To All,
I read this thread today, seems to me there is lake of info.
so I thought I shall post the company's SEC latest filing:
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General
Arterial Vascular Engineering, Inc. ("AVE" or the "Company") designs,
develops, manufactures and markets a variety of highly specialized stent systems
and percutaneous transluminal coronary angioplasty ("PTCA") balloon catheters.
The Company's stents are used as arterial support devices in connection with
balloon angioplasty or other minimally invasive treatments of atherosclerosis
(the formation of deposits in the arteries) and to prevent abrupt closure of
vessels in higher-risk angioplasty procedures. The Company commenced operations
in 1991 and began marketing its PTCA balloon catheters in October 1993, its
coronary stent systems in October 1994, and its peripheral stent systems in
December 1996. To date, the Company has sold over 160,000 coronary stent systems
and over 38,000 PTCA balloon catheters in more than 40 countries outside the
United States, primarily in Europe and Japan. In April 1996, the Company began
its first direct sales operation in Europe, and currently it has direct
operations in each of France, Germany, the Netherlands (to service the Benelux
countries), Switzerland and the United Kingdom. In Japan, the Company currently
sells only PTCA balloon catheters. In June 1997, the Company's Japanese
distributor received regulatory approval for the sale in Japan of the Company's
coronary stent systems; however, as of the date hereof, the Company's Japanese
distributor had not yet received the related reimbursement approval there. The
Company does not expect reimbursement approval in Japan prior to November 1997,
and there can be no assurance when or if such approval will be obtained. In
August 1997, the Company submitted a premarket approval ("PMA") application to
the United States Food and Drug Administration (the "FDA") in connection with
its ongoing efforts to gain approval to begin commercial sales of its coronary
stent systems in the United States. The Company does not expect FDA approval of
its stent systems for sale in the United States prior to 1998, and there can be
no assurance when or if such approval will be obtained. As a result, the Company
expects international sales to account for substantially all of its revenues
until at least 1998.
AVE Stent Technology
AVE believes that its line of coronary and peripheral stent systems
incorporates a number of unique and proprietary design features that enable the
Company to address effectively a variety of lesion and vessel types. The
Company's stents are constructed of seamless, medical grade stainless steel
rings that are precision-formed into sinusoidal shaped elements. These elements
are polished and connected in a helical pattern utilizing a proprietary
manufacturing process in order to form a fully connected, yet flexible, stent
device. The Company believes its stent design provides more consistent vessel
support and radial force than coiled stent designs as well as more flexibility
and easier delivery than tubular slotted or mesh stent designs. The Company's
stent products are available in a variety of diameters and lengths and are
provided pre-mounted on both over-the-wire and rapid exchange delivery systems
(available only outside the United States) with the same advanced technology as
the Company's PTCA balloon catheters. The Company's coronary stents have been
used in a variety of applications, including vessels in which other stent
procedures have failed, as well as in the treatment of lesions in curved or
tortuous vessels. The Company also sells stent systems for use in the peripheral
vessels. The Company believes the following technical features of its
proprietary stent systems provide the Company with a number of competitive
advantages:
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Smooth Edge Design and Sheathless Deployment System. The Company's
stent products consist of highly polished, rounded, sinusoidal-shaped elements
at either end of the stent (unlike mesh stents, which have flat edges at each
end). The Company believes that the smooth edges of its stent products optimize
their ability to be moved through a vessel without causing tears or dissections
or halting movement of the delivery catheter, thereby minimizing trauma to
treated vessels. The smooth edges of the stent also permit the stent to be
delivered without the protective sheath necessary for use of certain competing
stent products. The Company believes that eliminating the need to monitor and
remove a protective sheath enhances the ease of use of its products.
High Stent Flexibility and System Trackability. The Company's products
consist of sinusoidal-shaped elements that are connected in a helical pattern
designed to provide a highly flexible stent. Increased stent flexibility allows
the Company's stent products to be more easily maneuvered and placed at the site
of a lesion, particularly through curved or tortuous vessels or around other
deployed stents. In addition, flexible stent design allows the use of a single
stent in the treatment of a lesion in a curved vessel, as compared to more
inflexible designs that may require the use of multiple stents to treat a long,
curved lesion. The Company believes that the ease of use and enhanced handling
characteristics of its stent delivery systems, coupled with stent flexibility
and smooth edge design, allow it to provide a stent system with high
trackability. The ability to easily access or "track to" a lesion is an
important stent system characteristic in the treatment of a distant site or
tortuous vessel. The Company currently offers stents in lengths as long as 40mm
for use in the treatment of long, diffuse lesions.
Improved Stent Strength and Stability. The advanced designs of the
Company's GFX and Micro Stent II family of stent products combines high radial
strength, which minimizes vessel recoil, and axial stability, which provides
consistent vessel support along the entire length of the stent. The Company
believes these features allow a physician to better control and optimize final
minimal lumen diameter ("MLD"). Studies have indicated that optimizing the MLD
of a vessel following use of a stent product generally reduces the likelihood of
subsequent restenosis.
Moderate Radiopacity. The Company believes that the moderate
radiopacity of its devices optimizes angiographic identification of stent
position and enhances post-procedure stent assessment. Physicians commonly use
low level x-rays to accurately monitor the placement and deployment of a stent,
including final expansion using a high pressure balloon, as well as to conduct
post-operative assessment of MLD. As a result, a lack of radiopacity, which may
prevent illumination of a stent, or an excess of radiopacity, which may
overilluminate the stent and impede its visual identification, may affect the
outcome of stent procedures and subsequent diagnosis of treated vessels.
Proprietary, Pre-Mounted Delivery Systems. Unlike certain other stents,
which may require the physician to hand-crimp the stent on a balloon delivery
device, the Company's stents are pre-mounted onto its proprietary delivery
systems. The Company believes that pre-mounting its stents on balloon delivery
systems helps ensure more consistent and accurate stent delivery and deployment,
particularly as stents are used by a broader group of physicians with varying
levels of experience with stents. In addition, the Company believes that the
ease of use of its product has promoted physician acceptance.
Adaptable Design Characteristics. The Company believes that the design
features of its stents allow it to modify one or more stent performance
characteristics, such as mass or flexibility, as necessary to produce an
effective device for a particular application. To date, the Company has utilized
its stent technologies to develop families of more than ten distinct stent
products. Each product also is offered in a variety of lengths and diameters,
allowing the physician to choose the device that best suits the needs of a
patient based on lesion characteristics. The Company believes the adaptability
of its stent designs will allow their use as platform technologies for the
development of a variety of other coronary and non-coronary products. For
example, in fiscal 1997 the Company introduced in selected international markets
stents designed for use in the peripheral renal and iliac vessels. See "--
Products."
Despite such advantages, due to the number of clinical applications for
stent systems and the variety of available products, the Company's stent
products may not be superior to competitive products in all applications. In
addition, many of the Company's competitors have substantially greater capital
resources, name recognition and expertise in manufacturing, marketing and
product approval, which factors provide a competitive advantage to such
companies, in connection with the sale of these stent products. The medical
indications that can be treated by stents can also be treated by surgery,
minimally invasive bypass procedures, drugs or other medical devices, including
stand-alone balloon catheters, atherectomy catheters, irradiated devices and
lasers. Many of the alternative treatments are widely accepted in the medical
community and have a long history of use.
Company Strategy
The Company's goal is to expand its position as one of the leading
worldwide providers of coronary stent systems. The key elements of its strategy
are as follows:
Introducing New Products for Both Coronary and Non-Coronary
Applications. The Company intends to build on its stent designs to broaden the
coronary and non-coronary applications for its stents. For example, the GFX
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stent system introduced by the Company in fiscal 1997 was designed for increased
flexibility and trackability and improved vessel coverage and support, with a
goal of increasing the types of medical indications that may be treated with
stents. The Company believes that the inherent adaptability and flexibility of
the Company's stent designs will augment its ability to meet specialized
coronary needs, as well as to provide stents for use in peripheral vessels,
saphenous vein grafts and other applications. The Company has recently created a
separate operating division, "Peripheral AVE," whose purpose is to focus its
efforts on the design, development, manufacture and marketing of the Company's
peripheral stent systems.
Continuing Integration of Research and Development and Manufacturing
Operations. The Company believes that the design of products for
manufacturability and the rapid manufacture of products to satisfy market demand
are key success factors in new product development in the medical device
industry. To support these capabilities, the Company has designed and developed
internally the technology necessary to perform a number of proprietary
production processes and has developed the expertise to fabricate the majority
of the components of its stent and PTCA balloon catheter products. The Company
has also begun construction of a 130,000 square foot building adjacent to its
corporate headquarters in Santa Rosa, California, at an estimated cost of $20
million, which, when completed, will be largely devoted to manufacturing
activities. The design of the new facility is intended to allow continued
integration of the Company's research and development and manufacturing
operations as well as a significant expansion of the Company's production
capabilities. The Company intends to leverage its vertically integrated product
development and manufacturing approach to rapidly introduce innovative products.
Continuing to Expand Sales and Marketing Efforts. The Company
continually seeks to increase its market share and build product awareness in
each of the over 40 countries outside of the United States in which its products
are marketed. The Company has direct sales operations in its principal target
markets in Europe -- France, Germany, the Netherlands (to service the Benelux
countries), Switzerland and the United Kingdom -- and operates through
unaffiliated distributors in other countries internationally. The Company
believes that its direct sales presence allows it to focus greater attention on
such countries' physician communities, which it believes helps to increase the
advocacy base for the Company's products in Europe and other countries as well
as facilitating more direct feedback to the Company on its products. The Company
also believes that, in addition to building stronger relationships with its
customers, this direct sales strategy provides the Company with more complete
control of the distribution and growth of the Company's full product line, as
well as allowing it to better manage the pricing and regulatory approval process
for its products. The Company has also centralized its distribution services by
contracting with a provider in the Netherlands to support direct sales
operations and distributions throughout Europe. The Company intends to utilize a
direct sales force in the United States if and when regulatory approval is
received for the sale of its products in the United States, and has begun to
develop such a sales force. The Company may continue to implement direct sales
operations in selected markets where it believes such an approach will benefit
its competitive position.
Broadening Product Offerings to Provide More Complete Therapy
Solutions. The Company believes that an ability to offer a more complete line of
therapeutic products may enhance the Company's ability to compete effectively in
the interventional marketplace. For example, the Company believes its current
line of PTCA balloon catheters has provided the Company with expertise in
balloon delivery and deployment. The Company continually reviews possible
strategic acquisitions, third party technology licenses and marketing or
distribution relationships with companies that have medical products in certain
complementary product areas. However, there can be no assurance that the Company
will enter into any such arrangements.
Pursuing Regulatory Approval in the United States and Abroad;
Conducting Clinical Trials to Promote Market Acceptance of the Company's
Products. The Company is seeking FDA approval to allow sale of its products in
the United States, which the Company believes represents the largest stent
market in the world. In August 1997, the Company submitted a PMA to the FDA in
connection with its ongoing efforts to gain approval to begin commercial sales
of its coronary stent systems in the United States. Clinical studies under an
Investigational Device Exemption (an "IDE") are ongoing with other of the
Company's products. The Company does not expect FDA approval of its stent
systems for sale in the United States prior to 1998, and there can be no
assurance when or if such approval will be obtained. In addition to its United
States clinical program, the Company is sponsoring several ongoing clinical
studies in several countries outside the United States. The Company intends to
use data from these trials to obtain regulatory approvals in new markets, to
promote market acceptance of its products and to expand clinical applications of
the Company's products.
Developing and Maintaining Relationships with Leading Physicians. AVE
develops and maintains relationships with leading physicians worldwide. Through
these relationships, the Company seeks to work with opinion leaders who can
foster market awareness of the Company's products. The Company supports these
efforts through group training programs designed to increase physician
familiarity with the Company's products. The Company also has assembled a staff
of clinical specialists to expand its physician training, service and support
activities. These specialists help provide an increased presence at industry
trade shows and produce marketing material targeted toward physicians. In
addition, the Company maintains an active program of collaborating with key
physicians and medical centers to obtain feedback for new product development.
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<TABLE>
Products
The Company currently markets its stent systems in most countries in
Europe, including Germany, France and the United Kingdom, and in other countries
outside of the United States in both over-the-wire and rapid exchange catheter
delivery forms. In addition, the Company offers a line of PTCA balloon catheters
outside of the United States. The following table identifies the Company's
current products, their principal clinical application and their current
commercialization status:
CURRENT PRODUCTS
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CORONARY STENT SYSTEMS
Initial
Release
Product Description/Application Date Status
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<S> <C> <C> <C>
GFX Stent Systems
GFX Third-generation coronary stent system September 1996 Available for sale in over 40 countries.
designed to provide lower profile PMA submitted to the FDA in August 1997.
(most sizes capable of being used in 6
French guide catheters) and greater radial
strength and flexibility than Micro Stent
II.
GFX 2.5 Coronary stent designed for use in June 1997 Available for sale in over 40 countries
vessels as small as 2.5mm in diameter. outside the United States. Supplemental
IDE application was submitted in
September 1997.
GFX XL Coronary stent designed for use in the June 1997 Available for sale in over 40 countries
treatment of long and diffuse lesions. outside the United States. IDE
application was conditionally approved
by the FDA in July 1997.
Micro Stent II Systems
Micro Stent II Second-generation product, featuring October 1995 Available for sale in over 40 countries
helical connections and enhanced radial outside the United States. PMA submitted
strength. Designed for use in a variety to the FDA in August 1997.
of coronary applications.
Micro Stent 2.5 Coronary stent designed for use in December 1995 Available for sale in over 40 countries
vessels as small as 2.5mm in diameter. outside the United States. IDE received
in June 1996.
Micro Stent II XL Coronary stent designed for use in the December 1995 Available for sale in over 40 countries
treatment of long and diffuse lesions. outside the United States. PMA submitted
to the FDA in August 1997
Micro Stent II LP Similar configuration as the Micro Stent June 1996 Available in markets outside the United
II product with the added capability of States that prefer 6 French guide
being used in 6 Fr |
