Financial Scope

The Plan

Our Business Plan is to leverage and monetize the research and development of our already completed products and medical devices and to commercialize our endeavor by taking our products to market in both FDA and non-FDA approved environments with a focus on the treatment of tuberculosis. MEDICAL GRADE NITRIC OXIDE GAS & DELIVERY SYSTEMS FOR RESEARCH FOR HUMAN CLINICAL TREATMENT

  • Tuberculosis
  • Influenza A
  • Avian (Bird) Flu
  • Rhinovirus (common cold)
  • Sterlization
  • Other

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FDA and ISO 13485:2003

Our Business Plan includes a multi-track process of FDA and ISO 13485:2003 approved monetization of our Research & Development to bring our products to immediate commercial viability and revenue. Together, our management team, academic advisory board, our scientists and our research and development teams have determined that our products are ready for commercialization. Moreover, to bring our products to market and revenue generation we have determined that the best course is to follow a multi-track process:

Tuberculosis as a Disease Model for R&D of Nitric Oxide Inhaled Gas Treatments

With compelling evidence that tuberculosis is once again increasing in the world population, GeNOsys is focused on providing gNO therapies that have efficacy in the treatment of TB. Management has determined to follow a multi-track approach to best position GeNOsys and its research and products in the TB market place. GeNOsys' business plan includes foreign and US domestic market penetration. Foreign Countries Primarily targeting treatment of TB in foreign countries under the auspices of the World Heath Organization Stop TB Strategy. By aligning itself with the Global Alliance for TB Drug Development, GeNOsys is positioned not only for market exposure but for significant assistance in research, clinical trials, regulatory and registration, publication and financial support and rapid market penetration in both the public and private sectors. GeNOsys is planning simultaneous R&D activities with clinical studies to be conducted by contracted research laboratories in locations where TB is growing in epidemic proportions. Ghana in western Africa is a target location for research and continued development of the Company's tuberculosis treatment. United States Domestic GeNOsys will comply with the U.S. FDA regulations for approval of its NO generator as a medical device and will seek approval for use of its innovative NO tablet medium to be used as the delivery medium in its gas generating system to provide continuous flow of medical grade Nitric Oxide gas for human patient use in clinical environments and for use in research and scientific study laboratories. fdadev.jpg

International & US Regulatory Strategy

tb11.jpgMulti-Track Regulatory Approach (ISO 13485:2003 — Medical Device Regulations) GeNOsys will comply with this internationally recognized quality standard which outlines particular quality management system requirements specifically tailored to the manufacture and service of medical devices and related services. As such, it is the standard recognized and accepted by most regulatory bodies worldwide as proof of an effective quality system. Certification of our medical quality system to ISO 13485: 2003 is a mandatory requirement of many countries and regulatory agencies, and even where it is not dictated by regulation, a certification to this standard may ease your company's medical device entry into those developing markets. tb21.jpg510(k) – Equivalency to the predicate device – Nitric Oxide cylinder gas A 510(k) is a premarket submission made to the FDA to demonstrate that a device to be marketed is substantially equivalent to an existing legally marketed device in the U.S. Submitters must compare their device to one or more similar legally marketed devices and make and support their "substantial equivalency" claims. GeNOsys will claim our system of the GeNOx-B and GeNox-P Nitric Oxide gas generators and its GeNOx-Tablet Medium will have "substantial" equivalency to the predicate device – cylinder Nitric Oxide gas. The GeNosys products may be marketed after 510(k) clearance is granted.

Research and Markets: Nitric Oxide Market Expected to Rise to $96 Billion in 2010 as New Drugs with Nitric Oxide Based Mechanisms Are Introduced into the Market.

Business Wire April 2004

Where we are as of today

We have completed the research and development, engineering and constructed our patient-side GeNOx-B and portable GeNOx-P Nitric Oxide Gas Generators and have applied for patents to protect our interests. We have been issued a patent for our patient-side Nitric Oxide Gas Generator, (GeNOx-B) and we have applied for a patent for the GeNOx-P. You can read more about these products on the Global Health page. We have completed the preliminary research and development of our proprietary tablet medium GeNOx-Tablet and have a formula for bulk manufacture of the tablet medium that will enable us to develop our plan to have ongoing commercially viable reoccurring revenue streams that will provide the revenue and cash flow. Please feel free to contact us for more information about our fiscal forecast. We are in the process of development, subject to research findings, of our gNO delivery system GeNO-D that will provide for constant and measurable delivery of gNO, oxygen and to measure methemoglobin. We are in the process of making application to the FDA for equivalency for our Nitric Oxide bedside and field gas generating systems. We are in the planning stages for our field clinical studies in conjunction with our regulatory approval protocol with plans to collect data from the population of TB infected patients in Ghana, West Africa. Back To Top

Tuberculosis

Estimated 2010 Market for anti-TB Drugs, is projected to be between $612 million and $670 million. The potential market for a new anti-TB drug is estimated to be at least between $316 million and $345 million. If a minimum premium of 35% is charged in all but the public/tender market, the estimated potential market for a new anti-TB drug increases to between $396 million and $432 million. Source: Executive Summary for The Economics of TB Drug Development, The Global Alliance for TB Drug Development 2001 GeNOsys, Inc. has as its underlying business strategy to be: The industry leading research and development company focused on the use and delivery of Nitric Oxide (gNO) in the treatment and research of tuberculosis and other diseases. The Company plans include 4th Qtr. 2008 clinical trials in Ghana (West Africa) where in a population of 21,664,441, there were 44,733 cases of TB reported in 2004. Ghana ranks 13th in Africa for the highest estimated number of new cases per year, according to the WHO Global TB Report 2006. Moreover, in 2004, over 10,000 Ghanaians died of TB with 1,761 new cases confirmed in 2007. Source: www.usaid.gov/our_work/global_health/id/tuberculosis/countries/africa/ghana_profile.html

…Despite this need, no new class of anti-TB drug has been introduced in over 30 years, and TB has been a neglected disease.

Source: Executive Summary for The Economics of TB Drug Development, The Global Alliance for TB Drug Development 2001

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THE TUBERCULOSIS MARKET FOR GeNOsys PRODUCTS

We believe that this research into the economics of anti-TB drugs will reinvigorate the interest of the pharmaceutical industry and public research organizations in the battle against a disease that is not only a tremendous burden to the poorest countries but also a threat to all nations. (emphasis added)‏

Source: Dr. Giorgio Roscigno,Global Alliance for TB Drug Development

GeNOsys PRODUCTS WILL:

  • Have a treatment duration of less than 2 months,
  • Provide treatment at a reasonable cost to the patient,
  • Treat latent TB infection (LTBI) (that is, patients infected with Mycobacterium tuberculosis but who have yet to show symptoms of active TB),
  • Be an effective treatment for MDR-TB and extreme drug resistant TB (XDR-TB).
  • Be readily available to the poorest countries as well as the more affluent,
  • Provide treatment at patient-side, and,
  • Provide a portable NO generator for field and laboratory use.

Learn more about TB and spread of TB on the Tuberculosis page. Back To Top

A Look Forward‏

estimatedmarket-for-tb.jpg As shown below, the anti-TB drug market in 2010 is projected to be between $612 million and $670 million. This projection is based on several assumptions:

  • The private market in 2000 will remain the same to 2010, except for the treatment of LTBI(*) (see fourth assumption below). (*) LTBI – Latent Tuberculosis Infection.
  • The public/tender market will increase as DOTS coverage continues to expand, enabled in part by the Global TB Drug Facility's expected annual contribution of approximately $50 million.
  • While the total number of MDR-TB patients is assumed not to increase, the relative market will increase due to DOTS expansion, which would result in an increase in the percentage of MDR-TB patients diagnosed and treated.
  • The market for drugs to treat LTBI will increase due to increases in the percentage of patients treated.

Learn about the existing global strategies to stop TB on the Tuberculosis page.

The Market For TB Drugs

Two major market segments exist for anti-TB drugs: the private market and the public/tender market. The private market is composed of traditional pharmacy and hospital sales. The public/ tender market comprises (1) government purchases of anti-TB drugs at the federal, regional and/or local level, depending upon the country, and (2) international donors with an interest in TB control strategies that supply drugs to developing and high-burden countries. Such donors include the World Health Organization, the Canadian Agency for International Development, and the Stop TB Partnership. A substantial body of evidence suggests that nitric oxide (NO) is important in host defense against Mycobacterium tuberculosis. Source: Antimicrobial Agents and Chemotherapy, March 2005, p. 1209-1212, Vol. 49, No. 3 Back To Top

Funding and Fiscal Forecasts

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Funding and Revenue Forecast Models

Our Business Operations Development fiscal model is represented graphically in the Timeline overview on the following page and is further correlated with our Regulatory Approval Process Development model on the same page.

Incremental Funding Model With Benchmarks

We have constructed an incremental funding proposal with three funding benchmarks to complete the regulatory approval process. Our needs are budgeted, forecast and based on our progress in leveraging and commercializing our already completed Research & Development and the engineering of our patented NO Gas Generator and through the monetization of our proprietary Consumable Tablet Medium as a reoccurring and ongoing source of revenue. We have completed the R&D work, the design and engineering of our medical device's and created a formula for manufacture of our consumable proprietary Tablet Medium that will provide a constant and ongoing reoccurring revenue stream as hospitals, research laboratories and others buy and use our Nitric Oxide Gas Generator and consumable Tablets Medium on a regular basis. funding.jpg

2nd Round Funding

Relying on our initial seed capital and 1st Round Funding, through diligence and discipline we have successfully completed the development of our product line, including the bedside and portable NO Gas Generators and the development and formulization of the consumable NO Tablet Medium used in our gas generator platform. Regulatory Approval Requirements It is now time for us to make a return on our time and investment in R&D by commercializing our products. Our business plan includes implementing immediate animal and human testing to prove the efficacy and safety of our products. We have chosen to use contracted laboratory and research firms to provide the data through testing of our products to support our regulatory application process for an accelerated new drug and medical device. The entire budget of the 2nd round financing as well as the 3rd and 4th rounds are dedicated to successfully completing Phase I through Phase III of the regulatory approval process, that will allow us to take our products to market and to develop a constant and quantifiable revenue stream. Please feel free to contact us for more information about our funding and fiscal forecasts.

Our Timeline

q1.jpg Our Business Plan requires attention to not only managing our business but to the development of a financing plan and Research and Development of our products to take to market, but also requires attention to the regulatory approval process and efficacy of our products. Our scientists, researchers, medical team and academics are focused on the development, delivery and approval of our products while our managers administer the operation of our Company. Together we work to make sure that we are able to deliver a revenue stream that is commercially viable with products that will make a difference in patient care at responsible pricing. We are a Research & Development company with commercially viable products resulting from our R&D and science. Our shareholders and stakeholders are our principal customer. We will work diligently to bring our treatments to market to the betterment of mankind and with attention to the commercial viability of our products and the monetization and leverage of our research for economic returns to our shareholders and stake holders.

Simple Fiscal Fundamentals

pen.jpg Our projections and forecast are based on medical device equipment sales of our patented GeNOx–B bedside NO Gas Generator, our GeNOx-P portable NO Gas Generator, and most important, we have created a reoccurring revenue model based on the continued and ongoing use of our proprietary and patent pending GeNOx Tablet medium as a consumable item. With each Nitric Oxide Gas Generator used in a clinical hospital bedside setting or as a constant source NO Gas Generator in a research laboratory environment, the ongoing consumable Tablet Medium will provide for a constant and sustainable revenue source from which we are able to forecast revenue, cash flow and profitability. Back To Top