Here's one I think you know that is due for a real turn around. I think it just might happen soon too:
American BioMed Company Profile as Prepared by Coffin Communications:
Financials and beautifully done pictures not included:
American BioMed, Inc. (OTC BB: ABMI) utilizes state-of-the-art technology to
develop, manufacture and market minimally invasive medical devices for the
treatment of vascular disease. The company's products include 100% silicone
catheters, through its Cathlab subsidiary; the Evert-O-Cath T, a toposcopic
catheter for site-specific drug delivery and fluid removal; the OmniCathr, an
atherectomy catheter designed to remove atherosclerotic plaque from obstructed
blood vessels throughout the body; and the OmniFilter, which is used to
prevent blood clots. The company has over 25 patents and 11 FDA approvals
covering its product portfolio, and addresses an annual worldwide market
estimated to be in excess of $10 billion.
INVESTMENT CONSIDERATIONS
Experienced Senior Management Team. Steven B. Rash, Chairman, President & CEO
of the company is a turnaround and expansion specialist. He has over 15 years
experience in senior management and healthcare. Additionally, he increased
revenues at Maxum Health Care by almost 155% and grew revenues at Glassrock
from $25 to $250 million. Marshall Kerr, VP of Sales & Marketing, has 20 years
experience in domestic and international distribution.
Distinguished Scientific Advisory Board. Led by Dr Samuel S. Ahn, Associate
Clinical Professor of Surgery, University of California, Los Angeles, the
board is comprised of 8 highly specialized doctors in both the vascular and
medical regulatory fields.
In Phase II Clinical Trials for the OmniCathr Atherectomy catheters. The
Company completed prototypes for the stents and stent delivery system,
addressing a combined estimated market of $1.1 billion. Clinical trials are
expected to commence in the near future.
Sales increased 38.1% in the first quarter of 1998 compared to the same period
in 1997.
Contracts With top Worldwide Distributors. The Company is strategically
positioned nationally with nine specialty healthcare distributors and has
added numerous European and Pacific Rim distributors.
Barriers to Entry. The developmental process for medical devices consists of
significant investments in time and money including: capital equipment,
product development, potential product line acquisitions, marketing and
patents when appropriate. In addition, new products must go through clinical
trials and the FDA approval process which can be time consuming and costly.
Strong Patent Position - Premier Provider of 100%-Silicone Catheters. 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. With more than 25
patents covering its portfolio, the company is well-positioned to develop and
market its various product lines: the Evert-O-CathT drug delivery system
received marketing approval in June 1994; and the OmniCathr has been market-
approved for sale internationally.
Now Positioned for Further Commercialization of its Products. The company
recently signed an agreement for an up to $5 million equity line of credit
needed to fund clinical trials, other development activities and marketing.
This allows the company to further commercialize their products by increasing
market penetration and concentrating on their vascular product line.
Operating in a Market that is Growing 30-35-% per Year. 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.
Management has further incentive to insure growth of the company due to their
attractive multi-year stock option position.
THE INDUSTRY
Over 65 million Americans suffer from coronary or peripheral vascular disease.
Despite significant advances in product technologies, cardiovascular disease
continues to be the leading cause of death in the U.S. today.
Pharmaceuticals and minimally invasive procedures, such as balloon angioplasty
for the treatment of atherosclerosis, have created significant opportunities
for additional medical devices, including stents and carotid microfilter
devices.
The number of angioplasty procedures performed, and consequently, the market
for coronary and peripheral angioplasty devices and accessories, has grown at
a rapid rate. Each year there are 500,000 balloon angioplasties performed in
the U.S. and 1.2 million performed worldwide. In addition, industry sources
estimate the U.S. stent market at approximately $860 million. Carotid
microfilter devices could reach a potential U.S. market of $500M.
STRATEGIES FOR GROWTH
Alliances With Key Strategic Partners. 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.
If this strategy is successfully implemented, the company believes it could
generate annual revenues of $200 - $300 million within five years.
Increase Market Penetration. The Company currently markets its products in
Europe, Middle East, Central and South America. ABMI recently added
distributors in Japan, Korea and Turkey and will commence clinical trials of
the OmniCathr Atherectomy Catheter in Japan and the 100% silicone catheter
balloon in Korea and Turkey. ABMI plans to add an additional fifteen
international distributors during 1998.
Increase Top-Line Growth. Focus on commercial-ization of core technologies.
Contract Additional (OEM) Business. The Company operates a state-of-the-art
production facility that is ISO 9001 Certified, which now allows the company
to pursue additional OEM relationships. This world class production facility,
that recently passed FDA inspection, had no 483 deficiencies - almost unheard
of within the industry.
CE Mark Certification. The Company has filed for CE Mark Certification, which
will permit them to market medical devices within the 15 countries that
comprise the European Economic Community (EEC).
Introduction Of New Products. OmniCathr Atherectomy Catheter; OmniFilter;
Evert-O-CathT Drug Delivery Catheter; OmniStentT and stent delivery system.
SIGNIFICANT EVENTS
Founded in 1984, went public in 1991
Consolidated manufacturing operations into the Irvine, California facility. -
Sept. 1996
Filed with the FDA to conduct OmniCathr AV fistula graft clinical trials. The
annual worldwide market is estimated to be over $150 million. - Feb. 1997
Received second patent on its dual coil, endless loop design stent technology.
Analysts anticipate the worldwide market to reach approx. $2 billion in 1998.
- Apr. 1997
Received Notice of Allowance for additional patent for the OmniCathr
Atherectomy Catheter. - July 1997
Submitted its 100% silicone bi-lumen balloon catheters for thrombectomy and
thrombolysis for FDA approval. - Aug. 1997
Signed distribution agreement with Professional Hospital Supply and Clinical
Technology for its 100% silicone balloon catheters in the U.S. - Nov. 1997
Received patent for the OmniFilter. Industry analysts estimate an annual
world-wide market of $500 million, with the U.S. representing about 50% of
the market. Product launch is expected in 1999. - Dec. 1997
Signed distribution agreements with Hinck Medical and CVC, Inc. serving the
Northwestern U.S. market for its 100% silicone catheter line. - Dec. 1997
Signed distribution agreements with Simonsen & Weel, InnoMed, K's Projects and
Hospital Line S.A. for its 100% silicone catheters serving Belgium, Denmark,
Greece, Japan, Luxembourg, The Netherlands, Norway, and Sweden. - Dec. 1997
Obtained ISO 9001 certification. - Jan. 1998.
Received FDA approval for the Ahn thrombectomy catheter, the company's first
internally developed product. Product launch anticipated Q2 1998. - Jan. 1998
Entered an OEM agreement with Polamedco, Inc., a manufacturer of disposable
medical products. - Feb. 1998
Entered a distribution agreement with Stepic Medical for its 100% silicone
balloon catheters in New York and New England. - Feb. 1998
Signed distribution agreements with, Associated Health Systems, Progressive
Medical, and Mercury Medical, completing its North American coverage for its
100% silicone catheter line. - Mar. 1998
Received Notice of Allowance for the company's first stent delivery system and
sixth patent for the OmniCathr Distal Atherectomy Catheter - Mar. 1998
Received a $5 million equity line of credit - May 1998
CURRENT PRODUCTS
Silicone Balloon Catheters. The company has ten FDA-approved balloon
catheters, six of which are currently marketed worldwide. The 100%-silicone
design of these catheters is resistant to environmental factors, unaffected by
body temperature and more biocompatible than latex balloons or polyvinyl
chloride tubing. The patented one-piece balloon design eliminates glue and
ties, providing superior smoothness and preventing the possibility of balloon
dislodgment. Allergy to latex has been increasingly recognized as a cause of
life-threatening intraoperative anaphylaxis (a systemic reaction). 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.
Embolectomy and Bi-Lumen Irrigation Catheters are used to remove arterial
blockages and clotted blood, but also bacteria and other substances (emboli).
The embolectomy catheter is passed through a surgical incision or an opening
in the artery (arteriotomy) with the balloon deflated, past any suspected
emboli. Subsequently inflated with saline, the embolus is removed by
withdrawing the catheter tip through the arteriotomy. The bi-lumen
embolectomy and irrigation catheter is used to assist in the removal of clotted blood
from inside a vessel, as well as to irrigate with a saline or drug solution during a surgical
procedure. Occlusion Catheters are used to block the flow of blood in a vessel during
surgical procedures.
Biliary Catheters are used for the removal of stones and debris from the kidney.
Thermodilution Catheters are used in the assessment of a patient's hemodynamic
condition (the efficiency of the heart muscle) through direct intracardiac and pulmonary
artery pressure monitoring and cardiac output determination. It is also used for sampling
blood and infusing solutions. Angiographic/Angioscopic Catheters are used as a sheath
for the insertion of an angioscope to visually examine the interior of circulatory vessels.
New Ahn Thrombectomy Catheter. This unique thrombectomy 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. A
patent application has been filed with the U.S. Patent and Trademark Office for this
product. An additional balloon catheter
for thrombectomy and thrombolysis is currently pending FDA approval.
PRODUCTS UNDER DEVELOPMENT
The OmniCathr 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 OmniCathr 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.
The OmniFilter is a percutaneous guidewire microfilter that converts a
standard guidewire into a temporary microemboli filter. 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 1998. This technology is supported by an existing
patent.
The Evert-O-CathO Drug Delivery Catheter is used to inject fluids and drugs,
such as thrombolytic agents (drugs that dissolve blood clots) and
chemotherapeutic agents, into the body in an extremely precise and localized
manner, as well as to withdraw fluid from the body. An early stage version of
the Evert-O-CathT was approved by the FDA for certain non-coronary
applications in July 1994. This technology is patented and the company
received an additional patent for a modified version, the Evert-O-CathT with a
dilatation balloon.
The OmniStentO provides a foundation for support to a weakened vessel. It is
manufactured using a proprietary, patented process that makes a one-piece,
endless loop without soldering or annealing. The company has two distinct
configurations: the coil stent, for support of a longitudinal section of a
vessel; and the bifurcated stent, Y-shaped in design for use in aortic
bifurcation (small versions may be used at any branched blood vessel). 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. Clinical trials are anticipated to begin in late 1998.
Except for the historical information, the matters discussed in this document
are forward-looking statements that are subject to certain risks and
uncertainties that could cause actual results to differ materially from those
projected. Such factors include timely acquisitions, the Company's ability to
increase revenues, the rate of growth of the markets in which the Company
competes, as well as other risks detailed from time to time in the Company's
Form 10-KSB and other regularly filed reports with the Securities and Exchange
Commission. The Company assumes no obligation to update the forward-looking
statements included in this document. The information contained herein has
been furnished by the Company to which it relates and for which Coffin-Mottola
Communications serves as financial relations counsel and from which it
receives compensation for services on a continuing basis. The amount of such
compensation related to the preparation and distribution of this report is not
separately determinable.
Anyone interested in the financials can e mail me at jfhenken@ix.netcom.com.
The entire text as it is intended to be seen will be available for viewing soon at
the redone ABMI web site.
Regards, Jeff |
