may not be comparable to companies that comply with effective public company dates.
We could remain an emerging growth company for up to five years, or until the earliest of (i) the last day of the first fiscal year in which our annual gross revenues exceed one billion dollars, (ii) the date that we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, as amended, or the Exchange
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Act, which would occur if the market value of our common units that are held by non-affiliates exceeds $700.0 million as of the last business day of our most recently completed second fiscal quarter, and (iii) the date on which we have issued more than $1.0 billion in non-convertible debt during the preceding three-year period. At this time, we expect to remain both a “Smaller Reporting Company” and “Emerging Growth Company” for the foreseeable future.
Business
NU-MED was organized as a medical device company principally engaged in the design, innovation, development, enhancement and commercialization of beginning, early, and selective later-stage quality medical devices. The mission of NU-MED is to design, develop, and market technologies utilizing nitric oxide in the medical device field. Our technologies are focused on market niches in high growth trend areas. Our products are developed to target a current need in medical procedures by improving upon an existing technology or device or by designing a device to serve a currently unfilled need that is clearly defined and acknowledged by medical professionals. Our focus to date has been on the creation of a nitric oxide generating formulation, a hospital bedside nitric oxide delivery system, a clinical unit for use in medical clinics and rehabilitation centers and a mobile rechargeable device to deliver nitric oxide gas to offer solutions to the medical community throughout the world.
Products
Development of our products has been suspended until such time as a capital infusion is received which will enable the funding of further development. The following is a description of the medical application for the products that have been under development and the status of each of those products:
Nitric oxide is an extremely important bio-mediator in the human body that is produced from the amino acid l-arginine. Nitric oxide has anti-inflammatory properties, antibacterial, antiviral and antifungal properties which make it useful in certain medical treatments. At the present time inhaled nitric oxide (INO) is used as a selective vasodilator in infants. The only FDA approved use of nitric oxide at this time is for the treatment of Hypoxia in premature infants and newborn babies. Management is not aware of any other potential uses of nitric oxide that have been cleared by the FDA, but this may change as new submittals are made. The heavy cost of delivering nitric oxide to patients has created limitations in its use. Discoveries that have been made since the first FDA approved use of nitric oxide in 1999 have led to a number of new potential uses, which still need FDA approval, in a wide variety of diseases and health complications, including COPD, flu viruses, bacterial infections, tuberculosis, non-healing wounds, head injuries and much more. NU-MED hopes to take advantage of the expanding medical uses of nitric oxide by developing a new method to generate nitric oxide that reduces the delivery costs and can be used in a variety of medical and research settings. Given NU-MED’s size, we do not anticipate being involved in any clinical studies on new uses of nitric oxide and will rely on other parties to continue to advance the uses of nitric oxide.
NU-MED PLUS has focused on the development of five distinct products for the delivery of nitric oxide. NU-MED products have not been fully developed; therefore, we have not made any submission for FDA approval under any medical use.
| 1. | Nitric oxide proprietary formulation. Generates nitric oxide gas on demand, eliminating the need for |
compressed gas cylinders.
2. A hospital delivery device with controls and safety monitors built in that delivers inhaled nitric oxide to a patient at therapeutic levels. This delivery system is intended for hospitals, specifically intensive care units. The goal is to have a system that delivers a metered therapeutic dose (up to 40 ppm) of nitric oxide via a ventilator. The core technology allows dilution of nitric oxide to therapeutic levels to be accomplished without the use of injectors or valves. Safeguards such as concentration monitoring, flow and gas purity would be standard.
3. A clinical delivery unit that is designed for treatment in an office or physician’s clinic. A unit powered by a wall outlet, administration of the nitric oxide would be via cannula or non-rebreather face mask
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4. A compact, mobile/portable rechargeable device to deliver inhaled nitric oxide gas. The portable system necessitates a design which can be deployed where a reliable source of power is not available or is difficult to access. The key feature is a rechargeable battery pack that powers the unit for the full duration of a therapeutic session. It can be recharged using existing electrical sources, a solar array or other alternative energy sources. The unit is designed as a low power but fully functional nitric oxide delivery system for inhalation therapy, that can be used as a transport device during the movement of a patient or as a delivery device in those remote areas of the world that do not currently have electrical power readily available.
5. A disposable unit that will deliver a therapeutic dose of nitric oxide to a patient and will then be placed into a container to be incinerated. This unit would be used for the treatment of patients in a pandemic, where a large number of patients must be treated and there is insufficient capacity to sterilize the unit after use by each patient. The dispensing devices would be isolated and destroyed after use to ensure that another patient is not exposed to the bacteria or virus carried by the patient originally treated.
6. A unit that is one of the world’s first nitric oxide dilution systems designed for research. A patent pending technology utilizes pure 100% nitric oxide from a pressurized tank source and dilutes it with air or other non-reactive diluent gas to provide a 1 to 500 ppm source of high purity nitric oxide for investigational applications.
The principal gas we aim to generate through each of our systems described above is medical grade nitric oxide, along with other various combinations of beneficial medical gases. Non-medical grade nitric oxide gas is produced and sold commercially by major gas companies as a specialty gas mixture and calibration gas. Nitrogen dioxide is present in all nitric oxide gas currently produced. Its presence limits the size of the dose of nitric oxide gas that can be administered for prospective uses in both humans and animals.
A longer-term goal is to further develop our proprietary compound formulation option that will be utilized to produce medical-grade nitric oxide for use in all delivery units. Management believes that with the further refinement of our formulation, we can make and filter medical grade nitric oxide gas with minimal amounts of nitrogen dioxide, and that this process can produce medical grade nitric oxide gas in ample quantities for any current or prospective use and hopefully at a price less than that of all currently available technologies. For a number of years, the only approved and available medical grade nitric oxide delivery device was a product named Inomax. Since this is a single source market there is no price competition and price is set at a "market can bear" level. We believe, given this structure, there is ample room for a competitive response from NU-MED using on site generated nitric oxide at a lower cost to penetrate the market. The cost of materials and labor for the NU-MED product is anticipated to be low, while still providing attractive margins. Our product must have a known shelf life and be available in various configurations to yield known concentrations and volumes of gas. Packaging is a critical developmental process that we will address after completion of our formulation.
We approximate that the sale of our research unit for non-clinical laboratory work could take place earlier than FDA approval. Management anticipates that selling our units earlier into the market as laboratory equipment or to international groups will pave the way for sales of our medical delivery devices, but any financial contributions from intellectual property licenses and sales and other non-medical sales will not be adequate to fund the substantial costs of the FDA approval process for human medical uses. Even with sales to laboratories or other uses, we will require additional funding, which we currently do not have in place and have no assurance that we will be able to obtain, or to obtain at acceptable rates.
All human medical uses of nitric oxide gas require FDA approval prior to initiating sales in the United States and the approval of similar international agencies in their respective countries. Approval can be a long and expensive process, with no assurance that any such approval can or will be obtained. Our products from the compound formulation for nitric oxide to our delivery machines will have to be approved by the FDA prior to any sales for human use. Although the FDA can approve “uses” for nitric oxide and such uses can be expanded, our products, both the formulations and equipment, would also have to be approved to be used in association with the treatment using nitric oxide. Accordingly, although the use of nitric oxide for the treatment of hypoxia in newborns is approved by the FDA, we still will need to have our dispensing unit and compound approved by the FDA for such treatment. In order for our
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dispensing unit to be used we would not have to prove the efficacy of the treatment but only that our product and compounds are “substantially equivalent” to those already approved by the FDA. Even this level of approval requires time, carries substantial costs, and creates additional uncertainty as to our ability to bring a product to the marketplace. We currently do not have the funds to seek such approval. We are currently working to secure funding that will enable us to submit the hospital unit for FDA approval.
Current Product Development Status
Following is a discussion of the development state of each of the products. However, no further development work is planned until such time as adequate funding is in place to ensure the products can be finalized, tested and made ready for submission of approval to the FDA.
Hospital NO Unit. Our team has created an initial prototype and is nearing completion of the first production unit for use as a hospital nitric oxide gas delivery system. The device delivers a continuous intra-breath concentration of therapeutic NO to patients who are on a ventilator in a hospital setting. We are performing internal testing on the accuracy of the machine and dosage prior to moving forward with any animal or human tests. With any medical product, it will take a period of refinement and testing before the product is ready for the market.
Clinical Delivery System. The clinical system is a simplified version of the hospital unit. While it can be used in a hospital setting it was designed to be operated and used in a less medically intensive environment, such as a doctor’s office or physician’s clinic and does not incorporate the alarms needed in an intensive care setting. It is a smaller and more portable unit, lending itself to clinical use on an as needed basis, rather than full-time use for which the hospital unit is designed. Administration is via nasal cannula or non-rebreather face mask. Similar to a dialysis center concept, patients would be treated with nitric oxide in a clinical setting on an as needed basis.
Portable Delivery System. Nu-Med has also developed a prototype lightweight Portable NO Delivery System that can be worn comfortably by patients outside of the hospital setting for underserved chronic therapies, and for applications within the United States and in developing nations. This product has the capability to deliver high purity NO to the patient at prescribed intervals for 24 hours per day at controlled doses by means of a nasal cannula or a face mask. As with our hospital unit, we are in the preliminary testing phase and do not anticipate any commercialization in the near future.
Reagent Delivery. During development of the Nu-Med line of medical nitric oxide delivery systems it was discovered that a system could be built that would provide the research community with a variable concentration source of nitric oxide for conducting research and experiments. A preliminary system has been built that can provide a wide range of concentrations and flow rates of NO. This was reduced to practice and a delivery system is now available for research use.
Future Product Development. Utilizing our core technology, our newest product to be investigated is a one-time Single Treatment Disposable unit which will give rapid access to short-term NO treatment. The entire unit is disposed of after treatment and is unique in the marketplace, with no competitive product available. We also are investigating a Wound Healing System which may reduce the surgical loss of a partial or full foot for diabetics by healing diabetic wounds and sores caused by their disease.
Existing Clinical Applications of Inhaled Nitric Oxide and Potential Markets
Nitric oxide can be safely inhaled utilizing our delivery device, through a ventilator, face mask, by nasal cannula, or via an endotracheal tube. An ideal inhaled NO delivery device requires delivery synchronized with respiration and minimal production of NO2 and should be simple to use with full monitoring capacity (high and low alarms and precise monitoring of NO, NO2, and O2). Our delivery devices were designed with all of these requirements in mind. As a result, we believe it will be the best and most efficient delivery system available when it is commercialized.
Since the inception of the only FDA approved treatment of hypoxia in newborns with nitric oxide (INOMAX from
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Ikaria Holdings) initial research has shown approximately 394,000 patients have been treated worldwide over a ten-year period. Management believes the cost of a typical nitric oxide delivery system is approximately $30,000 each. Market expansion in the US will occur based on FDA approval for other medical uses of nitric oxide therapies.
Competition
Large companies with established brand names have a distinct advantage in the medical device arena. The cost of developing a device, followed by the costs of testing and licensing, favor larger, well-financed and established companies. It will be difficult for NU-MED to compete in this industry, and we will be required to focus on the niche products if we hope to be able to compete. The number of companies that have a product or products involving nitric oxide and free radicals is quite large and difficult to determine precisely as this is not the focus of these companies.
In addition to companies that may be working on similar solutions in the nitric oxide space but have not been public in any product offerings, NU-MED considers the following companies as direct competitors in the nitric oxide market space which they anticipate entering. This does not preclude that large pharmaceutical or medical supply companies will enter the critical care market with substantially similar products or systems.
Mallinckrodt Inc. acquired the company which, at that time, had the only FDA approved nitric oxide (INOMAX) delivery system for use in medical facilities. The FDA approval is limited to the treatment of persistent pulmonary hypertension in newborns (PPHN). Mallinckrodt Inc. has submitted several other specific medical uses of nitric oxide to the FDA for approval. The INOMAX system consists of a pressurized tank source of nitric oxide gas and a delivery and monitoring system and is intended for non-portable hospital use.
GeNO LLC is a technology company focused on their GeNOsyl Nitrosyl system of nitric oxide generation and delivery. This is a unique patented system based on the conversion of nitrogen dioxide/dinitrogen tetroxide to pure nitric oxide. Several delivery platforms have been submitted for FDA approval. The FDA has approved the GeNOsyl Advanced Delivery System (ADS) for use with neonates.
Beyond Air (formerly AIT Therapeutics) (AITB) is a company that has acquired technology that produces nitric oxide from air through electrical discharge. They are currently in clinical trials testing the product for use in the treatment of cystic fibrosis and chronic obstructive pulmonary distress.
Many of our competitors, either alone or with their strategic partners, may have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of product candidates, obtaining FDA and other regulatory approvals of products, and the commercialization of those products. Accordingly, our competitors may be more successful than we may be in obtaining approval for therapies or delivery hardware and achieving widespread market acceptance. We anticipate that we will face intense and increasing competition as new drugs and advanced technologies become available.
Employees
The Company currently has two employees and relies on its officers and consultants for most of its activities.
Regulations
Our proposed products would use nitric oxide gas for use in medical treatment. Accordingly, our products will require prior FDA Class II approval. We have not submitted our products for approval, and it is expected to take many years and may not be obtained, even after expending substantial resources in such efforts. Various laws and regulations govern or influence the research and development, manufacturing, safety, labeling, storage, record keeping and marketing of our products. The lengthy process of seeking these approvals and the subsequent compliance with applicable laws and regulations require the expenditure of substantial resources. Any failure by us to obtain or maintain, or any delay in obtaining or maintaining, regulatory approvals could materially adversely affect our business. Our policy will be to conduct our research and development activities in compliance with current FDA guidelines and
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with comparable guidelines in other countries where we may be conducting clinical trials or other developmental activities.
The following is a brief summary of applicable governmental regulations to which we may be subject in our planned business operations related to the use of our products in the medical field. It should be noted that the application for FDA regulatory approval of our devices is a long and costly pathway. As we do not currently have the capital to engage in any regulatory approval, for the foreseeable future we will be focused on the development of our technology and additional patent applications.
Clinical testing, manufacturing and marketing of human pharmaceutical products require prior approval from the FDA and comparable agencies in foreign countries. The FDA has established mandatory procedures and safety and efficacy standards that apply to the testing, manufacture and marketing of such products in the United States. In the United States, these procedures include pre-clinical studies, the filing of an Investigational New Drug Application ("IND") or equivalent, human clinical trials and approval of a New Drug Application ("NDA"). The results of pre-clinical testing, which include laboratory evaluation of product chemistry and animal studies to assess the potential safety and efficacy of the product and its formulations, must be submitted to the FDA as part of an IND that must be reviewed before clinical testing can begin.
The results of the preclinical and clinical testing are then submitted to the FDA in the form of an NDA for approval to commence commercial sales. The FDA may, in responding to an NDA, grant marketing approval, request additional information or deny the approval if it determines that the NDA does not provide an adequate basis for approval. Among the conditions for an NDA approval is the requirement that the prospective manufacturer's quality control and manufacturing procedures conform on an ongoing basis with current Good Manufacturing Practices ("GMP"). In complying with GMP, we must continue to expend time, money and effort in the areas of production and quality control to ensure full compliance or engage the services of outside contractors who are well versed in compliance with these requirements. Following approval of the NDA, we are subject to periodic inspections by the FDA. Any determination by the FDA of manufacturing deficiencies could materially adversely affect our business.
European countries generally follow the same procedures. The European Union has established a unified filing system administered by the Committee for Proprietary Medicinal Products ("CPMP") designed to reduce the administrative burden of processing applications for pharmaceutical products derived from new technologies. Following CPMP review and approval, marketing applications are submitted to member countries for final approval and pricing approval, as appropriate. In addition to obtaining regulatory approval of products, it is generally necessary to obtain regulatory approval of the facility in which the product will be manufactured. The approval process for medical devices in Europe is similar but is administered by private certification organizations known as Notified Bodies, which are accredited by each member state of the European Union. The receipt of regulatory approvals often takes several years, involves the expenditure of substantial resources and depends on a number of factors, including the severity of the disease in question, the availability of alternative treatments and the risks and benefits demonstrated in clinical trials. On occasion, regulatory authorities may require larger or additional studies, leading to unanticipated delay or expense. There can be no assurance that any approval will be granted and, even if granted, such approval may be withdrawn if compliance with regulatory standards is not maintained. In addition, the regulatory approval processes for products in the U.S., European countries and other countries around the world are undergoing or may undergo changes, and we cannot predict what effect any changes in the regulatory approval process may have on our business.
Clinical testing of an unapproved significant-risk medical device requires FDA approval in the form of an Investigational Device Exemption (IDE). The IDE application provides information to the FDA on device design and qualifications, as well as on the study protocol. The FDA is mandated to respond to the IDE application within 30 days. An IDE may also be required for studies in which an approved device is used for a purpose distinct from its approved indication. This is typically the case when a trial is sponsored by a company for the purpose of expanding the indication of a device or making significant changes in the instructions for use.
Medical devices are regulated in the United States by the Center for Devices and Radiological Health (CDRH) of the FDA. The FDA/CDRH mandate is to promote and protect public health by making safe and effective medical devices
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available in a timely manner. The standard for demonstrating safety and effectiveness is determined in part by the risk associated with the device in question. Devices are classified according to their perceived risk using a 3-tiered system (Class I, II, or III).
Class I devices (lowest risk) are subject to general controls, which are published standards pertaining to labeling, manufacturing, post-market surveillance, and reporting. Devices are placed into Class I when there is reasonable assurance that general controls alone are adequate to assure safety and effectiveness. The general controls that typically apply to Class I devices include prohibitions against adulteration and misbranding, requirements for establishing registration and device listing, adverse event reporting, and good manufacturing practices. Furthermore, remedies including seizure, injunction, criminal prosecution, civil penalties, and recall authority are provided to the FDA. Formal FDA review is not required for most Class I devices before their market introduction.
Class II devices are those higher-risk devices for which general controls alone have been found to be insufficient to provide reasonable assurance of safety and effectiveness, but for which there is adequate information available to establish special controls. Special controls may include performance standards, design controls, and post-market surveillance programs. In addition, most Class II devices require FDA clearance of a premarket notification application (PMA or 510(k)) before the device may be marketed. In the 510(k) applications, the medical device manufacturer must provide data to demonstrate that the new device is “substantially equivalent” to a legally marketed device. Although substantial equivalence can usually be demonstrated on the basis of bench and animal testing alone, approximately 10% of 510(k) applications include clinical data.
Class III devices, such as heart valves, pacemakers/implantable cardioverter-defibrillators, and coronary stents, are judged to pose the highest potential risk. These devices are either life-sustaining/supporting, of substantial importance in preventing impairment of human health, or present a high risk of illness or injury. Consequently, general and special controls alone are inadequate to provide reasonable assurance of safety and effectiveness. Most Class III devices require FDA approval of a PMA before they can be legally marketed. Approval of the PMA generally requires clinical data demonstrating reasonable assurance that the device is safe and effective in the target population.
The Human Device Exemption (HDE) is a new pathway to allow for commercialization of Class III devices designed to address small markets, i.e., diseases or conditions that affect fewer than 4,000 patients in the United States each year. Approval of an HDE requires demonstration that the device is safe and the probable benefits outweigh the probable risks. Although the process may require smaller clinical trials, an HDE device must continue to operate under local IRB approval at each participating institution and must continue to collect case report forms akin to an ongoing clinical trial. The PMA process typically involves a series of studies starting with first clinical use and culminating in a multicenter, prospective randomized control trial (pivotal trial). The complexity and extent of the clinical testing program is dictated by the nature of the device and its proposed use. The clinical study program is developed by the company in conjunction with clinician investigators, all in close collaboration with the FDA/CDRH.
The first and arguably most important step in this process is the pre-IDE meeting, in which the company, often accompanied by the lead clinical investigator(s), meets with the FDA/CDRH to present data about the device, its clinical development program, and its intended use after approval. The FDA/CDRH staff reviews existing bench and animal data (as well as any outside-the-United States clinical data) and makes informal, non-binding suggestions regarding the need (if any) for additional pre-clinical data (bench and animal), as well as the study design. The sponsor then submits an IDE application to the FDA/CDRH for formal review.
Clinical development of a new Class III device is typically divided into pilot and pivotal trial phases. The purpose of the pilot phase (starting with first clinical use) is to establish safety and to assist in design of the pivotal trial. Pilot-phase testing is typically limited to fewer than 100 patients treated at a few centers. The purpose of the pivotal trial is to generate data that defines patient populations in which use of the device is safe and effective. The dialogue initiated during the pre-IDE meeting continues and intensifies between the FDA/CDRH and the company over the specifics of the pivotal trial and includes the patient population, the control group against which the new device will be evaluated, and the primary and secondary end points of the evaluation. For first-in-class devices, e.g. drug-eluting stents, where there are few data regarding
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short- or long-term outcomes, the FDA/CDRH requires prospective randomized controlled studies. High profile devices that require randomized data for approval are the exception rather than the rule. The vast majority of device clinical trials are case series that carefully document product performance. Still more products are approved as “tools.”
When the FDA/CDRH has substantial data on the device class metrics, comparisons may be made to historical data or objective performance criteria. When few data on existing standards are available, the FDA typically requires randomized rather than single-arm studies, in which the new device is compared against concurrent controls treated with current best medical practice. The comparison may be powered to show that the new treatment is superior to prior approaches, or that it is non-inferior (equivalent or better) compared with a previously approved device in a new area.
The specifics regarding study design may have a profound impact on the time and cost of bringing a new device to market. Though the primary mission of the FDA/CDRH is to ensure safety and effectiveness of commercially available devices, when exerting regulatory oversight, the agency must balance its primary mission with the costs of introducing new technologies to the clinical marketplace. This has been codified by the FDA Modernization Act and the FDA Modernization Act-II, which require the agency to pursue the “least burdensome means” available to establish device safety and efficacy. The trial must be conducted according to good clinical practices standards, with the approval of the local IRB at each participating center.
Every clinical site is federally mandated to have an IRB responsible to ensure the protection of the rights, safety, and welfare of research subjects. Regulation of the IRB review of protocols involving medical devices is under the purview of the FDA. The Office of Protection from Research Risks (OPRR) is responsible for oversight regarding all human research and is in direct communication with the FDA/CDRH. Studies involving human subjects that do not involve products regulated by the FDA fall under the direct purview of the OPRR. Both the FDA and the OPRR are in the Department of Health and Human Services. Each IRB must meet standards for the composition, leadership, and processes set forth by that department. IRBs are subject to periodic audits by the FDA to ensure that records and procedures are in compliance with regulations. The IRB process typically requires approximately three months, but at times can take considerably longer.
The company must also negotiate agreements with each clinical site addressing the many issues associated with the clinical trial. In addition to the study costs/reimbursement (per-patient enrolled and overhead), these agreements typically include indemnification and the assignment of ownership rights of new discoveries (intellectual property) made in the course of the study. The resources required at each center to perform the high-quality research necessary for a PMA protocol are formidable. Pivotal studies required for a PMA application are typically large multicenter randomized trials and often represent the largest commercial risk and expense in the device development process. In addition to obtaining an IDE from the FDA and formally recruiting clinical sites, it also includes engaging a contract research organization (CRO), core laboratories, formation of a data safety monitoring board (DSMB), and an executive committee.
Though there are many similarities in the regulatory process in the United States and countries within the European Union, there are important differences that impact the time and cost associated with the introduction of a new medical device. The European Union system relies heavily on notified bodies (NBs), which are independent commercial organizations to implement regulatory control over medical devices. NBs have the ability to issue the CE mark, the official marking required for certain medical devices. NBs are designated, monitored, and audited by the relevant member states via the competent national authorities. Many functions performed by the FDA/CDRH within the United States are performed by NBs, including medical device certification, device type designation, assessment and verification of quality systems, and review of design dossiers for high-risk devices. Currently, there are more than 50 active NBs within Europe. A company is free to choose any notified body designated to cover the particular class of device under review. After approval, post-market surveillance functions are the responsibility of the member state via the competent authority. NBs typically function in a closed manner, providing little visibility on criteria required for approval. This dynamic allows for a high degree of variation as well as competition among NBs. As a result, NBs are perceived by industry to be less bureaucratic organizations that can respond more quickly and efficiently than the FDA.
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Criteria for approval of high-risk devices are different in the European Union. To receive approval to market a Class III high-risk (and some Class II) device in the United States, the manufacturer must demonstrate the device to be reasonably safe and effective, which typically requires a prospective, randomized controlled clinical trial. To receive approval to market a device in the European Union, the manufacturer must demonstrate that the device is safe and that it performs in a manner consistent with the manufacturer’s intended use. This difference has a profound impact on the size and scope of the clinical studies for regulatory approval.
The demonstration of safety and efficacy for a new medical device is a long, arduous, and expensive developmental path from early concept to introduction into clinical practice.
We will be subject to environmental and other rules related to the handling of nitric oxide. We will be using very small testing quantities of nitric oxide and do not anticipate any material issues in relation to nitric oxide as it relates to environmental or other regulatory issues.
In addition to the foregoing, our present and future business may be subject to various laws and regulations relating to safe working conditions, clinical, laboratory and manufacturing practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances, including radioactive compounds and infectious disease agents, used in connection with our research, as well as national restrictions on technology transfer, and import, export and customs regulations and similar laws and regulations in foreign countries. Due to the extensive regulatory requirements, management does not anticipate any submittals for some time until the technology is more developed and tested in the lab. At such time as management feels initial submittals are warranted, significant additional capital will need to be raised to proceed with even initial submittals. As such, we believe any commercialization of our product is years away and we will continue to be reliant on loans and stock sales to stay in business.
Concentration of Customers
Currently we do not have any customers and will not have any customers until our product is through the development and testing stages and receives FDA approval.
Patents, Trademarks, Licenses, Franchises, Concessions, Royalty Agreements or Labor Contracts, including Duration
Presently we have two patents approved and one patent pending for our Nitric Oxide systems and we hope to file additional patents for our products which will help us build a strong IP portfolio and value for our company and our shareholders. Our approved patents cover Gas Generator #62-014866 and our disposable delivery device. Our patent pending covers Controlled Delivery of Medical gases using Diffusion Membrane #14529112. We are also pursuing a proprietary protection strategy of our key formulations and methods for further strengthening the overall Intellectual Property portfolio. We have no trademarks. We also have no franchises, concessions, royalty agreements or labor contracts.
Research and Development Costs During the Last Two Fiscal Years
We are currently expensing our costs under a general operating expense category instead of capitalizing any research and development expenses.
ITEM 1A. RISK FACTORS
NU-MED’s operations are subject to a number of risks including:
Risk Factors Relating to NU-MED’s Proposed Activities
We currently do not have the capital to fund operations and are dependent on raising additional capital to stay in business.
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NU-MED is a medical device development company focused on the development of systems for the delivery of nitric oxide. NU-MED is currently undercapitalized and is relying on equity and debt investments to continue operations. We have identified the products we want to develop and market. We have moved forward in the design and development stage with these products. Given that we will be producing a medical device, it may take years of testing before we are able to start selling our product and we will need more capital infusions to get the product developed and to market. Investors in NU-Med would be placing their money in a company with some developed products which are potentially years away from being able to sell and with no support for the eventual commercial application or market for the product. Given the uncertainties facing the company, investors should look to an investment in NU-MED as highly speculative and risky with a high probability of losing their entire investment.
We are still in the product development phase of our operations, so the ultimate success of our products is unknown.
NU-MED is a development-stage business. NU-MED has focused on the development of medical products which require extensive capital investment and can be a very lengthy process subject to extensive regulatory approval. The ultimate success of NU-MED and its products is very uncertain. Investors will therefore be placing their money in an undercapitalized company with no proven operations.
Nitric oxide is a regulated chemical and is subject to extensive environmental regulations related to its handling and disposal, which may increase our costs and subject us to environmental regulations.
Although NU-MED operates as a research and development company at this time and we use only small quantities of nitric oxide, we are still subject to the environmental and other workplace rules related to the handling and disposal of nitric oxide. These rules require that we keep records of our handling and disposal of any nitric oxide. Additionally, if we mishandle or do not dispose properly of the nitric oxide, we could be subject to fines and penalties. At this time, we do not anticipate handling large quantities of nitric oxide and should not see substantial additional costs or contingencies from our use of nitric oxide. However, as we expand our operations, the environmental and workplace rules related to the handling of nitric oxide could increase our overall costs.
We may incur significant costs complying with environmental laws and regulations, and failure to comply with these laws and regulations could expose us to significant liabilities.
Certain aspects of our business are subject to a variety of federal, state and local laws and regulations governing the use, generation, manufacture, distribution, storage, handling, treatment and disposal of materials. For example, high-pressure gas cylinders can be regarded as hazardous materials. Although we believe our safety procedures for handling and disposing of these materials and waste products comply with these laws and regulations, we cannot eliminate the risk of accidental injury or contamination from the use, manufacture, distribution, storage, handling, treatment or disposal of hazardous materials. In the event of contamination or injury, or failure to comply with environmental, occupational health and safety and export control laws and regulations, we could be held liable for any resulting damages and any such liability could exceed our assets and resources. We do not maintain insurance for any environmental liability or toxic tort claims that may be asserted against us.
We will need additional financing, which will potentially dilute current investors, and we may not be able to obtain such financing.
NU-MED intends to engage in product development that will require substantial capitalization as we attempt to develop our products. Accordingly, NU-MED’s future success and profitability may be based on our ability to obtain additional financing on favorable terms. Any additional financing may cause dilution to current investors and there can be no assurance that any additional financing will be on terms that are favorable to NU-MED and our shareholders.
The medical product business is highly competitive and subject to extensive regulations, making it difficult and very expensive to bring new products into the marketplace.
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We face vigorous competition from companies throughout the world, including multinational companies which are better financed and have more experience in medical product design. Most of these competitors have greater resources than we do and may be able to respond to changing business and economic conditions more quickly than us. Our ability to compete with these companies will be limited. Additionally, with extensive regulation and testing of medical devices, it is extremely costly to bring a medical device to market and we may not be able to obtain the necessary capital to bring a medical device to market. As such, an investment in the Company is very risky and could result in the loss of an investor’s entire investment.
Our success will be dependent on the ability of management to develop medical devices.
Our success depends on our ability to develop medical products. With limited resources, we will be dependent on current management to be able to develop the medical devices. None of our current management members has extensive experience developing medical products or bringing them to market. As such, investors will be placing money with individuals with no proven success in developing and selling medical devices, thereby creating high risk of loss of an investor’s entire investment in the Company.
Our success depends, in part, on our key personnel.
Our success depends, in part, on our ability to retain our key personnel, including our executive officers and senior management team. Our management team has created our business model and the initial focus on our first medical device. The unexpected loss of one or more of our key executives could adversely affect our business. Our success also depends, in part, on our continuing ability to identify, hire, train and retain other highly qualified personnel. Competition for these employees can be intense. We may not be able to attract, assimilate or retain qualified personnel in the future, and our failure to do so could adversely affect our business.
Our ability to commercialize pharmaceutical products successfully may depend, in part, on the availability of reimbursement for our products from:
* Government and health administration authorities;
* Private health insurers; and
* Other third party payers, including Medicare.
We cannot predict the availability of reimbursement for health care products. Third-party payers, including Medicare, are challenging the prices charged for medical products and services. Government and other third-party payers progressively are limiting both coverage and the level of reimbursement for new drugs. Third-party insurance coverage may not be available to patients for any of our products.
The continuing efforts of government and third-party payers to contain or reduce the costs of health care may limit our commercial opportunity. If government and other third-party payers do not provide adequate coverage and reimbursement for any product we bring to market, doctors may not prescribe them, or patients may ask to have their physicians prescribe competing treatments with more favorable reimbursement. In some foreign markets, pricing and profitability of prescription pharmaceuticals are subject to government control. In the United States, we expect that there will continue to be federal and state proposals for similar controls. In addition, we expect that increasing emphasis on managed care in the United States will continue to put pressure on the pricing of pharmaceutical products. Cost control initiatives could decrease the price that we receive for any products in the future. Further, cost control initiatives could impair our ability to commercialize our products and our ability to earn revenues from this commercialization.
We May Be Subject to Product Liability Claims if People or Property Are Harmed by the Products We Sell.
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Some of the products we manufacture and sell may expose us to product liability claims relating to personal injury or death caused by such products. Although we will maintain liability insurance, we cannot be certain that our coverage will be adequate for liabilities actually incurred or that insurance will be available to us on economically reasonable terms, or at all.
Our auditors have indicated in their audit opinion that there is a substantial doubt about our ability to continue as a going concern, which will affect our ability to raise capital or borrow money.
Our auditors have issued an audit opinion indicating that there is a substantial doubt about our ability to continue as a going concern. As such, any potential investor or lender is unlikely to be willing to provide additional capital or loans to us. Without additional capital, we will be unable to remain in business or to execute on our business plan. Even if we are able to obtain additional capital, given the “going concern” modification, it is likely investors would suffer substantial dilution to their investment.
We are a small Company with a limited number of employees, which makes it impossible to implement the internal controls that provide investors with assurances as to reporting accuracies.
We have stated in Item 9A. Controls and Procedures that because there are material weaknesses in internal controls due to the limited number of persons responsible for the recording and reporting of financial information, the lack of separation of financial reporting duties, and the limited size of our management team in general.
General Risks Relating to Investors
We intend to take advantage of the disclosure requirements of the JOBS Act provided for emerging growth companies, including not providing all of the accounting disclosure that other companies will be required to provide, which may limit an investor’s ability to compare our financial statements with other companies.
Under the JOBS Act, we can elect to not comply with new or revised accounting standards which will allow us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies. Until the standards are required for private companies, we will not be required to adopt those standards. As such, our financial statements may not be comparable to those of companies that comply with public company effective dates. This could affect an investor’s ability to evaluate our financial statements compared to other public companies. In addition to the financial statements, as we qualify as a “Smaller Reporting Company”, the JOBS Act allows us to provide less disclosure on certain issues, such as executive compensation, which could affect an investor’s ability to compare us to other companies.
We do not intend to pay dividends in the near future.
NU-MED has not paid, and does not plan to pay, dividends in the foreseeable future, even if we were profitable. Earnings, if any, are expected to be used to expand operations, for research and development and for general corporate purposes, rather than to make distributions to shareholders.
Investors will not have cumulative voting and will not be able to elect directors based on the percentages of ownership.
Holders of common stock are not entitled to accumulate their votes for the election of directors or otherwise. The present shareholders of NU-MED will be able to elect all of the directors of NU-MED and effectively control NU-MED’s affairs, making it difficult for investors to be able to change management or the direction of NU-MED. (See "DESCRIPTION OF SECURITIES.")
We may issue more stock without shareholder input or consent, which could dilute the book value of your investment.
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The board of directors has authority, without action by or vote of the shareholders, to issue all or part of the authorized but unissued shares. In addition, the board of directors has authority, without action by or vote of the shareholders, to fix and determine the rights, preferences, and privileges of the preferred stock, which may be given voting rights superior to that of the common stock. Any issuance of additional shares of common stock or preferred stock will dilute the ownership percentage of shareholders and may further dilute the book value of our shares. It is likely we will seek additional capital in the future to fund operations. Any future capital will most likely reduce current shareholders’ percentage of ownership. Additionally, with the board of directors having the ability to set the rights, preferences and privileges of the preferred stock the board of directors, without shareholder approval, can create classes of stock which are superior to the common stock in both voting and preferences, including dividend and liquidation preferences. As such, current and future holders of common stock may have less voting power per share and dividend rights than subsequently issued preferred stock.
A relatively small number of stockholders and managers have significant influence over us, other stockholders will not be able to have a voice in the direction of the company, and stockholders may disagree with the decisions of management.
A small number of our stockholders and management, acting together, will be able to exert significant influence over us through their ability to influence the election of directors and all other matters that require action by our stockholders. The voting power of these individuals could have the effect of preventing or delaying a change in control of our company which they oppose, even if our other stockholders believe it is in their best interests. In addition, our executive officer has the ability to influence our day-to-day operations. These factors could negatively affect our company and our stock price, as other investors may be unwilling to invest in a company with such a consolidation of control. Additionally, if stockholders dislike the decisions of management, it will be difficult for stockholders to make changes to current management.
The departure of certain key personnel could affect the financial condition of NU-MED due to the loss of their expertise.
Our business plan was developed by our officers and will depend on their ability to design and create the initial models for our products. Without their expertise, it is unlikely we will be able to complete the development and design of initial products. We do not have the funds, at this time, to hire additional personnel, and without current management it is unlikely we will be able to obtain further funding. The loss of any member of management would severely hinder our ability to develop our proposed products. A failure on our part to retain the services of these key personnel could have a material adverse effect on our operating results and financial conditions. We do not maintain key man life insurance on any of our employees.
ITEM 1C. CYBERSECURITY
Item 1C. Cybersecurity.
Risk Management and Strategy
Our cybersecurity policies, standards, processes and practices are based on applicable laws and regulations and informed by industry standards and industry-recognized practices. Our strategy to assess, identify, and manage material cybersecurity risks is focused on preserving the confidentiality, security, and availability of our information systems and data. We implement security measures and processes to identify, prevent, and mitigate cybersecurity threats and to effectively respond to cybersecurity incidents when they occur. Our cyber risk management includes: (1) enterprise risk management to identify top cybersecurity risks; (2) vulnerability management to identify software vulnerabilities and risks related to compute infrastructure; (3) vendor risk management to identify risks related to third parties and business partners; (4) privacy risk management to identify privacy risks in our product and platforms and ensure regulatory compliance; and (5) security incident response to investigate, respond to, and mitigate cyber threats. As needed, we will engage
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Governance
ITEM 2. PROPERTIES
NU-MED’s corporate office is at 640 Belle Terre Rd., Building E 2, Port Jefferson, NY 11777. Our R&D facility is located at 5718 W Dannon Way, Suite B, West Jordan, UT 84081. The executive office arrangement provides us the flexibility to expand our corporate offices as needed, without being committed to long-term overhead for office space we currently do not need. Our executive office and laboratory space are currently being provided to the Company at no cost. Management believes these facilities will serve our purposes for at least the next twelve months.
ITEM 3. LEGAL PROCEEDINGS
None.
ITEM 4. MINING SAFETY DISCLOSURE
NU-MED has no mining operations.
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER
MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
The Company's Common Stock is quoted on the over-the-counter bulletin board and OTCQB under the symbol NUMD. The first sale of shares occurred in the third quarter of 2014. The Company’s common stock has traded sporadically and in low volume. Our closing stock price on January 30, 2026 was $0.0142 per share.
At April 9, 2026, the Company had approximately 178 shareholders of record. As of April 9, 2026, the Company had 83,548,469 shares of its Common Stock issued and outstanding.
Transfer Agent
NU-MED’s transfer agent is Equiniti Trust Company LLC, 1110 Centre Point Curve, Suite 101, Mendota Heights, MN 55120; their telephone number is 919-744-2722.
Recent Issuances of Unregistered Securities
None.
ITEM 6. [RESERVED]
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ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Special Note Regarding Forward-Looking Statements
Certain statements in this Report constitute “forward-looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that might cause such a difference include, among others, uncertainties relating to general economic and business conditions; industry trends; changes in demand for our products and services; uncertainties relating to customer plans and commitments and the timing of orders received from customers; announcements or changes in our pricing policies or that of our competitors; unanticipated delays in the development, market acceptance or installation of our products and services; changes in government regulations; availability of management and other key personnel; availability, terms and deployment of capital; relationships with third-party equipment suppliers; and worldwide political stability and economic growth. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date the statement was made.
CRITICAL ACCOUNTING POLICIES
Accounting policies are detailed in Note 2 of the financial statements.
Plan of Operations
NU-MED is focused on the development of medical devices with the first product aimed at the delivery of nitrogen oxide to patients. NU-MED believes the current delivery systems and supply of nitrogen oxide are costly and creates an opportunity to develop nitric oxide delivery devices that can utilize cheaper delivery devices for nitrogen oxide. In an effort to develop products, shortly after the founding of NU-MED, management raised initial capital to be able to establish a lab and purchase equipment to work on the initial designs for a new medical device to deliver nitrogen oxide.
Our lab has been successfully equipped and we are proceeding with the development of our proprietary product technology. Our technology is at the early development stage and management plans are to concentrate on further improvement of our technology. Our budget requirements for the next year will be centered upon factors relating to the testing, research and enhancement with the intention being to patent our formulation and design. Included in our budget for the next year is the costs of chemical standards, gases and equipment we have projected we will need. Contained also within our budget are auditing costs and legal fees, which include patent filing expenses. Projected costs to continue operation for the next year are $1,250,000 and may increase depending on the costs of patent applications, submission of products to the FDA for approval and ongoing development work. At this time, we do not have the funds to operate at this level and are seeking financing either through debt or equity. If we cannot raise the needed capital we may not be able to remain in business.
Management believes, with the costs to develop new technology and receive FDA regulatory approval for those devices, it is important to divide the capital needs into phases to be able to track development progress and anticipate capital needs better. Rather than trying to raise a larger amount of capital upfront, which management felt would result in higher dilution than otherwise would be required, management has chosen to raise capital in tranches as product development progresses. With the first phase of establishing a lab and initial design completed and with prototype development continuing, management anticipates having to seek additional capital in the near future to continue further development and testing for FDA application. The exact amount of capital and the time frame to continue the development of the products is still unknown as management continues to modify current designs during development. Management believes it may take some time before
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a commercial product is able to be marketed and will have to rely on outside funding to support operations through not only the development and testing phases, but the licensing phase and initial marketing cycles.
Liquidity and Capital Resources
At December 31, 2025, we had total assets of $7,911 with current assets of $7,911 and total liabilities of $279,189. Our current assets consisted of cash in the amount of $661. At December 31, 2024, we had assets of $9,373 with current assets of $9,373 and liabilities of $224,469. We currently have sufficient cash to pay ongoing expenses for the next two months, after which we will have to rely on loans from shareholders to cover expenses. Without additional capital, we will not be able to stay in business and move our business plan forward. We currently have no commitments for the needed capital. Since we will not have a commercial product in the next twelve months, we will have to rely on outside funding to support our operations and product development and testing efforts. Given the financial state of NU-MED, we will not be able to seek traditional bank financing and have to rely on private stock sales and potential loans from investors and shareholders. If we are unable to raise additional capital, we will be forced to suspend operations until such capital can be raised or go out of business. We cannot project the full costs to bring our proposed product to market or the timing of such commercialization. Given that our product is in the medical field, testing is very expensive, and we will need additional capital prior to completing the testing phase. Any refinement or modification of the product after the prototype is developed would also require additional capital. At this time, we will have to continue to rely on outside capital and a budget that may require adjustment as we move further in the product development phase.
RESULTS OF OPERATIONS
For the year ended December 31, 2025, we had no revenues, operating expenses of $48,955 and interest expense of $7,227, resulting in a net loss of $56,182. This compares to a net loss for the year ended December 31, 2024 of $68,345. Operating expenses in 2025 decreased $14,376 over 2024 due primarily from the reduction of dues and subscriptions by $4,673, filing fees by $2,004, investor relations by $2,941 and professional fees of $2,924. The net loss in 2024 was the result of $63,331 of operating expenses. We anticipate we will have operating losses for the foreseeable future and for the losses to increase as we work to evaluate a potential merger. Additionally, we are preparing patent applications which will require additional capital to pay for outside attorneys and consultants. We will be dependent on outside capital to support operations for the foreseeable future and at this time do not have any commitments for additional capital.
Off-balance sheet arrangements
The Company does not have any off-balance sheet arrangements, and it is not anticipated that the Company will enter into any off-balance sheet arrangements.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The financial statements of the Company are set forth immediately following the signature page to this Form 10-K.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON
ACCOUNTING AND FINANCIAL DISCLOSURE
The Company has had no disagreements with its independent registered public accounting firms with respect to accounting practices or procedures or financial disclosure.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
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Our management, including our Principal Executive Officer and Principal Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our Principal Executive Officer and Principal Financial Officer concluded that, for the reasons discussed below, our disclosure controls and procedures as of the end of the period covered by this report were not effective for the reasons listed below. The disclosure controls and procedures ensure that all information required to be disclosed by us in reports filed under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer, as appropriate to allow timely decisions regarding disclosure. A controls system cannot provide absolute assurance, however, that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.
Management’s Annual Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting (as defined in Rule 13a-15(f) under the Exchange Act). Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with accounting principles generally accepted in the United States.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Therefore, even those systems determined to be effective can provide only reasonable assurance of achieving their control objectives.
Our management evaluated the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”) in Internal Control - Integrated Framework - 2013. Based on this evaluation, our management concluded that, as of December 31, 2025, our internal controls over financial reporting were not effective to provide reasonable assurances based on the above criteria.
The material weaknesses relate to the limited number of persons responsible for the recording and reporting of financial information, the lack of separation of financial reporting duties, the lack of a formal independent oversight audit committee, and the limited size of our management team in general. We are in the process of evaluating methods of improving our internal control over financial reporting, including the possible addition of financial reporting staff and the increased separation of financial reporting responsibility, and intend to implement such steps as are necessary and possible to correct these material weaknesses.
This annual report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the Company’s registered public accounting firm since the Company is not an accelerated filer or large accelerated filed.
Changes in internal control over financial reporting
There have been no changes in internal control over financial reporting that occurred during the last fiscal year that has materially affected, or is reasonably likely to materially affect, the internal control over financial reporting.
ITEM 9B. OTHER INFORMATION
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.
None; not applicable.
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PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The following table sets forth information with respect to the officers and directors of NU-MED. NU-MED’s directors serve for a term of one year and thereafter until their successors have been duly elected by the stockholders and qualified. NU-MED’s officers serve for a term of one year and thereafter until their successors have been duly appointed by the Board of Directors and qualified.
| Name | Age | Title |
| William Hayde | 61 | CEO, Director |
| Keith Merrell | 80 | Chief Financial Officer, Director |
| Jeffrey L. Robins | 77 | Director |
· William Hayde: President/CEO. Mr. Hayde has been a Wall Street veteran for over 30 years, concentrating on investment banking and institutional trading, retiring from that portion of the industry after a long, successful career. Mr. Hayde has been the Managing Director of the Interim Opportunity Fund LLC and its advisor, Waterside Capital Advisors, Inc., since March 2018. During 2013, Mr. Hayde was a co-founder and Executive Vice-President of Intercontinental Beverage Capital, Inc. (“IBC”). IBC is a New York based merchant bank focused specifically on the beverage and consumer packed goods industries. Since January 2011 through March 2018 he served as Registered Vice President of Investment Banking Network 1 Financial Securities, Inc. and has held the following securities licenses: 4, 6, 7, 24, 55, 63 and 79. From 2002 through 2009 he was co-owner of Waterville Investment Research, which also operated the hedge fund Waterville Investment Partners LLP. Mr. Hayde maintains seats on the advisory boards of multiple public and private companies in the consumer and medical industries. From January 1997 through May 2010 he was head of investment banking for Brockington Securities and directed the firm’s underwriting activities, private placements, and initiation of trading of newly listed securities. Mr. Hayde received his B.A. degree from Stony Brook University.
· Keith L. Merrell: Chief Financial Offer and Principal Accounting Officer, Secretary and Treasurer. Mr. Merrell serves as our Chief Financial Officer, Secretary and Treasurer. Mr. Merrell draws on over 35 years of accounting experience to manage our accounting functions and interface with our independent public accountants. He spent two years in the field of public accounting and has served as Chief Financial Officer for four other public companies. He currently serves full-time as our Chief Financial Officer and also serves as part-time CFO of another public company. His business career includes extensive experience in management, sales and marketing, consulting, and merger and acquisition work. He graduated from Arizona State University with a B.S degree in Accounting.
· Jeffrey L. Robins: Director. Mr. Robins has 30 years of senior management experience in high technology companies coupled with 15 years of engineering leadership experience. For the past 10 years, Mr. Robins has been a management consultant for his private consulting company Robins Resource Associates. Through his consulting company, Mr. Robins served as COO of Asta Ltd until 2017 Mr. Robins served as VP of Operations at TSCO CO., Inc. until 2006 where he was a member of the Executive Staff with responsibilities for accelerated new product development and operations management. Mr. Robins has extensive global experience, including Operations Senior Director at Fujitsu Microelectronics, where he was responsible for foundry services, product development and two wafer fabrication plants from start up to full production and ultimately having P&L responsibility for a $450 million operation. He was Fabrication Director of Operations at International Rectifier and has held various positions at Intel and AMD. He is a past president of the Oregon Semiconductor Association. Mr. Robins holds a B.S. in Pharmacy from Idaho State University, a B.S. in Political Science from Weber State University and an Engineering Management Certificate from Idaho State University.
None of our officers and directors has filed for bankruptcy, been convicted in a criminal proceeding or been the subject of any order, judgment, or decree permanently, temporarily, or otherwise limiting activities (1) in connection with the sale or purchase of any security or commodity or in connection with any violation of Federal or State securities laws
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or Federal commodities laws, (2) engaging in any type of business practice, or (3) acting as a futures commission merchant, introducing broker, commodity trading advisor, commodity pool operator, floor broker, leverage transaction merchant, any other person regulated by the Commodity Futures Trading Commission or an associated person of any of the foregoing, or as an investment adviser, underwriter, broker or dealer in securities, or as an affiliated person, director or employee of an investment company, bank, savings and loan association or insurance company, or engaging in or continuing any conduct or practice in connection with such activity.
Family Relationships
The officers/directors have no family relationships to any other related parties.
COMPLIANCE WITH SECTION 16(A) OF THE EXCHANGE ACT
The Company believes all forms were filed.
ITEM 11. EXECUTIVE COMPENSATION
SUMMARY COMPENSATION TABLE
The following tables set forth certain summary information concerning the compensation paid or accrued for each of the Company's last two completed fiscal years to the Company's or its principal subsidiaries’ chief executive officer and each of its other executive officers that received compensation during such period (as determined at December 31, 2025, the end of the Company's last completed fiscal year):
Summary Compensation Table
|
Name and Principal Position |
Year |
Salary |
Bonus |
Stock Awards |
Option Awards |
Non-Equity Incentive Plan Compensation |
All Other Compensation |
Total |
| William Hayde | 2025 | $ -- | -- | -- | -- | -- | -- | $ -- |
| CEO | 2024 | -- | -- | -- | -- | -- | -- | -- |
| Jeffrey L. Robins | 2025 | $ -- | -- | -- | -- | -- | -- | $ -- |
| Director | 2024 | -- | -- | -- | -- | -- | -- | -- |
| Keith L. Merrell | 2025 | $ -- | -- | -- | -- | -- | -- | $ -- |
| CFO | 2024 | -- | -- | -- | -- | -- | -- | -- |
________________
Mr. Hayde joined the Company as President/CEO in September 2022.
Mr. Robins relinquished his position as President/CEO in September 2022 but continues as a Director.
Mr. Merrell joined the Company in August 2015.
Outstanding Equity Awards at Fiscal Year-End
We had no outstanding equity awards at fiscal year-end 2025 or 2024.
Option/Stock Appreciation Rights (SAR) Grants in Last Fiscal Year
In fiscal 2025 and 2024, there were no stock options or SAR Grants.
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Stock Option Exercise
In fiscal 2025 and 2024, none of the named executives exercised any options to purchase shares of common stock.
Long-Term Incentive Plan (“LTIP”)
There were no awards granted during fiscal year 2025 or 2024 under a long-term incentive plan.
Board of Directors Compensation
Each director may be paid his expenses, if any, for attendance at each meeting of the board of directors and may be paid a stated salary as director or a fixed sum for attendance at each meeting of the board of directors or both. No such payment shall preclude any director from serving the corporation in any other capacity and receiving compensation therefrom. We did not compensate our directors for service on the Board of Directors during fiscal 2025 or 2004.
No other compensation arrangements exist between NU-MED and our officers and directors.
Employment Contracts and Termination of Employment and Change-in-Control Arrangements
The Company has employment contracts with our executive officers. Outside of these agreements, no other compensatory plan or arrangements exist between the Company and our executive officers that results, or will result from the resignation, retirement or any other termination of such executive officers’ employment with the Company, or from a change in control.
Report on Executive Compensation
The Board of Directors determines the compensation of NU-MED’s executive officer and president and sets policies for, and reviews with the chief executive officer and president, the compensation awarded to the other principal executives, if any. The compensation policies utilized by the Board of Directors are intended to enable NU-MED to attract, retain and motivate executive officers to meet our goals using appropriate combinations of base salary and incentive compensation in the form of stock options. Generally, compensation decisions are based on contractual commitments, if any, as well as corporate performance, the level of individual responsibility of the particular executive and individual performance. At this time the Board of Directors has determined no compensation is warranted to the officers and directors until such time as a merger is completed or business operation is established. At such time executive compensation on an ongoing basis will be reviewed.
Code of Ethics
We do not have a code of ethics.
Option Plans
NU-MED has no option plans and no outstanding options.
Board of Directors Interlocks and Insider Participation in Compensation Decisions
No such interlocks existed nor were such decisions made during fiscal years 2025 or 2024.
Termination of Employment and Change of Control Arrangement
There are no compensatory plans or arrangements, including payments to be received from the Company, with respect to any person named in cash compensation set out above, which would in any way result in payments to any such person because
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of his resignation, retirement, or other termination of such person's employment with the Company or its subsidiaries, or any change in control of the Company, or a change in the person's responsibilities following a changing in control of the Company.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Security Ownership of Certain Beneficial Owners:
The following table sets forth certain information as of April 9, 2026, with respect to the beneficial ownership of the Company’s common stock by each director of the Company and each person known by the Company to be the beneficial owner of more than 5% of the Company’s outstanding shares of Common Stock. At April 9, 2026, there were 83,548,469 shares of common stock outstanding.
For purposes of this table, information as to the beneficial ownership of shares of common stock is determined in accordance with the rules of the Securities and Exchange Commission and includes general voting power and/or investment power with respect to securities. Except as otherwise indicated, all shares of our common stock are beneficially owned, and sole investment and voting power is held, by the person named. For purposes of this table, a person or group of persons is deemed to have beneficial ownership of any shares of common stock which such person has the right to acquire within 60 days after the date hereof. The inclusion herein of such shares listed beneficially owned does not constitute an admission of beneficial ownership.
| Amount of | Percentage of Outstanding | |
| Name and Address of Beneficial Owner | Beneficial Owner | Common stock |
| Principal Shareholders | ||
|
Jeffrey L. Robins 2152 W. Bryce Drive Kaysville, Utah 84037
|
5,200,000 | 6.22% |
|
William Hayde 640 Belle Terre Rd Blvd E 2 Port Jefferson, NY 11777
|
3,200,000 | 3.83% |
| Keith L. Merrell | 4,181,250 | 5.00% |
| 1240 Mueller Park Rd. | ||
| Bountiful, UT 84010 | ||
|
WLP Trust 455 East 500 South, Suite 201 Salt Lake City, Utah 84111
|
25,050,000 | 29.98% |
| Officers and Directors | ||
| William Hayde | 3,200,000 | 3.83% |
| Jeffrey L. Robins | 5,200,000 | 6.22% |
| Keith Merrell | 4,181,250 | 5.00% |
| Director and executive officer of the | ||
| Company (3 individuals) | 12,581,250 | 15.05% |
_________________________________
WLP Trust is owned and controlled by Wendy Smith, the widow of Karl Smith, who owned SCS. SCS was owed $230,100
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in principal and $118,542 in accrued interest. The Company was notified that SCS wished to convert the notes and accrued interest to shares of restricted common stock. Subsequent to providing the notice of conversion Mr. Smith died without a will. After his estate had been through probate the Company was given instructions to issue 25,000,000 shares to WLP Trust, 2,000,000 shares to Roger Gill and 1,000,000 shares to Henry Smith. Prior to the issuance of these shares WLP Trust was the holder of 50,000 shares of stock.
Control by Existing Stockholders
Current management owns 15.05% of the issued and outstanding shares of common stock. It is likely they will be able to control NU-MED due to their present control of the Board of Directors and will be in a position to recommend to dissolve, merge or sell the assets of NU-MED, and generally, to direct the affairs of NU-MED.
Dividends
We have not declared any cash dividends with respect to our common stock, and do not intend to declare dividends in the foreseeable future. Our future dividend policy cannot be ascertained with any certainty. There are no material restrictions limiting, or that are likely to limit, our ability to pay dividends on our securities.
Securities Authorized for Issuance under Equity Compensation Plans
| Plan Category | Number of Securities to be issued upon exercise of outstanding options, warrants and rights | Weighted-average exercise price of outstanding options, warrants and rights | Number of securities remaining available for future issuance under equity compensation plans excluding securities reflected in column |
| Equity compensation plans approved by security holders | None | None | None |
| Equity compensation plans not approved by security holders | None | None | None |
| Total | NA | NA | NA |
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR
INDEPENDENCE.
Transactions with Officers and Directors
On September 12, 2022 the Company entered into employment agreements with Mr. Hayde, its President/CEO and Mr. Merrell, its CFO. The employment agreements provide for no salary until such time as adequate funds are available, at which time the salaries will be determined by the Board of Directors.
Except as set forth above, there were no material transactions, or series of similar transactions, during our Company’s last five fiscal years, or any currently proposed transactions, or series of similar transactions, to which we or any of our subsidiaries was or is to be a party, in which the amount involved exceeded the lesser of $120,000 or one percent of the average of our total assets at year-end for the last three completed fiscal years and in which any promoter or founder of ours or any member of the immediate family of any of the foregoing persons, had an interest.
At this time, we have three directors, none of which qualify as independent. One of our directors is a founder and major shareholder of NU-MED. Additionally, given the limited size of our board of directors, we have not set up any committees of the board of directors such as compensation, audit or nominating committees. As our operations expand, we hope to be able to add outside directors and set up these committees, but at this time, do not know when we will be able to add additional directors and set up such committees.
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Transactions with Promoters
There have been no transactions between the Company and promoters during the last fiscal year.
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
The Company has selected Fruci & Associates II, PLLC as its independent public accounting firm, effective with the audit of our 2025 financial results. Expected fees to be paid are:
1) Audit Fees - The aggregate fees incurred for professional services rendered by our principal accountant for the audit of our annual financial statements ending December 31, 2024 was $26,250. It is anticipated that professional fees rendered by our principal account for the audit of our financial statements ending December 31, 2025 will be approximately $18,000 and $3,750 for the review of each of our quarterly financial statements during the initial three quarters of 2026.
2) Audit-Related Fees. $0 and $0.
3) Tax Fees. $0 and $0.
4) All Other Fees. $0.
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a)(1) FINANCIAL STATEMENTS. The following financial statements are included in this report:
| Title of Document | Page |
| Reports of Independent Registered Public Accounting Firm | 31 |
| Balance Sheets | 32 |
| Statements of Operations | 33 |
| Statements of Stockholders' Deficit | 34 |
| Statements of Cash Flows | 35 |
| Notes to Financial Statements | 36 |
(a)(2) FINANCIAL STATEMENT SCHEDULES. The following financial statement schedules are included as part of this report:
None.
(a)(3) EXHIBITS. The following exhibits are included as part of this report:
| Exhibit Number |
SEC Reference Number |
Title of Document | Location |
| Item 3 Articles of Incorporation and Bylaws | |||
| 3.01 | 3 | Articles of Incorporation | Incorporated by reference* |
| 3.02 | 3 | Bylaws | Incorporated by reference* |
| Item 4 Instruments Defining the Rights of Security Holders | |||
| 4.01 | 4 | Specimen Stock Certificate | Incorporated by reference* |
| 27 |
| 10.01 | 10 | Consulting Contract - SCS | Incorporated by reference** |
| 10.02 | 10 | Amended Promissory Note - SCS | Incorporated by reference*** |
| 10.03 | 10 | Promissory Note - SCS | Incorporated by reference*** |
| 31.01 | 31 | CEO certification | This filing |
| 31.02 | 31 | CFO certification | This filing |
| 32.01 | 32 | CEO certification | This filing |
| 32.02 | 32 | CFO certification | This filing |
101. INS XBRL Instance
101. XSD XBRL Schema
101. CAL XBRL Calculation
101. DEF XBRL Definition
101. LAB XBRL Label
101. PRE XBRL Presentation
*The exhibits were filed with the original Form 10 filed by NU-MED on December 10, 2012, file number 000-54808.
**The consulting contract was filed on Form 8-K dated January 7, 2014 and filed on January 8, 2014.
***Amended note filed with the Form 8-K dated September 27, 2013, and filed on October 1, 2013.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
NU-MED PLUS, INC.
| April 15, 2026 | By: /s/ William Hayde |
| William Hayde, CEO, Principal Executive |
| April 15, 2026 | By: /s/ Keith L. Merrell |
| Keith L. Merrell, CFO/Principal Accounting Officer |
In accordance with Section 12 of the Securities Exchange Act of 1934, the Registrant caused this registration statement to be signed on its behalf by the undersigned in the capacities and on the dates stated.
| Signature | Title | Date |
| /s/ William Hayde | Director, CEO, President | April 15, 2026 |
| William Hayde | ||
| /s/ Jeffrey L. Robins | Director | April 15, 2026 |
| Jeffrey L. Robins | ||
| /s/ Keith L. Merrell | Director, CFO | April 15, 2026 |
| Keith L. Merrell |
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Nu-Med Plus, Inc.
Financial Statements
December 31, 2025 and 2024
Table of Contents
| Page No. | ||
| Reports of Independent Registered Public Accounting Firm | 31 | |
| Balance Sheets | 32 | |
| Statements of Operations | 33 | |
| Statements of Stockholders' Deficit | 34 | |
| Statements of Cash Flows | 35 | |
| Notes to the Financial Statements | 36 | |
| 30 |
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Stockholders of Nu-Med Plus, Inc.:
Opinion on the Financial Statements
We have audited the accompanying balance sheets of Nu-Med Plus, Inc.(“the Company”) as of December 31, 2025 and 2024, the related statements of operations, stockholders’ deficit, and cash flows for each of the years in the two-year period ended December 31, 2025, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2025 and 2024 and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2025, in conformity with accounting principles generally accepted in the United States of America.
Going Concern
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements, the Company has incurred losses since inception, has negative cash flows from operating activities and an accumulated deficit. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 3. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
Critical audit matters are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. We determined that there were no critical audit matters.
/s/
Fruci & Associates II, PPLC - PCAOB ID #0
We have served as the Company’s auditor since 2017.
April 15, 2026
| 31 |
NU-MED PLUS, INC.
Balance Sheets
| December 31, | December 31, | |
| 2025 | 2024 | |
| ASSETS | ||
| Current assets | ||
| Cash | $ | $ |
| Prepaid expense | ||
| Total current assets | ||
| Total assets | $ | $ |
| LIABILITIES AND STOCKHOLDERS' DEFICIT | ||
| Current liabilities | ||
| Accounts payable | $ | $ |
| Accounts payable – related party | ||
| Convertible note payable | ||
| Notes payable – related party | ||
| Accrued expense | ||
| Total current liabilities | ||
| Long-term liabilities | ||
| Total liabilities | ||
| Commitments and contingencies | ||
| Stockholders' deficit | ||
| Preferred stock; $ authorized; - December 31, 2025 and 2024, respectively. | ||
| Common stock; $ authorized; outstanding, as of December 31, 2025 and 2024, respectively. | | |
| Additional paid-in capital | ||
| Accumulated deficit | ( | ( |
| Total stockholders' deficit | ( | ( |
| Total liabilities and stockholders' deficit | $ | $ |
The accompanying notes are an integral part of these financial statements.
| 32 |
NU-MED PLUS, INC.
Statements of Operations
| Year ended | Year ended | ||||
| December 31, 2025 | December 31, 2024 | ||||
| Revenue | $ | $ | |||
| Operating expenses | |||||
| General and administrative expense | |||||
| Payroll expense | |||||
| Rent expense | |||||
| Professional and consulting fees | |||||
| Total operating expenses | |||||
| Operating loss | ( | ( | |||
| Other income (expense) | |||||
| Interest expense | ( | ( | |||
| Total other income (expense) | ( | ( | |||
| Loss before income taxes | ( | ( | |||
| Income tax expense | |||||
| Net loss | $ ( | $ ( | |||
| Basic and diluted earnings per share | $ ( | $ ( | |||
| Weighted average common shares outstanding – basic and diluted | | | |||
The accompanying notes are an integral part of these financial statements.
| 33 |
NU-MED PLUS, INC.
Statements of Stockholders’ Deficit
| Preferred Stock | Common Stock | Additional Paid-In | Accumulated | ||||
| Shares | Amount | Shares | Amount | Capital | Deficit | Total | |
| Balance, December 31, 2023 | $ | $ | $ | $( | $ ( | ||
| Net loss for the year ended December 31, 2024 | - | - | ( | ( | |||
| Balance, December 31, 2024 | $ | $ | $ | $( | $ ( | ||
| Net loss for the year ended December 31, 2025 | - | - | ( | ( | |||
| Balance, December 31, 2025 | $ | $ | $ | $( | $( | ||
The accompanying notes are an integral part of these financial statements.
| 34 |
NU-MED PLUS, INC.
Statements of Cash Flows
| Year ended December 31, 2025 | Year ended December 31, 2024 | |||
| Cash flows from operating activities: | ||||
| Net income (loss) | $ ( | $ ( | ||
| Adjustment to reconcile net income (loss) to net cash used in operating activities: | ||||
| Stock-based compensation | ||||
| Prepaid expenses | ( | ( | ||
| Accounts payable | ||||
| Related party payables | ||||
| Accrued expense | ||||
| Net cash used in operating activities | ( | ( | ||
| Cash flows from financing activities | ||||
| Note payable – related party | ||||
| Net cash provided by financing activities | ||||
| Cash flows from investing activities | - | - | ||
| Net change provided by investing activities | ||||
| Net change in cash | ( | ( | ||
| Cash at beginning of period | ||||
| Cash at end of period | $ | $ | ||
| Supplemental schedule of cash flow information | ||||
| Cash paid for interest | $ | $ | ||
| Cash paid for income taxes | $ | $ | ||
| Notes payable – related party – accounts payable converted to note | $ | $ | ||
The accompanying notes are an integral part of these financial statements.
| 35 |
NU-MED PLUS, INC.
Notes to the Financial Statements
For the Years Ended December 31, 2025 and 2024
NOTE 1 - ORGANIZATION AND DESCRIPTION OF BUSINESS
Nu-Med Plus, Inc. (or “the Company”) is an emerging growth early-stage medical device company principally engaged in the design, innovation, development, enhancement and commercialization of beginning, early, and selective later-stage quality medical devices. The Company's immediate focus was on the development of Nitric Oxide delivery devices, including a hospital unit, a clinical unit to be used in doctors’ offices and extended care facilities, a portable unit and a single use disposable unit. We were also developing a powder formulation to generate Nitric Oxide that is
NOTE 2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
a. Basis of Presentation
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America. In the opinion of management, all adjustments which are necessary for a fair statement of the results for fiscal years have been included.
b. Estimates
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
c. Cash and Cash Equivalents
The Company considers all deposit accounts and investment accounts with an original maturity of 90 days or less to be cash equivalents. The cash balance we currently have on deposit is within the limits for which the FDIC insures.
d. Property and Equipment
Property and equipment is stated at cost. Expenditure for minor repairs, maintenance, and replacement parts which do not increase the useful lives of the assets are charged to expense as incurred. Expenditures, exceeding $500, for new assets or that increase the useful life of existing assets are capitalized. Depreciation is computed using the straight-line method. The lives over which the fixed assets are depreciated are five to seven years.
e. Fair Value
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. FASB Accounting Standards Codification (“ASC”) Topic 820 establishes a three-tier fair value hierarchy that prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (level 1 measurements) and the lowest priority to unobservable inputs (level 3 measurements), as follows:
Level 1 - Quoted market prices in active markets for identical assets or liabilities;
Level 2 - Inputs other than level one inputs that are either directly or indirectly observable; and
| 36 |
Level 3 - Unobservable inputs developed using estimates and assumptions, which are developed by the reporting entity and reflect those assumptions that a market participant would use.
All cash, accounts payable and accrued liabilities are carried at cost, which approximates fair value due to the short-term nature of these financial instruments.
f. Earnings per Share
The computation of basic earnings per share of common stock is based on the weighted average number of shares outstanding during the period of the financial statement.
For the year ended December 31, 2025 | For the year ended December 31, 2024 | |
| Net loss (numerator) | $ ( | $ ( |
| Shares (denominator) | ||
| Net earnings per share amount - basic | $ ( | $ ( |
| Shares (denominator) | ||
| Net earnings per share amount - diluted | $ ( | $ ( |
Diluted earnings per share is computed using the weighted average number of common shares plus dilutive common share equivalents outstanding during the period. As of December 31, 2025 and 2024 there were -
g. Concentrations and Credit Risk
The Company has relied on a small group of investors to fund its operations. If this group becomes unable or unwilling to provide additional funding, the Company may be unable to remain in business or to execute on its business plan.
h. Income Taxes
Deferred taxes are provided on an asset and liability approach whereby deferred tax assets are recognized for deductible temporary differences and operating loss and tax credit carryforwards and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax basis. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment.
i. Stock-based Compensation
The Company, in accordance with ASC 718, Compensation – Stock Compensation, records all share-based payments to employees at the grant-date fair value of the equity instruments issued. In accordance with ASC 718-10-30-9, Measurement Objective – Fair Value at Grant Date, the Company uses the closing price of the stock, as quoted by NASDAQ, on the date of the grant. The Company believes this pricing method provides the best estimate of fair the fair value of the consideration given. Compensation cost is recognized over the requisite service period.
| 37 |
j. Segment Reporting
In November 2023, the Financial Accounting Standard Board (“FASB”) issued Accounting Standard Update (“ASU”)
2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures (“ASU 2023-07”), which is intended to improve reportable segment disclosure requirements, primarily through additional and more detailed information about a reportable segment’s expenses.
k. Recent Accounting Pronouncements
In December 2023, the Financial Accounting Standards Board (“FASB”) issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The new guidance is expected to improve income tax disclosures primarily related to the rate reconciliation and income taxes paid information by requiring 1) consistent categories and greater disaggregation of information in the rate reconciliation and 2) income taxes paid disaggregated by jurisdiction. The new standard is effective for annual periods beginning after December 15, 2024. The guidance is effective on a prospective basis, although retrospective application and early adoption is permitted. The Company adopted this standard effective January 1, 2025.
In November 2024, the FASB issued ASU 2024-03, Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures, which requires additional disclosure of certain costs and expenses within the notes to the financial statements. The new standard is effective for annual periods beginning after December 15, 2026 and interim periods beginning in the first quarter of fiscal year 2028. Early adoption is permitted. The new standard is to be applied on a prospective basis, but retrospective application is permitted. The Company is evaluating the impact, if any, of adopting ASU 2024-03.
The Company has reviewed all other recently issued, but not yet adopted, accounting standards in order to determine their effect, if any, on its consolidated results of operation, financial position and cash flows. Based on that review, the Company believes that none of these pronouncements will have a significant effect on its current or future earnings or operations.
NOTE 3 - GOING CONCERN
The Company has incurred losses since inception, has negative cash flows from operating activities, and an accumulated deficit. The Company anticipates that the funds on hand as of December 31, 2025, will fund its reduced level of operations through approximately April 2026, but will not be sufficient to successfully prosecute its business plan. Funding through the sale of equity capital and short-term related parties and other shareholder loans in order to meet the planned expenditures for development, operations, and administrative costs over the next 12 months will be required. Planned expenditures are approximately $
NOTE 4 - PROPERTY AND EQUIPMENT
Property and equipment and related accumulated depreciation consisted of the following at December 31, 2025, and December 31, 2024:
| 38 |
| December 31, 2025 | December 31, 2024 | ||
| Computer and office equipment | $ | $ | |
| Accumulated depreciation | ( | ( | |
| Total Property and Equipment | $ | $ |
Depreciation expense for the years ended December 31, 2025 and 2024 was $-
NOTE 5 - PREFERRED STOCK
On October 19, 2011, the Company filed Articles of Incorporation with the State of Utah so as to authorize
NOTE 6 - COMMON STOCK
On October 19, 2011, the Company filed Articles of Incorporation with the State of Utah so as to authorize
Common Stock Issued to Officers:
The Company issued shares of restricted common stock to officers and directors in the years ended December 31, 2025 and 2024.
Employment and Consulting Agreements
In September 2022 the Company entered into employment agreements with Mr. William Hayde and Mr. Keith Merrell and a consulting agreement with Hanover International. Under each of the agreements there is a provision that provides for the issuance of
NOTE 7 - COMMITMENTS AND CONTINGENCIES
Operating Lease Obligations
The Company currently has no lease obligations related to office space.
NOTE 8- RELATED PARTY TRANSACTIONS
Accounts Payable
A director of the company provided $
Notes Payable
During the years ended December 31, 2025 and 2024 the Chief Financial Officer provided to the Company $
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The total of both accounts payable and notes payable to officers and directors at December 31, 2025 is $
Employment Agreements
Mr. Hayde and Mr. Merrell have received employment agreements. The agreements provide for no compensation until such time as a major funding event has been finalized, at which time the rate of compensation will be established by the Board of Directors.
Stock Grant
No stock grants were issued to officers or directors during the years ended December 31, 2025 and 2024.
NOTE 9 - CONVERTIBLE PROMISSORY NOTE
On September 11, 2022 the Board of Directors authorized Mr. Hayde to issue a convertible note in the amount of $
NOTE 10 – INCOME TAXES
In 2017, the U.S. enacted the Tax Cuts and Jobs Act which significantly changed U.S. tax law. The Act lowered the U.S. statutory federal income tax rate from
The income tax provision differs from the amount of income tax determined by applying the U.S. federal and applicable state income tax rates to pretax income from continuing operations for the years ended December 31, 2025 and 2024, due to the following:
| 2025 | 2024 | ||||
| Book Income (Loss) | $ | ( | $ | ( | |
| Depreciation | |||||
| Shares issued for services | |||||
| Meals and entertainment | |||||
| Amortization of debt discount | |||||
| (Gain) Loss on derivative | |||||
| Change in valuation allowance | $ | $ | |||
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Net deferred tax liabilities consist of the following components as of December 31, 2025, and 2024:
| 2025 | 2024 | ||||
| Deferred tax assets: | |||||
| NOL Carryover | $ | $ | |||
| Deferred tax liabilities | |||||
| Depreciation | |||||
| Valuation allowance | ( | ( | |||
| Net deferred tax asset | $ | $ | |||
Due to the change in ownership provisions of the Tax Reform Act of 1986, net operating loss carryforwards for Federal income tax reporting purposes are subject to annual limitations. If a change in ownership occurs, then net operating loss carryforwards may be limited as to use in future years. At December 31, 2025, the Company had net operating loss carryforward of approximately $
Included in the balance at December 31, 2025, are no tax positions for which the ultimate deductibility is highly certain but for which there is uncertainty about the timing of such deductibility. Because of the impact of deferred tax accounting, other than interest and penalties, the disallowance of the shorter deductibility period would not affect the annual effective tax rate but would accelerate the payment of cash to the taxing authority to an earlier period.
NOTE 11 - SUBSEQUENT EVENTS
Subsequent to December 31, 2025, the Chief Executive Officer provided $
The Company has evaluated subsequent events pursuant to ASC Topic 855 and has determined that there are no other events that require disclosure as of the date of issuance.
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