Brief Review of PlatiNUMs Medical Products and the Additional Funding Chief Investment Officer Westwood Ventures Irvine, California Prepared by AndrewS. McAlister, CEO, Co-Founder Jason J. Smith, Senior Vice President, Co-FounderDecember 6, 1999 TO: Mr. Greg Krel, Chief Investment Officer FROM: Andrew S. ,Chief Executive Officer, Co-Founder Jason J. , Senior Vice President, Co-FounderDATE: December 6, 1999 SUBJECT: Report on purpose of additional funding requiredfor future development of PlatiNUM Medical, Inc.
This is the report on thelatest cardiovascular medical device that you requested on November 17, 1999. This report discusses in explicit detail how we came to develop such aneffective device. The research and study methods, which were used, will beintroduced. We met with Doctors and patients in order to get accurate detailsfrom both parties. These surveys were conducted in both the United States and inseveral European Nations.
As you can see, we have studied all angles, and havedeveloped a product superior to our competitors. Our device, the PlatiNUMDevice offers the best in medical technology. PlatiNUMs developmentinvolved taking the best of other procedures and rolling it into onemultipurpose device. While eliminating the bad possibilities, which could occurwith other methods. Thank you for taking the time to read our proposal andallowing PlatiNUM the chance to further benefit the world with safer, moreeffective medical technology.
On behalf of PlatiNUM Medical, Inc. and all of ourstaff we are confident that this report will convince you to make the rightchoice, and help put an end to the suffering of the millions of people withheart disease. SUMMARY PlatiNUM Medical, Inc. was founded in 1995 and is locatedin Irvine, California, centrally located in one of the leading medical devicedevelopment areas in the country.
Our company is the leader in the developmentof a new type of medical device for treating cardiovascular disease, also knownas heart disease. Despite on going efforts to combat this disease, no otherpromising instruments have been introduced. The need still remains for a devicethat can easily and safely remove dangerous tissues found in the arteries andother problems associated with the heart. Through the past four years PlatiNUMhas conducted research in the U. S. as well as Europe.
Surveys and interviewswere held with leading cardiovascular physicians to determine the best featuresfor the device. When this process was completed, we then took the next step,which involved patient surveys and gathered input on what they thought wasneeded. Although our research and data collecting will never end, the past fouryears has given us the specifications, which must be met in the product that wedeveloped. Our research has led to the following: (1) A device, which eliminatesall possible complications, associated with heart disease today.
(2) Somethingthat would not be as dangerous and risky as By-pass surgery. (3) A device whichis simple to use and requires no additional training. (4) Finally, a devicewhich is affordable, and efficient. PlatiNUM has developed a device that meetsand exceeds all of these strict standards.
The PlatiNUM device with our patentedOmni Cutter does the trick. Hopefully, in the near future the citizens ofthe world who suffer from heart disease will be fortunate to have this deviceavailable. Physician Comments about the PlatiNUM device: Best device ever fortreating Heart Disease Thomas Ischeinger, MD Best device ever for FailedBypass David Cox, MD Incredibly easy to set up and use adoption willbe fast Gregg Stone, MD iv DISCUSSION ON THE ISSUE OF PREVENTING HEARTDISEASE AND COMPLICATIONS Introduction Heart problems are a way of life for manyAmericans throughout the nation. Whether it is heredity, our diets, or someother cause. Heart disease and related problems kill 10 million Americansannually with numbers on the rise. With these skyrocketing numbers, it showsthat something needs to be done about this horrible condition.
Fatality ratesdue to heart disease need to come down, and the millions of Americans who sufferfrom these problems deserve to lead happier, healthier lives. The methods usedtoday are drastically failing and do not have promising success rates. Highlyrespected medical physicians such as Dr. Thomas Ischeinger, Dr.
David Cox, andDr. Gregg Stone will tell you the same. This is why PlatiNUM felt the need todevelop a new, safer device. A device that will drastically bring down thefatality rates involved with heart disease. Purpose for the Research: Thepurpose for our research was to develop a device, which rose above the standardsof all the others.
One that eliminated all of the negative side effects of thecompetitors, and incorporated many of the good features of the others. Not onlythe helpful aspects of the others, but many new aspects as well. Mostimportantly above all else is the continued research to get FDA approval inorder for this device to be used in the United States. Answers were sought tothe following questions. 1.
What are the current problems associated with heartdisease treatment today? 2. What should our device be designed to do? 3. Whatlegal issues are raised regarding the use of this device? 4. Why would thisdevice be such a success? Methods and Procedures Used: Most of the informationand data collected was gathered through the countless surveys and interviewsconducted in both Europe and in the U.
S. Our staff visited numerous, highlyspecialized medical officials, each one at the top of their field. We asked themtheir opinions, and what they would like to see in a new product. We then hitthe books, researching the leading causes in heart disease treatment failures,and tried to determine that went wrong and why.
1 2 Problems Which FrequentlyOccur: Bypass surgery, which is the surgical procedure most historically,conducted is extremely risky. 20 percent fail within the first year and morethan 50 percent within 10 years. Because of the high risk of the surgery many gountreated. Another problem involves the use of Stents. Stents are small tubelike 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 isthese are primarily the only treatments currently being used and the problemswhich go along with them. Benefits of having the PlatiNum device: Our deviceeliminates all the problems I just mentioned. The PlatiNum device surpasses allcompetition and all of those medical professionals who use it, will love it. ThePlatiNum device removes dangerous clots in the arteries caused from massivetissue blocks or by the procedures I mentioned before.
With PlatiNumspatented Omni cutter we can now treat diseased coronary arteries. Bypositioning this cutter at the tip of whats called a catheter, a powerfulforce is created bringing dangerous, occlusive tissue into the catheter. Thisjunk is than removed by vacuum from the blood vessel. No major surgery neededand completely safe. So far from the news in Europe all is going well. Anotherbenefit is the way the device is packaged.
It comes is a simple, disposableunit. For doctors this is a tremendous convenience. This device comes fullyassembled 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.
LegalConsiderations in Marketing: Many considerations for the use of a medical devicemust be met to ensure product safety. Governmental agencies were established toset the standards and guidelines for the quality and use of medical devices inhumans. 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 andinsurance representatives which meet and review the safety and applications ofsuch medical devices and procedures. Approval by CE Mark was made earlier thisyear, with FDA approval just around the corner. As with all approval agencies,the burden of safety falls on the product. With the impressive safety recordsPlatiNUM has established, we see no reason for postponement of the FDA approvalnext fall.
3 Market Potential: Summary: This diagram illustrates the marketpotential, which can be reached by the PlatiNUM device within the next 2-3years. As you can see, there is enormous market potential for PlatiNUM Medicalto 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 next2 years at PlatiNUM. As you can see in 1998 the company was a small purelyinvolved in its research and development phase.
In 1999, PlatiNUM began toexpand, introducing a clean room facility for product assembly, which can laterbe used for manufacturing. In late 1999 CE Mark approval was granted, andPlatiNUM began gearing up for European exporting. By early 2000, the first majorprofits will show from the European market. By late 2000, FDA approval should begranted, and PlatiNUMs facilities will gear up for major production of itsdevice for use in the American market, revenues will exceed 10 million dollarsand the company will begin to liquidate debt and show profits.
By 2002, PlatiNUMwill be common practice in nearly all heart disease cases; we will haverevolutionized the medical industry. BibliographyEndiCOR Medical, Inc. Newsletter, Volume 6(15 November 1999) Responding toIssues of Interventional Cardiology with the X-Sizer. David D. Gutterman, MD. Professor of Cardiovascular Medicine, Medical College of Wisconsin,Cardiovascular Research Center (12 November 1999) Heart Disease Can Be a SilentKiller On-Line Available http://healthlink.
mcw. edu/article/942430653. html1999 November 29 National Institutes of Health (12 July, 1999) Heart FailureTreatments On-Line Available http://healthlink. mcw.
edu/article/931814766. html1999 November 29 Karen A. Matthews, Ph. D. , University of Pittsburgh School ofMedicine (September 18, 1998) Suppressed Anger Increases Heart Disease in BothMen and Women On-Line Available http://mentalhelp.
net/articles/anger2. htm1999 November 27 Encyclopedia. com, Heart Disease On-Line Available http://www. encyclopedia.
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htm 1999November 28 FDA / Center for Food Safety & Applied Nutrition. BiotechnologyOn-Line Available http://vm. cfsan. fda. gov/~lrd/biotechm. html 1999 November28 Cardiothoracic Surgery of Savannah.
Advances in Open Heart Surgery (February14,1999) On-Line Available http://www.openheartsurgery.com/ 1999 November 28Business