"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:
Continual surveillance of global opportunities for
acquisition/joint venture/exclusive commercialization
to build out our product line and enter complementary
markets;
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.
Efficiently introduce our new products
simultaneously to both existing and prospective customers
using:
No sales force (doctors no longer have time to
see diagnostic sales representatives);
Efficient Direct-to-Doctor sales, marketing and
service employing the latest database driven tools;
and
Doctor preferred direct response media and
events such as AMA & regionally sponsored
physician symposia.
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,
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.
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:
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:
Physicians - 300,000 (est. addressable portion
of total population)
Primary sites within hospitals - 115,000 (est.
including ICU's, ER's, OR's, surgical recovery
units, general wards, and labs)
Walk-in Clinics - 4,000
Nursing Homes - 34,000
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.
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.
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.
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.
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.