You should read the following discussion and analysis of our financial condition
and results of operations together with the section entitled "Explanatory Note"
immediately preceding Item 1 of this Annual Report, ''Selected Financial Data''
and our financial statements and related notes appearing elsewhere in this
annual report on Form 10-K. This discussion and analysis contain forward-looking
statements that involve risks, uncertainties and assumptions. The actual results
may differ materially from those anticipated in these forward-looking statements
as a result of certain factors, including, but not limited to, those set forth
under 'Risk Factors' and elsewhere in this annual report on Form 10-K.



Restatement



The accompanying Management's Discussion and Analysis gives effect to the
restatement adjustments made to the previously reported Financial Statements for
the years ended December 31, 2018 and 2017. For additional information and a
detailed discussion of the restatement, see Note 2, "Restatement" included in
this Annual Report under the caption Item 8, "Financial Statements and
Supplementary Data".



It also gives effect to the restatement adjustments made to the previously
reported unaudited Financial Statements for the quarterly and year to date
periods ended March 31, 2017, June 30, 2017, September 30, 2017, March 31, 2018,
June 30, 2018, September 30, 2018, March 31, 2019, June 30, 2019 and September
30, 2019. For additional information and a detailed discussion of the
restatements, see Note 2, "Restatement" included in this Annual Report under the
caption Item 8, "Financial Statements and Supplementary Data".




17





Results of Operations years ending December 31, 2019, 2018 and 2017

The following table sets forth a summary of certain key financial information for the years ended December 31, 2019, 2018, and 2017:





                                For the Years Ended December 31,
                             2019             2018             2017
                                           (Restated)       (Restated)
Revenue                  $      4,927     $     34,876     $    183,174

Gross profit             $      3,611     $     12,606     $     82,185

Operating (expenses)     $ (6,097,723 )   $ (1,909,580 )   $ (1,010,603 )

Operating (loss)         $ (6,094,112 )   $ (1,896,974 )   $   (928,418 )

Other income (expense) $ (508,183 ) $ (3,505,395 ) $ (538,371 )



Net (loss)               $ (6,602,295 )   $ (5,402,369 )   $ (1,466,789 )

Basic and diluted        $      (0.04 )   $      (0.03 )   $      (0.01 )

Year ended December 31, 2019 versus year ended December 31, 2018





During the year ended December 31, 2019 and 2018, the Company had $4,927 and
$34,876 of revenues, respectively. The decrease in revenues is due to the
continued focus which commenced in 2018 of substantially all the Company's
energy and resources being devoted towards making our technology and product
more commercially viable, by seeking to obtain FDA class III approval for
internal surgical purposes. The Company is continuing this strategy based on our
belief that the greatest value to our shareholders will come from this FDA Class
III approval for general surgical use, and pursuing opportunities that we
anticipate will be available to the Company if this FDA approval is obtained,
including, among other things, fostering interest from potential merger and
acquisition candidates. In this strategy and approach, the Company made a
determination not to engage new distribution partners as that could create
conflicts with a potential acquiror/commercialization candidate and tie the
Company's hands from a revenue or branding perspective. The Company expects that
if an acquisition candidate is identified it may also include a pre-acquisition
commercialization component and in that case current vendor and future
relationships and all pending purchase orders will likely be facilitated by that
company. No assurances can be given that the Company will identify an
acquisition or commercialization candidate or complete a transaction with such a
candidate on terms satisfactory to us, if at all.



Total operating expenses for the year ended December 31, 2019 and 2018 were
$6,097,723 and $1,909,580, respectively. The increase in operating expenses is
due primarily to an increase in consulting/professional fees and an increase in
research and development expenses. The increase in consulting/professional fees
include the issuance of 1,925,000 shares of our common stock for services valued
at $1,859,250 and stock based modification expense of $2,021,000 due to the
change in vesting conditions of 2,150,000 shares of common stock previously held
in escrow during the year ended December 31, 2019 compared to the Company
issuing 850,000 shares of common stock valued at $697,000 for services,
including 800,000 shares of common stock to various medical advisors during the
year ended December 31, 2018. The increase in research and development of
$589,437 is due to higher expenses related to the continued efforts to obtain
FDA Class III approval during the current year relative to the prior year.



Other income (expense) for 2019 and 2018 was $(508,183) and $(3,505,395),
respectively. The decrease in other expense was due to the decrease in loss on
debt settlement of $3,509,330 offset by an increase in interest expense of
$508,183. The decrease in loss on debt settlement was due to the Company issuing
a total of 3,387,000 shares of common stock to settle notes payable balance of
$172,500 and $10,000 of accrued interest. The Company recorded a $3,509,330 loss
on settlement of debt related to this transaction during the year ended December
31, 2018 and did not have these transactions during the year ended December 31,
2019. The increase in interest expense is due to amortization of beneficial
conversion features on convertible notes payable - related party during the
current year and the Company not having these transactions in the prior year.




18






Our net loss for the year ended December 31, 2019 was $6,602,295 as compared to
a net loss of $5,402,369 for the prior year. The increase in the net loss is due
to an increase in stock based stock compensation of $3,183,250, an increase in
research and development expenses $589,437 and an increase in interest expense
of $508,183 offset by a decrease in loss on debt settlement of $3,509,330
compared to the prior year for the reasons described above.



Year ended December 31, 2018 versus year ended December 31, 2017





During the year ended December 31, 2018 and 2017, the Company had $34,876 and
$183,174 of revenues, respectively. The decrease in revenues is due to a change
in focus and a pivot substantially of all the Company's energy in making our
technology and product more commercially viable, by attempting to obtain FDA
class III approval for internal surgical purposes as noted under the heading
"Year ended December 31, 2019 versus year ended December 31, 2018" above. We
continued this strategic focus though 2019.



Total operating expenses for the year ended December 31, 2018 and 2017 were
$1,909,580 and $1,010,603, respectively. The increase in operating expenses is
due primarily to an increase in research and development expenses of
approximately $57,000, an increase in advertising and marketing expenses of
approximately $124,000 and an increase of approximately $696,000 in
consulting/professional fees, which includes the Company issuing 850,000 shares
of common stock valued at $697,000, including 800,000 shares to eight medical
advisors.



Other income (expense) for 2018 and 2017 was $(3,505,395) and $(538,371),
respectively. The increase in other expense was due to the Company issuing a
total of 3,387,000 shares of common stock to settle notes payable balance of
$172,500 and $10,000 of accrued interest. The Company recorded a $3,509,330 loss
on settlement of debt related to this transaction. During 2017, the Company
issued 4,200,000 shares of common stock to settle notes payable balance of
$162,500 and accounts payable balances totaling $82,774. The fair value of the
stock issued was $664,000 and the Company recorded loss on debt settlement of
$418,726. In 2017, the Company had $82,166 related to a loss on disputed
inventory due to shipping product to a customer and the customer subsequently
not paying for the invoice. The Company determined that due to knowledge
currently available this transaction was not recorded as revenue and recorded on
a loss on the inventory. The Company had $0 interest expense in 2018 due to
paying off its notes payable in the first quarter of 2018 compared to $39,479
interest expense in 2017.



Our net loss for the 2018 was $5,402,369 as compared to a net loss of $1,466,789
for 2017. The increase in the net loss is due to the decrease in revenues for
the reasons described above and shares issued for services of $697,000 as
mentioned above along with the issuance of 3,387,000 shares of common stock to
settle $172,500 of outstanding notes payable and $10,000 of accrued interest.
The Company recorded a $3,509,330 loss on settlement of debt related to this
transaction.


UNAUDITED QUARTERLY DISCUSSION AND ANALYSIS





The following table sets forth selected unaudited financial data for each of the
periods indicated.



                                                                                   For the Quarters Ended (Unaudited)
                   Sept. 30,           Jun. 30,           Mar. 31,          Sept. 30,           Jun. 30,           Mar. 31,          Sept. 30,           Jun. 30,           Mar. 31
                      2019               2019               2019               2018               2018               2018               2017               2017               2017
                   (Restated)         (Restated)         (Restated)         (Restated)         (Restated)         (Restated)         (Restated)         (Restated)         (Restated)
Revenue          $            -     $        4,927     $            -     $        9,048     $        1,850     $       18,943     $       67,598     $       41,816             96,404
Cost of goods
sold                          -                502                  -              3,480              1,790             14,760             21,290             21,296             15,379

Gross profit                  -              4,425                  -              5,568                 60              4,183             46,308             20,520             81,025

Selling,
general and
administrative          328,720            393,893          2,635,993            289,833            901,951            369,199            181,819            129,290            149,754

Research and
development             149,994            214,863             27,405             13,527             39,041              9,391                  -                  -                  -
Total
operating
expenses                478,714            608,756          2,663,398            303,360            940,992            378,590            181,819            129,290            149,754

Income (loss)
from
operations             (478,714 )         (604,331 )       (2,663,398 )         (297,792 )         (940,932 )         (374,407 )         (135,511 )         (108,770 )          (68,729 )
Other income
(expense)               (46,154 )         (202,752 )                -                  -              3,886         (3,509,330 )           (5,000 )           (8,854 )          (15,625 )

Provision for
income taxes                  -                 --                  -                  -                  -                  -                  -                  -                  -

Net income       $                  $                  $                  $                  $                  $                  $                  $                  $
(loss)                 (524,868 )         (807,084 )       (2,663,398 )         (297,792 )         (937,046 )       (3,883,737 )         (140,511 )         (117,624 )          (84,354 )

Net loss per
share
Basic &
diluted          $        (0.00 )   $        (0.00 )   $        (0.02 )   $        (0.00 )   $        (0.01 )   $        (0.02 )   $        (0.00 )   $        (0.00 )            (0.00 )
Weight average
number of
shares
outstanding         176,588,907        175,270,956        174,322,581        172,822,654        171,939,365        169,970,509        154,385,816        153,704,591        153,591,591





19





Three Months ended September 30, 2019 versus Three Months ended September 30, 2018


During the three months ended September 30, 2019 and 2018, the Company had $0
and $9,048 of revenues, respectively. The decrease in revenues is due to the
Company not pursuing sales in the current quarter compared to achieving minimal
revenues in the comparable quarter of the prior year.



Total operating expenses for the three months ended September 30, 2019 and 2018
were $478,714 and $297,972, respectively. The increase in operating expenses is
due primarily to an increase in research and development expenses from $13,527
to $149,994. The increase in research and development expenses is due to higher
expenditures on the ongoing process to obtain FDA Class III approval during

the
current period.



Our net loss for the three months ended September 30, 2019 and 2018 was $524,868
and $297,792, respectively. The increase in the net loss is due to reduced
revenue, increased spending on research and development along with $46,154 of
interest expense related to amortization of debt discount on convertible notes.



Three Months Ended June 30, 2019 compared to Three Months Ended June 30, 2018





During the three months ended June 30, 2019 and 2018, the Company had $4,927 and
$1,850 of revenues, respectively. The increase in revenues is due to the Company
having one customer order product during the current year compared to minimal
revenues in the comparable quarter of the prior year.



Total operating expenses for the three months ended June 30, 2019 and 2018 were
$608,756 and $940,992, respectively. The decrease in operating expenses is due
primarily to a decrease in consulting/professional fees offset by an increase in
research and development expenses of $175,822. The decrease in
consulting/professional fees is due to the Company issuing 800,000 shares of
common stock for services valued at $642,500 to various medical advisors during
the three months ended June 30, 2018 and during the three months ended June 30,
2019 the Company did not issue any stock for services. The increase in research
and development expenses is due to the Company going through the process to
obtain FDA class III approval during the current period and not having these
expenses in the prior year.



Our net loss for the three months ended June 30, 2019 and 2018 was $807,084 and
$937,046, respectively. The decrease in the net loss is due to the Company not
issuing shares for services during the period compared to shares issued for
services of $642,500 as mentioned above, offset by an increase in research and
development expense of $175,822 and interest expense of $202,752 related to
amortization of debt discount related to beneficial conversion feature on notes
payable - related party.




20





Three Months Ended March 31, 2019 compared to Three Months Ended March 31, 2018





During the first quarter of 2019 and 2018, the Company had $0 and $18,943 of
revenues, respectively. Revenues decreased compared to the prior year due to the
continued focus which commenced in 2018 of substantially all the Company's
energy in making our technology and product more commercially viable, by
attempting to obtain FDA Class III approval for internal surgical purposes. This
process requires substantially all of the Company's resources and energy so the
focus and resources were redirected from sales and marketing efforts to the FDA
process. See the discussion under the heading "Year ended December 31, 2019
versus year ended December 31, 2018" above for the strategic reasons for our
change in focus.



Total operating expenses for the first quarter of 2019 and 2018 were $2,663,398
and $378,590, respectively. The increase in operating expenses is due primarily
to an increase in consulting/professional fees. The Company issued 400,000
shares of common stock for services valued at $380,000 and 2,150,000 shares of
common stock valued at $2,021,000 vested during the first quarter of 2019
compared to 50,000 shares of common stock for services valued at $54,500 during
the first quarter of 2018.



Our net loss for the quarter ended March 31, 2019 was $2,663,398 as compared to
net loss of $3,883,737 for the comparable period of the prior year. The decrease
in the net loss is due to the Company having an increase in operating expenses
of $2,284,808 as explained above offset by a decrease of $3,509,330 in loss

on
settlement of debt.


Three Months Ended September 30, 2018 compared to Three Months Ended September 30, 2017





During the three month ended September 30, 2018 and 2017, the Company had $9,048
and $67,598 of revenues, respectively. Revenues decreased compared to the prior
year due to the change in focus which commenced in 2018 of substantially all the
Company's energy in making our technology and product more commercially viable,
by seeking to obtain FDA class III approval for internal surgical purposes. See
the discussion under the heading "Year ended December 31, 2019 versus year ended
December 31, 2018" above for the strategic reasons for our change in focus.



Total operating expenses for the three months ended September 30, 2018 and 2017
were $303,360 and $181,819, respectively. The increase in operating expenses is
due primarily to an increase in consulting/professional fees of approximately
$57,000, an increase in advertising and marketing expenses of approximately
$24,200 and an increase in travel expenses of approximately $25,140.



Our net loss for the three months ended September 30, 2018 and 2017 was $297,792
and $140,511, respectively. The increase in the net loss is due to the decrease
in revenues and the increase in the expenses mentioned in the preceding
paragraph.



Three Months Ended June 30, 2018 compared to Three Months Ended June 30, 2017





During the three months ended June 30, 2018 and 2017, the Company had $1,850 and
$41,816 of revenues, respectively. Revenues decreased compared to the prior year
due to the change in focus which commenced in 2018 of substantially all the
Company's energy in making our technology and product more commercially viable,
by seeking to obtain FDA class III approval for internal surgical purposes. See
the discussion under the heading "Year ended December 31, 2019 versus year ended
December 31, 2018" above for the strategic reasons for our change in focus.
Total operating expenses for the three months ended June 30, 2018 and 2017 were
$940,992 and $129,290, respectively. The increase in operating expenses is due
primarily to an increase in consulting/professional fees. The Company issued
800,000 shares of common stock valued at $642,500 to various medical advisors
during the three months ended June 30, 2018.



Our net loss for the three months ended June 30, 2018 and 2017 was $937,046 and
$117,624, respectively. The increase in the net loss is due to the shares issued
for services of $620,000 as mentioned above. The Company did not have this
transaction during the three months ended June 30, 2017.



Three Months Ended March 31, 2018 compared to Three Months Ended March 31, 2017





During the first quarter of 2018 and 2017, the Company had $18,943 and $96,404
of revenues, respectively. Revenues decreased compared to the prior year due to
a change in focus of substantially all the Company's energy in making our
technology and product more commercially viable, by seeking to obtain FDA class
III approval for internal surgical purposes. See the discussion under the
heading "Year ended December 31, 2019 versus year ended December 31, 2018" above
for the strategic reasons for our change in focus. Total operating expenses for
the first quarter of 2018 and 2017 were $378,590 and $149,754, respectively. The
increase in operating expenses is due primarily to an increase in
consulting/professional fees. The Company issued 50,000 shares of common stock
for services valued at $54,500 during the first quarter of 2018 compared to $0
during the first quarter of 2017. The Company has also hired additional
consultants as the Company's operations have begun to increase.




21






Our net loss for the quarter ended March 31, 2018 was $3,883,737 as compared to
$84,354 for the comparable period of the prior year. The increase in the net
loss is due to the shares issued for services of $54,500 as mentioned above
along with the issuance of 3,877,000 shares of common stock to settle $172,500
of outstanding notes payable and $10,000 of accrued interest. The Company
recorded a $3,509,330 loss on settlement of debt related to this transaction.
The Company did not have either of these transactions during the first quarter
of 2017.


Financial Condition, Liquidity and Capital Resources





As of December 31, 2019, the Company had a negative working capital of $903,805.
The Company has not yet attained a level of operations, and for the foreseeable
future will not be pursuing commercial operations, which will allow the it to
meet its current overhead while it focuses on its strategy of seeking FDA class
III approval for internal surgical purposes, and opportunities which may arise
from that including, among other things, fostering interest from potential
merger and acquisition candidates or commercial partners. If we are not
successful in our strategy, we cannot assure that we will be able to adjust to
and fund a marketing and sale strategy, and if we do, we are unable to assure we
will attain profitable operations within the next few business operating cycles
or at all. The report of our independent registered public accounting firm on
our 2019, 2018 and 2017 financial statements includes an explanatory paragraph
expressing substantial doubt about our ability to continue as a going concern.
While the Company has funded its initial operations with private placements, and
secured loans from related parties, there can be no assurance that adequate
financing will continue to be available to the Company and, if available, on
terms that are favorable to the Company. Our ability to continue as a going
concern is also dependent on many events outside of our direct control,
including, among other things, our ability to achieve our business goals and
objectives, as well as improvement in the economic climate.



Cash Flows


The Company's cash on hand at December 31, 2019, December 31, 2018 and December 31, 2017 was $16,624, $31,273 and $189,942, respectively.

The following table summarizes selected items from our statements of cash flows for the years ended December 31, 2019, 2018, and 2017:





                                                    For the Years Ended December 31,
(in thousands)                                    2019             2018            2017

Net cash used in operating activities $ (1,766,764 ) $ (1,278,662 ) $ (649,675 ) Net cash used in investing activities

                    -                -              -

Net cash provided by financing activities 1,752,115 1,119,993

810,250



Net increase (decrease) in cash and cash
equivalents                                   $    (14,649 )   $   (158,669 )   $  160,575

Net Cash Provided by (Used in) Operating Activities


Net cash used in operating activities for the year ended December 31, 2019 was
$1,766,764. The Company had a net loss of $6,602,295 offset by stock-based
compensation of $3,880,250 and amortization of debt discount of $508,183. The
Company also had an increase in inventory of $44,868, an increase in accounts
payable and accrued expenses of $367,836, an increase in accrued liabilities -
related party of $74,130 and a decrease if prepaid and other assets of $50,000.




22






Net cash used in operating activities for the year ended December 31, 2018 was
$1,278,662. The Company had net loss of $5,402,369 offset by stock issued for
services of $697,000, expenses paid by an officer of $30,000 and loss on
settlement of debt of $3,509,330. The Company also had a decrease in accounts
receivable of $371, a decrease in inventory of $5,411, an increase in prepaids
and other current assets of $37,886, a decrease in accounts payable and accrued
expenses of $14,019 and a decrease in accrued liabilities - related party of
$71,500.



Net cash used in operating activities was $649,675 for the year ended December
31, 2017. The Company incurred a net loss of $1,466,789, an increase in
inventory of $71,040 and an increase in prepaid and other current assets of
$12,114 offset by a decrease in accounts receivable of $99,910, $144,000 in
stock for services, $416,726 in loss on debt settlement, $8,479 related to
common stock issued as debt financing costs, $82,166 related to loss on disputed
inventory an increase in accounts payable and accrued expenses of $61,432 and an
increase in accrued liabilities - related party of $87,555.



Net Cash Used by Investing Activities

The Company did not have any investing activities during the years ended December 31, 2019, 2018 or 2017.

Net Cash Provided by (Used in) Financing Activities





Net cash provided by financing activities for the year ended December 31, 2019
was $1,752,115. This was due to the Company receiving $1,255,750 in proceeds
from the sale of stock and receiving net proceeds of $496,365 from a related
party.



Net cash provided by financing activities for the year ended December 31, 2018
was $1,119,993. This was due to the Company receiving $1,415,200 in proceeds
from the sale of stock and repaying a net amount of $280,207 in related party
advances and $15,000 in notes payable.



Net cash provided by financing activities for the year ended December 31, 2017
was $810,250. The Company received net proceeds from related party of $133,750,
net proceeds on notes payable of $32,500 and $644,000 from the sale of common
stock.


Off-Balance Sheet Arrangements

As of December 31, 2019, 2018, and 2017, we have no off-balance sheet arrangements.





Related Parties



Information concerning related party transactions is included in the financial
statements and related notes, appearing elsewhere in this annual report on

Form
10-K.


Critical Accounting Policies





Revenue Recognition



During the year ended December 31, 2017, the Company recognized revenue per ASC
605 - Revenue Recognition.  Under ASC 605 revenue was recognized when persuasive
evidence of an arrangement existed, product had been delivered or services had
been rendered, the price was fixed or determinable and collectability was
reasonably assured. Revenue was recognized net of estimated sales returns and
allowances.



Effective January 1, 2018, the Company adopted ASC 606 - Revenue from Contracts
with Customers. Under ASC 606, the Company recognizes revenue from the sale of
its HemoStyp product by applying the following steps: (1) identify the contract
with a customer; (2) identify the performance obligations in the contract; (3)
determine the transaction price; (4) allocate the transaction price to each
performance obligation in the contract; and (5) recognize revenue when each
performance obligation is satisfied.



The Company receives orders for its HemoStyp products directly from its
customers. Revenues are recognized based on the agreed upon sales or transaction
price with the customer when control of the promised goods are transferred to
the customer.  The transfer of goods to the customer and satisfaction of the
Company's performance obligation will occur either at the time when products are
shipped or when the products arrive and are received by the customer.  The
Company provided a 3% net 30 discount to one of its customers. No other
discounts were offered by the Company. The Company does not provide an estimate
for returns as there is no anticipation for any returns in the normal course of
business.



Stock Based Compensation



The Company accounts for share-based compensation under the provisions of ASC
718, Compensation-Stock Compensation. Under the fair value recognition
provisions, stock-based compensation expense is measured at the fair value of
the consideration received, or the fair value of the equity instruments issued,
or liabilities incurred, whichever is more reliably measured. Share-based
compensation for all stock-based awards to employees and directors is recognized
as an expense over the requisite service period, which is generally the vesting
period.



The Company accounted for stock compensation arrangements with non-employees in
accordance with ASC 505-50-30-11, until January 1, 2019, which provides that an
issuer shall measure the fair value of the equity instruments in these
transactions using the stock price and other measurement assumptions as of the
earlier of the following dates, referred to as the measurement date:



i. The date at which a commitment for performance by the counterparty to earn


        the equity instruments is reached (a performance commitment); and

    ii. The date at which the counterparty's performance is complete.




As of January 1, 2019, the Company accounted for stock compensation arrangements
with non-employees in accordance with Accounting Standard Update (ASU) 2018-07,
Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee
Share-Based Payment Accounting, which requires that such equity instruments are
recorded at the value on the grant date.

© Edgar Online, source Glimpses