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EX-32.1 - CERTIFICATION - MEDICAL INTERNATIONAL TECHNOLOGY INCf10k2015ex32i_medical.htm
EX-31.1 - CERTIFICATION - MEDICAL INTERNATIONAL TECHNOLOGY INCf10k2015ex31i_medical.htm

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-K

 

(Mark One) 

☒   ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the fiscal year ended:  September 30, 2015

 

Or

 

☐   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ____________ to ____________

 

Commission file number: 000-31469

 

Medical International Technology, Inc.

(Exact name of registrant as specified in its charter)

 

 Colorado    84-1509950

(State or other jurisdiction of

incorporation or organization)

 

 (I.R.S. Employer

Identification No.)

 

1872 Beaulac, Ville Saint-Laurent

Montreal, Quebec, Canada H4R 2E7

 (Address of principal executive offices)(Zip Code)

 

Registrant’s telephone number, including area code: (514) 339-9355

 

Securities registered pursuant Section 12(b) of the Act:
     
Title of each class:   Name of each exchange on which registered:
None   None
 
Securities registered pursuant Section 12(g) of the Act:
 

Common Stock, par value $.0001

(Title of class)

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.  Yes ☐     No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.  Yes ☐     No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes ☐     No ☒

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes ☐     No ☒

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  ☒

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☐ Smaller reporting company ☒

(Do not check if a smaller reporting company)

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).  Yes ☐     No ☒

The aggregate market value of the voting and non-voting common equity held by non-affiliates as of September 30, 2015 is approximately $2,095,115 (based on its reported last sale price by the OTC Bulletin Board).

The number of shares outstanding of the registrant’s common stock as of February 18, 2016 is 84,304,627

 

 

 

 

 

Table of Contents

 

    PAGE
  PART I  
ITEM 1. Business 5
ITEM 1A. Risk Factors 11
ITEM 1B. Unresolved Staff Comments 11
ITEM 2. Properties 12
ITEM 3. Legal Proceedings 12
ITEM 4. Mine Safety Disclosures 12
     
  PART II  
ITEM 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 12
ITEM 6. Selected Financial Data 13
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of Operation 13
ITEM 7A. Quantitative and Qualitative Disclosures About Market Risk 19
ITEM 8. Financial Statements and Supplementary Data 20
ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 35
ITEM 9A. Controls and Procedures 35
ITEM 9B. Other Information 35
     
  PART III  
ITEM 10. Directors, Executive Officers and Corporate Governance 36
ITEM 11. Executive Compensation 37
ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 38
ITEM 13. Certain Relationships and Related Transactions, and Director Independence  
ITEM 14. Principal Accounting Fees and Services 39
     
  PART IV  
ITEM 15. Exhibits, Financial Statement Schedules 40
SIGNATURES   41

 

 2 

 

 

CAUTIONARY STATEMENT RELATED TO FORWARD LOOKING STATEMENTS

This Annual Report on Form 10-K (this “Report”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange Act. Forward-looking statements discuss matters that are not historical facts. Because they discuss future events or conditions, forward-looking statements may include words such as “anticipate,” “believe,” “estimate,” “intend,” “could,” “should,” “would,” “may,” “seek,” “plan,” “might,” “will,” “expect,” “predict,” “project,” “forecast,” “potential,” “continue” negatives thereof or similar expressions. These forward-looking statements are found at various places throughout this Report and include information concerning possible or assumed future results of our operations; business strategies; future cash flows; financing plans; plans and objectives of management; any other statements regarding future operations, future cash needs, business plans and future financial results, and any other statements that are not historical facts.

 

From time to time, forward-looking statements also are included in our other periodic reports on Forms 10-Q and 8-K, in our press releases, in our presentations, on our website and in other materials released to the public.  Any or all of the forward-looking statements included in this Report and in any other reports or public statements made by us are not guarantees of future performance and may turn out to be inaccurate. These forward-looking statements represent our intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors.  Many of those factors are outside of our control and could cause actual results to differ materially from the results expressed or implied by those forward-looking statements. In light of these risks, uncertainties and assumptions, the events described in the forward-looking statements might not occur or might occur to a different extent or at a different time than we have described. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Report. All subsequent written and oral forward-looking statements concerning other matters addressed in this Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report.

 

Except to the extent required by law, we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying such statements, or otherwise.

  

To Our Shareholders

 

The future of our Corporation has always been our key priority and at the core of our considerations from the start of the Corporation. From quarter to quarter we reassess our positioning in our different markets with each of our distributors and agents we have nationally and internationally, thereafter we take the decisions we deemed the most accurate for the Corporation to gradually improve its results and achieve growth within the medium term. The technological advances we have achieved over the past years in our Needle-Free jet injector market segment firmly places us as the most advanced devices on the market combining speed, regulated pressure, dosage/volume adjustability and accuracy to produce the most efficient method of drug delivery.

 

From the start of our business and to facilitate its rapid market penetration MIT is developing strategic alliances with distributors and agents per Country that have established a successful distribution network in each of the niche market where MIT products can be sold. MIT has developed, during the past several years, distribution networks in a few countries. MIT selects its distributors with the goal of building long-term relationships to ensure the success of MIT’s Needle-Free Injectors.

 

In our last year end financials (2014) we explained the benefits and the disadvantages of such a business model working with distributors. “The disadvantages are when the distributor for different reasons being political, economical or personnel could not perform as expected resulting in loss of sales and profits.”

 

During the year 2015 we have been in disadvantaged situation as some of our distributors did not perform as per our expectations, mainly because of their economic situations, resulting in low increases in our consolidated revenues of $544,816 or 28 % in comparison to fiscal year 2014 of $425,487.

 

Our Russian Distributor, who after making their first order which was paid for and shipped, had to put a hold on all scheduled sales after the Ukraine war started. As a result no product has been sold to our Russian distributor.

 

 3 

 

 

Other economic and private situations happened in other countries, South Korea and Mexico, to name few. Our Chinese partners had many delays in obtaining different certifications and price index in the province in which they had applied, resulting in loss of sales and orders to MIT Canada. This situation persisted during the entire year and impacted both revenue and cash flow throughout the year. At the same time, we have continued to focus on carefully managing our fixed operating expenses, making our 2015 year sales better than 2014.

 

We continue to believe that our marketing policy and strategy this year and in the future is to continue the search for distributors in different markets with the following criteria in place to become an MIT distributor:

 

Financial stability.
Strong management.
Strong marketing and sales team.
Understanding MIT technologies and have a medical team.
A strong technical support team.

 

We continue to believe the importance of providing adequate support to our distributors as we expand our network in order to increases sales. The Company could not establish an internal marketing representative to provide support for its distributors for financial reasons; the management and the operation director has regularly assisted our network of distributors in their marketing activities by training the distributor’s sales representatives via video-conferences, providing support for after-sales service, making regular visits, be present at certain important national and international exhibitions or presentations to potential buyers. In addition, MIT’s main priority has and always will be its customer satisfaction.

 

MIT’s marketing and sales strategies in the medium and long term are the following:

 

Conduct more trials with renowned doctors to respond to new needs in the medical community.
Hire and train qualified marketing representatives with international experiences.
Searching for new dynamic and experience distributors worldwide.

 

New products for 2016:

 

MIT experienced a delay in introducing the two new products mentioned in our Fiscal year 10K 2015:

 

1.MED-JET MIT H-4 will target all vaccination clinics, hospitals, and many other departments that have needs for single use disposable cartridge biologic injections.
2.MINI-JET for day old chick vaccination in hatcheries.
3.During the last quarter of 2015 we had the opportunity to introduce our two new products and had very good market reaction that will help us achieve our objectives for 2016.

 

The first new product MED-JET MIT H-4 will be used in different market for human vaccination and other medications in different countries including Africa, Asia and the Middle East.
The second new product MINI-JET will be introduced in different market for day old chick’s vaccination in different countries including USA, Canada, Europe, Africa, Asia and the Middle East.

 

These two new products should help the Company increase its sales with our existing distributors and new potential agent and distributors in different countries that are in negotiation for a potential agreement.

 

Publications issued in 2013:

 

Selection of Safe Parameters for Jet Injection of Botulinum Toxin in Palmar Hyperhidrosis Aesthetic Surgery Journal February 2013 33: 295-297,http://www.sagepublications.com/
THE ART OF INJECTING RE-INVENTED: THE FUTURE OF DRUG DELIVERY IS HERE NOW, Copyright © 2013 Frederick Furness Publishing Ltd, www.ondrugdelivery.com

 

Publications issued in 2014:

 

Treatment of Nail Psoriasis with Intralesional Triamcinolone Acetonide Using a Needle-Free Jet Injector: A Prospective Trial by Melissa Nantel-Battista, Vincent Richer, Isabelle Marcil, and AntranikBenohanian Canadian Dermatology Association | Journal of Cutaneous Medicine and Surgery, Vol 18, No 1 (January/February), 2014: pp 38–42

From the Department of Dermatology.St.Luc Hospital.Centre Hospitalier de l’Universite´ de Montreal (CHUM), Montreal, QC. Address reprint requests to: Melissa Nantel-Battista, MD, FRCPC. Department of Dermatology, St. Luc Hospital, CHUM, 264 Rene-Levesque, Est., Montreal, QC H2X 1P1; e-mail: melissa.nantel-battista@umontreal.ca

DOI 10.2310/7750.2013.13078

 

 4 

 

 

PART I

 

Item 1. Business

  

Medical International Technology, Inc. (“MIT” or the “Company”) was incorporated in the State of Colorado on July 19, 1999. Our wholly-owned subsidiary, Medical International Technologies (MIT Canada). Inc., a Canadian company, was acquired in June 2002 and is based in Montreal. We specialize in production, marketing and the sale of needle-free jet injector products designed for humans and animals applications, for single and mass injections. Needle-free jet injector technology and products provide advantages over traditional needle injection techniques and products, including; efficiency, handling security, biological waste elimination, and patient stress reduction.

  

The Company concentrates its activities in the medical and para-medical sectors, in particular, in the field of medical devices. Our strategy is to build a market for its different products and establish strategic alliances with different pharmaceutical companies, medical devices distributors and manufacturers to ensure good distribution channels for its products.

 

The benefits of needle-free injection compared to needle injection, in particular with respect to the features of our products, can be summarized as follows:

 

1. Less tissue damage and less painful;
2. Simple, fast and effective;
3. Precise, reliable and safe;
4. Good absorption of liquids;
5. Prevents stress from traditional needle syringes and infections from contaminated needles;
6. Friendly to the environment (no biological waste);
7. Affordable and economical; and
8. Efficient use of medication used.

 

General

 

We were incorporated in the State of Colorado on July 19, 1999.  We had three wholly-owned subsidiaries, Medical International Technologies (MIT Canada). Inc., a Canadian company acquired in June 2002, 3567940 Canada Inc., a Canadian company, acquired in June 2002 and merged with MIT Canada Inc. For the past 2 years 3567940 Canada Inc. had no activities, no assets and no liabilities. In August of 2011 3567940 Canada Inc. was dissolved.  In addition, ScanView, a Canadian company acquired in June 2007, has had no activities for the past several years.

 

China Joint Venture and other business development activities

 

On May 6, 2009, we entered into a joint venture agreement (the “Joint Venture Agreement”) with Jiangsu Hualan Biotechnology Ltd. (China) (“Jiangsu Hualan”). Pursuant to the Joint Venture Agreement, the parties established a joint venture company, Jiangsu Hualan MIT Medical Technology (MIT China) Ltd. (“MIT China”), focusing on research, production and sales of medical equipment, import and export of medical equipment and components products, especially Needle-Free Jet Injector products. 

 

The creation of MIT China in June of 2009 can give MIT a unique advantage to expand its production operations and increase its sales and profits in the worldwide needle-free injector market. Furthermore, the MIT China venture could help MIT supply large production volumes in less time, which could attract large medical and pharmaceutical partners.

 

 5 

 

 

The introduction of our Agro-Jet needle-free injector for animal application did not progress as well as believed. Our veterinary staff has successfully trained our distributors in various regions, and the distributors didn’t market the product as per our understanding. The Company has re-discussed with our distributors and we now expect that these efforts will result in sales growth in fiscal year 2015/2016.

 

During the third quarter of fiscal year 2011, MIT China purchased 151,000 sq. ft. of land and began construction of our first building in Taizhou (China Medical City). This first building of 40,000 sq. ft. when finalized will be used for the production of injectors for the Chinese market only.

 

Work in progress at MIT China for the construction of its 40,000 sq. ft. building, the first stage (the offices) has been completed, and our first move of all our employees to Taizhou was conducted in the beginning of August 2012. The other part of the construction was scheduled to be completed in the first quarter of 2013/2014 fiscal year, even though our managements and engineers where working hard to plan the purchasing of the equipment and tools necessary for the assembly and production of some of our Agro-Jet and Med-Jet products, they were not able to finalize on time. This production facility when finalized should be able to supply a large number of injectors and disposables to the Chinese market; we expect the production facility to be ready by the first quarter of 2016.

  

On November 2011 and per the discussions with our Chinese general manager, Mr. Ethan Sun, our Joint Venture partner, our plan of sales and expansion into the Chinese market is progressing and MIT China needed more money to expand its operations therefore MIT China agreed to sell and sold 9% of their joint venture for an investment of 18,000,000 RMB (US$3,000,000). This capital investment received has reduced the two original partners Jiangsu Jiabo Investment LTD percentage to 46.41% from 51% and MIT Canada to 44.59% from its 49% and Taizhou Amazon Investment Center, our new partner received 9% ownership in MIT China venture.

 

In 2012 we have supplied to CDC (Centre of Disease Control) vaccination clinic in China with one Med-Jet model MIT H-III, and requested an MIT China nurse to be present at the clinic at all times for training, supervision of the proper usage and procedures of our Med-Jet for vaccination., the results were very good and we have expected more uses of our Med-Jet H-III from many of the CDC clinics and hospitals across China in fiscal year 2013 which didn’t happen so far, because of the price index that is taking longtime to receive, we expect to have the price index issue resolved for 2016.

 

In 2012 we were proceeding positively with our Chinese SFDA for our new Med-Jet model H-4, and in 2013 we added the new product called DART that uses similar anti-contaminant single use disposable cartridge and we were expecting our certification in the second quarter of 2013/2014 fiscal year, unfortunately we couldn’t achieve our objective, it is now expected in the Second or third quarter of 2016.

 

Our Model Med-Jet H-4 will target all vaccination clinics, hospitals, all CDC Centers and many other departments that have needs for single use disposable cartridge biologic injections.

 

Also as per the Model Med-Jet H-4, the Model Med-Jet DART, was developed mainly for intra-dermal vaccination and more specifically for the Polio vaccination in collaboration with a major Chinese pharmaceutical company, the animal protocol trials took place in China during 2013 and it is now completed, we were expecting the final results and report during the second quarter of 2013/2014. If the results will be positive and in favor of MIT Canada, we will then be invited to participate in the second and final trial that will implicate human vaccine trials and will be expected to take place in China and towards the end of year 2014, thereafter we should expect a major supply agreement to be concluded with the same Chinese Pharmaceutical Company and hopefully many others. Unfortunately we didn’t receive so far the final results from the Animal study; we are still expecting the final report to be issued officially in the Second or third quarter of 2016.

  

Every year we face with new challenges, in 2015 these challenges were significant and only added to the hurdles we face in trying to achieve and realize positive results with the above business strategies we have outlined. During 2015, there were some significant distribution potential agreements, which did not materialize as expected even though there was strong interest in our products. In addition some of the countries, namely Russia, South Korea and Mexico, to name few, had very bad economical situations in their respective countries, Our Chinese partners had many delays in obtaining different certifications and price index in the province they had applied resulting in loss of sale and orders to MIT Canada, furthermore this situation persisted during the entire year impacted both revenue and cash flow throughout the year, at the same time we have continued to focus on carefully managing our fixed operating expenses

 

 6 

 

 

While revenues in 2015 were higher than in 2014, we have taken actions related to both revenue and cash management in an attempt to improve our results. Such actions has included focusing by Mr. Karim Menassa on increasing sales of our devices to our existing and active distributors and agents, giving them full support in their endeavour to sell our products. We have also opened three new Countries, Israel, Vietnam and Thailand. We are also exploring new options in regards to new possible joint ventures in marketing, sales and training centers in collaboration with distributors and doctors / nurses.

 

Our 2015 revenues and results of operations same as previous years have fluctuated and can be expected to continue to fluctuate significantly from quarter to quarter and from year to year. Various factors may affect quarterly and yearly operating results, including the following:

 

Worldwide economic situation since we are marketing and selling internationally.
The length of time to close product sales, especially with new distributors.
Customer budget cycles.
Certification time line in different markets.
Price index especially in China market.
New product introductions.
New attempt to achieve the US FDA 510K certification taking in consideration the new regulations.
Other unforeseen negative situation worldwide.

 

Needle-Free Injection

 

All liquid and non-liquid medications are currently delivered using various methods, each of which has both advantages and limitations.

 

The most commonly used drug delivery techniques include oral ingestion, intravenous, subcutaneous, intradermal, and intramuscular injection, inhalation and transdermal “patch «diffusion. Many drugs are effective only when injected.

 

Injections using traditional needle-syringes suffer from many shortcomings, including:

 

The risk of needle sticks injuries.
The risk of penetrating a patient's vein.
The patient’s fear of needles and discomfort.
The contaminated needle.
Stress from needle syringe injections.
Infection from contaminated needles.
Biological waste in the environment.
Transmit deadly blood-borne pathogens including such viruses as HIV and Hepatitis B.

 

During the last decade a growing awareness of the danger of blood-borne pathogen transmission, needle safety has become a big concern in hospitals, clinics within the healthcare professionals and their patients. As a result, pressure on the healthcare industry to eliminate the risk of contaminated needle stick injuries has increased, and the U.S. Occupational Safety and Health Administration (“OSHA”) issued regulations, effective in 1992, which require healthcare institutions to treat all blood and other body fluids as infectious. These regulations were changed by Congress with passage of the Needle stick Safety Prevention Act, which was effective in 2001. These regulations require implementing “engineering and work practice controls” to “isolate or remove blood-borne pathogen hazards from the workplace.” Among the required controls are special handling and disposal of contaminated “sharps” in biohazard “sharps” containers, safer medical devices, including needle-free systems, and follow-up testing for victims of needle stick injuries. To date, more than 30 states and the U.S. Occupational Safety and Health Administration have adopted, or have pending, legislation or regulations that require health care providers to utilize systems designed to reduce the risk of needle stick injuries.

  

According to the International Sharps Injury Prevention Society (http://www.isips.org), it has been estimated that one out of every seven workers is accidentally struck by a contaminated sharp point each and every year. The Center for Disease Control (CDC: http://www.cdc.gov/niosh/2000-108.html#5) estimates that there are 600,000 to 800,000 needle stick injuries per year in the U.S. alone, and many are not reported. More than 20 types of infectious agents have been transmitted through needle sticks, including hepatitis B and C, tuberculosis, syphilis, malaria, herpes, diphtheria, gonorrhea, typhus and Rocky Mountain spotted fever. The MED-JET will eliminate this risk to health care professionals and create a safer workplace. Other advantages include its light weight (0.5 kg) and an excellent medication absorption rate. Additionally, the system has the ability to increase or decrease the volume and pressure of injection. This technology is unique to MIT’s MED-JET MBX Injector. The system is designed to inject up to 600 individuals an hour.

 

 7 

 

 

The costs resulting from needle stick injuries vary widely. Accidental needle sticks involving sterile needles involve relatively little cost. Needle sticks with contaminated needles require investigation and follow-up. These are much more expensive. Investigation typically includes identifying the source of contamination, testing the source for blood-borne pathogens and repeatedly testing the needle stick victim for infection over an extended period. Some healthcare providers are requiring additional measures, including treating all needle stick injuries as contaminated unless proven otherwise. The most important problem that most needle stick victim will have is the stress during all these extended period not knowing what will happen to them day in day out and that sometime could be over a six month period for them and their families and friends waiting for each and every test result until the end of the process and sometime beyond.

 

Some effort has been done to protect healthcare workers from needle stick injuries, many healthcare facilities worldwide are trying to adopt more expensive alternative technologies, these technologies can help reduce accidental needle sticks, but they can’t eliminate the risk, unless they use needle-free technologies.

 

Medical International Technology Inc., objective is to ensure that our injectors become an indispensable and environmentally friendly product for doctors, dentists, nurses, veterinarians, farmers and home users around the world.

 

MIT is pleased to continue providing a safe and effective means to help prevent the spread of deadly diseases to both humans and animals through the use of the Med-Jet®, Agro-Jet® and Avian-Jet needle-free injection systems.

 

Description of our Products

 

Focusing on existing salable product line:

 

Human applications:

 

MED-JET Model MIT-MBX.(Medical, Cosmetic dermatology and Mesotherapy applications)
MED-JET Model MIT-H-III.(Medical,Cosmetic dermatology and Mesotherapy applications)
MED-JET Model MIT-MESO-JET. (Medical, Cosmetic dermatology and Mesotherapy applications)
MED-JET Model MIT-H4. (Single and Mass vaccination, uses auto-disabling single shot disposable cartridge to eliminate the possibility of both pre-injection contamination and post-injection cross-contamination

 

Animal applications:

 

AGRO-JET Model MIT-II (Small farm animal vaccination)
AGRO-JET Model MIT-III (Up to 50Kg animal vaccination)
AGRO-JET Model MIT-V(Pets clinic use vaccination)
AGRO-JET Model MIT-5D(Pets clinic use vaccination, uses auto-disabling single shot disposable cartridge to eliminate the possibility of both pre-injection contamination and post-injection cross-contamination
AGRO-JET Model MIT-VI(live stock vaccination)
AGRO-JET Model MIT-X(live stock vaccination)
AGRO-JET Model MIT-NBM (Small farm animal vaccination)
AVIAN-JET(Poultry vaccination)
MINI-JET (day old chick vaccination)

  

Medical International Technology Inc. will focus its Marketing and sales on the salable products line in the Human and Animal applications to their existing Distributors and Agents. The only new product that will be introduced in 2015/2016 will be the MED-JET H4 and the MINI-JET for day old chick vaccination.

 

MIT’s patented technology has received approval in several countries worldwide. The Company expects that the new products will be no exception.

 

 8 

 

 

The Company will do a new attempt in 2016 to achieve the US FDA 510K certification taking in consideration the new regulations. 

 

In the coming two fiscal years 2016 and 2017, MIT intent is to focus primarily on the marketing and sales of its existing products and the two new products namely MED-JET H4 for humans and the MINI-JET for day old chicks.

 

Market Breakdown

 

Human applications:

 

In the next fiscal year 2016, the Company plans to expand its market for cosmetic dermatology, plastic surgery, and general practitioner for single and mass injections.  It will do so through the use of the Med-Jet models MIT MBX, the MESO-JET and MIT-H-III. The Company will also introduce to few specific markets the new MED-JET H4 for single vaccine and other biologic injections.

 

Animal applications:

 

In the next fiscal year 2016, the Company plans to Market and sell its existing AGRO-JET line of products and its new MINI-JET for day old chick vaccination.

  

Patents and Trademarks

 

We have obtained trademark registration in the United States on the use of AGRO-JET (Reg. No. 2,712,089) and MED-JET (Reg. No. 2,798,613).

 

We have obtained trademark registration in Canada on the use of AGRO-JET (Reg. No. TMA 624,735) and MED-JET (Reg. No.TMA 624,737), and MESO-JET (Reg. No.TMA 885,180).

 

We have applied for a PCT Patent application in Europe, China, Taiwan, Japan, USA, and Canada for new patents.

 

Regulation and Approvals

 

We manufacture and sell products that may require various approvals by government agencies in the locals in which they are used. These regulations or approvals vary greatly depending upon the way our products are used. We may not have the required approvals for various applications of our products in those localities. We continue to seek approvals for various applications of our products but the costs associated with achieving such approvals may exceed our available resources or be commercially impracticable.

 

We have received full certification for our Quality Management System granted under the International Organization for Standardization's ISO: 9001:2000. This includes Certification for the “Canadian Medical Device Conformity Assessment System” (CMDCAS), for devices to be licensed by Health Canada. The company plans to aggressively market the MED-JET for human use for mass-inoculation. The company feels that Canada and other world markets can benefit greatly from the MED-JET. By using the MED-JET, health officials have an alternative delivery method that is safer and faster than the traditional needle. These certifications allow us to market the Med-Jet Needle-Free injector for human use in all countries other than the United States, at this point. The Med-Jet injector will be re submitted for FDA approval, which, if accepted, will allow us to sell the Med-Jet in the United States, making it a truly worldwide system.  The approval process for the U.S. FDA is expensive and may take an extended period of time. We will target for 2016 the actual MED-JET products to receive approval from the FDA.

 

In September 2014 we have initiated our Health Canada Certification for our Model Med-Jet H-4 that will target all vaccination clinics, hospitals in many Countries; the Med-Jet H-4 can also be used in many other departments that have needs for biologic single injections.

  

Product Development

 

Per our previous fillings for FDA approval for our needle-free injector, the MED-JET is designed specifically for human mass inoculations. The MED-JET is capable of delivering many types of medications such as vaccines, insulin and other types of injectables. Its low-pressure technology offers an advantage to alternative high pressure systems that can cause blowbacks and expose medical workers and patients alike to microscopic traces of blood.

 

 9 

 

 

According to the International Sharps Injury Prevention Society (http://www.isips.org), it has been estimated that one out of every seven workers is accidentally struck by a contaminated sharp point each and every year. The Center for Disease Control (CDC: http://www.cdc.gov/niosh/2000-108.html#5) estimates that there are 600,000 to 800,000 needle stick injuries per year in the U.S. alone, and many are not reported. More than 20 types of infectious agents have been transmitted through needle sticks, including hepatitis B and C, tuberculosis, syphilis, malaria, herpes, diphtheria, gonorrhea, typhus and Rocky Mountain spotted fever. The MED-JET will eliminate this risk to health care professionals and create a safer workplace. Other advantages include its light weight (0.5 kg) and an excellent medication absorption rate. Additionally, the system has the ability to increase or decrease the volume and pressure of injection. This technology is unique to MIT’s MED-JET MBX Injector. The system is designed to inject up to 600 individuals an hour.

 

The approval process can be expensive and may take an extended period of time. There can be no assurance that this system will receive approval from the FDA or if approved gain broad acceptance by the medical community or individual patients.

 

During the last quarter of 2011 we signed with an outside consultant to help MIT with the FDA approval process and to expedite the approval.  This work has been stopped temporarily and will restart during fiscal year 2016/2017. 

 

On December 15, 2005, we received full certification granted under the International Organization for Standardization, as well as the Canadian Medical Device Conformity Assessment System for devices to be licensed by HEALTH CANADA. These certifications allow MIT to currently market the Med-Jet Needle-Free Injector for human use in many countries other than the U.S. The Med-Jet injector has been submitted for FDA approval which, if accepted, will allow MIT to sell the Med-Jet and Meso-Jet in the United States, making it a truly worldwide system.

 

MIT's Needle-Free Injection System, designed specifically to allow fast, accurate and safe injections, is rapidly moving toward establishing itself as a valuable instrument in the fight against disease in both humans and animals. Spurred on by growing fears of a worldwide epidemic that could match or even exceed the deadly flu pandemic of 1918 which killed millions of people, the MIT team is focusing its efforts to make its Needle-Free Injection System available to the world.

 

Now that MIT is able to sell its Med-Jet in many countries other than the U.S., it will restart during fiscal year 2016/2017 The first of these will be for use of the Med-Jet for injecting anesthesia in a variety of situations. The second, and most significant in light of the news coming out of Asia concerning the spread of Influenza A (H1N1) to humans, will be the Med-Jet-H III and H-4, for mass vaccination in case of a pandemic, such as Avian Influenza, Polio, Tuberculosis, Malaria, HIV and the new Ebola virus outbreak.

 

MIT will increasingly promote its Agro-Jet and Avian-Jet needle-free injector designed specifically for poultry vaccination. Having the same benefits as Med-Jet, Agro-Jet and Avian-Jet will become a valuable instrument in the fight against Avian Flu via its ability to mass inoculate animals at over 1000 injections per hour.

 

Marketing and Competition

 

The traditional needle-syringe is currently the primary method for administering intradermal, subcutaneous and intramuscular injections.

 

For the past 30 years, many inventors attempted to develop portable needle-free multiple shots injection for diabetic insulin injections market, during the past 22 years inventors have developed single shot needle-free jet injection devices, in the two cases most of them have developed high pressure injectors without taking in consideration many of the following points:

 

1. Pressure power and control
2. Pressure control for different sites and skin
3. Control of penetration depth
4. Control and adjustment of injected volume
5. User friendly mechanism to adjust pressure and volume
6. Cost performance for manufacturing and reliability
7. User friendly cleaning and sterilization
8. Ergonomic design

 

 10 

 

 

During the past 10 to 15 years many needle-free products has been developed and sold mainly for diabetic markets, some of these spring loaded devices are making some inroad into the market place in many countries, these products could help create people awareness towards needle-free technology as another possible non-invasive and less painful environmentally friendly than the standard hypodermic needle/syringe, the fact that other needle-free products come on the market will also increase competition and some of the niche market that MIT is also targeting.

 

We can also see competition from various versions of new “safety syringe” that have been designed and marketed in different versions to have a certain plastic guard surrounding the needle that can retracted or removed in order to give an injection, the safety guard is designed to reduce or eliminate needle stick injuries while the safety syringe is in use and before the needle has been covered, the safety syringe still poses a big risk of injury to the users. Other type of safety syringes require manipulation after injection and pose a bigger risk of needle stick injury during manipulation.

 

We believe that our primary competition is the traditional, disposable needle-syringe and the safety syringe. Leading suppliers of needle-syringes and safety syringes include: Becton-Dickinson & Co., Sherwood Medical Co., a subsidiary of Tyco International, and Terumo Corp. of Japan and the new Chinese manufacturer. Usually needle-syringes manufacturers compete primarily on price, which generally ranges from approximately $0.15 to $0.45 per unit, manufacturers of safety syringes compete on price, features and quality, they are generally priced in a range of $0.45 to $1.45 per unit for volume sales.

 

Employees

 

Currently, the company has three employees and four consultants. As our operations are expanded additional employees and consultants will be required.

 

Item 1A. Risk Factors

 

The following risk factors should be considered in the evaluation of our business. Our business financial condition and results of operations could be materially adversely affected by any of these risks. Please note that additional risks not presently known to us or that we currently deem immaterial may also impair our business and operations.

 

We need to increase sales.
We need to raise Capital in 2016 to continue operations.
Sufficient Capital may not be available.
If available, may be subject to important conditions.
The unavailability of Capital could adversely affect our business and cause us to cease operations.

 

We continue to monitor our operation and cash flow daily as we have always done, we can also take drastic measures to reduce our expenditure rate. However, if we do not increase our sales, enter into one or more Agent, Distribution agreements increase sales, we may need to do one or more of the following to provide additional resources during 2016:

 

Secure additional debt financing.
Secure additional equity financing.
Secure a strategic partner.

 

Our common stock is listed on the Over-the-Counter Bulletin Board, which may impair the price at which our common stock trades, and the liquidity of the market for our common stock and our ability to obtain additional funding. The Over-the-Counter Bulletin Board is an electronic quotation service maintained by the Financial Industry Regulatory Authority. Our stock, like most stock listed on this service, has very limited trading volume. As a consequence, the ability of a stockholder to sell our common stock, the price obtainable for our common stock and our ability to obtain additional funding may be materially impaired.

  

Item 1B.  Unresolved Staff Comments

 

We are not required to provide this information as we are a smaller reporting company.

 

 11 

 

 

Item 2. Properties

 

The Company leases its office and warehouse space under an operating lease that expires on December 31, 2015.  The company has signed for six more years until December 31, 2021.  The lease calls for a monthly rent of $4,248 (CND). Rent expense for the years ended September 30, 2015 and 2014 was approximately $43,200 and $47,600, respectively.

 

Item 3. Legal Proceedings

 

We are currently not involved in any litigation that we believe could have a material adverse effect on our financial condition or results of operations. There is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of our company or any of our subsidiaries, threatened against or affecting our company, our common stock, any of our subsidiaries or of our companies or our subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

PART II

 

Item 5. Market for Common Equity and Related Stockholder Matters

 

Market Information

Our common stock is currently listed on the OTCBB under the symbol “MDLH.” As of September 30, 2015, 84,304,627 shares of our common stock were issued and outstanding.

 

Of the 84,304,627 shares of our common stock issued and outstanding, 68,964,408 of such shares are restricted shares. None of these restricted shares are eligible for resale absent registration or an exemption from registration.

 

Price Range of Common Stock

 

The following table sets forth the high and low trade information for our common stock for each quarter for the previous two years. The prices reflect inter-dealer quotations, do not include retail mark-ups, markdowns or commissions and do not necessarily reflect actual transactions.

 

   High   Low 
Fiscal Year 2014        
First quarter ended December 31, 2013  $.05   $.02 
Second quarter ended March 31, 2014  $.17   $02 
Third quarter ended June 30, 2014  $.05   $.02 
Fourth quarter ended September 30, 2014  $.03   $.02 
           
Fiscal Year 2015          
First quarter ended December 31, 2014  $.05   $.01 
Second quarter ended March 31, 2015  $.02   $.01 
Third quarter ended June 30, 2015  $.01   $.01 
Fourth quarter ended September 30, 2015  $.01   $.01 

 

Holders

 

As of the date of this Report there were approximately 93 holders of record of our common stock. This number does not include shares held by brokerage clearing houses, depositories or others in unregistered form.

 

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Dividend Policy

 

We have not paid a cash dividend on its common stock in the past 12 months. The company does not anticipate paying any cash dividends on its common stock in the next 12-month period.  Management anticipates that earnings, if any, will be retained to fund the company's working capital needs and the expansion of its business.  The payment of any dividends is at the discretion of the Board of Directors.

 

Securities Authorized for Issuance under Equity Compensation Plans

 

The following table sets forth certain information as of the date hereof, with respect to compensation plans under which our equity securities are authorized for issuance:

 

   (a)  (b)  (c)
   Number of securities
to be issued upon
exercise of
outstanding options,
warrants and rights
  Weighted-average
exercise price
of outstanding
options,
warrants and rights
  Number of securities remaining
available for future issuance
under equity compensation plans
(excluding securities
reflected in column (a))
          
Equity compensation  None   
Plans approved by         
Security holders         
          
Equity compensation  None      
Plans not approved         
By security holders         
Total         

 

Item 6. Selected Financial Data

 

We are not required to provide the information required by this Item because we are a smaller reporting company.

 

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations

 

CAUTIONARY STATEMENT RELATED TO FORWARD LOOKING STATEMENTS

 

This Annual Report on Form 10-K (this “Report”) contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act, and Section 21E of the Exchange Act. Forward-looking statements discuss matters that are not historical facts. Because they discuss future events or conditions, forward-looking statements may include words such as “anticipate,” “believe,” “estimate,” “intend,” “could,” “should,” “would,” “may,” “seek,” “plan,” “might,” “will,” “expect,” “predict,” “project,” “forecast,” “potential,” “continue” negatives thereof or similar expressions. These forward-looking statements are found at various places throughout this Report and include information concerning possible or assumed future results of our operations; business strategies; future cash flows; financing plans; plans and objectives of management; any other statements regarding future operations, future cash needs, business plans and future financial results, and any other statements that are not historical facts.

 

From time to time, forward-looking statements also are included in our other periodic reports on Forms 10-Q and 8-K, in our press releases, in our presentations, on our website and in other materials released to the public.  Any or all of the forward-looking statements included in this Report and in any other reports or public statements made by us are not guarantees of future performance and may turn out to be inaccurate. These forward-looking statements represent our intentions, plans, expectations, assumptions and beliefs about future events and are subject to risks, uncertainties and other factors.  Many of those factors are outside of our control and could cause actual results to differ materially from the results expressed or implied by those forward-looking statements. In light of these risks, uncertainties and assumptions, the events described in the forward-looking statements might not occur or might occur to a different extent or at a different time than we have described. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this Report. All subsequent written and oral forward-looking statements concerning other matters addressed in this Report and attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this Report.

  

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Except to the extent required by law, we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, a change in events, conditions, circumstances or assumptions underlying such statements, or otherwise.

 

The following discussion should be read in conjunction with the Consolidated Financial Statements and Notes thereto appearing elsewhere in this Form 10-K. The following discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 relating to future events or our future performance. Actual results may materially differ from those projected in the forward-looking statements as a result of certain risks and uncertainties set forth in this prospectus. Although management believes that the assumptions made and expectations reflected in the forward-looking statements are reasonable, there is no assurance that the underlying assumptions will, in fact, prove to be correct or that actual results will not be different from expectations expressed in this report.

 

Overview

 

Medical International Technology, Inc. (“MIT” or the “Company”) was incorporated in the State of Colorado on July 19, 1999.Our wholly-owned subsidiary, Medical International Technologies (MIT Canada). Inc., a Canadian company was acquired in June 2002 and is based in Montreal. We specialize in production, marketing and the sale of needle-free jet injector products designed for humans and animals applications, for single and mass injections. Needle-free jet injector technology and products provide advantages over traditional needle injection techniques and products, including; efficiency, handling security, biological waste elimination, and patient stress reduction.

  

The Company concentrates its activities in the medical and Para-medical sectors, in particular, in the field of medical devices. Our strategy is to build a market for its different products and establish strategic alliances with different pharmaceutical companies, medical devices distributors and manufacturers to ensure good distribution channels for its products.

 

The benefits of needle-free injection compared to needle injection, in particular with respect to the features of our products, can be summarized as follows:

 

1. Less tissue damage and less painful;
2. Simple, fast and effective;
3. Precise, reliable and safe;
4. Good absorption of liquids;
5. Prevents stress from traditional needle syringes and infections from contaminated needles;
6. Friendly to the environment (no biological waste);
7. Affordable and economical; and
8. Efficient use of medication used.

 

The Company’s major source of revenues is from sales of its Needle-Free products for Human and Animal application. The Company has maintained operations from these revenues and through equity and debt financing. The company has been dependent on advances from related parties to maintain operations. There are no agreements, assurances or commitments to continue providing these advances. Products are currently produced, assembled and shipped from our facility. Component manufacturing is subcontracted to various suppliers and machine shops.

  

MIT’slong-term goal is to become one of the leading suppliers of needle-free injection systems to the health industry worldwide. We have been focusing our business development efforts on new and existing companies to distribute our unique needle-free products in human and animal applications in the international market. We have collaborated and are still collaborating with different pharmaceutical corporations in China and other countries that could lead to long-term agreements. We are actively pursuing additional opportunities in the global market. However, finalizing long term agreements is a long process that could take even longer to negotiate given the current difficult global economic conditions.

 

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On May 6, 2009, we entered into a joint venture agreement (the “Joint Venture Agreement”) with Jiangsu Hualan Biotechnology Ltd. (China) (“Jiangsu Hualan”). Pursuant to the Joint Venture Agreement, the parties established a joint venture company, Jiangsu Hualan MIT Medical Technology (MIT China) Ltd. (“MIT China”), focusing on research, production and sales of medical equipment, import and export of medical equipment and components products, especially Needle-Free Jet Injector products.

 

The creation of MIT China in June of 2009 can give MIT a unique advantage to expand its production operations and increase its sales and profits in the worldwide needle-free injector market. Furthermore, MIT China venture could help MIT supply large production volumes in less time, which could attract large medical and pharmaceutical partners.

 

The introduction of our Agro-Jet needle-free injector for animal application did not progress as well as believed. Our veterinary staff has successfully trained our distributors in various regions, and the distributors didn’t market the product as per our understanding. The Company has re-discussed with our distributors and we now expect that these efforts will result in sales growth in fiscal year 2015/2016.

 

During the third quarter of fiscal year 2011, MIT China purchased 151,000 sq. ft. of land and began construction of our first building in Taizhou (China Medical City). This first building of 40,000 sq. ft. when finalized will be used for the production of injectors for the Chinese market only.

 

Work in progress at MIT China for the construction of its 40,000 sq. ft. building, the first stage (the offices) has been completed, and our first move of all our employees to Taizhou was conducted in the beginning of August 2012. The other part of the construction was scheduled to be completed in the first quarter of 2013/2014 fiscal year, even though our managements and engineers where working hard to plan the purchasing of the equipment and tools necessary for the assembly and production of some of our Agro-Jet and Med-Jet products, they were not able to finalize on time. This production facility when finalized should be able to supply a large number of injectors and disposables to the Chinese market; we expect the production facility to be ready by the first quarter of 2016.

  

On November 2011 and per the discussions with our Chinese general manager, Mr. Ethan Sun, our Joint Venture partner, our plan of sales and expansion into the Chinese market is progressing and MIT China needed more money to expand its operations therefore MIT China agreed to sell and sold 9% of their joint venture for an investment of 18,000,000 RMB (US$3,000,000). This capital investment received has reduced the two original partners Jiangsu Jiabo Investment LTD percentage to 46.41% from 51% and MIT Canada to 44.59% from its 49% and Taizhou Amazon Investment Center, our new partner received 9% ownership in MIT China venture.

 

In 2012 we have supplied to CDC (Centre of Disease Control) vaccination clinic in China with one Med-Jet model MIT H-III, and requested an MIT China nurse to be present at the clinic at all times for training, supervision of the proper usage and procedures of our Med-Jet for vaccination., the results were very good and we have expected more uses of our Med-Jet H-III from many of the CDC clinics and hospitals across China in fiscal year 2013 which didn’t happen so far, because of the price index that is taking longtime to receive, we expect to have the price index issue resolved for 2016.

 

In 2012 we were proceeding positively with our Chinese SFDA for our new Med-Jet model H-4, and in 2013 we added the new product called DART that uses similar anti-contaminant single use disposable cartridge and we were expecting our certification in the second quarter of 2013/2014 fiscal year, unfortunately we couldn’t achieve our objective, it is now expected in the Second or third quarter of 2016.

 

Our Model Med-Jet H-4 will target all vaccination clinics, hospitals, all CDC Centers and many other departments that have needs for single use disposable cartridge biologic injections.

  

Also as per the Model Med-Jet H-4, the Model Med-Jet DART, was developed mainly for intra-dermal vaccination and more specifically for the Polio vaccination in collaboration with a major Chinese pharmaceutical company, the animal protocol trials took place in China during 2013 and it is now completed, we were expecting the final results and report during the second quarter of 2013/2014. If the results will be positive and in favor of MIT Canada, we will then be invited to participate in the second and final trial that will implicate human vaccine trials and will be expected to take place in China and towards the end of year 2014, thereafter we should expect a major supply agreement to be concluded with the same Chinese Pharmaceutical Company and hopefully many others. Unfortunately we didn’t receive so far the final results from the Animal study; we are still expecting the final report to be issued officially in the Second or third quarter of 2016.

 

 15 

 

 

Every year we face with new challenges, in 2015 these challenges were significant and only added to the hurdles we face in trying to achieve and realize positive results with the above business strategies we have outlined. During 2015, there were some significant distribution potential agreements, which did not materialize as expected even though there was strong interest in our products. In addition some of the countries, namely Russia, South Korea and Mexico, to name few, had very bad economical situations in their respective countries, Our Chinese partners had many delays in obtaining different certifications and price index in the province they had applied resulting in loss of sale and orders to MIT Canada, furthermore this situation persisted during the entire year impacted both revenue and cash flow throughout the year, at the same time we have continued to focus on carefully managing our fixed operating expenses

 

While revenues in 2015 were higher than in 2014, we have taken actions related to both revenue and cash management in an attempt to improve our results. Such actions has included focusing by Mr. Karim Menassa on increasing sales of our devices to our existing and active distributors and agents, giving them full support in their endeavour to sell our products. We have also opened three new Countries, Israel, Vietnam and Thailand. We are also exploring new options in regards to new possible joint ventures in marketing, sales and training centers in collaboration with distributors and doctors / nurses.

 

Our 2015 revenues and results of operations same as previous years have fluctuated and can be expected to continue to fluctuate significantly from quarter to quarter and from year to year. Various factors may affect quarterly and yearly operating results, including the following:

 

Worldwide economic situation since we are Marketing and selling internationally.
The length of time to close product sales, especially with new Distributors.
Customer budget cycles.
Certification time line in different markets.
Price index especially in China market.
New product introductions.
New attempt to achieve the US FDA 510K certification taking in consideration the new regulations.
Other unforeseen negative situation worldwide.

 

Medical International Technology Inc.’s, objective is to ensure that our injectors become an indispensable and environmentally friendly product for doctors, dentists, nurses, veterinarians, farmers and home users around the world.

 

The Company is pleased to continue providing a safe and effective means to help prevent the spread of deadly diseases to both humans and animals through the use of the Med-Jet®, Agro-Jet® and Avian-Jet needle-free injection systems.

 

Management Plan of Operations

 

Medical International Technology's intends to concentrate its activities in the medical and veterinary sectors, in particular, in the field of equipment and instrumentation. The company's strategy is to build good, reliable and cost effective products, seek and establish strategic alliances with different pharmaceutical companies and manufacturers to ensure good distribution channels for its products.

 

MIT promotes and sells products in over 30 countries including the United States of America. MIT is exerting every effort and using its resources to promote its products and to open markets for its technology. As we continue to market our products, we hope to gain broader acceptance of the needle-free injection technology. MIT is continually researching and developing its products to the market needs.

 

We will continue to seek additional funding to expand operations and develop sales revenue to a volume sufficient to sustain operations and increase shareholders value.

  

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Results of Operations

 

Comparison for the year ended September 30, 2015 to the year ended September 30, 2014

 

The following table presents the statement of operations for the year ended September 30, 2015 as compared to the year ended September 30, 2014. The discussion following the table is based on these results.

 

   Years Ended September 30, 
   2015   2014 
         
Revenues  $544,816   $425,487 
Cost of sales   292,809    88,439 
Gross profit   252,007    337,048 
           
Operating expenses          
           
Selling, general and administrative expenses   294,644    405,275 
Total operating expenses   294,644    405,275 
Operating income (loss)   (42,637)   (68,227)
           
Other:          
Interest expense   (18,450)   (11,737)
Total other income (expense)   (18,450)   (11,737)
           
Net income (loss)  $(61,087)  $(79,964)

 

Revenues

 

The Company’s consolidated revenues increased by $119,329 or 28% to $544,816during the fiscal year ending September 30, 2015. This low growing of revenues was primarily due to the market situation in general.

 

Our Russian distributor started the year purchasing their first order. The order was paid for and shipped. Thereafter, the Ukraine war started and the distributor had to put a hold on all scheduled sales pending the situation. No other product has been sold to our Russian distributor.

 

Other economic and private situations happened in other countries. South Korea and Mexico, to name few, had very bad economic situations in their respective countries. Our Chinese partners had many delays in obtaining different certifications and price index in the province they had applied resulting in loss of sale and orders to MIT Canada, furthermore this situation persisted during the entire year impacting both revenue and cash flow throughout the year. At the same time, we have continued to focus on carefully managing our fixed operating expenses making our 2015 year sales very difficult and stressful.

 

We continue to believe that our marketing policy and strategy this year and in the future is to continue the search for distributors in different markets with the following criteria in place to become an MIT distributor:

 

Financial stability.
Strong management.
Strong marketing and sales team.
Understanding MIT technologies and have a medical team.
A strong technical support team.

  

We continue to believe the importance of providing adequate support to our distributors as we expand our network in order to increases sales. The Company could not establish an internal marketing representative to provide support for its distributors for financial reasons; the Management and the Operation Director has regularly assist our network of distributors in their marketing activities by training the distributor’s sales representatives via video-conferences, providing support for after-sales service, making regular visits, be present at certain important national and international exhibitions or presentations to potential buyers. In addition, MIT’s main priority has and always will be its customer satisfaction.

 

 17 

 

 

MIT’s marketing and Sales strategies in the medium and long term are the following:

 

Conduct more trials with renowned doctors to respond to new needs in the medical community.
Hire and train qualified marketing representatives with international experiences.
Searching for new dynamic and experience Distributors worldwide.

 

Cost of Sales

 

The cost of sales increased by $204,370 in 2015. This increase was directly related to our increase sales in 2015, and our ability to monitor our operation and cash flow daily as we have always done.

 

Gross Profit

 

The gross profit decreased by 25% for the year ending September 30, 2015. This decrease is due primarily as some of our distributors did not perform as per our expectations, mainly because of their economic situations, resulting in a low increase of sales in our consolidated revenues of $544,816 or 28 % in comparison to the year end 2014 of $425,487.

 

Our Russian distributor who has started the year purchasing the first order, the order was paid for and shipped, thereafter the Ukraine war started and the distributor had to put a hold on all scheduled sales pending the situations far not a single product has been sold to our Russian distributor.

 

Other economic and private situations happened in other countries. South Korea and Mexico, to name few, had very bad economic situations in their respective countries. Our Chinese partners had many delays in obtaining different certifications and price index in the province they had applied resulting in loss of sale and orders to MIT Canada, furthermore this situation persisted during the entire year impacting both revenue and cash flow throughout the year. At the same time, we have continued to focus on carefully managing our fixed operating expenses making our 2015 year sales very difficult and stressful.

 

Operating Expenses

 

We have managed to reduce our cost in our operations in general and were directly related to our reduced sales in 2015, and our ability to monitor our operation and cash flow daily including; selling, general and administrative expenses and the results was a decrease by $110,631 to $294,644 during the fiscal year ended September 30, 2015.

 

Liquidity and Capital Resources

 

During the fiscal year ending September 30, 2015 the Company’s cash position decreased by $33,767. Net cash provided by operating activities was $61,710, resulting primarily from inventories.  Net cash used in financing activities was $47,938, resulting primarily from repayment of bank loans of $51,225.  Net cash used by investing activities was $32,975 resulting primarily from the acquisition of patents.  The effect of exchange rates on cash during fiscal 2015 resulted in decrease in cash value of $14,564.

 

During the fiscal year ending September 30, 2014 the Company’s cash position increased by $32,747. Net cash provided by operating activities was $63,978, resulting primarily from accounts receivables.  Net cash provided by financing activities was $32,148, resulting primarily from repayment of bank loans of $56,028 and the increase of amounts due at related parties of $80,000.  Net cash used by investing activities was $26,774 resulting primarily from the acquisition of patents.  The effect of exchange rates on cash during fiscal 2014 resulted in decrease in cash value of $36,605.

  

The Company has reported accumulated losses since inception of $12,330,450, which raises substantial doubt about the Company’s ability to continue as a going concern. The continuation of the Company is dependent upon the continuing financial support of creditors and stockholders and upon obtaining the capital requirements for the continuing operations of the Company. Management believes actions planned and presently being taken provides the opportunity for the Company to continue as a going concern.

 

 18 

 

 

During the year ended September 30, 2015, 500,000 shares of common stock were issued for the settlement of a $50,000 advance from a related party.

 

The Company expects that revenues from existing and developing sales may not meet its liquidity requirements for the next 12-month period at its current level of operations. The company has been dependent on advances from related parties to maintain operations. There are no agreements, assurances or commitments to continue providing these advances. The company continues to rely on management to develop the business and work to develop sales. Management has and may continue to supplement cash flows from sales with additional equity and debt financing. Substantially, expanded operations are expected to require additional capital, either from a future offering of equity or the company pursuing other methods of financing, as appropriate.

 

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements, financings, or other relationships with unconsolidated entities or other persons, also known as “special purpose entities” (SPEs).

 

Critical Accounting Policies

 

The accompanying discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses, and related disclosure of contingent assets and liabilities. These estimates form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We base our estimates and judgments on historical experience and all available information. However, future events are subject to change, and the best estimates and judgments routinely require adjustment. US GAAP requires us to make estimates and judgments in several areas, including those related to recording various accruals, income taxes, the useful lives of long-lived assets, such as property and equipment and intangible assets, and potential losses from contingencies and litigation. We believe the policies discussed below are the most critical to our financial statements because they are affected significantly by management’s judgments, assumptions and estimates.

 

Foreign Currency Translations

 

The Company operates out of its offices in Montreal, Canada and maintains its books and records in Canadian Dollars. The financial statements herein have been converted into U.S. Dollars. Balance sheet accounts have been translated at exchange rates in effect at the end of the year.   Income statement accounts have been translated at average exchange rates for the year. Translation gains and losses are included as a separate component of stockholders’ equity.

 

New Accounting Pronouncements

 

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in ASC 605, Revenue Recognition. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, the FASB issued ASU No. 2015-14, Deferral of the Effective Date, which amends ASU No. 2014-09. As a result, the effective date will be the first quarter of fiscal year 2019 with early adoption permitted in the first quarter of fiscal year 2018. The adoption will use one of two retrospective application methods. The company has not determined the potential effects on the consolidated financial statements.

 

On February 18, 2015, the FASB and the International Accounting Standards Board issued a final standard that amends the current consolidation guidance. The standard amends both the variable interest entity and voting interest entity consolidation models. The standard is effective for public reporting entities in fiscal periods beginning after December 15, 2015, and early adoption is permitted. The Company is evaluating the impact, if any, of adopting this new accounting guidance on the consolidated financial statements.

 

Item 7A. Quantitative and Qualitative Disclosures about Market Risk

 

We are not required to provide the information required by this Item because we are a smaller reporting company.

 

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Item 8. Financial Statements and Supplementary Data

 

Medical International Technology, Inc.

Financial Statements

Contents

    Page
Report of Independent Registered Public Accounting Firm   21
Financial Statements    
Consolidated Balance Sheets   22
Consolidated Statements of Operations   23
Consolidated Statements of Comprehensive Income (Loss)   24
Consolidated Statement of Stockholders’ Equity   25
Consolidated Statements of Cash Flows   26
Notes to Consolidated Financial Statements   27

 

 20 

 

 

Report of Independent Registered Public Accounting Firm

 

To The Board of Directors and Stockholders of

Medical International Technology, Inc.

 

We have audited the accompanying consolidated balance sheets of Medical International Technology, Inc. and subsidiaries as of September 30, 2015 and 2014, and the related consolidated statements of operations, comprehensive income (loss), stockholders’ equity and cash flows for the years then ended. These consolidated 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 audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company has determined that it is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the 2015 consolidated financial statements referred to above present fairly, in all material respects, the financial position of Medical International Technology, Inc. and subsidiaries as of September 30, 2015 and 2014, and the results of its operations and its cash flows for the years then ended in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has suffered recurring losses from operations. Those conditions raise substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/ LBB & Associates Ltd., LLP

LBB & Associates Ltd., LLP 

February 18, 2016

 

 21 

 

 

 MEDICAL INTERNATIONAL TECHNOLOGY, INC.

CONSOLIDATED BALANCE SHEETS

 

   September 30, 
   2015   2014 
         
Assets        
Current assets    
Cash and cash equivalents  $-   $33,767 
Accounts receivable, net   57,031    1,461 
Inventories   210,579    326,348 
Prepaid expenses   7,183    4,965 
Total current assets   274,793    366,541 
Property and Equipment          
Tooling and machinery   558,706    654,976 
Furniture and office equipment   128,163    153,157 
Leasehold improvements   22,871    27,331 
Total property and equipment   709,740    835,464 
Less accumulated depreciation   (578,738)   (623,452)
Total property and equipment, net   131,002    212,012 
           
Patents (net of accumulated amortization of $56,993 and $40,625)   53,041    58,226 
Total assets  $458,836   $636,779 
           
Liabilities and Stockholder's Equity          
           
Current liabilities          
Line of credit  $74,663   $71,376 
Accounts payable and accrued expenses   109,712    123,931 
Advance from related party   -    50,000 
Current portion of  long term debt   35,795    44,222 
Total current liabilities   220,170    289,529 
Long-Term Debt   -    42,798 
Notes to related parties   30,000    30,000 
Total liabilities   250,170    362,327 
Commitments          
Stockholder's Equity          
Preferred stock, $.0001 par value; 3,000,000 shares authorized;
No issued and outstanding shares.
   -    - 
Common stock, $.0001 par value; 100,000,000 shares authorized;
84,304,627 and 83,804,627 issued and outstanding, respectively
   8,430    7,979 
Additional paid-in capital   12,917,025    12,867,476 
Accumulated deficit   (12,330,450)   (12,269,363)
Other comprehensive income (loss)   (386,339)   (331,640)
Total Stockholder's Equity   208,666    274,452 
           
Total Liabilities and Stockholder's Equity   $458,836   $636,779 

 

The accompanying notes are an integral part of these consolidated financial statements. 

 

 22 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

 

   Years Ended September 30, 
   2015   2014 
         
Revenues  $544,816   $425,487 
Cost of sales   292,809    88,439 
Gross profit   252,007    337,048 
           
Operating expenses          
Selling, general and administrative expenses   294,644    405,275 
Total operating expenses   294,644    405,275 
           
Operating income (loss)   (42,637)   (68,227)
           
Other income (loss)          
Interest expense   (18,450)   (11,737)
Total other income (expense)   (18,450)   (11,737)
           
Net Income ( loss)  $(61,087)  $(79,964)
           
Net Income ( loss) per common share  $(0.00)  $(0.00)
Weighted average common shares outstanding - basic and diluted   84,266,271    83,804,627 

 

The accompanying notes are an integral part of these consolidated financial statements. 

 

 23 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

 

   Years Ended September 30, 
   2015   2014 
         
Net income (loss)  $(61,087)  $(79,964)
Other comprehensive income (loss)          
Foreign currency translation adjustment   (54,699)   68,467 
Comprehensive income (loss)  $(115,786)  $(11,497)

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 24 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY

 

           Additional         
   Common Stock   Paid-in   Accumulated     
   Shares   Amount   Capital   Deficit   Total 
                     
Balance - September 30, 2013   83,804,627   $7,979   $12,867,476   $(12,189,399)  $686,056 
                          
Net loss for the year ended September 30, 2014   -    -    -    (79,964)   (79,964)
                          
Balance - September 30, 2014   83,804,627   $7,979   $12,867,476   $(12,269,363)  $606,092 
                          
Common stock issued for the settlement of debt   500,000    451    49,549    -    50,000 
                          
Net loss for the year ended September 30, 2015   -    -    -    (61,087)   (61,087)
                          
Balance - September 30, 2015   84,304,627   $8,430   $12,917,025   $(12,330,450)  $595,005 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 25 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

   Years Ended September 30, 
   2015   2014 
Cash flows from operating activities:        
Net income (loss)  $(61,087)  $(79,964)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:          
Depreciation and amortization expense   79,035    81,097 
Changes in:          
Accounts receivable   (55,570)   64,748 
Inventories   115,769    (32,655)
Prepaid expenses   (2,218)   28,765 
Accounts payable and accrued liabilities   (14,219)   1,987 
Net cash provided by operating activities   61,710    63,978 
           
Cash flows from investing activities:          
Acquisition of patents   (22,358)   (26,774)
Tooling and machinery   (10,617)   - 
Net cash used by investing activities   (32,975)   (26,774)
           
Cash flows from financing activities:          
Line of credit   3,287    8,176 
Repayment on notes payable   (51,225)   (56,028)
Increase in amounts due to related parties   -    80,000 
Net cash provided by (used in) financing activities   (47,938)   32,148 
           
Effect of exchange rates   (14,564)   (36,605)
           
Increase (decrease) in cash   (33,767)   32,747 
Cash, beginning of period   33,767    1,020 
Cash, end of period  $-   $33,767 
Supplemental disclosure of cash flow information:          
Cash paid for interest  $9,064   $13,247 
Cash paid for federal income taxes  $-   $- 
Supplemental disclosure for non-cash transactions          
Common stock issued for debt  $50,000   $- 

 

The accompanying notes are an integral part of these consolidated financial statements.

 

 26 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

YEARS ENDED September 30, 2015 and 2014

 

Note 1 – Business Activities and Related Risks

 

Medical International Technology, Inc. (the "Company") was incorporated in Colorado on July 19, 1999, under the name, Posterally.com, Inc. The Company filed an amendment to its articles of incorporation on September 24, 2002 changing its name to Medical International Technology, Inc.

 

The Company is in the business of manufacturing and marketing a needle free device for use in injecting medicine and supplements for human and animal use.

 

Going Concern:

 

The Company has accumulated losses of $12,330,450 since inception and has stockholder’s equity of $258,666 at September 30, 2015. These factors, amongst others, raise substantial doubt about the Company’s ability to continue as a going concern.

 

There can be no assurance that sufficient funds required during the next year or thereafter will be generated from operations or that funds will be available from external sources such as debt or equity financings or other potential sources. The lack of additional capital resulting from the inability to generate cash flow from operations or to raise capital from external sources would force the Company to substantially curtail or cease operations and would, therefore, have a material adverse effect on its business. Further, there can be no assurance that any such required funds, if available, will be available on attractive terms or that they will not have a significant dilutive effect on the Company’s existing stockholders.

 

The accompanying financial statements do not include any adjustments related to the recoverability or classification of asset carrying amounts or the amounts and classification of liabilities that may result should the Company be unable to continue as a going concern.

 

Note 2 – Summary of Significant Accounting Policies

 

Principles of consolidation

The accompanying financial statements include the accounts and transactions of Medical International Technology, Inc. and its wholly owned subsidiaries, Medical International Technologies (MIT Canada) Inc. and 9139-2449 Quebec Inc. (dba Scanview).  Intercompany transactions and balances have been eliminated in consolidation.

 

Foreign Currency Translations

The Company operates out of its offices in Montreal, Canada and maintains its books and records in Canadian Dollars. The financial statements herein have been converted into U.S. Dollars. Balance sheet accounts have been translated at exchange rates in effect at the end of the year. Income statement accounts have been translated at average exchange rates for the year. Translation gains and losses are included as a separate component of stockholders’ equity.

 

Cash and Cash Equivalents

For purpose of the statements of cash flows, the Company considers cash and cash equivalents to include cash on hand, amounts due to banks and any other highly liquid investments with original maturities of three months or less.

 

Allowance for Doubtful Accounts

The allowance for doubtful accounts on accounts receivable is charged to income in amounts sufficient to maintain the allowance for uncollectible accounts at a level management believes is adequate to cover any probable losses.

 

Management determines the adequacy of the allowance based on historical write-off percentages and the current status of accounts receivable. Accounts receivable are charged off against the allowance when collectability is determined to be permanently impaired.

 

 27 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

YEARS ENDED September 30, 2015 and 2014

 

Inventories

Inventories are stated at the lower of cost or net realizable value. Cost is determined on a first-in, first-out basis. At each balance sheet date, the Company evaluates its ending inventories for excess quantities and obsolescence. This evaluation includes an analysis of sales levels by product type. Among other factors, the Company considers historical and forecasted demand in relation to the inventory on hand, competitiveness of product offerings, market conditions and product life cycles when determining the net realizable value of the inventory. Provisions are made to reduce excess or obsolete inventories to their estimated net realizable values. Once established, write-downs are considered permanent adjustments to the cost basis of the excess or obsolete inventories.

 

Property and Equipment

The cost of property and equipment is depreciated over the estimated useful lives of the related assets, which range from 5 to 7 years. Depreciation is computed on the straight-line method. Depreciation expense for the years ended September 30, 2015 and 2014 was $57,028 and $61,327, respectively.

 

Long-Lived Assets

FASB Accounting Standards Codification 360-10-40, “Property, Plant, and Equipment, Impairment of Disposal of Long-Lived Assets” (ASC 360-10-40), requires that long-lived assets, such as property and equipment and purchased intangibles subject to amortization, be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the asset is measured by comparison of its carrying amount to undiscounted future net cash flows the asset is expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the asset exceeds its fair market value. Estimates of expected future cash flows represent our best estimate based on currently available information and reasonable and supportable assumptions. Any impairment recognized in accordance with ASC 360-10-40 is permanent and may not be restored. As of September 30, 2015, we had not recognized any impairment of long-lived assets in connection with ASC 360-10-40 based on our reviews.

 

Patents

Patents on our technologies are being amortized over their remaining lives ranging from 6.5 years through 18 years.

 

Revenue Recognition

The Company recognizes revenue when the related product is shipped to the respective customer provided that: title and risk of loss have passed to the customer; persuasive evidence of an arrangement exists; the sales price is fixed or determinable; and collectability is deemed probable.  Expenses are recognized in the period incurred.

 

Stock options

Effective October 1, 2005, we adopted the provisions of FASB Accounting Standards Codification 718, “Compensation — Stock Compensation” (ASC 718), previously referred to as Statement of Financial Accounting Standards No. 123R, “Share-Based Payment”.  We adopted ASC 718 using the modified prospective transition method. Under this transition method, compensation cost recognized includes (a) the compensation cost for all share-based awards granted prior to, but not yet vested, as of October 1, 2005, based on the grant-date fair value estimated in accordance with the original provisions of ASC 718 and (b) the compensation cost for all share-based awards granted subsequent to September 30, 2005, based on the grant-date fair value estimated in accordance with the provisions of ASC 718. Additionally, we accounted for restricted stock awards granted using the measurement and recognition provisions of ASC 718. We measure the fair value of the restricted stock awards on the grant date and recognize them in earnings over the requisite service period for each separately vesting portion of the award.

 

The Company determines the value of stock options utilizing the Black-Scholes option-pricing model. Compensation costs for share-based awards with pro rata vesting are allocated to periods on a straight-line basis.

 

 28 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

YEARS ENDED September 30, 2015 and 2014

 

Net Income (loss) per Common Share

Basic earnings per share (“EPS”) are computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted EPS reflects the potential dilution from the exercise or conversion of securities into common stock, including stock options and warrants. For the years ended September 30, 2015 and 2014, there were no dilutive effects of such securities as the Company either had no potentially dilutive shares outstanding or had incurred a net loss in the period.  At September 30, 2015, and 2014 the Company had no outstanding warrants or options to purchase common shares.  

 

Use of Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect certain reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Actual results could differ from those estimates.

 

Income Taxes

The Company and its subsidiaries file a consolidated federal income tax return under the accrual method of accounting.  The Company accounts for income taxes under ASC 740-10-25.  Under ASC 740-10-25, deferred tax assets and liabilities are recognized for the future tax consequences attributable to temporary differences between the tax basis of assets and liabilities and their carrying values for financial reporting purposes.  When management determines that it is more than likely that a deferred tax asset will not be realized, a valuation allowance is established. Deferred tax assets and liabilities are measured using enacted tax rates expected to be recovered or settled. Deferred tax expense or benefit is the result of changes in deferred tax assets and liabilities during the period.   The effect on deferred tax assets and liabilities of a change in tax rates is recognized as income in the period that includes the enactment date.

 

Effective January 1, 2009, the Company adopted guidance regarding accounting for uncertainty in income taxes. This guidance clarifies the accounting for income taxes by prescribing the minimum recognition threshold an income tax position is required to meet before being recognized in the financial statements and applies to all federal or state income tax positions. Each income tax position is assessed using a two step process. A determination is first made as to whether it is more likely than not that the income tax position will be sustained, based upon technical merits, upon examination by the taxing authorities. If the income tax position is expected to meet the more likely than not criteria, the benefit recorded in the financial statements equals the largest amount that is greater than 50% likely to be realized upon its ultimate settlement. As of September 30, 2015 and 2014 there were no amounts that had been accrued in respect to uncertain tax positions.

 

None of the Company’s federal or state income tax returns is currently under examination by the Internal Revenue Service (“IRS”) or state authorities.  

 

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash in banks and trade receivables.  The Company manages this risk by maintaining all deposits in high quality financial institutions and periodically performing evaluations of the relative credit standing of the financial institutions that are considered in the Company’s investment strategy. The Company grants unsecured credit to its customers during the normal course of business and performs ongoing credit evaluations of its customers to minimize any potential loss.

 

Fair Value of Financial Instruments

The Company’s financial instruments consist primarily of cash and cash equivalents, accounts receivable and accounts payable. Management believes that the carrying values of these assets and liabilities are representative of their respective fair values based on their short-term nature.

 

New Accounting Pronouncements

In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in ASC 605, Revenue Recognition. This ASU is based on the principle that revenue is recognized to depict the transfer of goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, the FASB issued ASU No. 2015-14, Deferral of the Effective Date, which amends ASU No. 2014-09. As a result, the effective date will be the first quarter of fiscal year 2019 with early adoption permitted in the first quarter of fiscal year 2018. The adoption will use one of two retrospective application methods. The company has not determined the potential effects on the consolidated financial statements.

 

On February 18, 2015, the FASB and the International Accounting Standards Board issued a final standard that amends the current consolidation guidance. The standard amends both the variable interest entity and voting interest entity consolidation models. The standard is effective for public reporting entities in fiscal periods beginning after December 15, 2015, and early adoption is permitted. The Company is evaluating the impact, if any, of adopting this new accounting guidance on the consolidated financial statements.

 

 29 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

YEARS ENDED September 30, 2015 and 2014

 

Note 3 – Inventories

 

Inventories at September 30, 2015 and 2014 consist of the following:

 

   2015   2014 
Raw materials  $136,842   $195,838 
Work in process   51,511    106,696 
Finished goods   22,226    23,814 
Total  $210,579   $326,348 

 

Note 4 – Patents

 

As of September 30, 2015, the Company has net patents on certain technologies aggregating $53,041. Amortization expense for the years ended September 30, 2015 and 2014 was $22,007 and $19,770, respectively. During the year ended September 30, 2015, the Company capitalized patent costs on its needle-free injector of $22,358.  Following is a detail of patents at September 30, 2015.

 

   Gross
Intangible
Assets
   Accumulated
Amortization
   Net
Intangible
Assets
   Weighted
Average
Life
(Years)
 
Patents  $110,034   $56,993   $53,041    5 

 

Note 5 – Joint Venture Agreement

 

On May 6, 2009, the Company entered into a certain joint venture agreement (the “Joint Venture Agreement”) with Jiangsu Hualan Biotechnology Ltd. (China) (“Jiangsu Hualan”).   Pursuant to the Joint Venture Agreement, the parties established a joint venture company, Jiangsu Hualan MIT Medical Technology (MIT China) Ltd. (“MIT China” or the “Joint Venture”), focusing on research, production and sales of medical equipments, import and export of medical equipments and components products, especially Needle-Free Jet Injector products. The total investment by the Joint Venture shall amount to $2,000,000. and the registered capital shall amount to $1,400,000.  The Company invested cash of $426,678 and transferred the license rights to produce and sell the Company’s needle-free injectors products into the Joint Venture.  The license rights were valued at $280,000 under the agreement.  The contributions by the Company resulted in the Company owning 49% of the registered capital of the Joint Venture.  Jiangsu Hualan contributed cash of $714,000, and owns 51% of the registered capital.

 

 30 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

YEARS ENDED September 30, 2015 and 2014

 

Under the agreement, the Company appointed 1 member to the Board of Directors of the Joint Venture and Jiangsu Hualan appointed 2 members to the Board of Directors.  Profits of the Joint Venture will be paid based on each party’s investment in the registered capital.

 

During the period from May 6, 2009 to September 30, 2009, the Joint Venture had not commenced operations.  The Joint Venture commenced operations during the Company’s 1st quarter of fiscal 2010.

 

During the third quarter of fiscal year 2011, MIT China purchased 151,000 sq. ft. of land and began construction of its first building in Taizhou (China Medical City). This first building of 40,000 sq. ft. will be used for the production of injectors for the Chinese market. The first stage (the offices) was completed and employees were moved into the facility in August 2012. The second part of the construction is scheduled to be complete during the first quarter of 2013, which will contain the production facility capable of supplying a large number of injectors and disposables to the Chinese market.

 

In March 2012, MIT China agreed and sold 9% of the joint venture for an investment of 18,000,000 RMB (US$3,000,000). Jiangsu Hualan now has 46.41%, the Company has 44.59%, and Taizhou Amazon Investment Center has 9% ownership in the MIT China joint venture.

 

The Company accounts for its investment in MIT China in accordance with Financial Accounting Standards Board Accounting Standards Codification 323, “Investment — Equity Method and Joint Venture” (ASC 323), Accordingly, the Company adjusts the carrying amount of its investment in MIT China to recognize its share of earnings or losses. Under the equity method of accounting, losses in the venture are not recorded if the losses cause the carrying value to be negative and there is no requirement of the Company to contribute additional capital. Under the MIT China Joint Venture Agreement, the Company is not required to contribute additional capital, therefore the Company is not recognizing losses in the venture for 2015 and 2014, as this would cause the carrying value to be negative. Had the Company recognized its share of the losses related to the venture, the Company would have recognized losses of approximately $(284,000) and $(356,000) for the years ended September 30, 2015 and 2014, respectively.

 

The following table presents summarized financial information for the MIT China Joint Venture (in thousands):

 

Income Statement data: 

Year Ended

September 30, 2015

  

Year Ended

September 30, 2014

 
Net loss   (637)   (798)

 

Balance sheet data: 

Year Ended

September 30, 2015

  

Year Ended

September 30, 2014

 
Current assets  $3,411   $3,635 
Noncurrent assets   2,819    2,640 
Current liabilities   3,501    4,168 
Noncurrent liabilities   1,258     
Equity   1,471    2,108 

 

 31 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

YEARS ENDED September 30, 2015 and 2014

 

During the year ended September 30, 2015, the Company had $230,520 in sales of products to the joint venture. As of September 30, 2015, the Company had a receivable from the joint venture of $51,165.

 

During the year ended September 30, 2014, the Company had $76,931 in sales of products to the joint venture.

 

Note 6 – Line of Credit

 

The Company, through a hypothec agreement, has a line of credit up to a maximum of $100,000. The line is secured by Investissement Quebec (a Quebec government entity) and by Karim Menassa (personally) and by account receivables, inventories, equipment and all other assets of the Company. The line bears interest at the prime rate plus 2.5% (5.75% at September 30, 2015). At September 30, 2015 and 2014, the Company had $74,663 and $71,376 outstanding under the agreement.

 

Note 7 – Related Party Transactions

 

As of September 30, 2015, the Company had two unsecured notes due to related parties totaling $30,000 that bear interest at 8% and are due December 15, 2015.

 

As of September 30, 2014, the Company had an unsecured advance from a shareholder of $50,000. This advance bears no interest and was converted to 500,000 common shares during 2015.

  

During 2015 and 2014, the Company paid approximately $123,600 and $133,000, respectively to a company owned by the President and CEO for consulting fees.

 

Note 8 – Income Taxes

 

Deferred income taxes are provided for the tax effects of temporary differences in the reporting of income for financial statement and income tax reporting purposes and arise principally from net operating loss carry-forwards, accrued expenses and basis differences in fixed assets. 

 

The Company’s effective tax rate differs from the Federal statutory rates due to the valuation allowance recorded for the unused net operating loss carry-forwards deferred tax asset. The company has operating losses aggregating approximately $12.3 million, which can be used to reduce future taxable income. Pursuant to ASC 740, we must consider all positive and negative evidence regarding the realization of deferred tax assets, including past operating results and future sources of taxable income. Under the provisions of ASC 740, we determined that the entire net deferred tax asset needed to be reserved given recent losses. The total valuation allowance at September 30, 2015 and 2014 was $12.3 million and $12.3 million, respectively.

 

We have adopted the provisions of FIN 48, now under ASC 740. Under ASC 740, the impact of an uncertain tax position taken or expected to be taken on an income tax return must be recognized in the financial statements at the largest amount that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An uncertain income tax position will not be recognized in the financial statements unless it is more likely than not of being sustained.

 

 32 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

YEARS ENDED September 30, 2015 and 2014

 

Note 9 – Stockholders’ Equity (Deficit)

 

Issuance of Common Stock

 

Year Ended September 30, 2015

 

From time to time, the Company will issue common stock for services rendered, debt reductions or as part of private placement offerings. 

 

For the year ended September 30, 2015, there were 500,000 shares of common stock issuances for the settlement of a related party advance in the amount of $50,000.

 

Year Ended September 30, 2014

 

For the year ended September 30, 2014, there were no common stock issuances.

 

Preferred Stock

 

As of September 30, 2015, there was no preferred stock outstanding. Dividend features and voting rights are at the discretion of the Board of Directors without the requirement of shareholder approval.

 

Outstanding Options

  

As of September 30, 2015 and 2014, there are no options outstanding to purchase shares of the Company’s common stock.

 

Outstanding Warrants

 

As of September 30, 2015 and 2014, there are no options outstanding to purchase shares of the Company’s common stock.

 

Note 10 – Operating Leases

 

The Company leases its office and warehouse space under an operating lease that expires on December 31, 2021.   The lease calls for a monthly rent of $4,248 (CND) Rent expense for the years ended September 30, 2015 and 2014 was approximately $43,200 and $47,600, respectively.

 

Future minimum lease commitments pertaining to the lease in Canadian Dollars areas follows:

 

Year ended    
     
September 30, 2016  $50,976 
      
September 30, 2017  $50,976 
      
September 30, 2018  $50,976 
      
September 30, 2019  $50,976 
      
September 30, 2020  $50,976 
      
September 30, 2021  $50,976 

 

 33 

 

 

MEDICAL INTERNATIONAL TECHNOLOGY, INC.

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

YEARS ENDED September 30, 2015 and 2014

 

Note 11 – Notes Payable

 

Long-term debt consists of the following at September 30, 2015 and 2014:

 

   September 30,
2015
   September 30,
2014
 
Note payable to a bank, bearing interest at prime plus 3% (6.25% at September 30, 2015), secured by equipment, due December 20, 2016.  $24,515   $55,572 
Loan Canada Economic Development, no interest, repayment of the contribution in sixteen (16) Equal and consecutive quarterly installments of $5,035 (CND) through May 2016   11,280    31,448 
Total long-term debt   35,795    87,020 
Current portion of  long-term debt   35,795    (44,222)
           
Long-term debt, net of current portion  $-   $42,798 

  

NOTE 12 –  Customer Concentration

 

 The Company had two customers that represented approximately 41%and 30% of revenues for the year ended September 30, 2015.  The Company had three customers that represented approximately 33%, 20% and 18% of revenues for the year ended September 30, 2014.  One customer accounted for 90%of accounts receivable at September 30, 2015.

 

Note 13 – Contingencies

 

Legal Proceedings

 

We are currently not involved in any litigation that we believe could have a material adverse effect on our financial condition or results of operations. There is no action, suit, proceeding, inquiry or investigation before or by any court, public board, government agency, self-regulatory organization or body pending or, to the knowledge of the executive officers of our company or any of our subsidiaries, threatened against or affecting our company, our common stock, any of our subsidiaries or of our companies or our subsidiaries’ officers or directors in their capacities as such, in which an adverse decision could have a material adverse effect.

 

 34 

 

 

Item 9.  Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 

None.

 

Item 9A. Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

Pursuant to Rule 13a-15(b) under the Securities Exchange Act of 1934 (“Exchange Act”), the Company carried out an evaluation, with the participation of the Company’s management, including the Company’s Chief Executive Officer (“CEO”) and Chief Financial Officer (“CFO”) (the Company’s principal financial and accounting officer), of the effectiveness of the Company’s disclosure controls and procedures (as defined under Rule 13a-15(e) under the Exchange Act) as of the end of the period covered by this report. Based upon that evaluation, the Company’s CEO and CFO concluded that the Company’s disclosure controls and procedures are effective to ensure that information required to be disclosed by the Company in the reports that the Company files or submits under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to the Company’s management, including the Company’s CEO and CFO, as appropriate, to allow timely decisions regarding required disclosure. 

 

Management's Annual Report on Internal Control over Financial Reporting.

 

The management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting for the Company.  Our internal control system was designed to, in general, provide reasonable assurance to the Company’s management and board regarding the preparation and fair presentation of published financial statements, but because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements.  Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.

 

Our management assessed the effectiveness of the Company’s internal control over financial reporting as of September 30, 2015.  The framework used by management in making that assessment was the criteria set forth in the document entitled “ Internal Control – Integrated Framework” issued by the Committee of Sponsoring Organizations of the Tread way Commission. Based on that assessment, our management has determined that as of September 30, 2015, the Company’s internal control over financial reporting was effective for the purposes for which it is intended.

 

This annual report does not include an attestation report of the Company’s registered public accounting firm regarding internal control over financial reporting. Management's report was not subject to attestation by the Company's registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the Company to provide only management's report in this annual report.

 

Changes in Internal Control over Financial Reporting

 

No change in our system of internal control over financial reporting occurred during the period covered by this report, the fourth quarter of the fiscal year ended September 30, 2015 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

Item 9B.  Other Information

 

None.

  

 35 

 

 

PART III

 

Item 10. Directors, Executive Officers, and Corporate Governance

 

Our directors and executive officers are as follows:

 

Name and Address   Age      Position(s)   
Karim Menassa                       64   President, Chief Executive Officer, Chief Financial Officer, interim Secretary, Director.
        Principal Financial Officer, Principal Accounting Officer and Director

 

Mr. Karim Menassa, 64, serves as the President, Chief Executive Officer, Chief Financial Officer, and interim Secretary of the Company since June 27, 2002. Mr. Menassa also serves as a member of the Board of Directors of the Company. Mr. Menassa has developed many state-of-the-art, efficient and reliable devices, and has marketed various medical devices in more than 60 countries. Mr. Menassa obtained a degree in Precision Mechanics Design from the InstitutoSalesiano Don Bosco in Cairo, Egypt.

 

Over the years he has gained a vast and varied experience as an entrepreneur, administrator and medical device product innovator. He has established a significant bank of important and influential contacts in Canada and abroad, touching all aspects of a modern manufacturing industry. His particular strengths are in administration, engineering, product development, and marketing. He is also extremely skilled in international negotiations, having successfully negotiated several multimillion dollar contacts and established distributor relationships in over 60 countries. Some major achievements in his career include:

 

Inventor of needle-free jet injector for diabetics
Inventor of needle-free jet injector for veterinary use
Inventor of semi-automatic assembly station
Founder of IDEE International R & D Inc. in 1984
Founder of IDEE Technologies Inc. in 1985
Founder of Alliance Medical Inc. in 1989
Founder of Medical International Technologies (MIT Canada) inc. in 2002

 

Involvement in Certain Legal Proceedings

 

To the best of our knowledge, none of our directors or executive officers has been convicted in a criminal proceeding, excluding traffic violations or similar misdemeanors, or has been a party to any judicial or administrative proceeding during the past ten years that resulted in a judgment, decree, or final order enjoining the person from future violations of, or prohibiting activities subject to, federal or state securities laws, or a finding of any violation of federal or state securities laws, except for matters that were dismissed without sanction or settlement. Except as set forth in our discussion below in “Certain Relationships and Related Transactions, and Director Independence – Transactions with Related Persons,” none of our directors, director nominees, or executive officers has been involved in any transactions with us or any of our directors, executive officers, affiliates, or associates which are required to be disclosed pursuant to the rules and regulations of the Commission.

 

Board of Director Meetings and Committees

 

The directors shall be elected at an annual meeting of the stockholders and except as otherwise provided within the Bylaws of Medical International Technology, Inc., as pertaining to vacancies, shall hold office until his successor is elected and qualified.

 

The Board of Directors held no meetings during the year ended September 30, 2015, but conducted board activities through unanimous consent board resolutions in lieu of meetings.

 

Our Board of Directors has no separate committees and our Board of Directors acts as the audit committee and the compensation committee.  We do not have an audit committee financial expert serving on our Board of Directors.

  

Section 16(a) Beneficial Ownership Reporting Compliance

 

Section 16(a) of the Securities Exchange Act of 1934 requires the company’s directors and officers, and persons who own more than ten-percent (10%) of the company’s common stock, to file with the Securities and Exchange Commission reports of ownership on Form 3 and reports of change in ownership on Forms 4 and 5. Such officers, directors and ten-percent stockholders are also required to furnish the company with copies of all Section 16(a) reports they file. Based solely on its review of the copies of such forms received by the company and on written representations from certain reporting persons, the company believes that all Section 16(a) reports applicable to its officers, directors and ten-percent stockholders with respect to the fiscal year ended September 30, 2015 were filed.

 

 36 

 

 

Code of Ethics

 

We have adopted a code of ethics that applies to our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions.  The code of ethics is designed to deter wrongdoing and to promote: 

 

Honest and ethical conduct, including the ethical handling of actual or apparent conflicts of interest between personal and professional relationships;
Full, fair, accurate, timely, and understandable disclosure in reports and documents that we file with, or submit to, the SEC and in other public communications made by MIT;
Compliance with applicable governmental laws, rules and regulations;
The prompt internal reporting of violations of the code to an appropriate person or persons identified in the code; and
Accountability for adherence to the code.

 

We will provide to any shareholder, upon request, a copy of our code of ethics.  Any such request should be directed to our corporate secretary at 1872 Beaulac, Ville Saint Laurent, Montreal, Quebec, Canada HR4 2E7.

 

Item 11. Executive Compensation

 

Compensation Summary

 

The following executives of the Company received compensation in the amounts set forth in the chart below for the fiscal years ended September 30, 2015 and 2014. No other item of compensation was paid to any officer or director of the Company other than reimbursement of expenses. 

 

EXECUTIVE OFFICER COMPENSATION TABLE

 

Name and

Principal

Position

  Year   Salary
($)
   Bonus
($)
   Stock Awards
($)
   Option Awards
($)
   Non-Equity Incentive Plan Compensation
($)
   Non-Qualified Deferred Compensation Earnings
($)
   All Other Compensation
($)
   Totals
($)
 
                                     
Karim Menassa, CEO, President, CFO.   2015   $0    0    0    0    0    0    0   $0 
Interim Secretary and Chairman of the Board   2014   $0    0    0    0    0    0    0   $0 

  

As of September 30, 2015, the Company had no group life; health, hospitalization, medical reimbursement or relocation plans in effect. Further, we had no pension plans or plans or agreements which provide compensation on the event of termination of employment or change in control of us.

 

Compensation of Directors

 

We do not pay members of our Board of Directors any fees for attendance or sireurse them for any out-of-pocurred by them in connection with our business.

 

Employment Agreements

 

No formal employment agreements exist with any officer or employee.

 

 37 

 

 

Long-Term Incentive Plan

 

The Company has a 2015 stock incentive plan under which directors are authorized to grant incentive stock options, to a maximum of five million (5,000,000) of the issued and outstanding shares, to directors, employees and consultants of the Company. The plan provides both for the direct award or sale of shares and for the grant of options to purchase shares.  There are no shares issued or outstanding under the plan.

 

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

 

The following table sets forth certain information as of September 30, 2015 with respect to the holdings of: (1) each person known to us to be the beneficial owner of more than 5% of our common stock; (2) each of our directors, nominees for director and named executive officers; and (3) all directors and executive officers as a group. To the best of our knowledge, each of the persons named in the table below as beneficially owning the shares set forth therein has sole voting power and sole investment power with respect to such shares, unless otherwise indicated.

 

   Amount and
Nature of
   Percent of 
Name and Address
Of Beneficial Holder
  Beneficial Ownership   Common Stock (1) 
         
Karim Menassa (2)       
President, CEO, CFO, Director          
1872 Beaulac, Ville Saint-Laurent          
Montreal, Quebec, Canada HR4 2E7   34,135,692     40.49%
           
The Estate of Michel Bayouk       
1872 Beaulac, Ville Saint-Laurent          
Montreal, Quebec, Canada HR4 2E9   4,522,560    5.39%
           
Sun Yi       
13 Building 6 Renmin University          
#175 Haidian Road, HaidianDist.A          
Beijing, China   4,928,576    5.88%
           
Les Consultants RainvilleTossounian& Associes Inc.       
1585 ST LOUIS,  ST LAZARE
QUEBEC, J7T-1Z1, Canada
   5,192,000    6.19%
Officers and Directors as a Group   34,135,692    40.49%

 

(1) Based on 84,304,627 shares issued and outstanding as of September 30, 2015.

 

(2) Karim Menassa directly holds 2,787,422 common shares of the Company, indirectly holds: (i) 21,466 shares through Paulette Menassa, his wife, (ii) 16,285,139 shares through 2849674 Canada, Inc., (iii) 13,666,667 shares through Idee R&D International, Inc., and 9 iv) 1,375,000 shares through 9162-9725 Quebec Inc., which are all controlled by Karim Menassa.

   

Changes in Control

 

We are not aware of any person who owns of record, or is known to own beneficially, five percent or more of our outstanding securities of any class, other than as set forth above. We do not have an investment advisor. There are no current arrangements which will result in a change in control, other than those set forth above.

 

 38 

 

 

Director Independence

 

We do not have any independent directors. Because our common stock is not currently listed on a national securities exchange, we have used the definition of “independence” of The NASDAQ Stock Market to make this determination.  NASDAQ Listing Rule 5605(a) (2) provides that an “independent director” is a person other than an officer or employee of the company or any other individual having a relationship which, in the opinion of the company’s Board of Directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director.  The NASDAQ listing rules provide that a director cannot be considered independent if:

 

The director is, or at any time during the past three years was, an employee of the company;
The director or a family member of the director accepted any compensation from the company in excess of $120,000 during any period of 12 consecutive months within the three years preceding the independence determination (subject to certain exclusions, including, among other things, compensation for board or board committee service);
a family member of the director is, or at any time during the past three years was, an executive officer of the company;
the director or a family member of the director is a partner in, controlling stockholder of, or an executive officer of an entity to which the company made, or from which the company received, payments in the current or any of the past three fiscal years that exceed 5% of the recipient’s consolidated gross revenue for that year or $200,000, whichever is greater (subject to certain exclusions);
the director or a family member of the director is employed as an executive officer of an entity where, at any time during the past three years, any of the executive officers of the company served on the compensation committee of such other entity; or 
The director or a family member of the director is a current partner of the company’s outside auditor, or at any time during the past three years was a partner or employee of the company’s outside auditor, and who worked on the company’s audit.

 

Mr. Menassa is not considered to be independent because he is an executive officer of the Company.  

 

We do not currently have a separately designated audit, nominating or compensation committee.

 

Item 14. Principal Accounting Fees and Services

 

Audit Fees

 

The aggregate fees billed for each of the last two fiscal years for professional services rendered by the principal accountant for the audit of the registrant's annual financial statements and review of financial statements included in the registrant's Form 10-Q or services that are normally provided by the accountant in connection with statutory and regulatory filings or engagements for the fiscal years ending September 30, 2015 and 2014 were: $21,500 and $15,000 respectively.

  

Audit Related Fees

 

There were no fees for audit related services for the years ended September 30, 2015 and 2014.

 

Tax Fees

 

The Company did not incur any fees for the fiscal years ended September 30, 2015 and 2014 for professional services rendered for tax compliance, tax advice, and tax planning.

 

All Other Fees

 

The Company did not incur any other fees related to services rendered by our principal accountant for the fiscal years ended September 30, 2015 and 2014.

 

Audit Committee

 

The registrant's Audit Committee, or officers performing such functions of the Audit Committee, have approved the principal accountant's performance of services for the audit of the registrant's annual financial statements and review of financial statements included in the registrant's Form 10-Q or services that are normally provided by the accountant in connection with statutory and regulatory filings or engagements for the fiscal year ending September 30, 2015. Audit-related fees, tax fees, and all other fees, if any, were approved by the Audit Committee or officers performing such functions of the Audit Committee.

 

Work Performance by Others

 

None.

 

 39 

 

 

PART IV

 

Item 15. Exhibits

 

31.1   Certification of Principal Executive Officer and the Principal Financial Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
     
32.1   Certification of Principal Executive Officer and the Principal Financial Officer, pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.SCH   XBRL Taxonomy Schema
101.CAL   XBRL Taxonomy Calculation Linkbase
101.DEF   XBRL Taxonomy Definition Linkbase
101.LAB   XBRL Taxonomy Label Linkbase
101.PRE   XBRL Taxonomy Presentation Linkbase

 

In accordance with SEC Release 33-8238, Exhibit 32.1 is being furnished and not filed.

 

 40 

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15 (d) of the Securities Exchange Act of 1934, the registrant had duly caused this report to be signed on its behalf to the undersigned, thereunto duly authorized.

  

  Medical International Technology, Inc.
     
Date: February 18th, 2016 By: /s/ Karim Menassa
    Karim Menassa
   

President and Principal Executive Officer,

Principal Financial Officer, interim Secretary,

Director

(Duly Authorized Principal Executive

Officer and Principal Financial Officer)

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed as of the 18th day of February, 2016 by the following persons on behalf of the registrant in the capacities indicated:

 

/s/ Karim Menassa   President and Principal Executive Officer, Principal Financial Officer, interim Secretary, Director
Karim Menassa    

 

 

41