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  HPD Business Overview  

"Rapid in-vitro diagnostics-are about to disrupt a $37 billion market. Healthcare Providers Direct entered a market controlled by the world's largest manufacturers, centralized laboratories, and distributors. Yet the buyers, insurers, and patients are not happy with the current market situation. The shift toward more personalized treatment has begun. We have developed and proven a break through distribution model that aligns the interested of doctors, managed care organizations, insurance companies, and most importantly - the patients."

Private citizens, insurance companies and governments around the globe spend billions of dollars annually on what is commonly called "lab work": expensive, time-consuming, inconvenient, centralized in-vitro diagnostic testing. While the global market is growing at 7% annually, centralized labs continue to lose market share at an increasing rate - over the next 5 years, equating to more than $1.3 billion in diverted sales. The money is now flowing directly into point-of-care solutions and the fast expansion of rapid in-vitro diagnostics: new, easily-administered tests that deliver accurate results in minutes, while the patient is still at the physician's office, allowing faster treatment and better patient care. With proven products, and a rapidly growing direct-to-doctor sales, marketing, and distribution operation, Healthcare Providers Direct is a proven business at the front of a global market shift.

Easy, accurate, fast, and cost-effective - rapid in-vitro diagnostics are coming to America's health care system from Healthcare Providers Direct.

Whether they give more weight to its economic or patient care benefits, experts agree that the multi-billion dollar U.S. and Global in-vitro diagnostic markets are the beginning of a major transition to rapid in-vitro testing technology. HPD gives investors an opportunity to get in at the beginning of an historic market shift.

Healthcare Providers Direct, a 2-year old company based in Lawrenceville, NJ, is a business focused on accelerating the diagnostic market shift, to faster, easier point-of-care technologies doctors can provide their patients, including:

  • a comprehensive line of FDA-approved CLIA-WAIVED rapid diagnostic test kits;
  • signed agreements for three new high user volume test kits in 2007;
  • a Direct-to-Doctor sales, marketing and distribution model;
  • a loyal -- and growing - customer and revenue base; and
  • gross margins in the 50-60% range.

What are rapid in-vitro diagnostic tests? The term was coined to describe a newly-developed class of in-vitro tests that, for the most part, share three defining traits:

  • Easy - So easy a 7th grader can do it (FDA criteria for CLIA waiver).
  • Accurate - Rigorously tested against conventional laboratory based methods.
  • Fast - In minutes, the results are in - while the patient is still at the doctor's office, clinic, or hospital.

To better understand why experts, including executives at some of the leading diagnostic test providers in the U.S., expect this technology to disrupt the status quo, consider the current reality in the IVD market. Diagnosing the illness or disease is the critical first step on the path to patient treatment and care. Diagnostic testing, accounts for approximately 2% of government healthcare expenditures, yet influences 60-70% of healthcare decisions - truly the tail wagging the dog. However, the process used to obtain IVD results is both time-consuming and can delay prognosis and treatment.

Often, patients have to go to an outside laboratory to have test samples drawn. Even when those samples are drawn in the doctor's office or clinic, patients still have to wait days for results, as the test samples are sent out to a lab, analyzed, and the results are reported back to the doctor, then to the patient. If treatment is delayed, infection or disease can spread.

Most patients would rather know right away what is causing their symptoms. More importantly, doctors want faster diagnoses - ideally, at the point-of-care. This allows faster treatment, which is critical to creating better patient outcomes.

The process also frustrates doctors: their income levels have fallen from managed care cuts in reimbursement rates, and they have increasing operating costs such as malpractice insurance. Although the primary care physicians do most of the "heavy lifting" with patients, they are losing revenue and profit.

Upon noticing an opportunity to help doctors improve patient care with their experience in the IVD market place, two highly respected and successful health-care entrepreneurs created Healthcare Providers Direct.

Our Vision
Provide doctors with a superior alternative to a patient care process that has not been materially improved for decades.

Our Concept
Be first to market with diagnostic technology advancements such as tests that are simple, accurate and fast enough to provide results at the point-of-care. Create market advantage and rapid growth with a simple business model platform:

  • Direct-to-doctor Customer Development
    Market, sell, and service doctors and healthcare providers directly, without the hassle of sales reps.
  • Product Distribution
    Distribute point-of-care diagnostic tools in a more efficiently direct way, for the same reasons Dell Computer did when they revolutionized the economics of the computer industry.
  • Consultation
    Add more value to our products by helping our customers - the doctors and their staff - understand how to develop new lines of business for their practice and inform them of product-specific reimbursement processes, guidelines, rates and rules.

"Physicians are not advised that a new test may totally replace an existing entity; they continue to order the new and the old. ….. As more (POC) tests come to market, physician education may become a critical part of successful new product marketing."

Trends in Healthcare Delivery and In Vitro Diagnostics, Kalorama's 5th ed., The Worldwide Market for In Vitro Diagnostic Tests.

A Direct-to-Doctor business model that is drawing customers, introducing new diagnostic products and building revenue & profit, with a very low cost base.

We help doctors provide better patient care and outcomes - while earning incremental profit from introducing in-office diagnostic products rather than using outside labs. It's simple to explain but difficult to operate or replicate.

"A major force driving the growth of this industry is the effort to provide better patient care by improving the time to treatment"

- BCC Research February 1, 2006

We create value for our business and our doctor-customers' businesses by providing primary care physicians with the tools they need to deliver faster patient diagnosis, faster time to treatment, and improved patient outcomes.

We will continue to develop this market focusing on six principles:

  1. Continual surveillance of global opportunities for acquisition/joint venture/exclusive commercialization to build out our product line and enter complementary markets;
  2. Rapidly commercialize new technologies leveraging our past experience, in-house expertise, and knowledge of the FDA approval process; and leverage this capability with global acquisitions/agreements as a large majority of foreign IVD manufacturers shy away from opening up the U.S. market due to the complex device approvals.
  3. Efficiently introduce our new products simultaneously to both existing and prospective customers using:
    1. No sales force (doctors no longer have time to see diagnostic sales representatives);
    2. Efficient Direct-to-Doctor sales, marketing and service employing the latest database driven tools; and
    3. Doctor preferred direct response media and events such as AMA & regionally sponsored physician symposia.
  4. Continue to expand our existing distribution network which already includes domestic channels for our Uni-Gold™ Recombigen® HIV 1 Test, and potential international channels in Turkey and China for our ZstatFlu® Rapid Test for Infuenza A&B, Avian (H5N1) flu and Hong Kong (H3N2) flu,
  5. Develop an industry leading customer database that can be used to direct marketing and sales efforts less expensively, run periodic operating reports, and support decision making.
  6. Take a customer focused approach to developing our product line, actively asking our customers what they need most, and calculating the business opportunity for each new product or service

U.S. Government and leading health associations are building awareness of critical health issues that rapidly increase test volumes.

Sept. 22, 2006 - Center for Disease Control (CDC) announced policy decision to include voluntary HIV testing in all health settings for all 13 - 64 year old U.S. citizens (203 million).

  • Since the first cases of AIDS were identified in 1981, 65 million people have become infected and 25 million people have died worldwide .
  • AIDS has been elevated to global pandemic status and is predicted to become the #3 killer in the entire world over the next 25 years.

Our Direct-to-Doctor distribution system is brand new to the industry and will revolutionize the medical device distribution system much the same as Dell did to the computer industry.

The total cost and time used to distribute products and provide patient diagnoses in the current market structure is not as efficient as it should be. Our direct-to-doctor model takes time and cost out of the current distribution system and provides additional benefits to the entire industry. Less time, less cost, faster diagnoses leading to faster treatments, and improving patient outcomes in the process.

A clearly defined path for growth.

As a public company with access to a larger base of capital, Healthcare
Providers Direct will rapidly scale up operations in the following manner:

  1. Accelerate organic growth with greater investment in direct-to-doctor database marketing. The primary current and potential users of rapid in-vitro diagnostic tests include but are not limited to:
    1. Physicians - 300,000 (est. addressable portion of total population)
    2. Primary sites within hospitals - 115,000 (est. including ICU's, ER's, OR's, surgical recovery units, general wards, and labs)
    3. Walk-in Clinics - 4,000
    4. Nursing Homes - 34,000
  2. Rapidly expand our product offering by using invested funds to acquire or partner with other companies to procure technology, product patents, intellectual property, and distribution licenses to expand our service offering. To cite one example, in early 2007, we will announce three new, exclusive sales, marketing and distribution contracts for diagnostics in three major illness categories. And we will own the FDA 510(k) and CLIA waiver approvals for these three products in the U.S.
  3. Increase HPD product penetration to our existing customer base growing our "share of diagnostic wallet" with each doctor, practice group, hospital, and clinic. At the same time, use these new products to acquire additional new customers. The chart below illustrates a conceptual example of our business expansion model for our share of customer spend on diagnostics.
  4. Leverage our proven track record for rapid commercialization to make us the partner of choice for international manufacturers looking to access the U.S. medical device markets, which are the most heavily regulated in the world.
  5. Expand internationally: we have already begun to address international sales opportunities with partnerships developing in China (the fastest growing market outside the U.S.) and other countries.
  6. Expand into adjacent market segments - Immunoassay, Molecular Assay, and Microbiology/Virology. The total value of these markets in 2007 is estimated at $11.4 billion. Technology developments in these segments are evolving and we will enter this market as the quality, sensitivity, and ease-of-use attributes for new rapid tests come about.
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