Revolutions Medical Corp - Recent Material Event
<![CDATA[FORWARD LOOKING STATEMENTS
This Report contains forward-looking statements within the meaning of The
Private Securities Litigation Reform Act of 1995 that address, among other
things, development-stage of our safety needle products, our pursuit of
collaborative arrangements; our need to obtain additional financing; factors
affecting the availability of capital; plans regarding the raising of capital.
These statements may be found under "Item 1- Business," "Item 1- Risk Factors,"
and "Item 6 - Plan of Operation" as well as in this Report generally. We
typically identify forward-looking statements in this Report using words like
"believe," "anticipate," "will," "expect," "may," "could," "intend," or similar
statements. There are important factors that could cause actual results to
differ materially from those expressed or implied by such forward-looking
statements, primarily our ability to raise additional capital to continue
operating. Readers are cautioned not to place undue reliance on these
forward-looking statements, which reflect management's analysis only as of the
date hereof. We undertake no obligation to publicly revise these forward-looking
statements to reflect events or circumstances that arise after the date hereof.
PART I
ITEM 1. BUSINESS
Since 1997, we have been working to design, develop and commercialize
retractable safety needle devices. Our present product development effort is
focused on the ReVac retractable safety syringe, which is designed specifically
to reduce accidental needlestick injuries. On February 6, 2007, the Company
announced an agreement with Strategic Product Development, Inc. ("SPD") to
provide FDA regulatory compliance, manufacturing management capabilities and
ongoing product development services. On March 5, 2007, the Company announced
that SON Medical, a privately held contract regulatory and testing consulting
firm located in the Boston area, was chosen to conduct lab testing for the
Company's ReVac retractable safety syringe. The Company is presently seeking the
funds necessary to commence and complete the lab testing, the results of which
will then be used as part of the Company's planned 510K submission to the FDA.
There is no assurance that sufficient funds will be raised on a timely basis or
at all or that the planned 510K submission to the FDA will be completed or
approved by the FDA. See "RISK FACTORS."
On January 26, 2007 the Company entered into a Plan and Agreement of
Reorganization with Clear Image Acquisition Corporation ("Acquisition Corp") for
the acquisition by the Company of all of the assets of Acquisition Corp in
exchange for the issuance by the Company for the benefit of the holders of the
Common Stock of Acquisition Corp. of 8,260,139 shares of the Company's Common
Stock. The Company will assume the minimal liabilities of Acquisition Corp which
are only the costs of Acquisition Corp's liquidation and dissolution. The shares
to be issued are not being registered, but are being issued in a private
offering under Section 4(2) of the Securities Act.
Acquisition Corp is a company which was formed by certain shareholders of
Clear Image, Inc. ("Clear Image"), an Oklahoma corporation, all of whom are
accredited investors, in order to assemble a control block of the shares of
Clear Image for the purposes of such a transaction. Accordingly, the sole asset
of Acquisition Corp is a block of 8,273,788 shares of the Common Stock of Clear
Image. Clear Image is a development stage company which has developed certain
proprietary technology and patent pending for (i) differential coloring, by
series, of MRI scans and (ii) auto-registration of the scan images. As a private
company, however, faced with the substantial competition of the leaders in the
field of MRI technology, Clear Image has had difficulty obtaining the necessary
working capital to complete the development of commercial components of its
technology. The Company, in acquiring control of Clear Image, believes that it
can provide sufficient working capital to complete commercialization of certain
aspects of Clear Image's technology to the point of supporting some licensing or
joint venture relationship financially adequate to permit Clear Image to
complete the development of the remaining aspects of its technology.
Because our planned products are in various stages of development, we have
no revenue. Our efforts to date have been funded almost entirely through sales
of our common stock. We require substantial additional capital to complete the
development of, to obtain approvals for and to begin commercializing the ReVac
retractable safety syringe and the Clear Image color MRI software. There is no
assurance that such capital will be available to us when needed, on acceptable
terms, or at all. There is no assurance that our planned products will be
commercially viable. Our present and future collaborative partners may require
significant amounts of time to complete product design, develop manufacturing
processes and/or to obtain specialized equipment, if any is required. Our
planned products will also require FDA approval before they can be sold in the
United States and similar approvals from foreign countries where our products
may be marketed. Obtaining government approval, whether in the U.S. or
elsewhere, is a time-consuming and costly process with no guarantee of approval.
It could be years, if ever, before our planned products are sold in the United
States or anywhere else in the world. Our business is subject to numerous risks
and uncertainties that are more fully described in "RISK FACTORS."
2. Distribution Method of Products and Services
In the U.S., the vast majority of decisions relating to the contracting for
and purchasing of medical supplies are made by the representatives of group
purchasing organizations ("GPOs") rather than the end-users of the product
(nurses, doctors, and testing personnel). GPOs and manufacturers often enter
into long-term exclusive contracts which can prohibit entry in the marketplace
by competitors. In the needle and syringe market, the market share leader, BD,
has utilized, among other things, long-term exclusive contracts which have
restricted entry into the market by most of our competitors. We may not be
successful in obtaining any contracts with GPO's, which would severely limit our
product's marketability in the U.S. See "RISK FACTORS."
We presently do not have any products for sale. We plan to seek
distribution arrangements with established medical device manufacturers in the
future, but there is no assurance that we will be successful in establishing or
maintaining such relationships. See "RISK FACTORS."
3. Status of Publicly Announced Products or Services
On February 6, 2007, the Company announced an agreement with Strategic
Product Development, Inc. ("SPD") to provide FDA regulatory compliance,
manufacturing management capabilities and ongoing product development services.
On March 5, 2007, the Company announced that SON Medical, a privately held
contract regulatory and testing consulting firm located in the Boston area, was
chosen to conduct lab testing for the Company's ReVac retractable safety
syringe. The Company is presently seeking the funds necessary to commence and
complete the lab testing, the results of which will then be used as part of the
Company's planned 510K submission to the FDA. There is no assurance that
sufficient funds will be raised on a timely basis or at all or that the planned
510K submission to the FDA will be completed, submitted to or approved by the
FDA. See "RISK FACTORS."
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On January 26, 2007 the Company entered into a Plan and Agreement of
Reorganization with Clear Image Acquisition Corporation for the purpose of
acquiring Clear Image's Color MRI technology. Clear Image is a development stage
company which has developed certain proprietary technology and patent pending
for (i) differential coloring, by series, of MRI scans and (ii)
auto-registration of the scan images. As a private company, however, faced with
the substantial competition of the leaders in the field of MRI technology, Clear
Image has had difficulty obtaining the necessary working capital to complete the
development of commercial components of its technology. The Company, in
acquiring control of Clear Image, believes that it can provide sufficient
working capital to complete commercialization of certain aspects of Clear
Image's technology to the point of supporting some licensing or joint venture
relationship financially adequate to permit Clear Image to complete the
development of the remaining aspects of its technology. If the Company is
successful in raising the necessary capital, it plans to complete the
development and beta testing of the Color MRI technology during 2007. There is
no assurance, however, that sufficient funds will be raised on a timely basis or
at all, that development of the Color MRI technology will be completed, or that
beta testing will commence, be completed, or result in a marketable product. See
"RISK FACTORS."
4. Competitive Business Conditions, Competitive Position and Methods of
Competition
The safety medical device market is highly competitive. The leading
manufacturers and marketers of safety medical devices are Becton-Dickinson, Tyco
International, Inc. (Kendall Healthcare Products Company), B. Braun, Terumo
Medical Corporation of Japan, Medi-Hut, Inc. and Johnson & Johnson. Developers
of safety medical devices, which we compete against for license and
collaborative arrangements with medical device and pharmaceutical companies,
include Med-Design Corporation, New Medical Technologies, Retractable
Technologies, Inc., Univec, Inc. and Specialized Health Products International.
Our competitors have substantially greater assets, technical staffs, established
market shares, and greater financial and operating resources than we do. There
is no assurance that we can successfully compete. See "RISK FACTORS."
Traditionally, competition regarding non-safety medical devices was
primarily based upon price with little differentiation between products. We
expect our products to compete against both safety products and non-safety
products based upon safety and ease of use and disposal. Most of the safety
medical devices we will compete with are priced substantially above the cost of
non-safety products. Market demand for safety devices is being driven by the
estimated costs associated with accidental needlesticks and by government
mandates.
5. Sources of Raw Materials and the Names of Principal Suppliers
We do not presently manufacture any products, so we have no raw materials
requirements at this time. The materials used to make our planned products are
commercially available from a number of suppliers. The manufacturing process
will be highly technical and demanding, with very low fault tolerances. There is
no assurance that we will be able to engage a company capable of manufacturing
the safety syringe in a cost-effective manner or at all. See "RISK FACTORS."
6. Dependence on One or Few Major Customers
We anticipate that our safety syringe will be marketed to the entire field
of medical professionals. We do not anticipate being dependent on any particular
customer, however, at this time we can not know if any one customer will account
for more than 1% of our anticipated safety syringe sales.
7. Patents, Trademarks, Licenses, Royalty Agreements or Labor Contracts
In June 2007, we filed four utility patents focused on its MRI imaging
software technology. These patents were based on the provisional patents filed
last June and acquired in the Clear Image Acquisition transaction earlier this
year. It is believed that these patents will provide the basis for a family of
MRI imaging and search product offerings and also firms up its established
intellectual property. See "RISK FACTORS".
Also in September 2005 we filed a patent under the Joint Venture with Globe
Med Tech and the Company owns 50% of this pending patent. The Company filed a
lawsuit to rescind, terminate and seek monetary damages for the non-fulfillment
and breach of the joint venture agreement and other related agreements, in
addition to an accounting of expenditures of funds under the terms and
provisions of the agreements. (see Item 3 - Legal Proceedings and "RISK
FACTORS").
RMCP 3CC SAFETY SYRINGE PATENT. A U.S. patent covering our retractable
safety syringe design was published on January 28, 2005. This patent will expire
on April 9, 2023. The Company has not yet filed any applications for foreign
patent protection. If any foreign patents applications are filed, there is no
assurance that any foreign patents will be issued. See "RISK FACTORS."
RMCP BLOOD SAMPLING DEVICE PATENT. A U.S. patent covering the Company's
blood sampling device was published on April 10, 2003. The Company does not plan
to devote development resources towards this product for the foreseeable future.
The Company has not yet filed any applications for foreign patent protection.
See "RISK FACTORS." There is no assurance that any international patents will be
issued.
PATENT APPLICATIONS FOR COLOR MRI TECHNOLOGY. During 2006, Clear Image
filed four patent applications related to the Color MRI technology, none of
which has yet been published. There is no assurance that any of the patent
applications will be published or that any patent protection for the Color MRI
technology can or will be obtained.
EMPLOYMENT AGREEMENTS
Employment Agreement with Ron Wheet, CEO
-----------------------------------------
Effective March 31, 2008, the Company and Mr. Wheet, our CEO, entered into
a three year employment agreement. The agreement provides for an annual salary
of $225,000.As of December 31, 2007, the Company owed Mr. Wheet $211,024
pursuant to his prior employment agreement. He is responsible for the Company's
substantive and financial reporting requirements of the Securities Exchange Act
of 1934, as amended, and is specifically allowed to hire any and all
professionals necessary to assist that process. The Company will provide him
with all reasonable and customary fringe benefits, including, but not limited
to, participation in pension plans, profit sharing plans, employee stock
ownership plans, stock option plans (whether statutory or not), stock
appreciation rights plans, hospitalization, medical dental disability and life
insurance, car allowance, vacation and sick leave. The Company will reimburse of
all his reasonable and necessary travel, entertainment or other related expenses
incurred by him in carrying out his duties and responsibilities under the
agreement. The Company will also provide him with a cell phone, suitable office
space, and membership dues in professional organizations and for any seminars
and conferences related to Company business.
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Mr. Wheet may elect, by written notice to the Company, to terminate his
employment with continued pay through the employment agreement term if (i) the
Company sells all of its assets, (ii) the Company merges with another business
entity with a change in control,(iii) more than 50% of the outstanding stock is
acquired by a third party, (iv) the Company requires Mr. Wheet to relocate or
assigns duties not commensurate with his position as CEO, (v) Mr. Wheet is
removed from the Board of Directors and (vi) the Company defaults in making
payments required to Mr. Wheet under this agreement. For two years following his
resignation or termination , Mr. Wheet will not work for or provide any services
in any capacity to any competitor and will not solicit any of the Company's
customers or accounts.
Amounts Accrued Pursuant To Other Employment Agreements
-------------------------------------------------------
As of December 31, 2007, the Company owed approximately $984,128 pursuant
to other employment agreements. Although the Company plans to settle these
amounts, there is no assurance that its efforts to settle will be successful. No
litigation related to these employment agreements has been initiated or
threatened. There is no assurance, however, that such litigation will not be
initiated in the future.
Mutual Release and Settlement Agreement With Former CEO
--------------------------------------------------------
On April 14, 2006, the Company and its former CEO entered into a mutual
release and settlement agreement, pursuant to which the Company issued to the
former CEO a promissory note for $203,920 (amount outstanding at December 31,
2007) and a warrant to purchase up to 12,913,239 shares of common stock at
$0.001 per share on or before April 14, 2010. In addition, the mutual release
and settlement provides for continued indemnification of the former CEO and
mutual releases. The note, which is unsecured and is presently in default, bears
interest at 18% per year as the note was due April 14, 2007. As of December 31,
2007, the Company had accrued interest payable of $91,176. The warrant is
exercisable only to the extent that the number of shares of common stock
exercised plus the number of shares presently owned by the warrant holder does
not exceed 4.99% of the outstanding shares of Common Stock of the Company on
such date. The exercise limit is revocable by the warrant holder upon 75 days
prior notice to the Company. During the three months ended March 31, 2006, the
former CEO exercised warrants to purchase 6,000,000 shares of common stock. The
exercise price of $6,000 was paid by reducing the principal balance of the
promissory note by $6,000During the quarter ended September 30, 2007, the
Company issued 345,662 shares of common stock upon the exercise of a warrant.
The exercise price of $6,913 was paid by reducing the principal balance of the
promissory note payable by the Company.
8. Need for Governmental Approval
Pursuant to the Federal Food, Drug and Cosmetic Act, the FDA regulates the
research, design, testing, manufacture, safety, labeling, storage, record
keeping, advertising and promotion, distribution, and production of medical
devices in the United States. The Company's safety needle devices are considered
to be medical devices, are subject to FDA regulation, and must receive FDA
approval prior to sale in the United States.
Medical devices are classified into one of three classes, depending on the
controls deemed by FDA to be necessary to reasonably ensure their safety and
effectiveness. Class I devices are subject to general controls (e.g. labeling,
pre-market notification and adherence to Quality System regulations, which have
replaced Good Manufacturing Practice regulations.) These devices are subject to
the lowest level of regulatory control. Class II devices are subject to general
controls and to special controls (e.g. performance standards, post-market
surveillance, patient registries, and FDA guidelines). Generally, Class III
devices are those that must receive pre-market approval by the FDA to ensure
their safety and effectiveness, and require clinical testing and FDA approval
prior to marketing and distribution. Class III devices are the most rigorously
regulated.
Generally, before a new device can be introduced into the market in the
United States, the manufacturer must obtain FDA clearance through a 510(k)
pre-market notification or approval of a premarket approval ("PMA") application.
If a medical device manufacturer can establish that a device is "substantially
equivalent" to a legally marketed Class I, Class II device, or a Class III
device for which FDA has not called for PMAs, the manufacturer may seek
clearance from FDA to market the device by filing a 510(k) pre-market
notification. The 510(k) pre-market notification will need to be supported by
appropriate data establishing the claim of substantial equivalence to the
satisfaction of the FDA.
If the Company or its collaborative partners cannot establish that the
Company's safety needle devices are substantially equivalent to legally marketed
predicate devices, pre-market approval of the device through submission of a PMA
application must be obtained. A PMA application must be supported by valid
scientific evidence, including pre-clinical and clinical trial data, as well as
extensive literature to demonstrate a reasonable assurance of the safety and
effectiveness of the device. The PMA represents the most rigorous form of FDA
regulatory approval.
The Medical Device User Fee and Modernization Act, enacted in 2002,
authorizes the FDA to assess and collect review fees for Section 510(k)
pre-market notifications and pre-market approval applications filed on or after
October 1, 2002. Fees for fiscal year 2007 for small businesses (companies with
less than $100 million in sales) range from $3,326 for Section 510(k) pre-market
notifications to $107,008 for PMAs, although fee reductions and waivers are
available for companies qualifying as small businesses.
We have not submitted an application for FDA approval for our ReVac
retractable safety syringe or any of our other planned products. There is no
assurance that the ReVac retractable safety syringe or any of our other planned
products will qualify for the 510(k) pre-market notification approval process or
that the Company will have the funds necessary to seek FDA approval. There is no
assurance that the ReVac retractable safety syringe or any of our other planned
products will obtain FDA approval.
If FDA approval is received, however, then the Company and/or its
collaborative partner (depending on who is manufacturing and marketing) would
also be required to comply with FDA post-market reporting requirements,
including the submission of reports on certain adverse events and malfunctions,
and requirements governing the promotion of medical devices. In addition,
modifications to our devices may require the filing of new 510(k) submissions or
pre-market approval supplements, and we will need to comply with FDA regulations
governing medical device manufacturing practices. The FDA requires medical
device manufacturers to register as such and subjects them to periodic FDA
inspections of their manufacturing facilities. The FDA requires that medical
device manufacturers produce devices in accordance with the FDA's current
Quality System Regulation (QSR), which governs the methods, facilities and
controls used for the design, manufacture, testing, packaging, labeling and
storage of medical devices.
There is a different set of regulatory requirements in place for the
European Union (EU). In the EU the company putting a medical device onto the
market must comply with the requirements of the Medical Devices Directive (MDD)
and affix the CE mark to the product to attest to such compliance. To achieve
this, the medical devices in question must meet the "essential requirements"
defined under the MDD relating to safety and performance, and the relevant
company must successfully undergo a verification of its regulatory compliance by
a third party standards certification provider, known as "Notified Body." The
nature of the assessment will depend on the regulatory class of products
concerned, which in turn determines the precise form of testing to be undertaken
by the Notified Body.
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The requirements of the MDD must be complied with by the "manufacturer of
the device," which is defined as the party responsible for the design,
manufacture, packaging and labeling of the device before it is placed on the EU
market, regardless of whether these operations are carried out by this entity or
on its behalf.
Accordingly, where medical devices are marketed by our potential licensees
or by collaborative partners under their names, compliance with the MDD will be
their responsibility. In the event that we decide to manufacture devices to be
distributed in the EU market under our name, all compliance responsibilities
will be borne by us.
There may be numerous other approvals needed before our products can be
sold in countries other than the United States or the European Union. There is
no assurance that the Company or its collaborative partners, if any, will be
successful in obtaining such approvals.
9. Effect of Existing or Probable Governmental Regulation
Regulatory actions at the federal and state level promote the use of safety
needles to reduce the risk of accidental needlesticks. On July 1, 1999,
California, through its state Occupational Safety and Health Administration
(OSHA) program, began requiring the use of safety needles. Other states such as
Texas, Tennessee, Maryland and New Jersey have passed similar legislation.
On November 6, 2000, President Clinton signed the Needlestick Safety and
Prevention Act amending OSHA's Bloodborne Pathogens Standard to require that
employers implement the use of safer medical devices in their facilities. To
implement the statutory mandates in the Needlestick Safety and Prevention Act,
OSHA has issued a number of further revisions to its Bloodborne Pathogens
Standard. The revised standard became effective on April 18, 2001. The new
standard provisions impose several needle device safety requirements on
employers, including:
- evaluation and implementation of safer needle devices as part of the
re-evaluation of appropriate engineering controls during an employer's
annual review of its exposure control plan;
- documentation of the involvement of non-managerial, frontline employees
in choosing safer needle devices; and
- establishment and maintenance of a sharps injury log for recording
injuries from contaminated sharps.
On November 27, 2001, OSHA issued a compliance directive (CPL 2-2.69) that
advises OSHA's regional offices on the proper interpretation and enforcement of
the revised Bloodborne Pathogens Standard provisions. The compliance directive
confirms that the consideration of safer needle devices, in annually reviewing
and updating the exposure control plan, is a critical element of the Bloodborne
Pathogens Standard. The directive also stresses that the standard requires
employers to use engineering controls (e.g., safer needle devices) if such
controls will remove or eliminate the hazards to employees. As a result of these
regulatory actions, we anticipate that the demand for safety medical devices
such as those we have designed will continue to increase for the foreseeable
future.
10. Estimate of the Amount Spent on Research and Development
R&D expenses for our retractable safety syringe design were $0 and $39,000
in 2007 and 2006, respectively.
11. Costs and effects of environmental compliance
The Company has not spent any sums on environmental compliance and does not
expect to be required to spend any sums on environmental compliance in the
future, unless the Company chooses to become a manufacturer of its own products,
which is not likely. Should the Company be successful in establishing
collaborative arrangements with an established manufacturer, all environmental
costs would be borne by the manufacturer.
12. Number of total employees and number of full time employees
We presently have no full-time employees. Services such as product design
and development, accounting and financial reporting are provided by third
parties on a contract basis. Consequently, developing our business may require a
greater period of time than if we had full time employees. See "RISK FACTORS."
RISK FACTORS
You should carefully consider the risks described below, together with all
of the other information included in this report, in considering our business
and prospects. The risks and uncertainties described below are not the only ones
facing the Company. Additional risks and uncertainties not presently known to us
or that we currently deem immaterial also may impair our business operations.
The occurrence of any of the following risks could harm our business, financial
condition or results of operations.
BECAUSE WE HAVE NO PRODUCTS FOR SALE, WE DO NOT GENERATE REVENUE AND DO NOT HAVE
OTHER RESOURCES TO FUND OPERATIONS; THESE CONDITIONS RAISE SUBSTANTIAL DOUBT
ABOUT OUR ABILITY TO CONTINUE AS A GOING CONCERN
Because the Company's planned products are in the development stage, the
Company has no revenue, earnings or cash flow to be self-sustaining. It could be
several more years before the Company can expect to have sales. The Company's
independent accountants have stated, in their opinion to the audited financial
statements for the period ended December 31, 2007, "the Company is a development
stage company with insufficient revenues to fund development and operating
expenses. The Company also has insufficient cash to fund obligations as they
become due. These conditions raise substantial doubt about its ability to
continue as a going concern." Our failure to obtain the funding necessary to
continue our activities will have a material adverse effect on our business,
financial condition, and on the price of our common stock.
WE REQUIRE SUBSTANTIAL ADDITIONAL CAPITAL TO CONTINUE DEVELOPING OUR PLANNED
PRODUCTS. WE MAY HAVE DIFFICULTY RAISING CAPITAL WHEN WE NEED IT, OR AT ALL.
RAISING SUCH CAPITAL MAY DILUTE STOCKHOLDER VALUE. IF WE ARE UNABLE TO RAISE
CAPITAL, WE MAY BE REQUIRED TO LIMIT OR CEASE OUR OPERATIONS, OR OTHERWISE
MODIFY OUR BUSINESS STRATEGY.
As of December 31, 2007, the Company did not have and continues to not have
sufficient cash to pay present obligations as they become due. We are searching
for additional financing to generate the liquidity necessary to continue our
operations. The company needs $1 million in the next six months. This will cover
$160,000 to complete outside lab testing and FDA application costs for our Rev
Vac safety syringe. Also this will cover the $400,000 to completely install our
proprietary MRI software in an existing PACS system. The rest will cover general
working capital expense. The
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company will seek additional capital of $3 million in six months if a strategic
partner is not found to fund both projects. This money will be used as follows:
$1.0 million of which is for costs to finalize product development and to begin
beta testing for the color MRI technology, $1.0 million of which is for safety
syringe product development, $1.0 of which is for manufacturing of safety
syringes if FDA approval is obtained, and $1.0 for working capital to cover
expenses, such as rent, telephone, auditing, financial reporting requirements,
and administrative expenses, including salaries. Due to current economic
conditions and the Company's risks and uncertainties, there is no assurance that
we will be able to raise any additional capital on acceptable terms, if at all.
Because of these uncertainties, the auditors have expressed substantial doubt
about our ability to continue as a going concern. We do not presently have any
investment banking or advisory agreements in place and due to the Company's
risks and uncertainties, there is no assurance that we will be successful in
establishing any such agreements. Even if such agreements are established, there
is no assurance that they will result in any funding. If we obtain additional
funds by selling any of our equity securities or by issuing common stock to pay
current or future obligations, the percentage ownership of our stockholders will
be reduced, stockholders may experience additional dilution, or the equity
securities may have rights preferences or privileges senior to the common stock.
If adequate funds are not available to us on satisfactory terms, we may be
required to cease operating or otherwise modify our business strategy.
We will require substantial additional capital thereafter to commercialize
our planned products. Our commercialization efforts will include, but are not
limited to, entering into agreements with third parties for manufacturing
(including building molds, designing manufacturing processes and obtaining
specialized equipment for our retractable safety syringe), marketing and
distribution, and obtaining FDA and/or other regulatory approvals, all of which
are necessary before our planned products can be sold and which may take a
significant amount of time, if not years, to complete.
Due to the current economic conditions and the risks and uncertainties
surrounding our Company, we may not be able to secure additional financing on
acceptable terms, if at all. If we obtain additional funds by selling any of our
equity securities, the percentage ownership of our stockholders will be reduced,
stockholders may experience substantial dilution, the price of our common stock
may decline, or the equity securities issued may have rights, preferences or
privileges senior to the common stock. To the extent that services are paid for
with common stock or stock options that are exercised and sold into the market,
the market price of our common stock could decline and your ownership interest
will be diluted. If adequate funds are not available to us on satisfactory
terms, we will be required to limit or cease our operations, or otherwise modify
our business strategy, which could materially harm our future business
prospects.
IF WE DO NOT OBTAIN FDA APPROVAL FOR OUR PLANNED PRODUCTS THEN OUR FUTURE
PROSPECTS WILL BE HARMED.
Our planned products will require FDA approval before they can be sold in
the United States. We have not yet applied for or received FDA approval for
these planned products. There is no assurance that our planned products will
qualify for the FDA's 510(k) pre-market notification approval process, which is
less rigorous than a PMA.
The FDA approval process can take years and be expensive, especially if a
PMA is required. A PMA is much more rigorous and expensive to complete than a
510(k). In addition, the Medical Device User Fee and Modernization Act, enacted
in 2002, now allows the FDA to assess and collect user fees for 510(k) and for
PMA applications. Fees for fiscal year 2007 for small businesses (companies with
less than $100 million in sales) range from $3,326 for Section 510(k) pre-market
notifications to $107,008 for PMAs, although fee reductions and waivers are
available for companies qualifying as small businesses. There is no assurance
that we will qualify for fee reductions or waivers or that we will have the
funds necessary to apply for or obtain FDA approval for our planned products.
The FDA approval process could take a significant amount of time, if not years,
to complete and there is no assurance that FDA approval will ever be obtained.
If FDA approval is not obtained, then we will not be able to sell our products
in the United States, which would have a material adverse effect on our future
business prospects.
OUR PLANNED PRODUCTS MAY PROVE TO BE TOO EXPENSIVE TO MANUFACTURE AND MARKET
SUCCESSFULLY, WHICH WOULD HARM OUR FUTURE PROSPECTS.
Our planned products may prove to be too expensive to manufacture and
market successfully. Market acceptance of our products will depend in large part
upon our ability to demonstrate the operational and safety advantages of our
product as well as the cost effectiveness of our product compared to both
standard and other safety needle products. If we are unable to produce products
that are competitive with standard products, we will not be able to sell our
products. This could have a material adverse effect on our operations.
IF WE ARE NOT ABLE TO ENTER INTO MANUFACTURING ARRANGEMENTS FOR OUR PLANNED
PRODUCTS THEN OUR FUTURE PROSPECTS WILL BE HARMED.
We have no experience in establishing, supervising or conducting commercial
manufacturing. We plan to rely on third party contractors to manufacture our
planned products. We may never be successful in establishing manufacturing
capabilities for our planned products. Relying on third parties may expose us to
the risk of not being able to directly oversee the manufacturing process, which
may adversely affect the production and quality of our planned products.
Furthermore, these third-party contractors, whether foreign or domestic, may
experience regulatory compliance difficulty, mechanical shutdowns, employee
strikes, or other unforeseeable acts that may delay or prevent production. We
may not be able to manufacture our retractable safety needle in sufficient
quantities at an acceptable cost, or at all, which could materially adversely
affect our future prospects.
IF WE ARE NOT ABLE TO ESTABLISH MARKETING, SALES AND DISTRIBUTION ARRANGEMENTS
FOR OUR SAFETY NEEDLE DEVICES THEN OUR FUTURE PROSPECTS WILL BE HARMED.
We must establish marketing, sales and distribution capabilities before our
planned products can be sold. We have no experience in establishing such
capabilities. Until we have established manufacturing arrangements, we do not
plan to devote any meaningful time or resources to establishing marketing sales
or distribution capabilities. We intend to enter into agreements with third
parties in the future to market, sell and distribute our planned products.
However, we may be unable to establish or maintain third-party relationships on
a commercially reasonable basis, if at all. In addition, these third parties may
have similar or more established relationships with our competitors.
If we do not enter into relationships with third parties to market, sell
and distribute our planned products, we will need to develop our own such
capabilities. We have no experience in developing, training or managing a sales
force. If we choose to establish a direct sales force, we will incur substantial
additional expenses in developing, training and managing such an organization.
We may not be able to build a sales force on a cost effective basis or at all.
Any such direct marketing and sales efforts may prove to be unsuccessful. In
addition, we will compete with many other companies that currently have
extensive and well-funded marketing and sales operations. Our marketing and
sales efforts may be unable to compete against these other companies. We may be
unable to establish a sufficient sales and marketing organization on a timely
basis, if at all. We may be unable to engage qualified distributors. Even if
engaged, they may fail to satisfy financial or contractual obligations to us.
They may fail to adequately market our products. They may cease operations with
little or no notice to us or they may offer, design, manufacture or promote
competing products.
IF WE ARE UNABLE TO PROTECT OUR PLANNED PRODUCTS, OR TO AVOID INFRINGING ON THE
RIGHTS OF OTHERS, OUR ABILITY TO COMPETE WILL BE IMPAIRED.
6
The Company does not yet have patent protection for some of its planned
products and there is no assurance that such patent protections will be sought
or secured. We do not have foreign patent protection for any of our planned
products. There is no assurance that we will have the financial resources to
apply for U.S. or foreign patent protections, that such U.S. or foreign patent
protections will be available to us or if available, that they will result in
any meaningful protection for our planned products. Even if we are successful in
obtaining patent protection, whether in the U.S. or abroad, it may not afford
protection against competitors with similar technology. Furthermore, others may
independently develop similar technologies or duplicate our technology.
Our commercial success depends in part on our avoiding the infringement of
patents and proprietary rights of other parties and developing and maintaining a
proprietary position with regard to our own technologies and products. We cannot
predict with certainty whether we will be able to enforce our patents. We may
lose part or all of patents we may receive in the future as a result of
challenges by competitors. Patents that may be issued, or publications or other
actions could block our ability to obtain patents or to operate as we would
like. Others may develop similar technologies or duplicate technologies that we
have developed or claim that we are infringing their patents.
Although we rely on trade secrets to protect our technology and require
certain parties to execute nondisclosure and non-competition agreements, these
agreements could be breached, and our remedies for breach may be inadequate. In
addition, our trade secrets may otherwise become known or independently
discovered by our competitors. If we lose any of our trade secrets, our business
and ability to compete could be harmed.
Despite our efforts to protect our proprietary rights, we face the risks
that pending patent applications may not be issued, that patents issued to us
may be challenged, invalidated or circumvented; that unauthorized parties may
obtain and use information that we regard as proprietary; that intellectual
property laws may not protect our intellectual property; and effective
protection of intellectual property rights may be limited or unavailable in
China, where we plan to manufacture our retractable safety syringe, or in other
foreign countries where we may manufacture and/or sell our retractable safety
needle devices. The lack of adequate remedies and impartiality under any foreign
legal system may adversely impact our ability to protect our intellectual
property.
We may become involved in litigation or interference proceedings declared
by the U.S. Patent and Trademark Office, or oppositions or other intellectual
property proceedings outside of the United States. If any of our competitors
have filed patent applications or obtained patents that claim inventions that we
also claim, we may have to participate in an interference proceeding to
determine who has the right to a patent for these inventions in the United
States. If a litigation or interference proceeding is initiated, we may have to
spend significant amounts of time and money to defend our intellectual property
rights or to defend against infringement claims of others. Litigation or
interference proceedings could divert our management's time and effort. Even
unsuccessful claims against us could result in significant legal fees and other
expenses, diversion of management time and disruption in our business. Any of
these events could harm our ability to compete and adversely affect our
business.
An adverse ruling arising out of any intellectual property dispute could
invalidate or diminish our intellectual property position. An adverse ruling
could also subject us to significant liability for damages, prevent us from
using processes or products, or require us to license intellectual property from
third parties. Costs associated with licensing arrangements entered into to
resolve litigation or an interference proceeding may be substantial and could
include ongoing royalties. We may not be able to obtain any necessary licenses
on satisfactory terms or at all.
WE MUST OBTAIN REGULATORY APPROVALS IN FOREIGN JURISDICTIONS TO MARKET OUR
PRODUCTS ABROAD
Whether or not FDA approval has been obtained, we must secure approval for
our planned products by the comparable non-U.S. regulatory authorities prior to
the commencement of marketing of the product in a foreign country. The process
of obtaining these approvals will be time consuming and costly. The approval
process varies from country to country and the time needed to secure additional
approvals may be longer than that required for FDA approval. These applications
may require the completion of pre-clinical and clinical studies and disclosure
of information relating to manufacturing and controls. Unanticipated changes in
existing regulations or the adoption of new regulations could affect the
manufacture and marketing of our products.
IF WE ARE NOT ABLE TO COMPETE SUCCESSFULLY, THEN OUR BUSINESS PROSPECTS WILL BE
MATERIALLY ADVERSELY AFFECTED.
Our retractable safety syringe, if developed, approved and commercialized,
will compete in the United States and abroad with the safety needle devices and
standard non-safety needle devices manufactured and distributed by companies
such as Becton Dickinson, Tyco International, Inc. (Kendall Healthcare Products
Company), B. Braun, Terumo Medical Corporation of Japan, Med-Hut, Inc. and
Johnson & Johnson. Developers of safety needle devices against which we could
compete include Med-Design Corp., New Medical Technologies, Retractable
Technologies, Inc., Univec, Inc. and Specialized Health Products International,
Inc. Our Color MRI technology, if developed, approved and commercialized, will
compete in the United States and abroad against technologies manufactured and
distributed by companies such as GE and Siemens. Most of our competitors are
substantially larger and better financed than we are and have more experience in
developing medical devices and/or software than we do. These competitors may use
their substantial resources to improve their current products or to develop
additional products that may compete more effectively with our planned products,
or may render our planned products obsolete. In addition, new competitors may
develop products that compete with our planned products, or new technologies may
arise that could significantly affect the demand for our planned products. Even
if we are successful in bringing our planned products to market, there is no
assurance that we can successfully compete. We cannot predict the development of
future competitive products or companies.
In the U.S., the vast majority of decisions relating to the contracting for
and purchasing of medical supplies are made by the representatives of group
purchasing organizations ("GPOs") rather than the end-users of the product
(nurses, doctors, and testing personnel). GPOs and manufacturers often enter
into long-term exclusive contracts which can prohibit entry in the marketplace
by competitors. In the needle and syringe market, the market share leader, BD,
has utilized, among other things, long-term exclusive contracts which have
restricted entry into the market by most of our competitors. We may not be
successful in obtaining any contracts with GPO's, which would severely limit our
product's marketability in the U.S. We will be materially adversely affected if
we are unable to compete successfully.
BECAUSE WE DEPEND ON A SINGLE TECHNOLOGY, WE ARE VULNERABLE TO SUPERIOR
COMPETING PRODUCTS OR NEW TECHNOLOGIES THAT COULD MAKE OUR RETRACTABLE SAFETY
NEEDLE DEVICES OBSOLETE
Because we have a narrow focus on a particular product and technology (e.g.
retractable safety syringe), we are vulnerable to the development of superior
competing products and to changes in technology which could eliminate or reduce
the need for our products. If a superior technology is created, the demand for
our product could greatly diminish causing our commercialization efforts and
future prospects to be materially adversely affected.
BECAUSE WE RELY ON THIRD PARTIES FOR RESEARCH AND DEVELOPMENT ACTIVITIES
NECESSARY TO COMMERCIALIZE OUR PRODUCT, WE HAVE LESS DIRECT CONTROL OVER THOSE
ACTIVITIES. THIS COULD HAVE A MATERIALLY ADVERSE EFFECT ON OUR FUTURE PROSPECTS.
7
We do not maintain our own laboratory and we do not employ our own
researchers. We have contracted with third parties in the past to conduct
research, development and testing activities and we expect to continue to do so
in the future. Because we rely on such third parties, we have less direct
control over those activities and cannot assure you that the research will be
done properly or in a timely manner, or that the results will be reproducible.
Our inability to conduct research and development may delay or impair our
ability to develop, obtain approval for and commercialize our retractable safety
syringe. The cost and time to establish or locate an alternative research and
development facility to develop our technology could have a materially adverse
effect on our future prospects.
YOUR OWNERSHIP INTEREST MAY BE DILUTED AND THE VALUE OF THE SHARES OF OUR COMMON
STOCK MAY DECLINE BY THE EXERCISE OF STOCK OPTIONS AND WARRANTS WE HAVE GRANTED
OR MAY GRANT IN THE FUTURE AND BY THE COMMON STOCK WE HAVE ISSUED OR WILL ISSUE
IN THE FUTURE.
As of March 31, 2008, we had a total of 11,092,500options and warrants
outstanding (after the 1 for 20 reverse-split effective January 23, 2006), which
consisted of options to purchase up to 110,000 shares of common stock at
exercise prices ranging from $1.00 to $10.00 per share (of which all were
exercisable) and warrants to purchase up to 107,500shares of common stock at
exercise prices ranging from $0.02 to $5.00 per share (all of which were
exercisable). 10,875,000 of the options were granted during 2007 at $0.08 per
share and are considered to be "in the money" at March 31, 2008. (the exercise
price is less than the market price of our common stock). The remaining 217,000
options and warrants outstanding are presently "out of the money". We may
decide, however, to modify the terms and/or exercise price of these "out of the
money" options and warrants. To the extent that the outstanding options and
warrants to purchase our common stock are exercised, your ownership interest may
be diluted. If the warrants and options are exercised and sold into the market,
they could cause the market price of our common stock to decline. $10,875,000
the options or warrants outstanding as of March 31, 2008 were granted to
officers or directors.
From time to time the Company has issued and plans to continue to issue
shares of its common stock to pay current and future obligations. During 2007,
the Company issued 1,225,000 shares for services (after the 1 for 20
reverse-split effective January 23, 2007). If and when, and to the extent that,
those shares are sold into the market, they could cause the market price of our
common stock to decline.
As of March 31, 2008, we had 250,000,000 shares authorized and 19,638,422
shares outstanding. The authorized but unissued shares have the same rights and
privileges as the common stock presently outstanding. The unissued authorized
shares can be issued without further action of the shareholders. If and when,
and to the extent that, the unissued authorized shares are issued and sold into
the market, they could cause the market price of our common stock to decline.
THE LOSS OF THE SERVICES OF CERTAIN THIRD PARTIES AND OUR OFFICER AND DIRECTOR
COULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS.
We are dependent upon the services of third parties related to development
and commercialization of our planned products. The loss of their services and
the inability to retain acceptable substitutes could have a material adverse
effect on our future prospects. We are also dependent upon the services of Ron
Wheet, our officer and director. The loss of his services or our inability to
retain suitable replacements could have a material adverse effect on our ability
to continue operating.
BECAUSE WE HAVE LIMITED EXPERIENCE IN THE MEDICAL DEVICE INDUSTRY AND OUR
OFFICER AND DIRECTOR HAS OTHER BUSINESS INTERESTS, OUR BUSINESS MAY TAKE LONGER
TO DEVELOP, WHICH COULD ADVERSELY AFFECT OUR FUTURE PROSPECTS.
We have had limited experience in the medical device industry. In addition,
our officer and director may be involved in a range of business activities that
are not related to our business. Consequently, there are potential conflicts in
the amount of time he can devote to our business. Not more than 50% of his time
will be devoted to RMCP's activities. Consequently, our business may take longer
to develop, which could adversely affect our future prospects.
IF WE CANNOT GENERATE ADEQUATE, PROFITABLE SALES OF OUR PLANNED PRODUCTS, WE
WILL NOT BE SUCCESSFUL
In order to succeed as a company, we must develop commercially viable
products and sell adequate quantities at a high enough price to generate a
profit. We may not accomplish these objectives. Even if we succeed in developing
a commercially viable product, a number of factors may affect future sales of
our product. These factors include:
- Whether we will be successful in obtaining FDA approval in the future;
- Whether physicians, patients and clinicians accept our product as a
viable, safe alternative to the standard medical syringe;
- Whether the cost of our product is competitive in the medical
marketplace; and
- Whether we successfully contract the manufacture and marketing of the
syringe to third parties or develop such capabilities ourselves
OUR PLANNED PRODUCTS, IF SUCCESSFULLY COMMERCIALIZED, COULD BE EXPOSED TO
SIGNIFICANT PRODUCT LIABILITY CLAIMS WHICH COULD BE TIME CONSUMING AND COSTLY TO
DEFEND, DIVERT MANAGEMENT ATTENTION AND ADVERSELY IMPACT OUR ABILITY TO OBTAIN
AND MAINTAIN INSURANCE COVERAGE, WHICH COULD JEOPARDIZE OUR LICENSE.
The testing, manufacture, marketing and sale of our planned products will
involve an inherent risk that product liability claims will be asserted against
us. We currently do not have insurance which relates to product liability, but
will seek to obtain coverage at such time as we have a product ready to sell,
although there is no assurance we will be able to obtain or to pay for such
coverage. Even if we obtain product liability insurance, it may prove inadequate
to cover claims and/or costs related to potential litigation. The costs and
availability of product liability insurance are unknown. Product liability
claims or other claims related to our planned product, regardless of their
outcome, could require us to spend significant time and money in litigation or
to pay significant settlement amounts or judgments. Any successful product
liability or other claim may prevent us from obtaining adequate liability
insurance in the future on commercially desirable or reasonable terms. In
addition, product liability coverage may cease to be available in sufficient
amounts or at an acceptable cost. Any inability to obtain sufficient insurance
coverage at an acceptable cost or otherwise to protect against potential product
liability claims could prevent or inhibit the commercialization of our planned
product. A product liability claim could also significantly harm our reputation
and delay market acceptance of our planned products.
STRINGENT, ONGOING GOVERNMENT REGULATION AND INSPECTION OF OUR PLANNED PRODUCTS
COULD LEAD TO DELAYS IN MANUFACTURE, MARKETING AND SALES
8
The FDA continues to review products even after they receive FDA approval.
If and when the FDA approves our planned products, manufacturing and marketing
will be subject to ongoing regulation, including compliance with current Good
Manufacturing Practices, adverse reporting requirements and the FDA's general
prohibitions against promoting products for unapproved or "off-label" uses. We
and any third party manufacturers we may use are also subject to inspection and
market surveillance by the FDA for compliance with these and other requirements.
Any enforcement action resulting from failure to comply with these requirements
could affect the manufacture and marketing of our planned products. In addition,
the FDA can withdraw a previously approved product from the market at any time,
upon receipt of newly discovered information.
HEALTHCARE REFORM AND CONTROLS ON HEALTHCARE SPENDING MAY LIMIT THE PRICE WE CAN
CHARGE FOR OUR PLANNED PRODUCTS AND THE AMOUNT WE CAN SELL
The federal government and private insurers have considered ways to change,
and have changed, the manner in which healthcare services are provided in the
United States. Potential approaches and changes in recent years include controls
on healthcare spending and the creation of large purchasing groups. In the
future, it is possible that the government may institute price controls and
limits on Medicare and Medicaid spending. These controls and limits might affect
the payments we collect from sales of our product, if and when it is
commercially available. Assuming we succeed in bringing our product to market,
uncertainties regarding future healthcare reform and private practices could
impact our ability to sell our product in large quantities at profitable
pricing.
It is quite possible that new regulations could be proposed and adopted
which could restrict marketing of our products. Although we are not presently
aware of any such pending or proposed regulations, there is no assurance that
they will not be enacted or imposed.
UNCERTAINTY OF THIRD-PARTY REIMBURSEMENT COULD AFFECT OUR ABILITY TO SELL OUR
PLANNED PRODUCTS AT A PROFIT
Sales of medical products largely depend on the reimbursement of patients'
medical expenses by governmental healthcare programs and private health
insurers. There is no guarantee that governmental healthcare programs or private
health insurers will cover the cost of our product, if and when it is
commercially available, or permit us to sell our product at a high enough price
to generate a profit.
OUR LIMITED OPERATING HISTORY MAKES EVALUATING OUR STOCK MORE DIFFICULT
Since inception in 1986, we have engaged primarily in research and
development, technology licensing, and raising capital. This limited history may
not be adequate to enable you to fully assess our ability to develop and
commercialize our planned products and to achieve market acceptance of our
planned products and to respond to competition.
WE HAVE A HISTORY OF LOSSES AND EXPECT FUTURE LOSSES
We have had annual losses since our inception in 1986. We expect to
continue to incur losses until we can sell enough products at prices high enough
to generate a profit. As of December 31, 2007, we had accumulated a deficit of
approximately $(19,231,810). There is no assurance that our planned products
will be commercially viable. There is no assurance that we will generate revenue
from the sale of our planned products or that we will achieve or maintain
profitable operations.
OUR STOCK PRICE IS VOLATILE AND YOUR INVESTMENT IN OUR SECURITIES COULD DECLINE
IN VALUE, RESULTING IN SUBSTANTIAL LOSSES TO YOU
The market price of our common stock, which is over the counter (National
Quotation Bureau "Pink Sheets") under the symbol "RMCP", has been, and may
continue to be, highly volatile. Spartan Securities has filed a Form 211 with
the Financial Industry Regulatory Authority (FINRA) to request that our stock be
traded on the over the counter bulletin board. FINRA has not approved this
request and we can not provide assurances that our stock will be traded on the
over the counter bulletin board in the future. Factors such as announcements of
product development progress, financings, technological innovations or new
products, either by us or by our competitors or third parties, as well as market
conditions within the medical devices industry may have a significant impact on
the market price of our common stock. In general, medical device stocks tend to
be volatile even during periods of relative market stability because of the high
rates of failure and substantial funding requirements associated with medical
device companies. Market conditions and conditions of the medical device sector
could also negatively impact the price of our common stock.
BECAUSE OUR STOCK IS CONSIDERED TO BE A "PENNY STOCK", YOUR ABILITY TO SELL YOUR
STOCK MAY BE LIMITED
The Penny Stock Act of 1990 requires specific disclosure to be made
available in connection with trades in the stock of companies defined as "penny
stocks". The Securities and Exchange Commission (SEC) has adopted regulations
that generally define a penny stock to be any equity security that has a market
price of less than $5.00 per share, subject to certain exceptions. If an
exception is unavailable, the regulations require the delivery, prior to any
transaction involving a penny stock, of a disclosure schedule explaining the
penny stock market and the risk associated therewith as well as the written
consent of the purchaser of such security prior to engaging in a penny stock
transaction. The regulations on penny stock may limit the ability of the
purchasers of our securities to sell their securities in the secondary
marketplace.
ALTHOUGH WE BELIEVE THAT OUR SYSTEM OF DISCLOSURE CONTROLS AND INTERNAL CONTROLS
OVER FINANCIAL REPORTING ARE ADEQUATE, SUCH CONTROLS ARE SUBJECT TO INHERENT
LIMITATIONS.
Although we believe that our system of disclosure controls and internal
controls over financial reporting are adequate, we can not assure you that such
controls will prevent all errors or all instances of fraud. A control system, no
matter how well designed and operated, can provide only reasonable, not
absolute, assurance that the control system's objectives will be met. Further,
the design of a control system must reflect the fact that there are resource
constraints, and the benefits of controls must be considered relative to their
costs. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances
of fraud, if any, within our company will be detected. These inherent
limitations include the realities that judgments in decision-making can be
faulty, and that breakdowns can occur because of simple error or mistake.
Controls can also be circumvented by the individual acts of some persons, by
collusion of two or more people, or by management override of the controls. The
design of any system of controls is based in part upon certain assumptions about
the likelihood of future events, and any design may not succeed in achieving its
stated goals under all potential future conditions. Over time, controls may
become inadequate because of changes in conditions or deterioration in the
degree of compliance with policies or procedures. Because of the inherent
limitation of a cost-effective control system, misstatements due to error or
fraud may occur and not be detected.
9
MR. WHEET, OUR CEO AND A DIRECTOR, HAS VOTING CONTROL OF THE COMPANY AND CAN
UNILATERALLY MAKE BUSINESS DECISIONS FOR US. ALTHOUGH WE HAVE TWO OUTSIDE
DIRECTORS, THERE ARE NO PROCEDURES IN PLACE TO RESOLVE POTENTIAL CONFLICTS AND
TO EVALUATE RELATED PARTY TRANSACTIONS THAT ARE TYPICALLY REVIEWED BY
INDEPENDENT DIRECTORS.
Because Mr. Wheet owns 1,000,000 Series 2007 Preferred shares, which gives
him the right to vote 6,250,000 shares in addition to the shares of common stock
he already owns, voting together as a single class with the Company's common
stock., he controls a majority of the Company's common stock and can
unilaterally make business decisions on our behalf. Although we recently
appointed two outside directors, there are no procedures in place to resolve
potential conflicts and evaluate related party transactions that are typically
reviewed by independent directors.
WE DO NOT EXPECT TO PAY DIVIDENDS
We have not declared or paid, and for the foreseeable future we do not
anticipate declaring or paying, dividends on our common stock.
ITEM 2. DESCRIPTION OF PROPERTY
None
ITEM 3. LEGAL PROCEEDINGS.
On November 3, 2005, the Company and Globe Med Tech, Inc. entered into a
definitive joint venture agreement to patent, develop, manufacture, market and
distribute safety needle products throughout the world. In connection with the
agreement, the Company issued restricted shares of its common stock, valued at
$625,066, to Globe. Subsequent to December 31, 2006, the Company ended the joint
venture and cancelled the shares common stock and options that were issued to
Globe pursuant to the agreement. On March 1, 2007, the Company filed a lawsuit
in the District Court of Tulsa County, Oklahoma against Globe Med Tech, Inc. to
rescind, terminate and seek monetary damages for the non-fulfillment and breach
of the joint venture agreement entered into November 3, 2005 and other related
agreements, in addition to an accounting of expenditures of funds under the
terms and provisions of the agreements. On May 11, 2007, a partial default
judgment against Globe was granted by the District Court of Harris County,
Texas. The partial default judgment as to liability only was granted with
respect to the Company's causes of action against Globe for breach of contract,
conversion and common law fraud with respect to the Company's Original Petition
and Application for Temporary and Permanent Injunctions against Globe on January
30, 2007. On August 13, 2007, the Company was granted a final default judgment
for permanent injunctive relief and for damages in the amount of $14,029,000
against Globe. Globe has appealed the judgment. On November 23, 2007, the Court
signed an order granting Globe's Motion for New Trial and setting aside the
Final Default Judgment entered in favor of the Company on August 13, 2007.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On November 17, 2006, the holders of a majority of our voting stock signed
a written consent approving (i) an amendment to our Articles of Incorporation
changing our name to "Revolutions Medical Corporation" (the "Name Change"), (ii)
an amendment to our Articles of Incorporation authorizing our board of directors
from time to time in their discretion and without approval of holders of a
majority of our outstanding shares entitled to vote, to approve a reverse stock
split of our outstanding common stock without a corresponding reduction of our
authorized shares of common stock (the "Charter Amendment"); and, (iii)
authorizing a 1 for 20 reverse stock split of our issued and outstanding shares
of common stock without corresponding reduction in the number of authorized
shares of common stock we are authorized to issue under our Articles of
Incorporation (the "Reverse Stock Split"). As a result, the Name Change, the
Charter Amendment to the Articles of Incorporation, and the Reverse Stock Split,
were approved, and neither a meeting of our stockholders nor additional written
consents were necessary. A Definitive Information was mailed to shareholders on
or about November 29, 2007.
PART II
ITEM 5. MARKET PRICE AND DIVIDENDS ON THE REGISTRANT'S COMMON EQUITY
(a) Market Information
Our common stock is traded over the counter under the trading symbol
"RMCP". The high and low prices for our common stock during the calendar
quarters ended were:
<TABLE>
<CAPTION>
Quarter ended High Low
------------- ---- ---
<S> <C> <C>
December 31, 2007 $0.300 $0.060
September 30, 2007 $0.650 $0.260
June 30, 2007 $1.000 $0.410
March 31, 2007 $1.250 $0.180
December 31, 2006 $0.059 $0.025
September 30, 2006 $0.050 $0.027
June 30, 2006 $0.039 $0.018
March 31, 2006 $0.050 $0.022
</TABLE>
Quotations on the National Quotation Bureau Pink Sheets reflect bid and ask
quotations, may reflect inter-dealer prices, without retail markup, markdown or
commission, and may not represent actual transactions
10
(b) Holders
As of March 31, 2008, we estimate that there were approximately 450 holders
of record of our common stock. This figure does not take into account those
shareholders whose certificates are held in the name of broker-dealers or other
nominees.
(c) Dividends
We have not declared any dividends in the past, and we do not plan to
declare dividends in the future.
ITEM 6. PLAN OF OPERATION
The following discussion of our cash requirements and liquidity and
resources contains forward-looking statements that are based upon current
expectations. These forward-looking statements fall within the meaning of the
federal securities laws that relate to future events or our future financial
performance. In some cases, you can identify forward-looking statements by
terminology such as "may," "will," "expect," "plan," "anticipate," "believe,"
"estimate," "intend," "potential" or "continue" or the negative of these terms
or other comparable terminology. Forward-looking statements involve risks and
uncertainties. Our actual results and the timing of events could differ
materially from those anticipated in our forward-looking statements as a result
of many factors; including, our ability to obtain financing when needed. A
discussion of these risks and uncertainties can be found under the heading "RISK
FACTORS" and elsewhere in this report. We cannot guarantee future results,
levels of activity, performance or achievements. We assume no obligation to
update any of the forward-looking statements after the date of this report or to
conform these forward-looking statements to actual results.
1. Plan of Operation for the Next Twelve Months
(i) Cash Requirements
LIQUIDITY, CAPITAL RESOURCES AND CASH REQUIREMENTS
As of December 31, 2007, the Company did not have and continues to not have
sufficient cash to pay present obligations as they become due. We are searching
for additional financing to generate the liquidity necessary to continue our
operations. The company needs $1 million in the next six months. This will cover
$160,000 to complete outside lab testing and FDA application costs for our Rev
Vac safety syringe. Also this will cover the $400,000 to completely install our
proprietary MRI software in an existing PACS system. The rest will cover general
working capital expense. The company will seek additional capital of $3 million
in six months if a strategic partner is not found to fund both projects. This
money will be used as follows: $1.0 million of which is for costs to finalize
product development and to begin beta testing for the color MRI technology, $1.0
million of which is for safety syringe product development, $1.0 of which is for
manufacturing of safety syringes if FDA approval is obtained, and $1.0 for
working capital to cover expenses, such as rent, telephone, auditing, financial
reporting requirements, and administrative expenses, including salaries. Due to
current economic conditions and the Company's risks and uncertainties, there is
no assurance that we will be able to raise any additional capital on acceptable
terms, if at all. Because of these uncertainties, the auditors have expressed
substantial doubt about our ability to continue as a going concern. We do not
presently have any investment banking or advisory agreements in place and due to
the Company's risks and uncertainties, there is no assurance that we will be
successful in establishing any such agreements. Even if such agreements are
established, there is no assurance that they will result in any funding. If we
obtain additional funds by selling any of our equity securities or by issuing
common stock to pay current or future obligations, the percentage ownership of
our stockholders will be reduced, stockholders may experience additional
dilution, or the equity securities may have rights preferences or privileges
senior to the common stock. If adequate funds are not available to us on
satisfactory terms, we may be required to cease operating or otherwise modify
our business strategy. See "RISK FACTORS."
Because we do not currently generate any cash from operations and have no
credit facilities available, our only means of funding is through the sale of
our common stock. We presently have 250,000,000 shares of common stock
authorized, of which 19,638,422 shares were issued and outstanding as of March
31, 2008. If we obtain additional funds by selling any of our equity securities
or by issuing common stock to pay current or future obligations, the percentage
ownership of our stockholders will be reduced, stockholders may experience
additional dilution, or the equity securities may have rights preferences or
privileges senior to the common stock. If adequate funds are not available to us
when needed on satisfactory terms, we may be required to cease operating or
otherwise modify our business strategy.
(ii) Product Development and Research Plan for the Next Twelve Months
If the Company raises the necessary funds, the Company plans to complete
the testing of the safety syringe and to prepare and submit an application
for FDA approval, and 5he Company also plans to complete the development
and beta testing of the Color MRI software.
(iii) Expected Purchase or Sale of Plant and Significant Equipment.
None.
(iv) Expected Significant Changes in the Number of Employees
None.
ITEM 7. FINANCIAL STATEMENTS
See Part F/S
ITEM 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND
FINANCIAL DISCLOSURE
None
11
ITEM 8A. CONTROLS AND PROCEDURES
The Company's disclosure controls and procedures are designed to ensure (i)
that information required to be disclosed by the Company in the reports the
Company files or submits under the Exchange Act are recorded, processed,
summarized, and reported within the time periods specified in the SEC's rules
and forms; and (ii) that information required to be disclosed by the Company in
the reports it files or submits under the Exchange Act is accumulated and
communicated to the Company's management, including its principal executive
officer, or persons performing similar functions, as appropriate to allow timely
decisions regarding required disclosure.
MANAGEMENT'S ANNUAL REPORT ON INTERNAL CONTROL OVER FINANCIAL REPORTING
Management is responsible for establishing and maintaining adequate internal
control over financial reporting, as such term is defined in the Exchange Act
Rules 13a-15(f). A system of 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 generally accepted accounting principles.
Under the supervision and with the participation of management, including the
principal executive officer and the principal financial officer, the Company's
management has evaluated the effectiveness of its internal control over
financial reporting as of December 31, 2007 based on the criteria established in
a report entitled "Internal Control - Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission" and the
interpretive guidance issued by the Commission in Release No. 34-55929. Based on
this evaluation, the Company's management has evaluated and concluded that the
Company's internal control over financial reporting was ineffective as of
December 31, 2007 and identified the following material weaknesses:
o There is a lack of accounting personnel with the requisite
knowledge of Generally Accepted Accounting Principles in the US
("GAAP") and the financial reporting requirements of the Securities
and Exchange Commission.
o There are insufficient written policies and procedures to insure
the correct application of accounting and financial reporting with
respect to the current requirements of GAAP and SEC disclosure
requirements.
o There is a lack of segregation of duties, in that we only had one
person performing all accounting-related duties.
Notwithstanding the existence of these material weaknesses in our internal
control over financial reporting, our management believes that the consolidated
financial statements included in its reports fairly present in all material
respects the Company's financial condition, results of operations and cash flows
for the periods presented.
The Company will continue its assessment on a quarterly basis and when it become
practicable, will make efforts to add personnel and resources to address these
material weaknesses. There has been no change in its internal control over
financial reporting that occurred during the Company's most recent fiscal
quarter that has materially affected, or is reasonably likely to materially
affect, the Company's internal control over financial reporting.
This annual report does not include an attestation report of the Company's
independent registered public accounting firm regarding internal control over
financial reporting. The Company's registered public accounting firm was not
required to issue an attestation on its internal controls over financial
reporting pursuant to temporary rules of the Securities and Exchange Commission.
The Company will continue to evaluate the effectiveness of internal controls and
procedures on an on-going basis.
PART III
ITEM 9. DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS; COMPLIANCE
WITH SECTION 16(A) OF THE EXCHANGE ACT
(a) Identity of Directors and Executive Officers
Rondald Wheet, age 42, is Chairman, CEO and a Director of RMCP and has
served in such capacity since March 16, 2006.
Thomas M. Beahm, MD, FACS, age 57, is a practicing plastic surgeon, who
lives in Chattanooga, Tennessee. He is an active member of the American Society
of Plastic Surgeons, American College of Surgeons, and American Medical
Association, and simultaneously owns and runs his own practice. In addition, he
is Secretary of Integrated Voice Systems, which has software in over 130
hospitals, and is also serving on the board of Clear Image, Inc., a privately
held company specializing in proprietary MRI Software and Hardware. Dr. Beahm
also has experience directing plastic surgery mission work in various third
world countries, coming to the aid of thousands of people in Asia, Africa, and
South America. He has served as a director of the Company since October, 2007.
Thomas O'Brien, age 60, is acting President and CEO of Clear Image, Inc.
(MRI Software/Hardware), and has more than twenty (20) years of general
management experience in the medical device industry. His background includes
domestic and international sales, marketing and distribution of high technology
medical systems and services. He is fluent in Mandarin, and served at the
National Security Agency, holding a Top Secret Crypto Clearance as a Chinese
linguist. Mr. O'Brien has held executive positions with medical industry leaders
such as Pfizer, Toshiba, and Johnson and Johnson's subsidiary the Technicare
Corporation. He has served as a director of the Company since October, 2007.
(b) Other Directorships.
Mr. Wheet and Mr. O'Brien were previously directors of Clear Image, Inc., a
private company that was acquired by the Company on January 30, 2007.
(c) Family Relationships
None.
12
(d) Involvement in Legal Proceedings of Officers, Directors, and Control
Persons
None.
ITEM 10. EXECUTIVE COMPENSATION
<TABLE>
<CAPTION>
SUMMARY COMPENSATION TABLE
Long Term Compensation
-------------------------
AnnualCompensation Awards Payouts
----------------------------------------- ------------------------- ---------
Other Securities
Name and Annual Restricted Underlying All Other
Principal Compen- Stock Options LTIP Compen-
Position Year Salary Bonus sation Awards /SARs Payouts sation
--------- ------- -------------- ---------- ------------- ------------ ----------- -------- ----------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
Ron
Wheet,
CEO 2006 $ 150,000(1) $ -0- $ -0- $ (2) 20,000(3) $ -0- $ -0-
Ron
Wheet,
CEO 2007 $ 150,000(3) $ -0- $ -0- $ (4) 142,000(4) $ -0- $ -0-
</TABLE>
(1) Represents Mr. Wheet's accrued salary for 2006, pursuant to his employment
agreement. As of December 31, 2006, approximately $147,024 of his accrued
salary remained unpaid.
(2) Represents the fair market value of the $1,000,0000 shares of Series 2006
preferred stock issued to Mr. Wheet during 2006.
(3) Represents Mr. Wheet's accrued salary for 2007, pursuant to his employment
agreement. As of December 31, 2007, approximately $211,024 of Mr. Wheet's
accrued salary from 2007 and prior remained unpaid. $64,000 remained upaid
related to 2007 and $147,024 remained unpaid related to 2006.
(4) Represents the fair market value as of March 15, 2007 of the 8,000,000
stock options issued to Mr. Wheet during 2007.
<TABLE>
<CAPTION>
Aggregated Option/SAR Exercises in Last Fiscal Year and FY-End Option/SAR Values
--------------------------------------------------------------------------------
Number of
Securities Value of
Underlying Unexercised
Unexercised In-the-Money
Options/SARs at Options/SARs
Shares FY-End at FY-End
Acquired Exercisable/ Exercisable/
Name on Exercise Value Realized Unexercisable Unexercisable
-------------- ----------- -------------- --------------- -------------
<S> <C> <C> <C> <C>
Ron Wheet, CEO N/A N/A 7,000,000 .08 exercise price
</TABLE>
ITEM 11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following shareholders are known to us to own more than 5% of the
outstanding common stock of the Company. Except as otherwise indicated, all
information is as of March 31, 2008 and ownership consists of sole voting and
investment power.
<TABLE>
<CAPTION>
Beneficial Percentage of
Relationship to Outstanding Ownership
Name and Address Company Common Stock Common Stock
------------------------- ---------------- ------------- --------------
<S> <C> <C> <C>
Rondald L. Wheet CEO and Director 2,314,000 11.78%*
2073 Shell Ring Circle
Mt. Pleasant, SC 29466
Dr. Thomas Beahm Director 1,910,849 9.73%
Thomas O'Brien Director 1,784,349 9.09%
Officer and Directors As a Group (3 persons) 6,009,198 30.60%
</TABLE>
* Does not include the 1,000,000 shares of Series 2007 Preferred Stock,
described below.
13
Preferred Stock
----------------
The Company has 5,000,000 shares of Preferred Stock ($0.001 par value)
authorized. On October 24, 2006, the Company designated 1,000,000 shares as
Series 2007 Preferred Stock, which were then issued the shares to Mr. Wheet, the
Company's CEO. Each Series 2006 Preferred is convertible, at any time at the
discretion of Mr. Wheet, into one share of the Company's common stock for each
share of Series 2006 Preferred. Each Series 2006 Preferred has voting rights of
125 votes per share of Series 2006 Preferred voting together as one class with
the Company's common stock. As a result, Mr. Wheet has effective voting control
of the Company's common stock and as such can unilaterally decide on business
matters. Upon conversion of the Series 2006 Preferred, each share of common
stock resulting from the conversion shall be entitled to one vote per share-not
125 votes per share.
Common Stock Options and Warrants Outstanding
---------------------------------------------
As of March 31, 2008, we had a total of 11,092,500options and warrants
outstanding (after the 1 for 20 reverse-split effective January 23, 2006), which
consisted of options to purchase up to 110,000 shares of common stock at
exercise prices ranging from $1.00 to $10.00 per share (of which all were
exercisable) and warrants to purchase up to 107,500shares of common stock at
exercise prices ranging from $0.02 to $5.00 per share (all of which were
exercisable). $10,875,000 of the options were granted during 2007 at $0.08 per
share and are considered to be "in the money" at March 31, 2008. (the exercise
price is less than the market price of our common stock). The remaining 217,000
options and warrants outstanding are presently "out of the money". We may
decide, however, to modify the terms and/or exercise price of these "out of the
money" options and warrants. To the extent that the outstanding options and
warrants to purchase our common stock are exercised, your ownership interest may
be diluted. If the warrants and options are exercised and sold into the market,
they could cause the market price of our common stock to decline. $10,875,000
the options or warrants outstanding as of March 31, 2008 were granted to
officers or directors.
ITEM 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
On October 24, 2006, the Company issued 1,000,000 shares of its Series 2006
Preferred Stock to Mr. Wheet. The Series 2006 Preferred Stock gives Mr. Wheet
the right to vote 125,000,000 shares together with the common stock as a class.
Accordingly Mr. Wheet will have the right to vote a total of 83% of all the
Company's shares entitled to vote on any matter presented to the Company's
stockholders. A Form 8-K regarding the issuance of the Series 2007 Preferred
Stock to Mr. Wheet was filed with the SEC on November 1, 2006.
In 2007, in connection with the acquisition of Clear Image, Inc., Mr. Wheet
received 2,286,000 shares of restricted common stock, Dr. Beahm received
1,599,125 shares of restricted common stock, and Mr. O'Brien received 1,645,625
shares of restricted common stock. Mr. Wheet and Mr. O'Brien were directors and
shareholders and Dr. Beahm was a shareholder of Clear Image, Inc. prior to its
acquisition by the Company.
In 2007, each director was granted 2,000,000 options (a total of 6,000,000)
to purchase common stock at $0.08 per share and we executed a new employment
agreement with Mr. Wheet which included granting 5,000,000 options at $.08, both
granted pursuant to Stock Option Plan, previously registered on Form S-8.
ITEM 13. EXHIBITS AND REPORTS ON FORM 8-K
Exhibits:
See "Index to and Description of Exhibits"
Reports on Form 8-K
ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES
Audit Fees
Audit Fees consist of assurance and related services that are reasonably
related to the performance of the audit or review of our financial statements.
This category includes fees related to the performance of audits and attest
services not required by statute or regulations, and accounts consultations
regarding the application of GAAP to proposed transactions. The aggregate Audit
Fees billed for the fiscal years ended December 31, 2007 and 2006 were $9,212
and $9,610 respectively.
Audit Related Fees
The aggregate fees billed for assurance and related services by our
principal accountant that are reasonably related to the performance of the audit
or review of our financial statements, other than those previously reported in
this Item 14, for the fiscal years ended December 31, 2007 and 2006 were $-0-
and $-0-.
Tax Fees
Tax Fees consist of the aggregate fees billed for professional services
rendered by our principal accounts for tax compliance, tax advice, and tax
planning. These services include preparation for federal and state income tax
returns. The aggregate Tax Fees billed for the fiscal years ended December 31,
2007 and 2006 were $830 and $765, respectively.
Audit Committee
The Company's Board of Directors functions as its audit committee. It is
the policy of the Company for all work performed by our principal accountant to
be approved in advance by the Board of Directors. All of the services described
above in this Item 14 were approved in advance by our Board of Directors.
14
PART F/S
INDEX TO FINANCIAL STATEMENTS
<TABLE>
<CAPTION>
AUDITED FINANCIAL STATEMENTS
----------------------------
<S> <C>
Independent Registered Public Accounting Firm........................................16
Balance Sheet At December 31, 2007...................................................17
Statements Of Operations From Inception (August 16, 1996) Through December 31, 2007
And For The Years Ended December 31, 2007 and 2006...................................18
Statements Of Cash Flows From Inception (August 16, 1996) Through December 31, 2007
And For The Years Ended December 31, 2007 and 2006...................................19
Statements Of Shareholders' Equity From Inception (August 16, 1996) Through
December 31, 2007....................................................................20
Notes to Financial Statements........................................................23
</TABLE>
15
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Shareholders of
Revolutions Medical Corporation (formerly Maxxon, Inc.)
Tulsa, Oklahoma
We have audited the accompanying consolidated balance sheet of Revolutions
Medical Corporation (formerly Maxxon, Inc.) (a development stage company) for
the year ended December 31, 2007, and the related statements of operations,
shareholders' equity, and cash flows for the years ended December 31, 2007 end
2006 and for the period from December 16, 1996 (inception) to December 31, 2007.
These financial statements are the responsibility of the Company's management.
Our responsibility is to express an opinion on these consolidated financial
statements based on our audit.
We conducted our audit in accordance with auditing standards of the Public
Company Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Maxxon, Inc. as of December 31,
2007, and the results of its operations and its cash flows for the years ended
December 31, 2007 and 2006 and for the period from December 16, 1996 (inception)
to December 31, 2007 in conformity with generally accepted accounting
principles.
The accompanying financial statements have been prepared assuming that the
Company will continue as a going concern. As discussed in Note 2 to the
financial statements, the Company has suffered recurring losses from operations
and has a net capital deficiency, which raises substantial doubt about its
ability to continue as a going concern. Management's plans regarding those
matters also are described in Note 2. The financial statements do not include
any adjustments that might result from the outcome of this uncertainty.
/s/ Sutton Robinson Freeman & Co., P. C.
Sutton Robinson Freeman & Co., P. C.
Certified Public Accountants
April 21, 2008
16
REVOLUTIONS MEDICAL CORPORATION (FORMERLY MAXXON, INC.)
(A Development Stage Company)
<TABLE>
<CAPTION>
BALANCE SHEET
December 31, 2007
ASSETS
<S> <C>
CURRENT ASSETS
Cash $ 2,398
Goodwill 23,276
-------------
TOTAL ASSETS $ 25,674
=============
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Accounts payable and accrued liabilities $ 284,286
Accrued Salaries 1,214,563
Notes Payable and Accrued Interest 295,097
-------------
Total current liabilities 1,794,036
-------------
Total liabilities 1,794,036
-------------
Minority Interest (122,750)
-------------
SHAREHOLDERS' DEFICIENCY
Preferred stock, $0.001 par value,
5,000,000 shares authorized; 1,000,000 shares issued and outstanding 1,000
Common stock, $0.001 par value,
250,000,000 shares authorized; 18,127,422 shares issued and outstanding 18,127
Paid in capital 17,537,824
Deficit accumulated during the development stage (19,202,563)
-------------
Total shareholders' deficiency (1,645,612)
-------------
TOTAL LIABILITIES AND SHAREHOLDERS' DEFICIENCY $ 25,674
=============
</TABLE>
The accompanying notes are an integral part of the interim financial statements
17
REVOLUTIONS MEDICAL CORPORATION (FORMERLY MAXXON, INC.)
(A Development Stage Company)
STATEMENTS OF OPERATIONS
From Inception (August 16, 1996) Through December 31, 2006 and
For The Years Ended December 31, 2006 and 2005
<TABLE>
<CAPTION>
STATEMENTS OF OPERATIONS
From Inception (August 16, 1996) Through December 31, 2006 and
For The Years Ended December 31, 2006 and 2005
FROM INCEPTION
(AUGUST 16,
1996) THROUGH YEAR ENDED YEAR ENDED
DECEMBER 31, 2007 DECEMBER 31, 2007 DECEMBER 31, 2006
-------------------------------------------------------------
<S> <C> <C> <C>
Investment Income $ 170,753 $ - $ -
Other Income 3,857 - -
-------------------------------------------------------------
174,610 - -
-------------------------------------------------------------
EXPENSES
Research and development 2,037,016 166,030 39,000
Purchased R&D- Clear Image
Transaction (See Note 3) 3,309,515 3,309,515 -
General and administrative 13,736,236 847,166 524,334
-------------------------------------------------------------
Total operating expenses 19,082,767 4,322,711 563,334
-------------------------------------------------------------
Operating loss (18,908,157) (4,322,711) (563,334)
-------------------------------------------------------------
Interest income 17,276 - -
-------------------------------------------------------------
Interest expense 122,297 37,663 34,968
-------------------------------------------------------------
Loss on disposal of assets (794) - -
-------------------------------------------------------------
Depreciation and amortization 75,536 - -
-------------------------------------------------------------
Compensation cost for options 223,248 223,248 -
-------------------------------------------------------------
Minority Interest in Subsidiary Loss (108,605) (108,605) -
-------------------------------------------------------------
Net loss from operations $ (19,202,562) $ (4,475,017) $ (598,302)
=============================================================
Weighted average shares
outstanding 42,510,545 17,597,226 7,110,458
-------------------------------------------------------------
Net loss per share (Note 1) $ (0.45) $ (0.25) $ (0.08)
=============================================================
</TABLE>
The accompanying notes are an integral part of the interim financial statements
18
REVOLUTIONS MEDICAL CORPORATION (FORMERLY MAXXON, INC.)
(A Development Stage Company)
<TABLE>
<CAPTION>
STATEMENTS OF CASH FLOWS
From Inception (August 16, 1996) Through December 31, 2006 and
For The Years Ended December 31, 2006 and 2005
FROM INCEPTION
(AUGUST 16,
1996) THROUGH YEARS ENDED
DECEMBER 31, 2007 DECEMBER 31, 2007 DECEMBER 31, 2006
-------------------------------------------------------------
<S> <C> <C> <C>
OPERATING ACTIVITIES
Net loss $ (19,202,562) $ (4,475,017) $ (598,302)
Plus non-cash charges to earnings:
Stock compensation expense 223,248 223,248 -
Depreciation and amortization 75,525 - -
Purchase R&D - Clear Image 3,309,514 3,309,514 -
Common stock issued for services 3,357,408 - 108,500
Preferred stock issued for services 20,000 - 20,000
Expenses paid by third parties 57,134 - -
Contribution of services by officer and employees 799,154 - -
Services by officer and employees paid for
with non-cash consideration 167,500 - -
Compensation cost for option price reduction 50,000 - 50,000
Amortization of compensation cost for options
granted to non-employees and common stock
issued for services 1,775,577 - -
Allowance for doubtful accounts 50,900 - -
Write-off of Notes Receivable 14,636 - -
Write-off of organizational costs 3,196 - -
Write-off of zero value investments 785,418 - -
Write-off of leasehold improvements and computer equipment 2,006 - -
Compensation costs for stock options and warrants
granted to non-employees 1,205,015 - -
Change in working capital accounts:
(Increase) decrease in receivables from related parties (68,900) - -
(Increase) decrease in goodwill (23,276) (23,276) -
(Increase) decrease in other receivables (176,577) - -
Increase (decrease) in accrued salaries and consulting 989,601 273,501 220,774
Increase (decrease) in accrued interest 91,177 37,664 34,968
Increase (decrease) in accounts payable and accrued liabilities 1,375,834 300,259 54,590
-------------------------------------------------------------
Total operating activities (5,118,472) (354,107) (109,470)
-------------------------------------------------------------
INVESTING ACTIVITIES
Purchase of equipment (67,042) - -
Investment in syringe patent development (10,000) - -
Investment in Ives Health Company (251,997) - -
Investment in The Health Club (10,000) - -
-------------------------------------------------------------
Total investing activities (339,039) - -
-------------------------------------------------------------
FINANCING ACTIVITIES
Loans from shareholders 13,907 - -
Repayment of loans from shareholders (8,005) - -
Repayments of Promissory Notes 190,754 - -
Common stock subscribed 34,000 - 34,000
Sale of preferred stock for cash: (1,000) - -
Sale of common stock for cash:
To third-party investors (prior to merger) 574,477 - -
To third-party investors 3,701,044 474,999 -
From exercise of stock options 924,800 - 78,000
Less: Issue Costs (102,318) - -
Convertible debentures issued for cash 355,000 - -
Payment of exclusive license note payable (100,000) - -
-------------------------------------------------------------
Total financing activities 5,582,659 474,999 112,000
-------------------------------------------------------------
Minority interest (122,750) (122,750) -
-------------------------------------------------------------
Change in cash 2,398 (1,858) 2,530
Cash at beginning of peri od - 4,256 1,726
-------------------------------------------------------------
Cash at end of period $ 2,398 $ 2,398 $ 4,256
=============================================================
Supplemental disclosure of cash flow information:
Cash paid for interest and taxes during the period 57,571 28,487 -
-------------------------------------------------------------
Non-cash financing and investing activities:
Investment in Globe Joint Venture (637,566) - (637,566)
Common stock issued to founders 7,000 - -
Common stock issued in connection with merger
with Cerro Mining Corporation 300 - -
20 to 1 reverse stock split 138,188 138,188 -
Common stock issued in Ives merger 346,262 - -
Common stock subscriptions 69,800 - -
Capitalized compensation cost for options granted 1,487,700 - -
Common stock issued in exchange for promissory note 676,500 - -
Common stock issued for payment of debt 89,802 6,914 6,000
Common stock issued for convertible debentures 190,660 - -
Common stock issued for services 706,663 235,000 -
Common stock issued to pay Ives debt 27,000 - -
</TABLE>
19
REVOLUTIONS MEDICAL CORPORATION (FORMERLY MAXXON, INC.)
(A Development Stage Company)
<TABLE>
<CAPTION>
STATEMENTS OF STOCKHOLDERS' EQUITY
From Inception (August 16, 1996) Through December 31, 2007
Deficit
Accumulated
during the
Preferred Stock Common Stock Paid-In Development Subscription
Shares Amount Shares Amount Capital Stage Receivable Total
--------- ------ ----------- ------- ---------- ------------ ------------- -----------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
Balance at Inception
(August 16, 1996) - - - - - -
Cerro Mining/Maxxon-
OK Merger:
Cerro Mining 531,000 531 (231) 300
Maxxon-OK:
Shares issued
to founders 7,000,000 7,000 - 7,000
Shares sold
for cash to
third-party investors 578,000 578 573,899 574,477
Ives Transactions:
Investment in Ives
Health Company 311,240 311 310,951 311,261
Investment in The
Health Club 35,000 35 34,965 35,000
Conversion of
Ives Debt 18,513 19 26,981 27,000
Issuance of Common
Stock for:
Cash from third-
party investors 218,569 219 353,501 353,720
Cash from related party
Promissory Notes 64,500 65 128,935 129,000
Subscriptions Receivable 52,757 53 69,747 (69,800) -
Services Rendered 90,499 90 173,337 173,427
Debentures Converted 102,673 103 74,897 75,000
Net Income (Loss) at
December 31, 1997 (795,376) (795,376)
------------ -----------
Balance at December 31,
1997 9,002,751 9,003 1,746,982 (795,376) (69,800) 890,808
Issuance of Common
Stock for:
Conversion of Ives
Debt 44,827 45 54,955 55,000
Cash from third-
party investor 50,000 50 90,950 91,000
Options exercised by
third-parties for cash 545,867 546 359,354 359,900
Options exercised by
third-parties for
services 24,133 24 18,076 18,100
Services Rendered by
third-parties 988,007 988 573,560 574,549
Debentures Converted by
third parties 548,574 549 274,451 275,000
Settlement with
related party 350,000 350 - 350
Certificates canceled: (91,572) (92) (40,173) (40,265)
Value of Services
Contributed
by Officer
and Employees 114,154 114,154
Compensation Cost
for Stock
Options Granted
To Non-Employees 918,187 918,187
Cancellation of
Subscriptions
Receivable from related
party 69,800 69,800
Net Income (Loss) at
December 31, 1998 (2,584,383) (2,584,383)
------------ -----------
Balance at December
31, 1998 11,462,587 11,463 4,110,497 (3,379,759) 0 742,201
Issuance of Common
Stock for:
Cash from third-party
investor 390,693 390 342,034 342,424
Less: Issue Costs (16,743) (16,743)
Options exercised by
third-parties for cash 300,000 300 149,700 150,000
Services Rendered by
third-parties 164,069 164 166,579 166,743
Value of Services
Contributed
by Officer and Employees 280,000 280,000
Compensation Cost
for Stock
options Granted to
Non-Employees 89,728 89,728
Net Income (Loss)
at December 31, 1999 (1,014,555) (4,014,555)
------------ -----------
Balance at December
31, 1999 12,317,349 12,317 5,121,795 (4,394,314) 0 739,798
</TABLE>
20
REVOLUTIONS MEDICAL CORPORATION (FORMERLY MAXXON, INC.)
(A Development Stage Company)
<TABLE>
<CAPTION>
STATEMENTS OF STOCKHOLDERS' EQUITY
From Inception (August 16, 1996) Through December 31, 2007
Deficit
Accumulated
during the
Preferred Stock Common Stock Paid-In Development Subscription
Shares Amount Shares Amount Capital Stage Receivable Total
--------- ------ ---------- ------ ----------- ------------ ------------- -----------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
Issuance of Common
Stock for:
Cash from third-party
investor 862,776 863 249,525 250,388
Less: Issue Costs
Value of Services
Contributed
by Officer and
Employees 405,000 405,000
Net Income (Loss) at
December 31, 2000 (1,347,859) (1,347,859)
-------------------------------------------------------------------------
Balance at December
31, 2000 13,180,125 13,180 5,776,320 (5,742,173) 0 47,327
Issuance of Common
Stock for:
Cash from third-
party investor 6,558,333 6,558 1,598,142 1,604,700
Purchased by Employees 3,650,000 3,650 543,850 (547,500) -
Issued for Repayment
of Debt 50,000 50 7,450 7,500
Less: Issue Costs (85,575) (85,575)
Services Rendered by
third-parties 450,000 450 422,000 422,450
Compensation Cost of
stock issued
and options granted for services 200,000 200 1,487,500 1,487,700
Compensation Cost
of stock issued
and options granted
for services
to be amortized (1,048,754) (1,048,754)
Net Income (Loss) at
December 31, 2001 (2,199,085) (2,199,085)
-------------------------------------------------------------------------
Balance at December 31,
2001 24,088,458 24,088 8,700,933 (7,941,258) (547,500) 236,263
Issuance of Common
Stock for:
Cash from third-party
investor 3,625,000 3,625 358,875 362,500
Exercise of Options 2,006,822 2,007 (2,007) -
Payment towards
promissory
note balances 102,803 102,803
Amortized Compensation
Cost of stock
issued and options granted
for services 759,795 759,795
Compensation Cost of
stock issued and
options granted for services 1,200,000 1,200 323,300 324,500
Net Income (Loss) at
December 31, 2002 (1,933,676) (1,933,676)
-------------------------------------------------------------------------
Balance at December
31, 2002 30,920,280 30,920 10,140,896 (9,874,934) (444,697) (147,815)
Issuance of Common
Stock for:
MPI settlement costs
of stock issued
and options granted
for services 1,140,000 1,140 139,560 140,700
Compensation cost
of stock issued
and options granted
for services 7,000,000 7,000 133,000 140,000
Amortized compensation
cost of stock
issued and options granted for
services 288,959 288,959
Indemnification cost
of stock issued
and options granted
for services 4,000,000 4,000 76,000 80,000
Payment towards
promissory note
balances 69,201 69,201
Net Income (Loss) at
December 31, 2003 (1,391,518) (1,391,519)
-------------------------------------------------------------------------
Balance at December
31, 2003 43,060,280 43,060 10,778,415 (11,266,452) (375,496) (820,473)
Issuance of Common
Stock for:
Cash from third-
party investor 100,000 100 4,900 5,000
Exercise of Options 5,866,000 5,866 248,234 254,100
Exercise of Warrants 1,462,000 1,462 71,638 (1,000) 72,100
Compensation cost
of stock issued
for services 32,850,000 32,850 881,150 914,000
</TABLE>
21
REVOLUTIONS MEDICAL CORPORATION (FORMERLY MAXXON, INC.)
(A Development Stage Company)
<TABLE>
<CAPTION>
STATEMENTS OF STOCKHOLDERS' EQUITY
From Inception (August 16, 1996) Through December 31, 2007
Deficit
Accumulated
during the
Preferred Stock Common Stock Paid-In Development Subscription
Shares Amount Shares Amount Capital Stage Receivable Total
--------- ------ ------------- ---------- ------------ ------------- -------------- ------------
<S> <C> <C> <C> <C> <C> <C> <C> <C>
Payment towards
promissory
note balances 18,750 18,750
Net Income (Loss) at
December 31, 2004 (1,552,008) (1,552,008)
------------------------------------------------------------------------------------
Balance at December
31, 2004 83,338,280 83,338 11,984,337 (12,818,460) (357,746) (1,108,531)
Issuance of Common
Stock for Cash:
From third-party
investors 13,039,187 13,039 277,661 290,700
From the exercise
of options 1,800,000 1,800 43,200 45,000
Issuance of Common
Stock for
Subscription 5,200,000 5,200 28,800 (34,000) -
Common stock
issued for services 21,250,000 21,250 455,250 476,500
Common stock
issued
pursuant to Joint
Venture 5,833,331 5,833 132,000 137,833
Value of warrants
granted
pursuant to Joint
Venture - 499,733 499,733
Value of options
granted
for services 130,900 130,900
Reclassification
of receivables
against amounts
owed 357,746 357,746
Net Income (Loss) at
December 31, 2005 (1,310,783) (1,310,783)
------------------------------------------------------------------------------------
Balance at December
31, 2005 130,460,798 130,460 13,551,881 (14,129,243) (34,000) (480,902)
Issuance of Common
Stock:
From the exercise
of options
for services 1,000,000 1,000 - 1,000
From the exercise
of options
for cash 3,000,000 3,000 72,000 75,000
From the exercise
of warrants 6,000,000 6,000
Payment of Common
Stock Subscription 34,000 34,000
Common Stock issued
for services 5,500,000 5,500 102,000 107,500
Preferred Stock issued
for services 1,000,000 1,000 19,000 19,000
Capital contributed
by shareholder 3,000 3,000
Cancellation of Joint
Venture
with Globe (625,066) (625,066)
Common stock
issued to
Globe then returned
to treasury (500,000) (500) (12,000) (12,500)
Compensation
cost for
option price
reduction 50,000 50,000
Net Income (Loss) at
December 31, 2006 ]]> |