Laserscope Reports Additional FDA Clearances for Its New Gemini Product
April 06 2004 - 8:00AM
PR Newswire (US)
Laserscope Reports Additional FDA Clearances for Its New Gemini
Product FDA Clears Gemini Laser System for Acne Treatment,
Permanent Hair Reduction, and Wrinkle Reduction SAN JOSE, Calif.,
April 6 /PRNewswire-FirstCall/ -- Laserscope , a pioneer in the
development and commercialization of medical lasers and advanced
fiber-optic devices, today reported that the Food and Drug
Administration (FDA) has cleared Laserscope's Gemini(TM) laser
system for three major additional indications, including acne
treatment, permanent hair reduction, and wrinkle reduction.
Including these new clearances, Laserscope's Gemini laser system is
FDA-cleared to perform 21 total procedures. "We are very pleased
and excited with this news, and believe the three new FDA
clearances validate the tremendous versatility of the Gemini
product platform," said Eric Reuter, Laserscope's President and
Chief Executive Officer. "Using the Gemini, a physician can now
perform over 90% of all aesthetic laser procedures currently
available in the physician's office." "Because of its versatility,
we believe the Gemini will have significant appeal to those
physicians who prefer to use a single product platform rather than
several different and disparate laser systems," continued Reuter.
"This is especially important and appealing in the so-called
'non-traditional' aesthetic market segment which includes
physicians such as gynecologists, family practitioners, and other
physicians who are seeking additional fee-for-service revenue
streams such as those offered by cosmetic laser procedures. These
physicians typically do not have space or finances to purchase
several laser systems and would prefer to devote only a single
treatment room in which to perform cosmetic treatments." About the
Gemini The Gemini laser system combines, via an intuitive
touch-screen display, two of the most versatile and clinically
proven laser wavelengths, 532 nanometers and 1064 nanometers, in
one powerful system with two easily selectable, ergonomically
designed treatment handpieces. The innovative, continuously
adjustable Versastat handpiece allows for the physician to choose
up to 42 different spot sizes, enabling very precise treatment
control of isolated vascularities and/or pigmentation areas. Unlike
Intense Pulse Light (IPL) and some other laser sources which are
typically only available in a single spot or several discrete spot
sizes and are often heavy, bulky and difficult to use around
certain areas of the body, the Gemini's treatment flexibility
allows for precise treatment control around the face, nose, and
other contoured areas as well as large treatment areas. The Gemini
is additionally complemented by a large spot handpiece which allows
for fast laser coverage of large areas, making treatments for Acne,
Skin Rejuvenation and Hair Removal less tedious and more
cost-effective for the physician. Additionally, the Gemini
incorporates the same continuous contact cooling technology as the
Aura and Lyra lasers to aid in physician and patient safety and
comfort. The Gemini's technology platform is based in part on the
GreenLight PV(TM) surgical laser system which was released in early
2002 and is being used in many areas of the world for the
pioneering new treatment alternative for Benign Prostatic
Hyperplasia (BPH) called Photoselective Vaporization of the
Prostate (PVP(TM)). About Laserscope Laserscope designs,
manufactures, sells and services on a worldwide basis an advanced
line of medical laser systems and related energy delivery devices
for the office, outpatient surgical center, and hospital markets.
More information about Laserscope can be found on the Company's web
site at http://www.laserscope.com/. Except for historical
information presented, the matters discussed in this announcement
may contain forward-looking statements that are subject to certain
risks and uncertainties that could cause actual results to differ
materially from those projected. These risks are 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
public disclosure filings with the SEC, including the most recent
Annual Report on Form 10-K and the most recent forms 10-Q
areavailable upon request from its Investor Relations Department.
For further information please contact: Eric Reuter, President
& CEO, or Dennis LaLumandiere, CFO, both of Laserscope,
+1-408-943-0636; or Tricia Ross, Analysts, or Laurie Berman,
General Inquiries, both of Financial Relations Board,
+1-310-407-6555, for Laserscope DATASOURCE: Laserscope CONTACT:
Eric Reuter, President & CEO, or Dennis LaLumandiere, CFO, both
of Laserscope, +1-408-943-0636; or Tricia Ross, Analysts, or Laurie
Berman, General Inquiries, both of Financial Relations Board,
+1-310-407-6555, for Laserscope Web site:
http://www.laserscope.com/
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