PlatiNUM Medical Products
Brief Review of PlatiNUM’s Medical Products and the Additional
Funding
Chief Investment Officer Westwood
Ventures Irvine, California Prepared by Andrew
S. McAlister, CEO,
Co-Founder Jason J. Smith, Senior Vice President, Co-Founder
December 6,
1999 TO: Mr. Greg Krel, Chief Investment Officer FROM: Andrew S. ,
Chief
Executive Officer, Co-Founder Jason J. , Senior Vice President,
Co-Founder
DATE: December 6, 1999 SUBJECT: Report on purpose of
additional funding required
for future development of PlatiNUM Medical, Inc.
This is the report on the
latest cardiovascular medical device that you
requested on November 17, 1999.
This report discusses in explicit detail
how we came to develop such an
effective device. The research and study
methods, which were used, will be
introduced. We met with Doctors and
patients in order to get accurate details
from both parties. These surveys
were conducted in both the United States and in
several European Nations. As
you can see, we have studied all angles, and have
developed a product
superior to our competitors. Our device, the "PlatiNUM
Device" offers the
best in medical technology. PlatiNUM’s development
involved taking the best
of other procedures and rolling it into one
multipurpose device. While
eliminating the bad possibilities, which could occur
with other methods.
Thank you for taking the time to read our proposal and
allowing PlatiNUM the
chance to further benefit the world with safer, more
effective medical
technology. On behalf of PlatiNUM Medical, Inc. and all of our
staff we are
confident that this report will convince you to make the right
choice, and
help put an end to the suffering of the millions of people with
heart
disease. SUMMARY PlatiNUM Medical, Inc. was founded in 1995 and is located
in
Irvine, California, centrally located in one of the leading medical
device
development areas in the country. Our company is the leader in the
development
of a new type of medical device for treating cardiovascular
disease, also known
as heart disease. Despite on going efforts to combat this
disease, no other
promising instruments have been introduced. The need still
remains for a device
that can easily and safely remove dangerous tissues
found in the arteries and
other problems associated with the heart. Through
the past four years PlatiNUM
has conducted research in the U.S. as well as
Europe. Surveys and interviews
were held with leading cardiovascular
physicians to determine the best features
for the device. When this process
was completed, we then took the next step,
which involved patient surveys and
gathered input on what they thought was
needed. Although our research and
data collecting will never end, the past four
years has given us the
specifications, which must be met in the product that we
developed. Our
research has led to the following: (1) A device, which eliminates
all
possible complications, associated with heart disease today. (2)
Something
that would not be as dangerous and risky as By-pass surgery. (3) A
device which
is simple to use and requires no additional training. (4)
Finally, a device
which is affordable, and efficient. PlatiNUM has developed
a device that meets
and exceeds all of these strict standards. The PlatiNUM
device with our patented
"Omni Cutter" does the trick. Hopefully, in the
near future the citizens of
the world who suffer from heart disease will be
fortunate to have this device
available. Physician Comments about the
PlatiNUM device: "Best device ever for
treating Heart Disease" Thomas
Ischeinger, MD "Best device ever for Failed
Bypass" David Cox, MD
"Incredibly easy to set up and use...... adoption will
be fast" Gregg Stone,
MD iv DISCUSSION ON THE ISSUE OF PREVENTING HEART
DISEASE AND
COMPLICATIONS Introduction Heart problems are a way of life for
many
Americans throughout the nation. Whether it is heredity, our diets,
or some
other cause. Heart disease and related problems kill 10 million
Americans
annually with numbers on the rise. With these skyrocketing numbers,
it shows
that something needs to be done about this horrible condition.
Fatality rates
due to heart disease need to come down, and the millions of
Americans who suffer
from these problems deserve to lead happier, healthier
lives. The methods used
today are drastically failing and do not have
promising success rates. Highly
respected medical physicians such as Dr.
Thomas Ischeinger, Dr. David Cox, and
Dr. Gregg Stone will tell you the
same. This is why PlatiNUM felt the need to
develop a new, safer device. A
device that will drastically bring down the
fatality rates involved with
heart disease. Purpose for the Research: The
purpose for our research was to
develop a device, which rose above the standards
of all the others. One that
eliminated all of the negative side effects of the
competitors, and
incorporated many of the good features of the others. Not only
the helpful
aspects of the others, but many new aspects as well. Most
importantly above
all else is the continued research to get FDA approval in
order for this
device to be used in the United States. Answers were sought to
the following
questions. 1. What are the current problems associated with heart
disease
treatment today? 2. What should our device be designed to do? 3. What
legal
issues are raised regarding the use of this device? 4. Why would this
device
be such a success? Methods and Procedures Used: Most of the information
and
data collected was gathered through the countless surveys and
interviews
conducted in both Europe and in the U.S. Our staff visited
numerous, highly
specialized medical officials, each one at the top of their
field. We asked them
their opinions, and what they would like to see in a new
product. We then hit
the books, researching the leading causes in heart
disease treatment failures,
and tried to determine that went wrong and why. 1
2 Problems Which Frequently
Occur: Bypass surgery, which is the surgical
procedure most historically,
conducted is extremely risky. 20 percent fail
within the first year and more
than 50 percent within 10 years. Because of
the high risk of the surgery many go
untreated. Another problem involves the
use of Stents. Stents are small tube
like instruments, which are designed to
maintain a normal bloodstream. Well,
20-25 percent of these cases fail
within the first 6 months. As small as it is
these are primarily the only
treatments currently being used and the problems
which go along with them.
Benefits of having the PlatiNum device: Our device
eliminates all the
problems I just mentioned. The PlatiNum device surpasses all
competition and
all of those medical professionals who use it, will love it. The
PlatiNum
device removes dangerous clots in the arteries caused from massive
tissue
blocks or by the procedures I mentioned before. With PlatiNum’s
patented
"Omni cutter" we can now treat diseased coronary arteries. By
positioning
this cutter at the tip of what’s called a catheter, a powerful
force is
created bringing dangerous, occlusive tissue into the catheter. This
junk is
than removed by vacuum from the blood vessel. No major surgery needed
and
completely safe. So far from the news in Europe all is going well.
Another
benefit is the way the device is packaged. It comes is a simple,
disposable
unit. For doctors this is a tremendous convenience. This device
comes fully
assembled and is easy to use. I believe this device pretty much
sells itself,
all we need is to get this wonderful product available in the
U.S. Legal
Considerations in Marketing: Many considerations for the use
of a medical device
must be met to ensure product safety. Governmental
agencies were established to
set the standards and guidelines for the quality
and use of medical devices in
humans. As with the United States and the FDA
or Food and Drug Administration,
Europe has its agency known as CE Mark,
a review board made up of doctors and
insurance representatives which meet
and review the safety and applications of
such medical devices and
procedures. Approval by CE Mark was made earlier this
year, with FDA approval
just around the corner. As with all approval agencies,
the burden of safety
falls on the product. With the impressive safety records
PlatiNUM has
established, we see no reason for postponement of the FDA approval
next fall.
3 Market Potential: Summary: This diagram illustrates the market
potential,
which can be reached by the PlatiNUM device within the next 2-3
years. As you
can see, there is enormous market potential for PlatiNUM Medical
to grow into
in the future years. 4 Forecast for PlatiNUM over the next 2
years:
Summary: This graph illustrates the profits and revenues
forecasted for the next
2 years at PlatiNUM. As you can see in 1998 the
company was a small purely
involved in its research and development phase. In
1999, PlatiNUM began to
expand, introducing a clean room facility for product
assembly, which can later
be used for manufacturing. In late 1999 CE Mark
approval was granted, and
PlatiNUM began gearing up for European
exporting. By early 2000, the first major
profits will show from the European
market. By late 2000, FDA approval should be
granted, and PlatiNUM’s
facilities will gear up for major production of its
device for use in the
American market, revenues will exceed 10 million dollars
and the company will
begin to liquidate debt and show profits. By 2002, PlatiNUM
will be common
practice in nearly all heart disease cases; we will have
revolutionized the
medical industry.
Bibliography
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Killer
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