Item
1. Business.
Our Company
NL One Corporation was incorporated in the
State of Nevada, United States of America, on October 17, 2007 under the name Nevada Legacy Enterprises Corporation. Our fiscal
year end is December 31. On February 4, 2010, we changed our name to NL One Corporation. On June 27, 2016, we changed our name
to Flagship Global Corporation.
We own two patent provisional patent applications that may be used
to develop fiber optic and electronic technologies to monitor a health care patient’s blood glucose levels, and for monitoring
intravenous injection sites for infiltration of medication into tissue surrounding an intravenous injection site. As of the date
of this Prospectus, development of our technologies into viable working products has not begun.
On May 11, 2016, Thomas DeNunzio, our control
shareholder at the time of NL One Corporation (the “Company”), entered into a Share Purchase Agreement (the “Agreement”)
with Stansbridge Limited, (“Stansbridge”), a United Kingdom company. Pursuant to the Agreement, Mr. DeNunzio transferred
to Stansbridge 40,501,000 post-split (324,008,000 (presplit)) shares of our common stock, which represented approximately 92.87%
of our issued and outstanding shares.
On May 16, 2016, Mr. Jeffrey DeNunzio resigned as our Chief Executive Officer, President, Chief Financial Officer, Chief Accounting
Officer, President, and Director. The resignation was not the result of any disagreement with us on any matter relating to our
operations, policies or practices.
On May 16, 2016, Mr. Paul Moody resigned as our Secretary.
The resignation was not the result of any disagreement with us on any matter relating to our operations, policies or practices.
On May 16, 2016, Mr. Gary Richard Brown was appointed as
Chief Executive Officer, Chief Financial Officer, President, and Director.
On May 31, 2016, the Company’s Board
of Directors and majority vote of shareholders approved a one-for-eight stock split of the Company’s issued and outstanding
common stock, par value $.0001 per share and to change the name of the Company from “NL One Corporation” to “Flagship
Global Corporation.” In addition, the board of directors and shareholders approved and voted to change our ticker symbol
from NLLN to FGCN.
On June 27, 2016, we filed a Certificate of Amendment pursuant
to NRS 78.385 and 78.390 to change our name with the Nevada Secretary of State from NL One Corporation to Flagship Global Corporation.
The effective date of the name change is June 17, 2016.
On June 27, 2016, we filed a Certificate of Change pursuant
to NRS 78.209 with Nevada Secretary of State in regards to the aforementioned 1:8 reverse stock split. The effective date of the
split is June 17, 2016.
The total outstanding shares of the Company
following the reverse stock split was 43,611,250 shares of common stock.
Following the reverse stock split Stansbridge Limited
remained and still continues to remain our largest controlling shareholder.
General
We currently own the rights
to two patent pending technologies for health care monitoring devices, a Non Invasive Blood Glucose Tester, and a Thermal Detector
of Intravenous Infiltration.
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Our
Market
The
healthcare industry faces many challenges in today's environment of governance and regulatory compliance, and this picture will
become even more complex if a national healthcare system takes shape in the coming years. Today, in order to remain competitive,
healthcare organizations must focus on cost-control, and protect against risks. These are the precise issues to which our current
technologies are dedicated.
Home
Healthcare Industry
Home
healthcare care can be tailored to meet the individual’s needs, and provides an alternative to expensive stays in hospitals
or skilled care facilities. Familiarity and patient comfort are the best arguments for home care even in cases where the household
has not been ideally equipped.
Clients
typically require services due to permanent disability, long-term health conditions, acute illness, or permanent illness. Advances
in medical devices and technology have made home care a viable alternative to institutional care for the treatment of many conditions,
and although hospitals remain the primary providers of medical services, Home Healthcare services have capitalized on the need
to lower the overall cost of medical care.
Prevalent
ongoing home healthcare services include treatment for diabetes, and delivery of nutrients and medications intravenously.
Our
Products (Technology)
Note: We have
no physical prototypes of any of the technologies described below.
Non
Invasive Blood Glucose Level Tester
Our
blood glucose level tester technology has not been tested or proven, and we have not yet developed a working
prototype. The product is designed to continuously monitor a patient’s blood glucose levels using a non-invasive
sensor, preferably taped to a patient’s arm. The sensor uses a chemical switch that does not puncture the
patient’s skin, and does not come in contact with the patient’s blood.
Monitoring
the level of glucose in certain individuals is vitally important to their health. High or low levels of glucose may have detrimental
effects. The monitoring of glucose is particularly important to individuals with diabetes, as they must determine when insulin
is needed to reduce glucose levels in their bodies or when additional glucose is needed to raise the level of glucose in their
bodies.
A
conventional technique used by many diabetics for personally monitoring their blood glucose level includes the periodic drawing
of blood, the application of that blood to a test strip, and the determination of the blood glucose level using calorimetric,
electrochemical, or photometric detection. This technique does not permit continuous or automatic monitoring of glucose levels
in the body, but typically must be performed manually on a periodic basis. Unfortunately, the consistency with which the level
of glucose is checked varies widely among individuals. Many diabetics find the periodic testing inconvenient and they sometimes
forget to test their glucose level or do not have time for a proper test. In addition, some individuals wish to avoid the pain
associated with the test. These situations may result in dangerous hyperglycemic or hypoglycemic episodes.
Many
devices have been developed for continuous or automatic monitoring of glucose in the blood stream. A number of these
devices use electrochemical sensors, which are directly implanted into a blood vessel or in the subcutaneous tissue of a
patient. However, these devices are typically large, bulky, and/or inflexible, and many cannot be used effectively outside of
a controlled medical facility, such as a hospital or a doctor's office, unless the patient is restricted in his or
her activities. Additionally, these devices require a sensor to be implanted in the patient. Such examples of these products
are the Dexcom G5 CGM and Freestyle Libre Pro (which both rely on a sensor below the skin),
Other
devices that have been developed or are in development that are not intravenous have been found to be inconsistent. To our
knowledge no such intravenous device exists at this time that is FDA approved, found to be accurate, and does not in any way
rely upon a transmitter or sensor in the body to provide glucose readings.
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There is a need for a small,
comfortable device, not requiring surgical implantation, which can continuously monitor the level of glucose while still permitting
the patient to engage in normal activities. Continuous and/or automatic monitoring of glucose can provide a warning to the patient
when their glucose is at or near a threshold level so that the patient can take appropriate action in a timely manner.
Flagship
Global Corporation’s blood glucose level tester technology comprises a procedure and device for the continuous and/or automatic
monitoring of the patient’s glucose levels using a sensor taped or otherwise removable element attached to the patient.
If we are successful in our development we hope to have the device use a sensor which will contain a bio-chemical switch known
as a fullerene, which will (if we are successful in development) trigger an alarm when a patient becomes hyperglycemic or hypoglycemic.
Our
blood glucose level tester technology is in the very early development stage, and there is no proof as to whether this technology
will function as anticipated. To date the only step we have taken is to file a patent application to protect our intellectual
property rights, and no steps have been taken to develop a product based on the technology.
Thermal
Detection of Intravenous Infiltration
Our
technology for thermal detection of intravenous infiltration has not been tested
or proven, and we have not yet developed a working prototype.
Intra-venous
infiltration, a major complication of IV therapy also known as extravasation, occurs when IV fluid penetrates the tissue surrounding
an IV injection site. Infiltration may develop in different ways – the steel needle or plastic cannula
may pierce the wall of the vein, allowing fluid to flow into the interstitial space; a clot distal to the cannula may develop,
causing narrowing of the vein wall, blocking blood flow, increasing backpressure, and infiltration at the needle insertion site;
certain IV fluids may cause change in blood pH and constriction of veins with increasing pressure and subsequent infiltration;
the IV cannula or the infused solution may cause an inflammatory reaction, increasing permeability of the vein and allowing fluid
to leak into surrounding tissues; and the cannula may be dislodged from the vein. The extent of tissue damage caused
by infiltration depends on the drug, the dosage, the site of IV administration, and the exposure duration. Severe infiltration
injuries often require surgical treatment and even amputation.
There
are several methods currently existing for detecting infiltration: visual and tactile examinations; monitoring IV line pressure;
checking for blood return; and electromagnetic radiation detection.
Visual
and tactile examinations of IV sites are the most widely used methods for detecting infiltrations. The infiltrated site may
appear swollen or puffy. In this case erythema may also be present. Infiltrations may also appear as a pale area where
the infiltrate has pooled below the skin. The skin may feel cooler than the surrounding area due to rapid entrance of the
IV fluid into the tissue before it can be warmed to body temperature. However, visual and tactile examination does little
or nothing to prevent tissue damage; by the time infiltration is discoverable by these methods, damage has already occurred.
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Our
thermal detection of intravenous infiltration technology is in the very early development stage, and there is no proof as to whether
this technology will function as anticipated. To date the only step we have taken to further the development of this technology
is to file a patent application to protect our intellectual property rights. No steps have been taken to develop a product based
on the technology. While we believe that our method with regards to this technology is sound, product development has not begun,
and development and testing are a significant hurdles which will require substantial investments of both money and time.
Intellectual
Property
We
believe that our competitive position will depend in part upon our ability to obtain and enforce intellectual property
rights protecting our technology. To protect our intellectual property rights, we intend to rely on a combination of patents,
trademarks and trade secret laws, as well as confidentiality, consulting and employee agreements. As of April 14, 2017, we
own two pending provisional U.S. patent applications, covering non-invasive blood glucose level tester, and thermal detection
of IV infiltration. We may file for additional patents when appropriate to strengthen our intellectual property rights. We
also may license and acquire intellectual property from third parties.
Our
patent applications may not result in issued patents, and we cannot assure you that any patents that might be issued will
protect our intellectual property rights or will be able to be successfully enforced. Even if valid and enforceable, our patents
may not be sufficiently broad to prevent others from developing products that are similar to ours. Any patents issued to us may
be challenged by third parties as being invalid or unenforceable, or third parties may independently develop similar or competing
technology that avoids our patents. We cannot be certain that the steps we take will prevent the misappropriation of our intellectual
property, particularly in foreign countries where the laws may not protect our proprietary rights as fully as in the United States.
The
medical device industry has been characterized by frequent and extensive intellectual property litigation. It is possible that
our competitors or other patent holders may assert that products we develop are covered by their patents. In addition, our competitors
may infringe our issued patents, if any, on the basis that their devices or the methods employed in their procedures are covered
by our patents. Enforcing our patent rights, however, will be expensive and time-consuming and could distract management and harm
our business and such enforcement efforts might not be successful.
An
adverse determination in litigation or interference proceedings to which we may become a party relating to intellectual property
could subject us to significant liabilities to, or require us to seek licenses from, third parties. Furthermore, if we are found
to willfully infringe third-party intellectual property rights, we could, in addition to other penalties, be required to pay treble
damages. Although intellectual property disputes in the medical device area have often been settled through licensing or similar
arrangements, costs associated with such arrangements may be substantial and could include ongoing royalties. We may be unable
to obtain necessary licenses on satisfactory terms, if at all. Adverse determinations in a judicial or administrative proceeding
or failure to obtain necessary licenses could have an adverse material effect on our business.
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Government
Regulation
The
products we may develop will be medical devices,
subject to extensive and rigorous regulation under the Federal Food, Drug and Cosmetic Act, or the FDCA, as implemented and
enforced by the FDA, as well as the laws and regulations implemented and enforced by other federal, state and local
regulatory bodies in the United States and comparable authorities in other countries. We may be required to file for and
obtain either 510(k) clearance or a pre-market approval application for those products or indications. Pursuit of FDA
approval may involve clinical trials, and can require large capital expenditures. Even if we do raise sufficient
funds to pursue FDA approval, there is no guarantee that the FDA will ultimately approve our products. At this time we have
no plans to raise such funds.
We
may be required to submit a pre-market approval application to the FDA for review that is supported by extensive data,
including technical, preclinical, clinical trials, manufacturing, and labeling to demonstrate to the FDA’s satisfaction
the safety and effectiveness of the products we intend to sell. As the Company has limited resources, and is in a very early
growth stage, we have not yet determined the scope of the FDA’s statutory and regulatory requirements for approval of the
products we intend to sell in the future.
Employees
We
currently have no employees with the exception of our Sole Officer and Director, Gary Richard Brown, whom does not receive
any salary or have any formal employment agreement(s) with us. Mr. Brown works less than 20 hours per month on our business plan.
It
should be noted that our Sole Officer and Director does not have any experience in the medical field and that any
advancements to our technology will most likely require the implementation of medical professionals. We have no plans
to hire such medical professionals at this time. We also do not have the funds to hire the necessary firms that
could assist us in designing or creating physical prototypes of our technologies described above.
Item
1A. Risk Factors.
The
following risk factors and other information included in this Report on Form 10-K should be carefully considered. The risks
and uncertainties described below are not the only ones we face. Additional risks and uncertainties not presently known to us
or that we presently deem less significant may also impair our business operations. If any of the events or circumstances described
in the following risk factors actually occurs, our business, operating results and financial condition could be materially adversely
affected.
Risks
Related to Our Business
Our
technologies are not fully developed
Our
technologies are in the development stage, have not been tested, and have not been reduced into fully functioning prototypes.
There is no guarantee that products based on our current technologies will be viable, or that we will be able to develop or acquire
viable technologies.
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We
must obtain governmental approvals or clearances before we can sell products based on our technologies
In order to market medical products in the
United States we must first obtain US FDA approval. We currently have not begun the process of determining the scope of the US
FDA’s statutory and regulatory requirements for approval of the products we intend to sell, and there is no guarantee that
once we initiate the process of obtaining approval by the US FDA, that we will be able to obtain such approval. We
also have not begun the process of determining the scope of regulation or obtaining approval by governmental agencies in other
countries in which we may market our products. Failure to obtain such approvals will have a negative impact on
our business plans. It should be noted however, at this time we have no tangible products to be sold.
We
have not researched the availability of governmental and private reimbursement systems on our planned business
Governmental
and private medical reimbursement systems play an important role in the health care field. Failure of a product to
qualify for reimbursement may limit the usage or desirability of such product. Because our business is in the very early growth
stage and we have very limited resources, we have not examined the effect of government or private reimbursement systems on our
planned business, or the steps necessary to qualify our planned products for reimbursement. Failure to qualify our
products for governmental and private reimbursement may have a material adverse effect on our business.
Impracticability
of exhaustive investigation
Our
lack of financial resources may make it impracticable to conduct a complete and exhaustive investigation and analysis of technologies
before we commit our capital or other resources thereto. Management decisions, therefore, will likely be made without detailed
feasibility studies, independent analysis, market surveys and the like which, if we had more funds available to us, would be desirable.
Lack
of diversification
Our
lack of financial resources may prevent diversification of our technologies. The inability to diversify our activities into several
unrelated areas may subject us to economic fluctuations within a particular business, industry or market segment, and therefore
increase risks associated with our operations.
Detriments/Risks
of Refiling a Provisional Patent Application.
Risk
of Losing Our Patent Rights
. Our provisional patent applications have expired and we have not refiled our applications with
the USPTO. A refiled provisional patent application cannot claim priority to the first provisional patent application's filing
date like a non-provisional can. Under the new first to file patent system implemented by the United States on March 16,
2013, losing our earlier filing date for the second provisional application could result in the loss of our patent rights if our
provisional patent applications expire and a third party files before we refile our applications.
Delayed
Patent Rights
. By filing a third provisional patent application instead of a non-provisional patent application, we
are delaying examination of our patent application another year since a provisional patent application is not examined (the average
pendency of a non- provisional patent application is approximately 30 months -by filing three consecutive provisional applications
this pendency period is effectively increased to 66 months).
Due
to the previous factors your investment in us may be adversely effected.
We
cannot assure the safety or effectiveness of our future products
To obtain and maintain
required regulatory approvals and secure the confidence of physicians and others whose acceptance is needed for our medical
products, we will need to demonstrate that our products are safe and effective. We cannot assure that our products
will be deemed safe and effective. Our planned products have not been developed, used or tested, therefore, we cannot predict
their safety and effectiveness.
Our
patent applications and proprietary rights may not provide us with significant competitive advantage
Our
success may depend heavily on our ability to obtain and retain patent protection for our product candidates, to preserve our trade
secrets and to operate without infringing the proprietary rights of third parties. We currently own two pending patent applications. We
may file additional patent applications in the US and in other countries. Claims in the pending patent applications may not issue
as patents, and issued patents may not provide us with meaningful competitive advantages. In addition, challenges may be instituted
against the validity or enforceability of any patent owned or licensed by us. Furthermore, others may independently develop
similar or superior technologies, duplicate our technologies or design around the patented aspects of our technologies. Our inability
to obtain and retain patent protection and to otherwise protect our intellectual property would be materially adverse to our business.
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Even
if we obtain patent protection, our proposed products may infringe on third party patents
Conducting
an infringement analysis to determine if our proposed products will infringe on third party intellectual property rights is
expensive, and we have not had the funds to pursue such infringement analyses. As a result we do not know if any of our proposed
products would infringe upon prior or future patents owned by others. In the event that our products would infringe
on third party intellectual property rights we may be forced to acquire licenses for technology potentially useful or necessary
to our business. These licenses may not be available on terms acceptable to us, if at all. Moreover, patents issued to or licensed
by us may be infringed by others. The cost of litigation involving patents, whether brought by or against us, can be substantial,
and can result in adverse determinations to us, including declaration of our patents as invalid. In the event that
we are unable to secure necessary licenses from third parties, or in the event that we are forced to engage in patent litigation,
we may be forced to abandon our business plan and cease operations.
We
may not be able to compete successfully against our competitors
We
are engaged in rapidly evolving and highly competitive fields. Competition from biotechnology companies, medical device manufacturers, electronics
developers, and other competitors is intense. Academic institutions, hospitals, governmental agencies, and other public and
private research organizations are also conducting research and seeking patent protection and may develop competing
products or technologies on their own or through joint ventures. These and other competitors’ technological advances
could render our products noncompetitive or obsolete. We may be unable to respond to technological advances through the development
and introduction of new products. Moreover, many of our existing and potential competitors have substantially greater financial,
marketing, sales, distribution, manufacturing and technological resources than our Company. These competitors may be in the process
of seeking FDA or other regulatory approvals or clearances, or patent protection, for competitive products. Our competitors could,
therefore, commercialize competing products in advance of our products.
We
may rely on consultants for certain strategic activities, which results in less control over such activities
We
may rely upon consultants and advisors to assist in formulating research and development strategies, testing and manufacturing,
and marketing-related issues. We have less control over the activities of our consultants which
may reflect negatively in the time and effort devoted to such activities. Consultants and advisors may be employed outside
of our Company and may have commitments or consulting or advisory contracts with other entities that could conflict with
their service to our Company.
We
may be exposed to large product liability claims
Our
business exposes us to potential liability risks that are inherent in the testing, manufacturing, and marketing of medical
and other electronic and fiber optic products. The use of our proposed products in clinical trials may expose us to
product liability claims and possible adverse publicity. These risks also exist with respect to our proposed products, if
any, that receive regulatory approval for commercial sale. We do not have Product Liability Insurance coverage. Any
product liability claim brought against us, with or without merit, could result in the increase in the inability to secure coverage
in the future. A product liability or other judgment against our Company would have a material adverse effect upon our
financial condition.
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Lack
of funds limit our ability to begin actual research and development to further our provisional patents.
We
cannot begin actual research and development of a prototype until we receive the necessary funds to accomplish this goal.
We have no source or anticipated source of any funds that will allow us to be able to fund the operations we set out to
conduct in the future.
Our
inability to fund our capital expenditure requirements may adversely affect our growth and profitability
Our
success is dependent upon our ability to raise capital from outside sources. In the future we may be unable to obtain the necessary
financing on a timely basis and on acceptable terms, and our failure to do so may adversely affect our financial position, competitive
position, growth, and profitability. Our ability to obtain acceptable financing at any time may depend on a number of factors,
including: our financial condition and results of operations, the condition of the economy, and conditions in relevant financial
markets in the United States and elsewhere in the world.
There
is doubt about our ability to continue as a going concern
Our
auditor’s report expresses an opinion that considerable doubt exists as to whether we can continue as an ongoing business.
Our sole officer and director, Gary Richard Brown, may be reluctant or unable to loan or advance additional capital to the Company.
We believe that if we do not raise additional capital, we may be required to suspend or cease the implementation of our business
plans. You may be investing in a company that will not have the funds necessary to continue to deploy its business strategies. As
the Company has been issued an opinion by its auditors that substantial doubt exists as to whether the Company can continue as
a going concern, it may be more difficult for the Company to attract investors.
Our
sole officer and director Gary Richard Brown works
on a part-time basis. As a result, we may be unable to develop our business and manage our public reporting
requirements.
Our
operations depend on the efforts of our sole officer and director Gary Richard Brown. Mr. Brown currently
devotes approximately 15 hours per week each to our operations. Because of this, we may be unable to develop and
manage our business. If we lose Gary Richard Brown the Company may, consequently, be forced
to terminate operations and go out of business.
Risks
related to our common stock
The
market price for our common stock may be volatile
The
market price for our common stock is likely to be highly volatile and subject to wide fluctuations in response to factors
including the following: actual or anticipated fluctuations in our quarterly operating results, announcements of new products
by us or our competitors, changes in financial estimates by securities analysts, announcements by our competitors of significant
acquisitions, strategic partnerships, joint ventures or capital commitments, additions or departures of key personnel, potential
litigation, or conditions in the market. In addition, the securities markets have from time to time experienced significant price
and volume fluctuations that are not related to the operating performance of particular companies. These market fluctuations
may also materially and adversely affect the market price of our common stock.
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Shareholders
could experience substantial dilution
We
may seek funding through the issuance of convertible notes and warrants, private placements, convertible debentures, and other
issuances of our capital stock. If we issue additional shares of our capital stock, our shareholders will experience
dilution in their respective percentage ownership in the Company.
We
have no present intention to pay dividends
We
have never paid dividends or made other cash distributions on our common stock, and we do not expect to declare or pay any dividends
in the foreseeable future. We intend to retain any future earnings for working capital and to finance current operations and expansion
of our business.
A large
portion of our common stock is controlled by a single shareholder.
As
of the date of this report approximately 86.11% of our common stock is held by a single shareholder. As a result our majority
shareholder is able to substantially influence the outcome of shareholder votes on various
matters, including the election of directors and extraordinary corporate transactions, including
business combinations.
Our
board of directors can change the voting power of our common shares without shareholder approval.
Article
X of our Company’s Bylaws permits our board of directors to amend our bylaws. The board of directors can change the voting
power of our Company’s common shares without shareholder approval. This may cause you to lose some or all of your investment
due to the fact that shareholders’ voting power can be changed or altered. This also means that the Company may face difficulty
in acquiring future investments. It may also impact the personal ownership of shares as the voting power can be changed or altered
at any time if designated by the Company’s board of Directors.
Our
Common Stock’s small public float and lack of liquidity could adversely affect investors.
The ratios
of ownership of our common stock reduce the public float and liquidity of our common stock. Because less than 50% of
our common stock is in the public float, investors have limited ability to affect corporate decisions. Additionally,
reduced liquidity can have a negative impact on the market price of our common stock and make it difficult or impossible for investors
to sell their shares.
Our
common stock is considered a "penny stock" and may be difficult to sell
Our
shares as penny stocks are covered by section 15(g) of the Securities Exchange Act of 1934 which imposes additional sales practice
requirements on broker/dealers who sell the Company’s securities including the delivery of a standardized disclosure document;
disclosure and confirmation of quotation prices; disclosure of compensation the broker/dealer receives; and, furnishing of monthly
account statements. For sales of our securities, the broker/dealer must make a special suitability determination and
receive from its customer a written agreement prior to making a sale. The imposition of these additional sales practices
could adversely affect your ability to dispose of our stock.