First Long-Term Study of Photoselective Vaporization of the Prostate (PVP) Reinforces Procedure as an Effective, Long-Term Treat
September 26 2005 - 8:00AM
PR Newswire (US)
In Support of Milestone Study Published in the October Issue of the
Journal of Urology, Laserscope Launches National 'Heal BPH'
Initiative in Partnership With the Men's Health Network SAN JOSE,
Calif., Sept. 26 /PRNewswire-FirstCall/ -- Laserscope
(NASDAQ:LSCP), a pioneer in the development and commercialization
of minimally-invasive medical devices, including medical lasers and
advanced fiber-optic delivery devices, today announced the results
of a milestone study evaluating the long-term outcomes of men
treated with photoselective vaporization of the prostate (PVP) for
benign prostatic hyperplasia (BPH) using the GreenLight(TM) laser
system. The study, conducted at the Mayo Clinic by Dr. Reza Malek,
was published in the October 2005 issue of the Journal of Urology.
Laserscope also announced that in conjunction with the publication
of this landmark study, the Company has partnered with the Men's
Health Network to launch a national campaign designed to provide
men and other consumers with the resources they need to better
understand BPH, prostate health, sexual health and other related
men's health issues. Long-Term Study Methodology and Results The
Mayo Clinic study evaluated 94 patients suffering from obstructive
BPH who were treated with PVP using Laserscope's GreenLight(TM)
laser system and disposable fiber optic delivery devices. All of
the patients studied were candidates for standard transurethral
resection of the prostate (TURP) and exhibited significant
obstructive urinary tract symptoms. "The results of our study
demonstrate significant and sustainable improvements in the
outcomes of patients suffering from obstructive BPH," said Dr. Reza
S. Malek, lead author of the study and Professor Emeritus of
Urology who pioneered and performed PVP in this cohort of patients
at the Mayo Clinic. "Given that PVP has a well established record
for safety, low morbidity and rapid recovery, we are very pleased
to reinforce its contribution as an effective, long-term treatment
solution for many men suffering from obstructive BPH." "Until now,
the medical community did not have peer-reviewed follow-up data at
these time frames for patients who had been treated with PVP. This
study validates our strong belief that the procedure is a viable
treatment option for sufferers of BPH that provides long-lasting,
positive results," said Eric Reuter, President and Chief Executive
Officer of Laserscope. "There is no other technology that we are
aware of for treating BPH that can demonstrate these kinds of
clinical outcomes, speed, and safety profile with this kind of
durability. PVP is quickly becoming the treatment of choice because
it is safe and effective, and we now have additional evidence that
PVP provides lasting relief from the symptoms related to BPH."
National Heal BPH Initiative Launched In conjunction with the
publication of this important study, Laserscope and the Men's
Health Network today announced the "Heal BPH" initiative to provide
men with in-depth information about BPH including symptoms, causes
and diagnosis, treatment options, frequently asked questions,
physician locator and other informative resources. Additional
information and timely topics will be explored, including the
relationship between erectile dysfunction (ED) and other medical
conditions such as cardiovascular disease, metabolic syndrome
(pre-diabetes), and lower urinary tract symptoms, which are often
caused by BPH. The initiative will also include seminars held in
major cities throughout the country. "We're pleased that Laserscope
has chosen to partner with the Men's Health Network to help
increase the understanding and awareness of BPH among men and their
partners," said Cece Dorough, MSW and Marketing Manager of the
Men's Health Network. "The 'Heal BPH' campaign is in alignment with
our mission to improve the health and wellness of men by linking
them to the best health care resources available." The initiative
was developed in consultation with Dr. Kevin Billups, MD, an
internationally recognized expert in the fields of Urology and
Sexual Health, and author of a soon-to-be published book on
Erectile Dysfunction as an early indicator of cardiovascular
disease and other medical problems related to men's health. "The
'Heal BPH' initiative presented an excellent opportunity to expand
the dialogue surrounding the role that conditions such as BPH and
ED play in our evolving understanding of cardiovascular disease,"
said Dr. Billups. "This campaign is meant to empower men with the
information needed to better understand and deal with the long-term
implications of BPH and erectile difficulty for their overall
cardiovascular health." "Heal BPH" campaign materials and resources
are available online at http://www.healbph.com/, or patients can
speak directly to a "Heal BPH" representative at 1-866-HEAL BPH.
About BPH and the GreenLight Laser System Benign Prostatic
Hyperplasia or BPH is a non-cancerous enlargement of the prostate
that restricts urine flow. With age and time, this enlargement
places pressure on the urethra, causing problems with urination and
in some cases, complete urinary pathway obstruction. It is
estimated that half of all men over the age of 50 will develop this
condition and by the age of 70, 80% will experience some form of
urinary symptoms. Laserscope's GreenLight(TM) laser system is a
minimally invasive surgical procedure that uses a high-powered
laser to vaporize and remove enlarged prostate tissue. To date,
more than 90,000 PVP procedures have been successfully performed
worldwide. About The Men's Health Network Men's Health Network
(MHN) is a non-profit educational organization comprised of
physicians, researchers, public health workers, individuals and
other health professionals. MHN is committed to improving the
health and wellness of men through education campaigns,
partnerships with retailers and other private entities, workplace
health programs, data collection, and work with health care
providers to provide better programs and funding for men's health
needs. More information about the Men's Health Network can be found
at http://www.menshealthnetwork.org/. 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/. Safe Harbor
Statement This press release contains forward-looking information
within the meaning of Section 21E of the Securities Exchange Act of
1934 and is subject to the safe harbor created by this section.
These forward-looking statements include statements about
Laserscope's future business, competition, expected continued
momentum of Laserscope's business and growth and market
penetration. These statements are subject to a number of risks and
uncertainties, including among other risks: uncertainties regarding
the introduction of new technologies competitive to Laserscope's
products and the degree to which the Company's current and new
products are accepted by customers, which could affect the level of
demand for our products; our dependence on sole source providers
for key components and products; risk of reductions in government
and private insurance reimbursement of hospitals and physicians for
health care costs, which may negatively impact hospitals and
physicians decisions to purchase our products reducing adoption
rates and sales growth; risks that we may be unable to protect
adequately the integrity, safety and proper use of our disposable
fiber optic delivery device with the GreenLight PV(R) laser system,
which could result in negative patient outcomes and reduce our
disposable fiber recurring revenue stream; risks that patents and
licenses that we hold may be challenged, invalidated or
circumvented or that we may become the subject of intellectual
property litigation; and uncertainties that new products will
receive regulatory approval in applicable jurisdictions. Actual
results may differ materially due to these and other factors. The
matters discussed in this press release also involve risks and
uncertainties described from time to time in Laserscope's filings
with the Securities and Exchange Commission. In particular, see the
Risk Factors described in Laserscope's most recent Quarterly Report
on Form 10-Q and Annual Report on Form 10-K. 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 are
available upon request from its Investor Relations Department at
its website at http://www.laserscope.com/ or at the SEC's website
at http://www.sec.gov/. Laserscope assumes no obligation to update
the forward-looking information contained in this press release.
CONTACT Laserscope: Dorland Global Public Relations: Derek
Bertocci, CFO Jamie Dippman (408) 943-0636 (415) 262-5205 The Men's
Health Network: Steve Cragle Cece Dorough (415) 262-5206 (202)
543-6461 Ext. 111 DATASOURCE: Laserscope CONTACT: Derek Bertocci,
CFO of Laserscope, +1-408-943-0636, ; or Cece Dorough of The Men's
Health Network, +1-202-543-6461, ext. 111, ; or Jamie Dippman of
Dorland Global Public Relations, +1-415-262-5205, , or Steve
Cragle, +1-415-262-5206, Web site: http://www.healbph.com/ Web
site: http://www.menshealthnetwork.org/ Web site:
http://www.laserscope.com/
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