The following plan of operation provides information which management believes
is relevant to an assessment and understanding of our results of operations and
financial condition. The discussion should be read along with our financial
statements and notes thereto. This section includes a number of forward-looking
statements that reflect our current views with respect to future events and
financial performance. Forward-looking statements are often identified by words
like believe, expect, estimate, anticipate, intend, project and similar
expressions, or words which, by their nature, refer to future events. You should
not place undue certainty on these forward-looking statements. These
forward-looking statements are subject to certain risks and uncertainties that
could cause actual results to differ materially from our predictions.
Plan of Operations
In January 2014, Mr. Weissberg negotiated with Lifewave Ltd., a public company
organized under the laws of the State of Israel, for the purpose of acquiring
certain of Lifewave's IP assets pertaining to a wound healing device. The
Registrant signed a patent purchase agreement with Lifewave on January 6, 2014
(the "Agreement"), the closing of which was subject to several material
conditions, including our ability of raising equity capital sufficient to
develop and commercially exploit the technology.
On June 4, 2014, we completed the purchase of all right, title and interest to
certain IP assets, including rights to a wound treatment device. The IP assets,
including the wound healing device, acquired by the Registrant are designed for
wound treatment incorporating Bioelectrical Signal Therapy ("BST Device"). The
BST Device implements patented and proprietary electrical stimulation
technologies to treat hard-to-cure wounds and ulcers up to complete closure
and/or cure.
Pursuant to the Agreement, the Registrant has agreed to pay Lifewave a royalty
of from 10% to 20% of the profits (as defined in the Agreement) generated from
the BST Device.
During the first quarter of fiscal 2020, we were granted approval from the
Helsinki committee to launch a Randomized Control Study (RCT) on 60-100 patients
in order to assess the efficacy of the BST Device on diabetic foot patients in
collaboration with Clalit Health Services Organization, Israel's largest HMO,
and the Israeli Ministry of Health (MOH). The study will be conducted at 3 to 5
sites including leading clinics and hospitals in Israel. To date, we have
agreements with two outpatient clinics and one private clinic to conduct our
clinical trial study. We have enrolled 15 to 20 patients out of the required
minimum 60 patients for our study. Our enrollment process has been negatively
impacted by COVID 19, but expect to complete our enrollment by the end of the
year 2021. We expect trial completion within 12 to 18 months upon completion of
the enrollment. We plan to enroll between 60 to 100 patients based on a ratio of
2:1 between BST treatment group and the control group receiving only standard
care. The double arm clinical trial will be conducted on patients with diabetic
foot ulcers. The BST arm will be treated with the BST device three times a day.
Our trial protocol requires two weeks of pre-trial screening to determine if the
wounds qualify for the trial by showing no self-healing of more than 10%.
Subsequent to the screening period, the trial period will consist of 112
treatment days with the BST device followed by 28 days monitoring the
post-treatment wounds. The control group will be monitored the same way except
it will not receive the BST device treatment.
The Company has concluded a 35-wound, one arm clinical pilot, treating
recalcitrant wounds in a leading wound clinic in Tel Aviv Israel, with 78% of
the treated wounds completely healed within 20 weeks (Avg. wound duration at the
base was 8 months) and an additional 16% of the treated wounds reaching wound
area reduction of greater than 75%. Only 6% of the patients had no substantial
positive clinical effect.
The Company's success is dependent upon the successful clinical trial of its BST
Device. The Device may need additional development and may never achieve safety
or efficacy. The Company believes that its design and procedure show promise,
but the path to commercial success, even if development milestones are met, may
take more time and might be more costly.
There are a number of potential obstacles the Company might face, including the
following:
? We may not be able to raise additional funds we may need to complete the
clinical trials.
? Competitors may develop alternatives that render BST Device redundant or
unnecessary.
? We may not have a sufficient and sustainable intellectual property position.
? Our device may be shown to have harmful side effects or other characteristics
that indicate it is unlikely to be safe and effective
? Our device may not receive regulatory approval.
? Even if our device receives regulatory approval, it may not be accepted by
patients, the medical community or third-party payers.
17
Recent Developments
During the first quarter of fiscal 2020, we were granted approval from the
Helsinki committee to launch a Randomized Control Study (RCT) on 60-100 patients
in order to assess the efficacy of the BST Device on diabetic foot patients in
collaboration with Clalit Health Services Organization, Israel's largest HMO,
and the Israeli Ministry of Health (MOH). The study will be conducted at 3 to 5
sites including leading clinics and hospitals in Israel. To date, we have
agreements with two outpatient clinics and one private clinic to conduct our
clinical trial study. We have enrolled 15 to 20 patients out of the required
minimum 60 patients for our study. Our enrollment process has been negatively
impacted by COVID 19, but expect to complete our enrollment by the end of the
year 2021. We expect trial completion within 12 to 18 months upon completion of
the enrollment. We plan to enroll between 60 to 100 patients based on a ratio of
2:1 between BST treatment group and the control group receiving only standard
care. The double arm clinical trial will be conducted on patients with diabetic
foot ulcers. The BST arm will be treated with the BST device three times a day.
Our trial protocol requires two weeks of pre-trial screening to determine if the
wounds qualify for the trial by showing no self-healing of more than 10%.
Subsequent to the screening period, the trial period will consist of 112
treatment days with the BST device followed by 28 days monitoring the
post-treatment wounds. The control group will be monitored the same way except
it will not receive the BST device treatment.
The Company has concluded a 35-wound, one arm clinical pilot, treating
recalcitrant wounds in a leading wound clinic in Tel Aviv Israel, with 78% of
the treated wounds completely healed within 20 weeks (Avg. wound duration at the
base was 8 months) and an additional 16% of the treated wounds reaching wound
area reduction of greater than 75%. Only 6% of the patients had no substantial
positive clinical effect.
The Company's distributor in Colombia, TekMedica SAS, has successfully concluded
a clinical pilot study at the Hospital de la Samaritana in Bogota, Colombia.
Colsanitas, a leading Colombian HMO/Health insurance provider and operator of
comprehensive healthcare services in Colombia and a member of the Sanitas group
worldwide, intends to commence a clinical pilot study which is expected to be
concluded by the end of the year 2021. If positive results are achieved, similar
to those achieved in the one arm clinical pilot in Tel Aviv, Israel, the Company
believes that upon regulatory approval it will be successful in marketing and
selling the BST device treatment with to Colsanitas health services in Colombia.
On February 20, 2017, the Registrant received the official certification from
the Israeli Ministry of Health authorizing the use of the Registrant's BST
Device in Israel. The BST Device implements patented and proprietary electrical
stimulation technologies to treat hard-to-cure wounds and ulcers up to complete
closure and/or cure.
On January 8, 2017, the Registrant entered into a five-year distribution
agreement (the "Distribution Agreement") with TekMedica SAS, organized under the
laws of Colombia ("TekMedica" or the "Distributor"). Pursuant to the
Distribution Agreement, the Registrant granted TekMedica the exclusive rights to
distribute the Registrant's medical device for the treatment of chronic wounds
(the "BST Device™") and the accompanying disposable electrodes (sometimes
collectively, the "Products") in Colombia (the "Territory"). The Company
terminated its Distribution Agreement with TekMedica in March 2021.
Our distribution agreements provide that the Company will provide the
distributor with supplies of the BST Devise and disposable electrode for
treatment of patients in hospitals, long-term care facilities, medical centers
and out-patient clinics. The distributor will make an initial advance payment to
be applied against the first year's quota as set forth in the Distribution
Agreement, with minimum annual quota's during the five-year term. The
distributor will be responsible for securing any product certification, permit,
license or approval that may be required in the territory for the marketing,
sale, sublicensing and delivery and use of the BST Devise in the territory.
Results of Operations during the year ended December 31, 2020 as compared to the
year ended December 31, 2019
We have not generated any revenues since inception. We had operating expenses
mainly related to general and administrative expenses and research and
development expenses. During the year ended December 31, 2020, we incurred
$647,661 in net loss from operations due to general and administrative expenses
of $408,725 and research and development expenses of $238,936 as compared to a
net loss from operations of $429,804 due to general and administrative expenses
of $247,654 and research and development expenses of $182,150 during the year
ended December 31, 2019. During the year ended December 31, 2020 and 2019, we
had interest expenses of $16,636 and $7,008, respectively.
Our net losses from continuing operations during the years 2020 and 2019 were
$612,356 and $436,812, respectively.
We had net losses during the years 2020 and 2019 of $612,356 and $436,812,
respectively. We had comprehensive net losses during the years 2020 and 2019 of
$630,275 and $436,812, respectively.
Liquidity, Capital Resources and Strategy
On December 31, 2020, we had total assets of $81,070 consisting of cash in the
same amount. As of December 31, 2019, we had total assets of $18,278 consisting
of cash in the same amount. We had total current liabilities of $479,921 as of
December 31, 2020 consisting of $2,996 in accounts payable, $1,564 in accrued
interest, $309,456 in accrued salaries and 165,905 in loans from shareholders
payable. We had total current liabilities of $277,381 as of December 31, 2019
consisting of $4,050 in accounts payable, $1,564 in accrued interest, $105,862
in accrued salaries and $165,905 in loans from shareholders payable.
We used $393,180 in our operating activities during the year 2020, which was due
to a net loss of $612,356 offset by imputed interest of $16,636, a decrease in
accounts payable of $2,618 and an increase in accrued expenses due to a related
party of $205,158.
18
We used $500,386 in our operating activities during the year 2019, which was due
to a net loss of $436,812 offset by imputed interest of $7,008, an increase in
accounts payable of $4,050, a decrease in accrued salaries due to a related
party of $79,514, and a decrease in other assets of $4,882.
We financed our negative cash flow from operations in 2020 through proceeds from
stock payables of $473,891. We financed our negative cash flow from operations
in 2019 through borrowings of $128,169 from related parties.
We had no investing activities during the years ended December 31, 2020 and
2019.
The accompanying financial statements have been prepared in conformity with
accounting principles generally accepted in the United States of America with an
auditor's going concern opinion for the years 2020 and 2019. This means that
there is substantial doubt that we can continue as an on-going business for the
next twelve months unless we obtain additional capital to pay our bills and meet
our other financial obligations. This is because we have not generated any
revenues and no revenues are anticipated.
The Company has reported a net loss of $612,356 for the year ended December 31,
2020 and $436,812 for the year ended December 31, 2019 and had accumulated
deficits of $34,681,693 and $34,069,337 as of December 31, 2020 and 2019,
respectively.
The Company had no revenues from operations during the years ended December 31,
2020 and 2019. As of December 31, 2020, the Company had $81,070 cash on hand and
had negative working capital of $471,851.
We believe that our current cash on hand of $81,070 as of December 31, 2020,
will not be sufficient to meet our operating requirements throughout the ensuing
twelve-month period. We require additional financing at satisfactory terms and
conditions, of which there can be no assurance, in order to satisfy our ongoing
capital requirements for the next twelve months in order to execute our plan of
operation as presently constituted.
We do not expect to generate cash flow from operations unless we receive
regulatory for our BST Device.
Our management believes that our operations will generate revenues commencing in
2022. We expect that regulatory approval for our BST Device will improve our
ability to generate revenues from sales in other geographic areas. Our future
ability to generate cash flows from operations will depend on the demand for our
BST Device, as well as general economic, financial, competitive and other
factors, many of which are beyond our control.
If and when we receive regulatory approval of our BST Device, of which there can
be no assurance, our business might not generate sufficient future cash flow in
an amount sufficient to enable us to fund our liquidity needs, including working
capital, capital expenditures, investments and other general corporate
requirements.
Availability of Additional Capital
We have no commitments or arrangements, formal or otherwise, from any person or
entity to provide us with any additional capital. The Company may be unable to
implement its present plan of operation and this could have a material adverse
effect on our business, prospects, financial condition and results of
operations.
Our future financing transactions may include the issuance of equity and/or debt
securities. In the event that we seek to raise funds through additional private
placements of equity or convertible debt, the trading price of our common stock
could be adversely effected. Further, if we issue additional equity or debt
securities, stockholders may experience dilution or the new equity securities
may have rights, preferences or privileges senior to those of existing holders
of our common stock. We are not aware of any material trend, event or capital
commitment, which would or could potentially adversely affect our liquidity. We
do not have any arrangements with potential investors or lenders to provide us
with any additional financing and there can be no assurance that any such
additional financing will be available when required in order to proceed with
the business plan.
Off-Balance Sheet Arrangements
As of December 31, 2020 and 2019, we did not have any off-balance sheet
arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K promulgated
under the Securities Exchange Act of 1934.
Critical Accounting Policies
Our significant accounting policies are described in the notes to our financial
statements for the years ended December 31, 2020 and 2019, and are included
elsewhere in this annual report.
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