ITEM 1.01 ENTRY INTO A MATERIAL DEFINITIVE AGREEMENT
On
The members of the Corporation's Board of Directors were also members of the Board of Directors of Medi-Scan when the Exchange Agreement was negotiated.
ITEM 5.03 AMENDMENT TO ARTICLES OF INCORPORATION
On
ITEM 2.01 COMPLETION OF ACQUISITION OR DISPOSITION OF ASSETS
On
As a result of the Share Exchange, there are currently 323,375,633 shares of the Corporation's Common Stock outstanding on a fully-diluted basis.
We have included in Item 5,06 below the information that would be required if the registrant were filing a general form for registration of securities on Form 10, including a complete description of the business and operations of Medi-Scan.
ITEM 3.02 UNREGISTERED SALE OF EQUITY SECURITIES
As a condition to closing of the Share Exchange, on
ITEM 5.01 CHANGES IN CONTROL OF REGISTRANT
As a result of the closing of the Exchange Agreement, the former shareholders of Medi-Scan now own 97% of the Corporation's equity interest.
ITEM 5.03 CHANGES IN FISCAL YEAR
The fiscal year-end for Medi-Scan is
2 ITEM 5.06 CHANGE IN SHELL CORPORATION STATUS
On
DESCRIPTION OF BUSINESS
Since
· Method and Process for evaluating an intubated COVID-19 patient disease state
based on ultrasound findings
· Method and Process for quantifying extravascular lung water (EVLW) in a
COVID-19 infected lung patient
· Method and Process for discriminating between blood and water in a COVID-19
infected lung patient
· Method and Process for detecting the progression or decline of a COVID-19
infected lung patient
· Method and Process for generating a predictive metric for monitoring the
progression or decline of a COVID-19 infected lung patient
· Method for Automated Digital Ultrasound Analysis and Reporting
· Method and Process for Predictive Analytical Imaging
· A Method and process to repair cardiac muscle damage
What we have developed is a novel medical imaging technology APP, which features interpretation based on observation (something that can be seen) rather than inference (an educated guess). Our software applies this analysis to classic B-mode ultrasound, but converts the gray scale images into digital images, identifying water-filled hypoechoic structures (tissue in the body that is more dense than usual), thus permitting an objective evaluation of tissue integrity. Hypoechoic structures are typically found in tissue linings, are readily identified by our APP technology, and yield images in our APP of fine lines with all background speckle noise removed. Once we have seen the structure of the underlying tissue in this way, we can apply observational metrics to give numerical evaluations instead of subjective guesses.
We have adapted the Parker IP into an APP, so that the user requires only a cell phone to accept images into the APP from a conventional ultrasound machine. Those images are then loaded into our Cloud processor, manipulated on the cell phone display, and within three to five minutes a final processed report is returned to the cell phone (or email). Our APP's report then permits the doctor to see into what is a blur on a conventional ultrasound report by resolving water-filled boundary layers to indicate firm outlines. That identification enables structural evaluation and, in particular, identifies injuries expressed as broken tissue component.
Our APP permits the user to publish reports that express tissue health, tissue dimensions and comparative analysis. Among the faculties are:
· Comparison of patient visit reports over time.Our system tracks fiber bundle
counts which are reduced with injury but increased with rehabilitation. By
month-to-month comparison, we are able to track patient improvement digitally.
3
· Identification and computation of organ dimensions.Deep internal organ
structures must be imaged with lower frequency ultrasounds. Nevertheless, our system permits evaluation of the same tissue boundary conditions and, in particular, evaluates the incident reflation (surface) as well as the backscatter reflation (interior). Once these structures are identified, we are able to build a 3D articulated model, which also enables internal and external measurements.
· Tissue Taggingtm. Frequent tissue structures have overlapping regions that
inhibit a visual evaluation. As our technology first converts the underlying tissue structure to a digital form, we are developing a capacity to take that form, integrate it into a unified form, and then make that structure become transparent. Once the "Tissue Tag" has been applied and the structure is transparent, our system reveals the underlying tissue. In addition, as each tendon is a separate structure, we can compute the diameter of each tendon and the internal volume of related areas. This volume can then be translated directly into pressure metrics and displayed to the patient to demonstrate that the therapy is working.
· Detect and prevent future injuries. Dense tissues consisting of rope-like
structures go through several discrete stages as they are stressed. A tendon,
for example, is stretched and then returns to its original length and
condition. When the tendon is stressed beyond a certain point, however, it
enters a "
shape. If stressed beyond this point, the tendon will break. Unfortunately, in
all dense tissues, the range from linear stress to plastic region is very
difficult to observe on B-mode ultrasound. However, through a technique known
as acoustoelasticity coupled with our technology, we can identify plastic
regions and alert the physician to the risk that has developed.
By means of a cell phone (Apple or Android) and a portable ultrasound device, the Medi-Scan technology has the potential to offer high definition medical imaging in situ, potentially altering the efficiency and effectiveness of sports medicine and ER services everywhere.
COVID-19 Applications
Our current development plan contemplates that we will initiate human testing under an EUA (Emergency Use Authorization) from the FDA relating to the COVID-19 pandemic. We have filed two EUA applications, one for use of our system to image the heart, one to image the lungs. If granted, the EUA would enable us to accelerate human testing of our technology for the duration of the pandemic.
Our cloud-based application is peculiarly useful within the COVID-19 context, as it provides 3D high-definition ultrasound images that enable the physician to discern the presence of COVID-19 lung lesions within a cloudy ultrasound image. Using a portable ultrasound device coupled to our APP reduces the pressure on hospitals to transport patients to land-locked CT/MRI devices for scans, with the resulting risk of transient infection. By bridging the gap in imaging, the Medi-Scan APP system helps triage COVID-19 patients at the ER.
Our template-guided system also facilitates ongoing monitoring of the COVID-19 patient by capturing the current region of interest, computing the relative brightness and fiber count (density) of the lesion, and comparing the results against prior scans, thus alerting medical personnel to changes within a chart.
The ER staff at a major
Competition
The direct competition for our system will come from manufacturers of ultrasound scanning machines. The leading competitors in volume are Phillips, Siemens and Toshiba, but there are at least fourteen other significant competitors. The focus of most competitors is on high-priced machines for institutions. We intend our system to be mobile and inexpensive.
4 Employees
Property
HYB's executive offices are located at
RISK FACTORS
Investing in our common stock involves risk. You should carefully consider the risks described below together with all of the other information contained in this Report, including the financial statements and the related notes, before deciding whether to purchase any shares of our common stock. If any of the following risks is realized, our business, financial condition or operating results could materially suffer. In that event, the trading price of our common stock could decline and you may lose all or part of your investment.
Our business plan will fail unless we are able to secure substantial additional capital contributions.
In its report on the Medi-Scan financial statements for the year ended
We have no full time employees.
There are currently two individuals who devote most of their business time to Medi-Scan. They are assisted by seven hourly part-time employees. This situation enables us to adjust to increases and decreases in our cash resources. It is, however, not a satisfactory situation for sound administration. The lack of a full-time management staff impedes the development of long-term goals and the consistent implementation of such goals as we have. The lack of a dedicated research staff likewise impedes the development of a long-term research strategy and its implementation. We intend to expand our staff and engage more full-time personnel when we have the cash resources needed. In the meantime, there is a risk that our lack of a complete management team will delay or imperil the implementation of our business plan.
Our business plan will not be effective unless we develop and effective marketing network.
We have not yet commenced the development of the marketing network that will deliver our imaging system to the medical community. An important part of our sales process will include the education of physicians on the safe and effective use of our products. There is a learning process for physicians to become proficient in the use of our products and it typically takes several procedures for a physician to become comfortable using the product. If a physician experiences difficulties during an initial procedure or otherwise, that physician may be less likely to continue to use our product, or to recommend it to other physicians. It is critical to the success of our commercialization efforts that our marketing agents educate physicians on the proper use of the system, and provide them with adequate product support during clinical procedures. If, therefore, we do not organize a skilled marketing network, our product launch will fail. . . .
ITEM 9.01 FINANCIAL STATEMENTS AND EXHIBITS
Financial Statements
The financial statements filed herewith are:
· Audited financial statements of
and the period from inception (
· Unaudited financial statements of
· Unaudited pro forma financial information of the Corporation and subsidiaries
for the year ended
Exhibits 2.1 Share Exchange Agreement datedNovember 12, 2020 amongHYB Holding Corp. ,Medi-Scan, Inc. , and the Shareholders ofMedi-Scan, Inc. 3.1 Articles of Amendment to Articles of Incorporation ofHYB Holding Corp. filed onNovember 16, 2020 . 3.2 Form of 7% Convertible Debenture 10.1 Technology Assignment Agreement datedDecember 18, 2018 amongRichard Parker , 6Sigma LLC andMedi-Scan, LLC . 15
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