PDT Treatment of Head and Neck Cancer to be filed with the FDA for Pre-Market Approval. Looks like the business plan is evolving; I think the second half of the year should be stronger as well, at these prices we are probably looking at a good opportunity here.
Cheers -=- Dick Martin
BusinessWire, Wednesday, May 12, 1999 at 08:10
SAN JOSE, Calif.--(BW HealthWire)--May 12, 1999--Laserscope
(NASDAQ:LSCP) today announced it will be co-submitting a Pre-Market
Approval (PMA) application for its Photodynamic Therapy (PDT) Laser
Systems with a New Drug Application (NDA) for Foscan(R) being
submitted by Scotia Pharmaceuticals Ltd, UK.
The submissions, expected to occur in September 1999, will be for
the PDT treatment of head and neck cancer. Foscan(R) has been assigned
"fast-track" status by the FDA for the palliation of head and neck
cancer. Approval, if granted, could come as early as six months
following submission.
PDT is an innovative, outpatient, non-surgical treatment that
uses lasers, disposable fiber-optic devices, and light-sensitive
pharmaceuticals to selectively destroy cancerous cells with little
damage to healthy tissue and which allows normal healing of tissue.
According to the American Cancer Society, more than 60,000 people
are diagnosed with head and neck cancer each year in the U.S., with
another 480,000 diagnosed annually outside the U.S. The incidence of
head and neck cancer is much greater outside the U.S., particularly in
Asian countries.
Robert V. McCormick, Laserscope President and CEO, said, "The
potential of being able to treat neck and neck cancer with our
portfolio of products should further strengthen the Company's position
in PDT systems and devices. Currently, Laserscope lasers are being
used to treat lung and esophageal cancers at more than 100 cancer
treatment centers around the world. In the United States, our share of
the PDT laser device market is more than 75 percent."
In a PDT procedure, patients are injected with a photosensitizer
drug such as Foscan which accumulates in malignant tissue. The tissue
is then exposed directly to light energy from a PDT laser system such
as Laserscope's 800/600 Series Systems. When activated by the laser's
light energy, the drug creates a toxic form of oxygen that destroys
the cancerous cells with minimal damage to surrounding healthy tissue.
Both the drug injection and the laser activation can be performed on
an outpatient basis.
More information on PDT can be found on the Internet at
www.photodynamictherapy.com.
Laserscope is a pioneer in the development and commercialization
of lasers and disposable fiber-optic devices for use in photodynamic
therapy. The Company developed its PDT capabilities by capitalizing on
its own position as a leading manufacturer of fiber optics and
solid-state medical laser systems, and by working for more than eight
years with leading-edge pharmaceutical firms.
Statements in this announcement about future results are
preliminary and based on partial information and assumptions, and
actual results may differ. Except for historical information
presented, the matters discussed in this announcement contain
forward-looking statements that involve risks and uncertainties,
including the continued development and growth of new markets and
treatments such as PDT, the timing of the above referenced and future
FDA approvals relating to PDT, the impact of competitive products and
technologies, physician and consumer acceptance and demand for the
medical procedures targeted by the company, general economic
conditions in the U.S. and abroad, and other risks detailed from time
to time in the company's public disclosure filings with the U.S.
Securities and Exchange Commission (SEC). Copies of Laserscope's most
recent forms 10K and 10Q are available upon request from its Investor
Relations Department.
More information about Laserscope can be found on the Company's
web site at www.laserscope.com.
CONTACT: Laserscope
Richard Wood, 408/943-0636 (IR/Media)
Dennis LaLumandiere, 408/943-0636 (Financial)
or
PR Agency Contacts:
Hilary Kaye Associates
Joan Murray or Hilary Kaye, 714/426-0444
or
IR Agency Contacts:
FIN-COM
Larry Selwitz, 562/493-2770
Eugene Anton, 714/426-0228
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