PlatiNUM Medical Products Brief Review of PlatiNUMs 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.
PlatiNUMs 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 PlatiNums patented “Omni cutter” we can now treat diseased coronary arteries. By positioning this cutter at the tip of whats 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 PlatiNUMs 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 EndiCOR Medical, Inc. Newsletter, Volume 6(15 November 1999) Responding to Issues 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 Silent Killer [On-Line] Available http://healthlink.mcw.edu/article/942430653.html [1999 November 29] National Institutes of Health (12 July, 1999) Heart Failure Treatments [On-Line] Available http://healthlink.mcw.edu/article/931814766.html [1999 November 29] Karen A. Matthews, Ph.D., University of Pittsburgh School of Medicine (September 18, 1998) Suppressed Anger Increases Heart Disease in Both Men and Women [On-Line] Available http://mentalhelp.net/articles/anger2.htm [1999 November 27] Encyclopedia.com, Heart Disease [On-Line] Available http://www.encyclopedia.com/articles/05744.html [1999 November 27] World Medical Manufacturing Corp. Talent Stent-Graft System [On-Line] Available http://www.worldmedical.com/booklet/contents.htm [1999 November 28] FDA / Center for Food Safety & Applied Nutrition. Biotechnology [On-Line] Available http://vm.cfsan.fda.gov/~lrd/biotechm.html [1999 November 28] Cardiothoracic Surgery of Savannah. Advances in Open Heart Surgery (February 14,1999) [On-Line] Available http://www.openheartsurgery.com/ [1999 November 28].