|
Forward looking statements in
this web site are subject to certain risks and uncertainties that
could cause the actual outcomes of future events to differ materially
from expectations and projections stated herein. Factors that
could cause actual results to differ materially include, but are
not limited to, market demand for the Company's products, the
Company's ability to shift market focus successfully, distribution
efforts by the Company's distributors, the timing of orders and
shipments, the impact of competitive products and pricing, results
of ongoing litigation and other risks detailed in the Company's
reports filed with the Securities and Exchange Commission and
press releases, copies of which are available. The Company assumes
no obligation to update any forward-looking statements contained
herein.
The
Company 
General
Surgical Innovations, Inc. (GSI) is a leading developer and marketer
of tissue dissection systems, based on the Company's patented
SPACEMAKER® balloon technology, which are used
to provide access for minimally invasive surgery (MIS). Using
GSI's balloon technology, surgeons are able to create a predictable
space between naturally occurring tissue layers, such as skin,
muscle and fat, allowing greater access to the surgical site in
MIS procedures. The Company believes this increased access may
facilitate potentially safer, relatively atraumatic procedures,
resulting in clinical and cost benefits for the patient, surgeon,
hospital and healthcare provider.
To accelerate the conversion to minimally invasive surgery, GSI's
development teams are working with surgeons to define, develop
and deliver innovative products utilizing GSI's patented technology.
Approximately fifteen percent of surgeries performed each year
in the United States use minimally invasive techniques. GSI is
committed to expanding the use of MIS with innovative new products
as well as a comprehensive education and training program for
surgeons, physician assistants and patients.
In response to market demand, GSI continues to develop new products.
GSI believes that the cardiovascular market is very responsive
to new surgical systems and techniques that may reduce patient
trauma and decrease procedure costs. GSI also believes that the
numerous patient benefits associated with cardiovascular MIS potentially
make this a highly patient-driven market. As a result, GSI is
focusing significant resources on establishing and building a
measurable presence in the cardiovascular field.
A network of distribution partners is being established to address
the hernia, general surgery, plastic (aesthetic and re-constructive),
tissue expansion, and stress urinary incontinence markets. GSI
believes its SPACEMAKER® products designed for
these uses offer valuable and innovative alternatives to surgeons,
patients and healthcare providers. Many of GSI's products are
now distributed worldwide.
Patented
Technology
GSI
believes that its current patent and regulatory approval status
provides it with a competitive advantage in the balloon dissection
market, and the Company plans to capitalize on its proprietary
position in establishing and maintaining market leadership. To
date, the Company has received 510(k) clearances from the FDA
for the use of its SPACEMAKER® balloon dissection
technology to perform dissection of tissue planes during general,
vascular and cosmetic and reconstructive surgery using a broad
range of balloon sizes and shapes. The Company believes that these
FDA clearances allow the use of the Company's balloon dissection
technology for many surgical applications that the Company may
pursue, including applications involving other balloon sizes and
shapes. GSI currently has 37 issued United States patents and
two issued foreign patents, and numerous additional United States
and foreign patent applications covering the Company's SPACEMAKER®
technology. In May 1996, the Company was issued a United States
patent that contains claims regarding the use of balloons to dissect
tissue planes anywhere in the body. The Company believes that
the scope of these claims could provide a long-term competitive
advantage for many of its balloon dissection products. The Company
is currently in patent litigation with the Guidant Corporation
unit of Origin MedSystems, Inc., pursuant to which each party
has alleged patent infringement by the other party. A decision
against the Company in this litigation could have a material adverse
effect on the Company's business.
Corporate
Information
Headquarters: Cupertino, California
Employee Total: 90
Company
Management
Gregory D. Casciaro, President,
Chief Executive Officer
James Jervis, Vice President of Research and Development
Stephen J. Bonelli, Vice President of Finance and Administration,
Chief Financial Officer and Treasurer
Ferolyn T. Powell, Vice President of Operations
Stock
Listing
Exchange: NASDAQ
Symbol: GSII
Stock
Data (9/30/98)
Shares Outstanding: 13.4
million
Fiscal Year Ends: June 30
Transfer
Data
U.S. Stock Transfer Corp.
Glendale, CA
(800) 835-8778
Investor
Relations
Stephen J. Bonelli
V.P. of Finance & Admin., Chief Financial Officer
(408) 863-2500
invrel@gsii.com
World
Wide Web Site
http://www.gsii.com
webmaster@gsii.com
Product
Development
General Surgical Innovations'
product development is currently focused on the creation of product
kits designed around its balloon dissector technology, to allow
greater ease of use for physicians and physician assistants.
Cardiovascular Devices
Cardiovascular sales were kicked off with the February 1997 FDA
clearance of the Company's SAPHtrak™ balloon dissection system,
which facilitates the harvesting of the saphenous vein in a minimally
invasive manner for use in coronary bypass procedures. Components
using the same technology are incorporated into an ENDOSAPH™
kit which includes two disposable products: the SAPHfinder™
surgical balloon dissector and the SPACEKEEPER™ retractor.
The GSI Hook dissectors and Fork dissectors are complementary
reusable products. The SPACEMAKER® balloon dissector
for subfascial endoscopic perforator surgery (SEPS) is available
for the correction of incompetent perforating veins of the lower
leg, a condition which is commonly manifested in chronic skin
ulcers. For convenience, GSI's SEPS procedural kit provides the
SPACEMAKER® SEPS balloon dissector, a 5mm. trocar
with a short cannula, and two 60 cc. syringes.
Hernia Repair / Stress Urinary Incontinence Devices
GSI's SPACEMAKER® and SPACEMAKER®
II surgical balloon dissectors are available to enable the surgeon
to create a working space outside the peritoneum in extraperitoneal
laparoscopic hernia repair and treatment of stress urinary incontinence.
An abstract published in the The New England Journal of Medicine,
May 29, 1997, concluded that "Patients with inguinal hernias
who undergo laparoscopic repair recover more rapidly and have
fewer recurrences than those who undergo open surgical repair".
Products designed for these uses are currently distributed through
a non-exclusive agreement with Ethicon Endo-Surgery, a division
of Johnson and Johnson, and others.
Plastic Surgery (Aesthetic and Reconstructive)
GSI recently received 510(k) marketing clearance from the FDA
for its combination Dissector/Expander. This innovative device
integrates GSI's proprietary balloon dissector with a traditional
tissue expander into one device, which the Company believes will
enable surgeons to perform faster and easier tissue expansion
procedures. Genzyme Surgical Products has exclusive rights to
market and distribute GSI's surgical balloon dissectors worldwide
for use in plastic surgery procedures. The first product currently
being distributed is GSI's SPACEMAKER® Breast Balloon
Dissector for use in breast reconstruction and augmentation surgeries.
Marketing
and Commercialization
GSI's objective is to become the leading provider of balloon dissection
systems and specialty surgical instruments for MIS procedures.
Our mission is to "significantly improve patients' lives
with our value-added surgical solutions, by focusing on the treatment
of cardiovascular diseases and through technology alliances".
In the U.S., within the Cardiovascular Group, GSI is utilizing
a combination of a direct sales force to sell saphenous vein harvest
products and regional distributors to sell all other cardiovascular
products. This allows GSI the opportunity to call on customers
directly and provide technical support in all cardiovascular areas.
In the international marketplace, we currently have an exclusive
agreement with Japan Lifeline to sell GSI's balloon dissection
systems in Japan for use in vascular procedures. Japan Lifeline
is expected to begin distribution following receipt of the Japanese
Ministry of Health and Welfare approval, planned for mid 1998.
In addition, since receiving the Conformite Europeene (CE) Mark
approval for our SPACEMAKER® balloon dissection
systems and related products, regulatory approval necessary for
commercialization in European Union countries, we are actively
pursuing distribution alliances with European distributors.
GSI recently formed a Technology Alliance Group to form strategic
partnering opportunities for non-cardiovascular applications.
We are committed to continue establishing partnerships to distribute
our technology in the U.S. and abroad. These relationships with
leading medical device companies are expected to support technical
training in the use of GSI's products and to augment GSI's direct
sales and marketing capabilities.
Financial
Snapshot
(in thousands except per
share data)
|
Three Months Ending
(unaudited)
|
|
Sept.
30, 1998
|
Sept.
30, 1997
|
| Revenues |
$ 2,021
|
$ 2,342
|
| Operating expenses |
$4,013
|
$ 3,237
|
| Net loss per share |
$ (0.19)
|
$ (0.09)
|
|
|
|
| Weighted shares |
13,439
|
13,314
|
|
|
|
|
Sept.
30, 1998
|
June
30, 1998
|
Cash/equivalents,
and
available for sale securities |
$ 34,616
|
$ 37,469
|
|
|
| Total assets |
$ 41,292
|
$ 42,824
|
| Shareholders equity |
$ 37,771
|
$ 40,238
|
|
GSI
Wins Patent Litigation
Against Guidant Corporation; Awarded $12.9 Million in Damages 2/99