To: Ray Tarke who wrote (457 ) 10/21/1998 11:49:00 PM From: Jeffrey L. Henken Respond to of 939
American BioMed may be just a little more than 1 year away from delivering a technology to the market that could easily prevent the majority of post operative vascular surgery strokes. That product is the Guidewire Microfilter. Strokes are actually the third leading cause of death in the United States. Fully 25% of our population is going to have to undergo some kind of vascular surgery in the future. The majority of these patients would benefit from a little extra preventative medicine in the form of the Guidewire Microfilter. American BioMed is actually developing a broader product line than any other company in the minimally invasive surgical field. The Guidewire Microfilter, or Omnifilter, is in my opinion and many others, the company's patent protected home run product but ABMI has much more going for it than just the Omnifilter. Let me give you a brief overview of the company, it's products and potential. American BioMed, Inc. manufactures, develops and markets minimally invasive medical devices for the treatment of vascular disease. ABMI is making inroads into a market that is growing 30 to 35% per year. In fact, the minimally invasive surgery segment is the fastest growing segment of the healthcare industry. One in four Americans suffer from some form of coronary or peripheral vascular disease. Although a small company, American BioMed is developing one of the broadest product lines in the industry. American BioMed is already a premier provider of 100% silicone catheters. Sales increased 38.1% in the first quarter of 1998 compared to the same period in 1997. Second quarter numbers were down due to a delay in sales for the most part due to the need to complete CE Mark approval. CE Mark approval has now been obtained and the company's third quarter may be the first of many quarters of continued revenue growth:biz.yahoo.com Silicone balloon catheters offer many advantages over latex or PVC catheters. The most important of these advantages may be that a silicone catheter will not provoke an allergic response. Increasingly high numbers of latex allergies are being reported. Nearly 1 out of every 5 healthcare workers may be sensitive to latex due to their increased exposure. Even among the general population the number of sensitive individuals may be as high as 6%. This rise in sensitivity, and corresponding litigation, is forcing the healthcare industry to look to alternatives to latex. Frequent use of latex in patients or by healthcare workers can result in sensitization that may place some individuals at risk for life-threatening allergic reactions. The 100%-silicone design of the company's catheters negates the potential risk of intraoperative anaphylaxis. The Company has the only complete line of 100% silicone balloon catheter line for use in treating vascular disorders. Currently ABMI has 10 FDA approved balloon catheters, six of which are currently marketed worldwide. The company recently began selling the Ahn Thrombectomy Catheter, used for the removal of clots from blood vessels. This unique catheter incorporates a distal dual balloon design to more effectively remove emboli, as well as a proximal indicator safety balloon that allows the surgeon to visually determine inflation volume. The US market for this product is estimated to be as high as $30 million dollars a year.americanbiomed.com Other products in R&D include the OmniCath, an atherectomy catheter designed to remove atherosclerotic plaque from obstructed blood vessels throughout the body. This product is entering phase II clinical testing. The OmniCath Atherectomy Catheter System allows physicians to remove atherosclerotic plaque from obstructed blood vessels throughout the body by enlarging the narrowed vessel openings and restoring normal blood flow. When positioned within a target vessel, the plaque is gently shaved away from the vascular wall by a small rotating blade, designed into the catheter, and suctioned out through a vacuum line for further analysis. The OmniCath is designed to reduce or eliminate surgery, lessen surgical morbidity and mortality, and decrease hospital stays with associated cost/rehabilitation. The company commenced Phase II clinical studies in the U.S. in August 1996, and these trials are continuing. This product is protected under six patents. If the FDA approves it's use for all indications, as expected, the OmniCath market opportunities will be in excess of $550 million a year in the U.S. alone. Although growth in the atherectomy market has slowed, this is still a growing market. The need for a device with the myriad of advantages that the OmniCath has over competing devices seems unquestionable to me.americanbiomed.com The OmniFilter, a percutaneous guidewire microfilter that converts a standard guidewire into a temporary microemboli filter will be American BioMed's flagship product. No one else has figured out a way to to bring an arterial-side microfilter to the market. It is because of this single product, whose use could be so widely adopted, that I am spending the time preparing this information. The OmniFilter is used to prevent stroke-causing blood clots from reaching various organs of the body during carotid balloon angioplasty procedures. Its patented "purse string" closure secures clot removal without loss into the blood stream, and its cost-effective design reduces the chance of stroke and prevents distal embolization. Currently under development, prototypes are anticipated to be available by the end of December. This technology is supported by an existing patent. Industry analysts estimate an annual world-wide market of $3 billion, with the U.S. representing about 50% of the market. Product launch is expected in 1999.americanbiomed.com The OmniStent, in two separate stent designs, which will be used to hold open weakened blood vessels. Stents are one of the hottest growth areas of minimally invasive surgery. Unique in design, no other company has met the challenge of manufacturing and deploying a bifurcated stent. Made of nitinol, the company's stents have memory properties that allow them to return to a predetermined shape and adjust to the size of the artery. The stents are available in both balloon-expandable and self-expandable delivery systems. This technology is supported by two existing patents and a related Continuation In Part, filed in June 1995. americanbiomed.com The company currently has over 25 patents and 11 FDA approvals covering it's broad product portfolio, and addresses an annual worldwide market estimated to be in excess of $10 billion and growing. American BioMed is an ISO 9001 certified company. As a result, the company signed it's first OEM deal with Polamedco in February. The company is currently negotiating other OEM opportunities. American BioMed has also received CE Mark approval which allows for sales to take place in the 15 countries making up the European Economic Community (EEC). American BioMed is looking at opportunities to increase it's market penetration. A well designed plan to add world class distributors is paying off but the company continues to look for other ways to grow. As such the company is currently communicating with several major U.S. and international medical companies. Management will continue to identify healthcare companies seeking new proprietary products to strengthen their existing market position. By selecting the appropriate strategic alliances, joint venture arrangements, and licensing and distribution agreements, ABMI can become a dominant player in their market. Today American BioMed won a lawsuit brought on it by former chairman Dr Summers. This judgement could lift a dark cloud off the stock. In addition the company has received coverage from securities analyst Stuart Bockler of International Market Call. It's been a tough few months for ABMI but tomorrow is another day.imcadvisors.com imcadvisors.com Regards, Jeff